List of ARV Pharmaceutical Products

classified according to the Global Fund Quality Assurance Policy

Edition: Version 175 - 22-Mar-2024

The list is an overview of pharmaceutical products subject to the Global Fund Quality Assurance Policy that are listed in National and/or WHO standard treatment guidelines and classified
according to the various options (A, B, and ERP reviewed) defined in the Global Fund Quality Assurance Policy (November 2023). The list is developed as a tool to assist Principal Recipients
(PR) of Global Fund grants to identify the status of finished pharmaceutical products according to the Global Fund Quality Assurance Policy.

The pharmaceutical products are classified based on the following information

A classified product - Listed on WHO prequalification list;

B classified product - Stringent NDRA Registration letter/Marketing Authorization;
C classified product - Authorised for use by WLA if the scope of listing includes the marketing authorisation function as published and regularly updated in the WHO website
ERP reviewed product- Permitted for time-limited procurement based on advice by the Expert Review Panel (ERP);

Please note that the list is not an exhaustive list. A PR can procure product(s) not listed in the current list as long as PR demonstrates that the product is compliant with the Global Fund Quality
Assurance Policy.

The Global Fund list includes the following information:

- "Important Notes" for helpful information;

- A, B, C and ERP reviewed products;
- Period validity of the ERP reviewed products;
- "+" means combination product, both fixed-dose combination (co-formulated) and co-packaged product ( i.e. co-blister)
- [A+B]+C means A and B are in fixed-dose formulation and C is co-packaged
YELLOW signifies a new entry; PINK signifies modification of an existing entry.

For more information, please look at:

https://www.theglobalfund.org/en/sourcing-management/quality-assurance/.

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 Expert Review Panel (ERP): Expert Review Panel is an independent technical body composed of external technical experts, hosted by WHO Department of Essential
Medicines and Pharmaceutical Policies, to review the potential risks/benefits associated with the use of FPPs that are not yet WHO-prequalified or SRA/WLA -
authorized and to advise the Global Fund in its decision on whether to allow grant funds to be used to procure FPP. ERP reviewed products can be procured for a
limited time (maximum 12 months). However, under certain circumstances, it is possible to extend the recommendation period. Contracts to supplier/manufacturer
for an ERP reviewed products should not be longer than the validity period of the recommendation of that product. For detail information on ERP process and Quality
Assurance information, please look at https://www.theglobalfund.org/en/sourcing-management/quality-assurance/.

Procurement of ERP Reviewed Products: Principal Recipients (PRs) must inform the concerned Fund Portfolio Manager (FPM) at the Global Fund in writing by filling
the “Notification Form” ( available on website) if they intend to procure
ERP-reviewed product(s). The Global Fund Secretariat will review the notification request and upon issuing a “ no objection” letter to the PR for the requested
selection, procurement can only proceed.

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 Important Notes
This List may be used by Principal Recipients of Global Fund grants when considering options with respect to procurement of pharmaceutical products pharmaceutical products subject to the
Global Fund Quality Assurance Policy. The list aims at providing countries with information that will assist them in their procurement options. Please note that the list is not designed to be a
basis for countries to select medicines to be included in their National Treatment Guidelines or to replace any applicable and legally required procurement processes. The Global Fund requires
its grant recipients to comply with applicable procurement laws and provides the list only for the identification of products/manufacturers that comply with the Global Fund’s
quality assurance policy. It is important to note that there is no strict requirement to procure according to the list, as long as the Principal Recipients can ensure that the product selected is
compliant with the Quality Assurance policy criteria. Furthermore, the Principal Recipient should not rely solely on the information provided in the list but should obtain evidence of products
compliance with the Quality Assurance policy. For the above reasons, we strongly encourage users to ensure they are using the most recent version on our website when
conducting procurement.

The Lists will be updated regularly based on evidence received by the Global Fund. Interested parties are invited to supply information and evidence of products meeting
the policy criteria on an ongoing basis. For the above reasons, we strongly encourage users to ensure they are using the most recent version on our website when conducting
procurement.

According to the Global Fund QA policy, if there are two or more A or B classified manufacturers available for any given product AND the product is available from
these manufacturers (available-means that the manufacturer can supply the selected product within 90 days after receiving the Purchase Order), then such product
must be procured from A or B classified product manufacturers. The PR must notify by writing to the Global Fund Secretariat (Fund Portfolio Manager) and recieve
the "No Objection" letter from GF secretariat before procuring any products complying with option " ERP Reviewed".

For ease of reference, each "product" with similar formulation and dosage has been identified in this list with a unique "Product reference number" (Column A).
Please see examples below.

However, different dosage forms may be grouped under the same Product Reference Number and therefore will be considered the same type of products when identifying the number of
available manufacturers for the application of this policy. These products share the same dosing protocol, target the same population, and there are no significant differences among them
regarding interchangeability. For example, within solid forms, some capsules will have same reference number as tablets while within liquids, oral solution and suspension are grouped
together. Following the same principles, the entero coated tablet or dispersible tablet will not share the same reference number as a normal tablets.

WHO Pre-
Product International Global Fund
Strength Dosage form Supplier/Manufacturer* qualified/ Manufacturing site* Country Material Pack
Ref.No Non-proprietary name QA Standard
SRA/WLA

XYZ 50mg Tablet "Pharma Company A" A-B Yes "Pharmaville" Country A HDPE bottle 60
A16
100mg Tablet "Pharma Company B" A-B Yes "Pharmaville" Country B HDPE bottle 60
A17

The example above shows 2 different variants of the same medicine. Because the strength is different, it is considered 2 different products (there are two different reference numbers A16 and
A17). If the strength had been the same but the dosage form had been different (i.e. tablet and liquid) it would also have been considered two different "products".

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 WHO Pre-
Product International Global Fund
Strength Dosage form Supplier/Manufacturer* qualified/ Manufacturing site* Country Packaging
Ref.No Non-proprietary name QA Standard
SRA/WLA

ABC 150mg Tablet "Pharma Company A" A-B Yes "Pharmaville"

Blister, HDPE Country A
10, 60
A25
bottle
Capsules "Pharma Company B" A-B Yes "Pharmaville" Country B HDPE Bottle, 60, 10
Blister
In this second example both products have same reference number (A25) because both manufacturers are supplying the same strength and the dosage forms are considered similar as per
explanation above.
* See below

Disclaimer:

The Global Fund does not endorse or warrant the fitness of any product on the List for a particular purpose, including in regard of its safety and/or efficacy in the treatment of HIV/AIDS,
HCV,tuberculosis or malaria. In addition, the Global Fund assumes no responsibility for any misstatement or omission from the list and directs Principal Recipients of Global Fund grants to
conduct their own independent confirmation that the information on a given product on the list is accurate before relying on it to make a purchase order for that product, and to ensure that any
purchase is in compliance with all the requirements of the Global Fund’s quality assurance policy. The Global Fund does not warrant or represent that the products listed have obtained
regulatory approval for use of treatment of any disease in any particular country of the world, or that their use is otherwise in accordance with the national laws and regulations of any country,
including, but not limited to, intellectual property laws. The Global Fund disclaims any and all liability and responsibility for any injury, death, damage or loss of any kind whatsoever that may
arise as a result of, or in connection with the procurement, distribution and use of any product included in the list.

* As from version 137, please note that we consider under

Supplier / Manufacturer :
Marketing authorization/ product authorization or license holder

Manufacturing Site:
The Site responsible for the release of the FPP

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 List of A or B products:

If there are two or more ‘A’ or ‘ B” products available, then the product must be procured from one of the A or B or C products.
Note: if the product intended for selection is not listed in this list , please refer to the List of ERP ( Expert Review Panel) Reviewed Products which are permitted for
time limited procurement:

WHO
Global
International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

A1 Abacavir 20 mg / ml Oral solution ViiV HealthCare A Yes Mississauga, Ontario Canada HDPE bottle 240ml

Unit III, Survey No. 313

&314 Bachupally,
Oral Aurobindo Pharma
Abacavir 20 mg / ml B Yes Quthubullapur Mandal India HDPE Bottle 240ml
Solution Ltd Hyderabad, Andhra
Pradesh

Hetero Drugs Limited

Unit III Plot No. 22-110,
Oral
Abacavir 20 mg / ml Hetero Labs Limited B NDA201107 Part-II, IDA Jeedimetla, India HDPE Bottle 240ml
Solution Hyderabad, Telangana
India. -500 055

Dispersible A-33, MIDC

A2 Abacavir (as Sulfate) 60 mg Cipla Ltd. A -B Yes India HDPE Bottle 60
Tablet Patalganga
Mylan Laboratories Sinnar, Nashik,
Abacavir (as Sulfate) 60 mg Tablet A -B Yes India HDPE 60
Ltd Maharashtra

Micro Labs Ltd, Phase

III & Phase IV, Plot
Dispersible
Abacavir (as Sulfate) 60 mg Microlabs Ltd A HA674 No. S-155 to S-159 & India HDPE 60
Tablet
N1 Verna Industrial
Estate, Verna, Goa

A-23, MIDC
A3 Abacavir 300 mg Tablet Cipla Ltd. A-B Yes India HDPE Bottle, 60
Patalganga

Glaxo Operations UK,

Ltd, Ware,
Abacavir 300 mg Tablet ViiV HealthCare A-B Yes Herthfordshire, UK; UK Blister 60
GSK, Poznan (packaging
and release), Poland

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 WHO
Global
International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

Sinnar,Nashik,
Maharashtra / Mylan
Laboratories Limited,
Plot No.11, 12 & 13,
Mylan Laboratories ANDA Indore Special Economic HDPE Bottle; 60;
Abacavir 300 mg Tablet B India
Ltd 078742 Zone, Pharma Zone, Blister 6*10
Phase - II, Sector - III,
Pithampur – 454775
Dist. Dhar, Madhya
Pradesh.

36/7,
Film coated Strides Arcolab Suragajakkanahalli HDPE Bottle; 60;
Abacavir (as Sulfate) 300 mg A-B Yes India
Tablet Limited Indlavadi cross Anekal Blister 6*10
Taluk Bangalore

Unit III 22 - 110,

Industrial development HDPE Bottle;
60, 100, 500;
Abacavir 300 mg Tablet Hetero labs limited A-B Yes Area, Jeedimetla, India Blister Film
Hyderabad -500 055 10
Package
Andhra Pradesh,

Unit III, Survey No 313

Bachyupally,
Quthubullapur Mandal
Aurobindo Pharma Hyderabad, Andhra
Abacavir 300 mg Tablet B Yes Pradesh
India HDPE Bottle; 60
Ltd
Unit-VII (SEZ),
Mahaboob Nagar (DT),
Andhra Pradesh

Plot No. S-155 to S- 159

ANDA & N1, Phase III & IV ,
Blister, HDPE
Abacavir 300 mg Tablet Microlabs Ltd B 206725 Verna Industrial Estate, India 10, 60
Verna Salcette, Goa -403 Bottle
22/12/17
722

Laurus Labs Limited,

Plot No:19, 20 & 21,
Western Sector, APSEZ,
Abacavir + Dolutegravir Laurus Laboratories ANDA
A113 600+50+300 mg Tablet B Atchutapuram Mandal, India HDPE Bottle 30
Lamivudine Ltd 210899 Visakhapatnam-District-
531011,
Andhra Pradesh

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 WHO
Global
International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

APL Healthcare Limited

Unit-IV Plot No.16,
APIIC, M.P. SEZ,
Abacavir + Dolutegravir Aurobindo Pharma ANDA
600+50+300 mg Tablet B Menakuru Village, India HDPE Bottle 30
Lamivudine Limited 210642 Naidupeta Mandal,
Tirupati District Andhra
Pradesh, 524421 - India

APL Healthcare
Limited,Unit-IV,
Plot No.16, APIIC Multi
Abacavir + Dolutegravir 60 mg /5 mg / Dispersible Aurobindo Pharma ANDA Products SEZ,
A136 B India HDPE Bottle 90, 180
+ Lamivudine 30 mg tablet Limited 217070 Menakuru Village,
Naidupeta Mandal,
Tirupati District,
Andhra Pradesh, INDIA

Mylan Laboratories
Limited, Plot No.11, 12 &
13, Indore Special
Abacavir + Dolutegravir 60 mg /5 mg / Dispersible Mylan Laboratories ANDA Economic Zone, Pharma
B India HDPE Bottle 60, 90, 120, 180
+ Lamivudine 30 mg tablet Ltd 218193 Zone, Phase - II, Sector -
III, Pithampur – 454775
Dist. Dhar, Madhya
Pradesh.

Cipla Limited, Indore

Unit IV,
Plot No. 9 & 10,
Pharma Zone, Phase-
Abacavir + Dolutegravir 60 mg /5 mg / Dispersible II, Indore Special
Cipla Limited A HA779 India HDPE bottle 30; 90
+ Lamivudine 30 mg tablet Economic Zone,
Pithampur, District
Dhar,
Madya Pradesh, India.
Pin code- 454775.

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 WHO
Global
International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA
Mylan Laboratories Limited
(FDF-2) Plot No. H-12 & H-13,
MIDC Waluj, Aurangabad -
431136 Maharashtra, India;
Tablets for Mylan Laboratories Limited
Mylan Laboratories ANDA
A6 Abacavir + Lamivudine 120 mg / 60 mg Oral B (FDF-3) Plot No 11, 12 & 13, India HDPE bottle 30, 60
Ltd 204915 Indore Special Economic
Suspension
Zone, Pharma Zone, Phase II,
Sector III, Pithampur, District
Dhar, Madya Pradesh, 454
775, India

Plot No A – 33, A – 2
HA662 (Unit – I), MIDC,
Abacavir (as Sulfate) +
120 mg / 60 mg Disp. Tablet Cipla Ltd. A-B NDA Patalganga District India HDPE Bottle 30, 60
Lamivudine
208775 Raigad, Maharashtra,
410 220

Micro Labs Ltd, Plot

No. S-155 to S-159 &
Abacavir (as Sulfate) + N1, Phase III & Phase
120 mg / 60 mg Disp. Tablet Microlabs Ltd A HA763 India HDPE Bottle 30
Lamivudine IV, Verna Industrial
Estate, Verna, Goa,
403 722, India

Unit - III Survey No.

313 & 314, Bachupally,
600 mg + 300 Aurobindo Pharma HDPE Bottle; 30;
A7 Abacavir + Lamivudine Tablet B Yes Quthubullapur India
mg Ltd Blister 10
Mandal Hyderabad,
Andhra Pradesh
Ware,Hertfordshire; 30
HDPE Bottle
Aranda de Duero,
600 mg + 300 Tablet Film UK, Spain,
Abacavir + Lamivudine Glaxo SmithKline Ltd. B Yes Burgos;
mg coated Research Triangle Park,
USA
30
NC Blister

A-33, MIDC
Abacavir Sulfate+ 600 mg + 300 HDPE Bottle; 30;
Tablet Cipla Ltd. B Yes Patalganga India
Lamivudine mg Blister 3*10
Cipla Goa Unit 7

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 WHO
Global
International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA
Mylan Laboratories Ltd, F4 &
F12 Malegaon MIDC, Sinnar,
Nashik District, Maharashtra,
422 113, India
Mylan Laboratories Ltd, Plot
600 mg + 300 Mylan Laboratories ANDA0905
Abacavir + Lamivudine Tablet A-B No 11, 12 & 13, Indore Special India HDPE Bottle 28; 30
mg Ltd 19HA635 Economic Zone, Pharma Zone,
Phase II, Sector III,
Pithampur, District Dhar,
Madya Pradesh, 454 775,
India

Hetero Labs Limited,

Unit-V SEZ Unit I
600 mg + 300 HDPE Bottle 30
Abacavir + Lamivudine Tablet Hetero labs limited A-B HA657 Survey No. 439, 440, India
mg 441 & 458 Mahaboob Blister 10's x 10
Nagar.

Glaxo Operations UK Limited,

Priory Street, Ware, United
Hertfordshire, SG12 0DJ, Kingdom of Child resistant
United Kingdom of Great
600 mg + 300 Great Britain blister,
Abacavir + Lamivudine Tablet ViiV Healthcare UK A HA706 Britain and Northern Ireland 1x1;10x3
mg GlaxoSmithKline and PVC/PVdC-
Limited
Pharmaceuticals S. A. ul., Northern Alu/Paper
Grunwaldzka 189, 60-332 Ireland
Poznan, Poland

Village Ganguwala,
600 mg + 300 Tablet, Film- Sun Pharmaceutical Paonta Sahib, District
Abacavir + Lamivudine A HA698 India Bottle, HDPE 30x1, 90x1
mg coated Industries Ltd Sirmour, Himanchal
Pradesh, 173 025

Macleods Macleods
Pharmaceuticals Ltd, Pharmaceuticals Ltd,
304 Atlanta Arcade, Block No. N2, Village
Abacavir (as Sulfate) + 600 mg + 300 Tablet, Film- Bottle HDPE, 30x1, Blister of
Marol Church Road, A HA740 Theda, P.O. Lodhi India
Lamivudine mg coated Majra, Tehsil Baddi, Blister 6x10
Andheri (East),
Mumbai, 400 059, District Solan, Himachal
India Pradesh, 174 101, India

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 WHO
Global
International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

HDPE bottle 30, 3X30

Remedica Ltd,
Aharnon Street, PVC/PE/PVDC 3X10
600 mg + 300 Tablet, Film-
Abacavir + Lamivudine Remedica B 22346 Limassol Industrial Cyprus /Aluminium 3X3X10
mg coated
Estate, 3056 Limassol, blisters
Cyprus

Laurus Labs Limited,

(VSP-2) Plot No. 19, 20
600 mg + 300 Tablet, Film- Laurus Laboratories and 21, Western Sector,
Abacavir + Lamivudine B NDA216332
APSEZ, Atchutapuram
India HDPE Bottle 30, 90, 180
mg coated Ltd
Visakhapatnam, Andhra
Pradesh India 531011

Abacavir (as Sulfate)+

60 mg + 30 mg + Mylan Laboratories Sinnar,Nashik,
A8 Lamivudine + Tablet A Yes India HDPE 60
60 mg Ltd Maharashtra
Zidovudine

Glaxo Operations UK,

Ltd, Ware,
Abacavir + Lamivudine + 300 mg + 150 mg Hertfordshire, UK; HDPE Botte 60;
A9 Tablet ViiV HealthCare A-B Yes UK
Zidovudine + 300 mg GSK, Poznan Blister, 40; 60
(packaging and
release), Poland
Abacavir (as Sulfate)+
300 mg + 150 mg Mylan Laboratories Sinnar,Nashik,
Lamivudine + Tablet A-B Yes India HDPE Bottle 60
+ 300 mg Ltd Maharashtra
Zidovudine
A11 Atazanavir 50 mg / 1.5g Oral powder Bristol-Myers Squibb B Yes Hounslow UK Bottle (HDPE) 180g
Hard Bottle (HDPE) 60,
A12 Atazanavir 100 mg Bristol-Myers Squibb B Yes Hounslow UK
Capsule Blister (alu) 60

Emcure
Atazanavir 100 mg Capsule Pharmaceuticals B Yes Hinjwadi, Pune India HDPE bottle; 60;
Limited

Unit-VII (SEZ), 60,500

Aurobindo Pharma HDPE bottle
Atazanavir 100 mg Capsule B Yes Mahaboob Nagar India
Ltd Blister
(DT), Andhra Pradesh 10

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 WHO
Global
International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

Evansville, Indianna,
A13 Atazanavir 150 mg Capsule Bristol-Myers Squibb A Yes Mount Vernon, Indianna USA HDPE bottle 60
(primary packaging)

Capsule Bottle (HDPE) 60

Atazanavir 150 mg Bristol-Myers Squibb B Yes Hounslow UK
Hard Blister (alu) 60

Emcure
Atazanavir 150 mg Capsule Pharmaceuticals B Yes Hinjwadi, Pune India HDPE bottle 60
Limited

Elizabeth (Pty) Ltd,

Corner Fairclough and
Aspen Pharmacare ANDA
Atazanavir 150 mg Capsule B Gibaud Roads, South Africa HDPE bottle 60
Limited 091641
Korsten, Port
Elizabeth, 6020

Sinnar, Nashik
District, Maharashtra,
Mylan Laboratories India;
Atazanavir ( as Sulfate) 150 mg Capsule A -B Yes India HDPE Bottle 30, 100
Ltd Waluj, Aurangabad,
Maharashtra,
India

Unit-VII (SEZ),
Aurobindo Pharma HDPE bottle 60,180, 500
Atazanavir ( as Sulfate) 150 mg Capsule B Yes Mahaboob Nagar India
Ltd Blister 10
(DT), Andhra Pradesh
Capsule Bottle (HDPE) 60,
A14 Atazanavir 200 mg Bristol-Myers Squibb B Yes Hounslow UK
Hard Blister (alu) 60
Emcure
Atazanavir 200 mg Capsule Pharmaceuticals B Yes Hinjwadi, Pune India HDPE bottle; 60;
Limited

Unit-VII (SEZ),
Aurobindo Pharma HDPE bottle 60,180, 500
Atazanavir 200 mg Capsule B Yes Mahaboob Nagar India
Ltd Blister 10
(DT), Andhra Pradesh

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 WHO
Global
International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

Elizabeth (Pty) Ltd,

Corner Fairclough and
Aspen Pharmacare ANDA
Atazanavir 200 mg Capsule B Gibaud Roads, South Africa HDPE bottle 60
Limited 091641
Korsten, Port
Elizabeth, 6020
A15 Atazanavir ( as Sulfate) 300 mg Capsule Bristol-Myers Squibb B Yes Evansville, Indiana, USA HDPE Bottle 30
Emcure
Atazanavir ( as Sulfate) 300 mg Capsule Pharmaceuticals B Yes Hinjwadi, Pune India HDPE Bottle 30
Limited
Sinnar, Nashik District,
Maharashtra,
Mylan Laboratories India;
Atazanavir ( as Sulfate) 300 mg Capsule A- B Yes India HDPE Bottle 30, 100
Ltd Waluj, Aurangabad,
Maharashtra,
India

Unit-VII (SEZ), 30, 90,500

Aurobindo Pharma HDPE bottle
Atazanavir ( as Sulfate) 300 mg Capsule B Yes Mahaboob Nagar India
Ltd Blister
(DT), Andhra Pradesh 10

PLIVA Croatia Ltd., Prilaz baruna

Filipovica 25, 10000 Zagreb;
TEVA PHARMA S.L.U., C/C, n. 4, Poligono
Industrial Malpica, 50016 Zaragoza; Croatia, Spain,
Teva Operations Poland Sp. z.o.o, ul.
Mogilska 80. 31-546, Krakow;
Poland,
TEVA Pharmaceutical Works, Private Germany,
Limited Company, Pallagi út 13, 4042
Debrecen;
Hungary,
TEVA Pharmaceutical Merckle GmbH, Ludwig- Merckle-Straße United
Atazanavir ( as Sulfate) 300 mg Capsule A HA750 3, 89143 Blaubeuren; HDPE Bottle 30
Israel Ltd Merckle GmbH, Graf-Arco-Str. 3, 89079
Kingdom of
Ulm; Great Britain
TEVA UK Ltd, Brampton Road, Hampden
Park, Eastbourne, East Sussex, BN22 9AG;
and Northern
MPF B.V., 13 Appelhof, Oudehaske, 8465; Ireland,
MPF B.V., Neptunus 12, 8448 CN
HEERENVEEN
Netherlands
TjoaPack Netherlands B.V., Nieuwe Donk
9, 4879 A.C Etten-Leur

Atazanavir (sulfate)+ Mylan Laboratories NDA Sinnar,Nashik,

A16 300mg + 100mg Tablet B India HDPE Bottle 30, 90, 120
Ritonavir Ltd 022282 Maharashtra
Emcure
Atazanavir Tablet
300mg+100mg Pharmaceuticals B Yes Hinjwadi, Pune India HDPE Bottle 30
(sulfate)+Ritonavir (FDC)
Limited
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 WHO
Global
International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

Cipla, Unit 2, Plot A-

42 MIDC Industrial
Atazanavir Bottle HDPE 30x1;
300mg+100mg Tablet Cipla Ltd. A HA632 Area, Patalganga, India
(sulfate)/Ritonavir Alu/Alu Blister 10x3
Raigad District,
Maharashtra
Lupin Limited, Unit 1,
Plot No. 6A1, 6A2,
Film Coated Sector-17, Special
Atazanavir
300mg+100mg Tablet Lupin Limited A HA720 Economic Zone, India Bottle HDPE 30
(sulfate)/Ritonavir
MIHAN, Nagpur,
Maharashtra, 441 108,
India

Shanghai Desano Bio-

Pharmaceutical Co Ltd,
1479 Zhangheng Road,
Film Coated
Atazanavir Shanghai Desano Bio- China (Shanghai) Pilot
300mg+100mg Tablet A HA749 China Bottle HDPE 30
(sulfate)/Ritonavir Pharmaceutical Co Ltd Free Trade Zone,
Shanghai, 201203,
China (People's Republic
of)

Laurus Labs Limited

Unit-II, Plot No:19, 20 &
Film Coated 21, Western Sector,
Atazanavir
300mg+100mg Tablet Laurus Labs Limited A HA772 APSEZ, Gurajapalem India HDPE Bottle 30, 90
(sulfate)/Ritonavir Village, Rambilli Mandal
Anakapalli, Andhra
Pradesh 531011 India

Cartons containing 5 blister

packs (consisting of PVC/Aclar
[Atazanavir Sulfate+ [300 mg / 100
co-packaged Mylan Laboratories Sinnar, Nashik District film and coated aluminum foil),
A17 Ritonavir] +[Lamivudine mg] +[150 mg / B Yes India PVC blister each containing two 1-day
Tablets Ltd 422 113, Maharashtra cards, for a 10 day supply. Three
and Zidovudine] 300 mg] cartons are further packaged
together for a 30 day supply

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 WHO
Global
International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA
Glaxo Operations UK Type I glass
Limited (trading as vial, sealed
Prolonged- Glaxo Wellcome with rubber
Operations)
Cabotegravir (as 600 mg/3 mL release ViiV Healthcare Pty ARTG ID stopper and an single 3 mL vial or
A137 B Harmire Road UK
cabotegravir free acid) vial Suspension Ltd 377474 Barnard Castle
aluminum 25 x 3 mL vials
for Injection County Durham DL12 overseal with a
8DT removeable
UK plastic cap
Glaxo Wellcome, S.A.
Cabotegravir (as Film coated ViiV Healthcare Pty ARTG ID Avda. Extremadura, 3
A138 30mg B Spain HDPE bottle 30
cabotegravir sodium) tablets Ltd 377442 Aranda De Duero
Burgos 09400 Spain
EMEA
Art58
Sever Pharma
H/W/0021 Opaque, heat-
International Solutions (formerly
25 mg, vaginal Vaginal 68/001 sealed
A114 Dapivirine Partnership for B QPharma) P.O. Box Sweden 1/pk or 3/pk
delivery system Ring EMEA Art laminate
Microbicides 590, 201 25 Malmö,
58 pouch
Sweden
H/W/0021
68/002

Mylan Laboratories
Ltd
F-4, F-12, Malegaon
Mylan Laboratories M.I.D.C,
A20 Darunavir 75mg Tablets B Yes India HDPE Bottle 100; 500; 480
Ltd Sinnar, Nashik –
422113,
Maharashtra state,
India.

Janssen-Cilag HA529 (a) Janssen-Cilag SpA

Darunavir (as International NV, Via C. Janssen Borgo
75 mg Tablets A-B Italy HDPE Bottle 480
Ethanolate) Turnhoutseweg 30, B- EU/1/06/3 San Michele 04100
2340 Beerse, Belgium 80/005 Latina, Italy

Plot No. 15B, Phase 1

Darunavir (as A, Verna Industrial
75 mg Tablets Lupin Limited B Yes India HDPE Bottle 480
Ethanolate) Area, Verna, Salcette
Goa - 403722

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International Non- Supplier/ Prequalificati
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Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

Remedica Ltd, HDPE Bottle 480

Aharnon Street,
Film coated and Alu-
Darunavir 75 mg Remedica B 22546 Limassol Industrial Cyprus 30 (3x10)
Tablets Transparent-
Estate, 3056 Limassol, PVC/PE/PVDC 60 (6x10)
Cyprus blisters 90 (9x10)

Cipla Limited, Plot no

a-33, a-42, a-2,
Patalganga Industrial
Film coated ANDA
Darunavir 75 mg Cipla B Area, Patalganga India HDPE Bottle 480
Tablets 207189
District - Raigad,
Maharashtra IN
410220

Cipla Limited, Plot no

a-33, a-42, a-2,
Patalganga Industrial
Darunavir (as ANDA
A21 150 mg Tablets Cipla B Area, Patalganga India HDPE Bottle 240
Ethanolate) 207189
District - Raigad,
Maharashtra IN
410220
Mylan Laboratories
Ltd
F-4, F-12, Malegaon
Mylan Laboratories M.I.D.C,
Darunavir 150mg Tablets B Yes India HDPE Bottle 240; 300
Ltd Sinnar, Nashik –
422113,
Maharashtra state,
India.

Janssen-Cilag Janssen-Cilag SpA

HA530 (a)
Darunavir (as International NV, Via C. Janssen Borgo
150 mg Tablets A-B EU/1/06/3 Italy HDPE Bottle 240
Ethanolate) Turnhoutseweg 30, B- San Michele 04100
80/004
2340 Beerse, Belgium Latina, Italy

Plot No. 15B, Phase 1

Darunavir (as A, Verna Industrial
150 mg Tablets Lupin Limited B Yes India HDPE Bottle 240
Ethanolate) Area, Verna, Salcette
Goa - 403722

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Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

Plot No. S-155 to S- 159

ANDA & N1, Phase III & IV ,
Darunavir (as
150 mg Tablets Micro Labs Ltd, B 210187 Verna Industrial Estate, India HDPE Bottle 60 120 240
Ethanolate)
14/12/20 Verna Salcette, Goa -403
722

Remedica Ltd, HDPE Bottle 240

Aharnon Street,
Film coated and Alu-
Darunavir 150 mg Remedica B 22547 Limassol Industrial Cyprus 30 (3x10)
Tablets Transparent-
Estate, 3056 Limassol, PVC/PE/PVDC 60 (6x10)
Cyprus blisters 90 (9x10)
Mylan Laboratories
Ltd
F-4, F-12, Malegaon
Mylan Laboratories
A115 Darunavir 300mg Tablets B Yes M.I.D.C, India HDPE Bottle 120; 360
Ltd
Sinnar, Nashik –
422113,
Maharashtra state,

Plot No. 15B, Phase 1

Darunavir (as A, Verna Industrial
300 mg Tablets Lupin Limited B Yes India HDPE Bottle 120
Ethanolate) Area, Verna, Salcette
Goa - 403722

Mylan Laboratories Ltd

F-4, F-12, Malegaon
Mylan Laboratories M.I.D.C,
A22 Darunavir 400mg Tablets B Yes Sinnar, Nashik – 422113,
India HDPE Bottle 60; 180; 360
Ltd
Maharashtra state,
India.

(Unit-2), Plot No:19, 20

& 21, Western Sector,
Tablet, Film- APSEZ, Atchutapuram
Darunavir 400mg Laurus Labs Limited A HA709 Mandal,Visakhapatnam-
India HDPE Bottle 60
coated
District, Andhra
Pradesh, 531011

Janssen-Cilag Janssen-Cilag SpA

International NV, EU/1/06/3 Via C. Janssen Borgo
Darunavir 400 mg Tablets B Italy HDPE Bottle 60
Turnhoutseweg 30, B- 80/003 San Michele 04100
2340 Beerse, Belgium Latina, Italy
Darunavir 400mg Tablet Hetero Labs limited B Yes UNIT-III, Hyderabad India HDPE Bottle 60

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Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

HA627 (Unit II), MIDC,

Darunavir (as
400mg Tablet Cipla A-B ANDA Patalganga India HDPE Bottle 60
Ethanolate)
207189

Plot No. 15B, Phase 1

Darunavir (as A, Verna Industrial
400mg Tablet Lupin Limited B Yes India HDPE Bottle 60
Ethanolate) Area, Verna, Salcette
Goa - 403722
Plot No. S-155 to S- 159
ANDA & N1, Phase III & IV ,
Darunavir (as
400mg Tablet Micro Labs Ltd, B 210187 Verna Industrial Estate, India HDPE Bottle 60
Ethanolate)
14/12/20 Verna Salcette, Goa -403
722
Remedica Ltd, HDPE Bottle 60
Aharnon Street,
Film coated and Alu-
Darunavir 400 mg Remedica B 22549 Limassol Industrial Cyprus 30 (3x10)
Tablets Transparent-
Estate, 3056 Limassol, PVC/PE/PVDC 60 (6x10)
Cyprus blisters 90 (9x10)

Janssen Infectious
Diseases - Diagnostics
Jansen Ortho LLc,
A116 Darunavir 600 mg Tablets BVBA/ B Yes Puerto Rico HDPE Bottle 60
Gurabo
Pharmacare South
Africa

(Unit-2), Plot No:19, 20

& 21, Western Sector,
Tablet, Film-
Darunavir 600 mg Laurus Labs Limited A HA710 APSEZ, Atchutapuram India HDPE Bottle 60
coated Mandal,Visakhapatnam-
District, Andhra
Janssen-Cilag HA780 Janssen-Cilag SpA
Darunavir (as International NV, Via C. Janssen Borgo
600 mg Tablets A -B Italy HDPE Bottle 60
Ethanolate) Turnhoutseweg 30, B- EU/1/06/3 San Michele 04100
2340 Beerse, Belgium 80/002 Latina, Italy

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List of HIV/AIDS drugs classified according to the GF QA Policy 17/58
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International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

Darunavir 600mg Tablet Hetero Labs limited B Yes UNIT-III, Hyderabad India HDPE Bottle 60

Manufacturer
LEK farmacevtska družba d.d.
Verovškova 57, 1526 60x1 unit dose
Ljubljana, Slovenia
or
Aluminium- blister
Salutas Pharma GmbH, Otto- Slovenia PVC/PE/PVDC 10, 30, 60, 90,
Film coated
Darunavir 600 mg Sandoz Ltd, UK B Yes von-Guericke-Allee 1, Sachsen- Germany perforated 120
Tablet Anhalt, 39179 Barleben, Cyprus blisters 60, 120 (2x60),
Germany
or HDPE bottles 180 (3x60), 240
Remedica Ltd, Aharnon (4x60)
Street, Limassol Industrial
Estate, 3056 Limassol, Cyprus
a, d.d., Novo mesto, Šmarješka cesta 6,
8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann -
Straβe 5, 27472 Cuxhaven, Germany 30 (1x30); 60
Slovenia,
Film coated Prestige Promotion Verkaufsförderung (2x30), 90
Darunavir 600 mg Krka, d.d., Novo mesto A HA733 & Werbeservice GmbH, Lindigstraße 6, Germany, Bottle, HDPE
Tablet 63801 Kleinostheim, Germany (3x30), 180
(Additional secondary packaging) Greece
RAFARM S A, Thesi Pousi-Xatzi Agiou (6x30)
Louka, Paiania Attiki TK 19002, TΘ 37,
Greece

Remedica Ltd, HDPE Bottle

60
Aharnon Street, and Alu-
Film coated 30 (3x10)
Darunavir 600 mg Remedica B 22550 Limassol Industrial Cyprus Transparent-
Tablet 60 (6x10)
Estate, 3056 Limassol, PVC/PE/PVDC
90 (9x10)
Cyprus blisters

HA628 (Unit II), MIDC,

Darunavir (as
600mg Tablet Cipla A-B ANDA Patalganga India HDPE Bottle 60
Ethanolate)
207189

Plot No. 15B, Phase 1

Darunavir (as A, Verna Industrial
600mg Tablet Lupin Limited B Yes India HDPE Bottle 60
Ethanolate) Area, Verna, Salcette
Goa - 403722

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List of HIV/AIDS drugs classified according to the GF QA Policy 18/58
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International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA
FDF-Unit-2,
Aurangabad site,
(Plot No. H-12 and H-
Darunavir (as Mylan Laboratories HDPE
600mg Tablet A HA685 13), India 60
Ethanolate) Ltd MIDC, Waluj Industrial
Container
Area
Aurangabad-431136

Plot No. S-155 to S- 159

ANDA & N1, Phase III & IV ,
Darunavir (as
600mg Tablet Micro Labs Ltd, B 210187 Verna Industrial Estate, India HDPE Bottle 60
Ethanolate)
14/12/20 Verna Salcette, Goa -403
722

(Unit-2), Plot No:19, 20

& 21, Western Sector,
Tablet, Film- APSEZ, Atchutapuram
A117 Darunavir 800 mg Laurus Labs Limited A HA711 India HDPE Bottle 30
coated Mandal,Visakhapatnam-
District, Andhra
Pradesh, 531011

Plot No. 15B, Phase 1 A,

Darunavir (as Verna Industrial Area,
800mg Tablet Lupin Limited B Yes India HDPE Bottle 30 & 90
Ethanolate) Verna, Salcette Goa -
403722

FDF-Unit-2,
Aurangabad site,
(Plot No. H-12 and H-
Darunavir (as Mylan Laboratories HDPE
800mg Tablet A HA683 13), India 30
Ethanolate) Ltd MIDC, Waluj Industrial
Container
Area
Aurangabad-431136
Remedica Ltd, HDPE Bottle
30
Aharnon Street, and Alu-
Film coated 30 (3x10)
Darunavir 800 mg Remedica B 22551 Limassol Industrial Cyprus Transparent-
Tablet 60 (6x10)
Estate, 3056 Limassol, PVC/PE/PVDC
90 (9x10)
Cyprus blisters

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List of HIV/AIDS drugs classified according to the GF QA Policy 19/58
 WHO
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International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

Hetero Labs Ltd,

Hetero Corporate, 7-2- Hetero Labs Ltd, Unit
A2, Industrial Estates, III, Plot No 22-110
Darunavir (as Sanath Nagar, IDA, Jeedimetla,
A118 400mg/50mg Tablet A HA719 India HDPE Bottle 30x1, 60x1,120x1
Ethanolate) / Ritonavir Hyderabad, Ranga Hyderabad,
Reddy District, Telangana, 500 055,
Telangana, 500 018, India
India

Glaxo Operations UK
Limited, Priory Street,
Ware, Hertfordshire,
ViiV Healthcare BV, SG12 0DJ, United
Van Asch van Kingdom of Great
Dolutegravir (as sodium
A119 5mg Disp. Tablet Wijckstraat 55H, A HA768 Britain and Northern India HDPE Bottle 60x1
salt) Ireland;
Amersfoort, 3811 LP,
Netherlands Glaxo Wellcome SA,
Avenue de Extremadura
3, Aranda de Duero,
Burgos, Spain

Plot No.11, 12 & 13,

Indore Special
Economic Zone,
Tablet for
Dolutegravir (as sodium Mylan Laboratories NDA Pharma Zone, Phase -
A120 10mg Oral B India HDPE Bottle 30,60,90
salt) Ltd 214521 II, Sector - III,
Suspension
Pithampur – 454775
Dist. Dhar, Madhya
Pradesh.

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List of HIV/AIDS drugs classified according to the GF QA Policy 20/58
 WHO
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International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

1. Macleods Pharmaceuticals
limited Plot No. 25-27, Survey No.
366, Premier Industrial Estate,
Kachigam Daman, PIN-396210
ANDA India
90, 180
Dispersible 214566 2. Macleods Pharmaceuticals
Macleods Limited Plot No. M-50 to M-54-A,
Dolutegravir (as sodium Tablets for
10mg Pharmaceuticals A-B SEZ Phase - II Pithampur, Tehsil- India HDPE bottle
salt) oral Patera Dhar Indore, Madhya
Limited
suspension Pradesh - 454774 India 90
3. Macleods Pharmaceuticals Ltd
HA765 Unit 1, Survey No 10 IDA,
Gaddapothoram Village,
Jinnaram (M), Sangareddy
District Telangana 502319 India

Macleods
Pharmaceuticals
limited Plot No. 25-27,
Macleods
Dolutegravir (as sodium ANDA Survey No. 366, 30's, 90's and
ARV121 10mg Tablets Pharmaceuticals B India HDPE bottle
salt) 214397 Premier Industrial 180's
Limited
Estate, Kachigam
Daman, PIN-396210
India

Macleods
Pharmaceuticals
limited Plot No. 25-27,
Macleods
Dolutegravir (as sodium ANDA Survey No. 366, 30's, 90's and
A122 25mg Tablets Pharmaceuticals B India HDPE bottle
salt) 214397 Premier Industrial 180's
Limited
Estate, Kachigam
Daman, PIN-396210
India

Glaxo Operations UK
Ltd, Hertfordshire
(manufacturing and
Dolutegravir (as sodium Tablets, Film- quality control), UK;
A34 50mg ViiV Healthcare A Yes UK Bottle 30
salt) coated Glaxo Wellcome S.A.,
Burgos (primary and
secondary packaging,
batch release), Spain

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List of HIV/AIDS drugs classified according to the GF QA Policy 21/58
 WHO
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Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

Unit III, Plot No 22-110

IDA, Jeedimetla,
Hyderabad, Telangana,
500 055; Unit V,
Dolutegravir (as sodium Tablets, Film- Sy.No.439, 440, 441 & Blister,Alu/Alu;
50mg Hetero Labs Ltd A HA682 India 10x8; 30x1; 90x1
salt) coated 458 Bottle,HDPE
TSIIC Formulation SEZ
Polepally Village,
Jadcherla Mandai
Mahaboobnagar District

Plot No 11, 12 & 13,

Indore Special Economic
Zone, Pharma Zone,
Dolutegravir (as sodium Tablets, Film- Mylan Laboratories Blister,PVC/ACLAR; 10x1;
50mg A HA678 Phase II, Sector III, India Bottle,HDPE
salt) coated Ltd Pithampur, District 30x1,90x1,180x1
Dhar, Madya Pradesh,
454 775

Cipla Ltd, Unit IV, Plot

No 9, 10 & 15 Indore
Dolutegravir (as sodium Tablets, Film- Special Economic Zone,
50mg Cipla Ltd A HA680 India Bottle, HDPE 30x1;90x1
salt) coated Phase II, Pithampur,
Dhar District, Madhya
Pradesh, 454 775, India

Aurobindo Pharma Ltd,

Unit –VII, SEZ, TSIIC,
Plot No. S1, Survey No.’s
411, 425, 434, 435 &
Dolutegravir (as sodium Aurobindo Pharma ANDA
50mg Tablets B 458, Green Industrial India HDPE bottle 30, 90
salt) Ltd 208355 Park, Polepally village,
Jedcherla Mandal,
Mahaboob Nagar
District, Telangana State
(Unit-2), Plot No:19, 20
& 21, Western Sector,
HA718-
Dolutegravir (as sodium Tablets, Film- APSEZ, Atchutapuram
50mg Laurus Lab Ltd A-B ANDA India HDPE bottle 30, 90
salt) coated Mandal,Visakhapatnam-
210963 District, Andhra
Pradesh, 531011

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List of HIV/AIDS drugs classified according to the GF QA Policy 22/58
 WHO
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Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

Plot No P-2, ITBT Park,

Dolutegravir (as sodium Tablets, Film- Emcure Phase II MIDC, 30x1, 90x1,
50mg A HA701 India Bottle, HDPE
salt) coated Pharmaceuticals Ltd Hinjwadi, Pune, 180x1
Maharashtra, 411057

Village Ganguwala,
Dolutegravir (as sodium Tablets, Film- Sun Pharmaceutical Paonta Sahib, District
50mg A HA708 India Bottle, HDPE 30x1, 90x1
salt) coated Industries Limited Sirmour, Himachal
Pradesh, 173 025

479 Zhangheng Road,

Dolutegravir (as sodium Tablets, Film- Shanghai Desano Bio- China (Shanghai) Pilot
50mg A HA694 China Bottle, HDPE 30x1
salt) coated Pharmaceutical Co Ltd Free Trade Zone,
Shanghai, 201203

Plot No. S-155 to S-159

& N1, Phase III &
Dolutegravir (as sodium Tablets, Film-
50mg Micro Labs Ltd, A HA751 Phase IV, Verna India Bottle, HDPE 30x1, 60x1, 90x1
salt) coated
Industrial Estate,
Verna, Goa, 403 722

Macleods
Pharmaceuticals
limited Plot No. 25-27,
Macleods
Dolutegravir (as sodium ANDA Survey No. 366, 30's, 90's and
50mg Tablets Pharmaceuticals B India HDPE bottle
salt) 214397 Premier Industrial 180's
Limited
Estate, Kachigam
Daman, PIN-396210
India

Edition: Version 175 - 22-Mar-2024

List of HIV/AIDS drugs classified according to the GF QA Policy 23/58
 WHO
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International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

Strides Pharma Science

Limited, Oral Solid
Dosage Forms Division,
KRS Gardens, 36/7,
Dolutegravir (as sodium Strides Pharma 28x1, 30x1, 56x1,
50mg Tablets A HA731 Suragajakkanahalli, India HDPE bottle
salt) Science Limited Indlawadi Cross, Anekal 60x1, 84x1, 90x1
Taluk, Bangalore,
Karnataka, 562 106,
India

(Unit-2), Plot No:19,

20 & 21, Western
Dolutegravir + NDA Sector, APSEZ,
50 mg+200 Tablets, Film-
A123 Emtricitabine+ Tenofovir Laurus Labs Limited B 213681 Atchutapuram India Bottle, HDPE 30, 90,180
mg+25 mg coated
Alafenamide* Mandal,Visakhapatna
m-District, Andhra
Pradesh, 531011

Plot No. 11, 12 & 13

Indore Special Economic
Dolutegravir + NDA Zone
50 mg+200 Tablets, Film- Mylan Laboratories
Emtricitabine+ Tenofovir B 210237 Pharma Zone, Phase II, India Bottle, HDPE 30, 90
mg+25 mg coated Ltd Sector III, Pithampur
Alafenamide
Dhar, Madhya Pradesh,
India, 454775

Lupin Limited Unit-1,

Plot No. 6A1, 6A2,
Dolutegravir +
50 mg+200 ANDA Sector-17 Special 30, 60, 90 and
Emtricitabine+ Tenofovir Tablets Lupin Limited B India Bottle, HDPE
mg+25 mg 214544 Economic Zone, MIHAN 1000
Alafenamide Nagpur, Maharashtra,
India - 441108

APL Healthcare Limited,

Unit IV Plot No. 16,
Dolutegravir + APIIC M.P. SEZ,
50 mg+200 Aurobindo Pharma ANDA
Emtricitabine+ Tenofovir Tablets B Menakuru Village India Bottle, HDPE 30, 90
mg+25 mg Ltd 215448 Naidupeta mandal,
Alafenamide
Tirupati, Andhra
Pradesh -524421, India

Edition: Version 175 - 22-Mar-2024

List of HIV/AIDS drugs classified according to the GF QA Policy 24/58
 WHO
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International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

Plot No. 11, 12 & 13

Indore Special Economic
Dolutegravir + Zone
50 mg+300 Mylan Laboratories NDA
A124 Lamivudine+ Tenofovir Tablet B Pharma Zone, Phase II, India Bottle, HDPE 30, 90,180
mg+25 mg Ltd 210865 Sector III, Pithampur
Alafenamide
Dhar, Madhya Pradesh,
India, 454775

Laurus Labs Limited,

(VSP-2), Plot No. 19,
20 and 21, Western
Dolutegravir + NDA
50 mg+300 Film coated Sector APSEZ,
Lamivudine+ Tenofovir Laurus Labs Limited B 213696 India Bottle, HDPE 30, 90,180
mg+25 mg Tablet Atchutapuram,
Alafenamide
Visakhapatnam
Andhra Pradesh –
531011, India

Cipla Limited –
Patalganga
Plot No. A – 42 (Unit -
Dolutegravir + II)
50 mg+300 NDA
Lamivudine+ Tenofovir Tablets Cipla Limited B MIDC Patalganga, India HDPE Bottle 30, 90
mg+25 mg 212527
Alafenamide District Raigad,
Patalganga 410220
Maharashtra, India

Lupin Limited
Unit 1, Plot No. 6A1,
Dolutegravir + 6A2, Sector-17, Special
50 mg+300 NDA
Lamivudine+ Tenofovir Tablets Lupin Limited B Economic Zone, India HDPE Bottle 30, 90
mg+25 mg 215187
Alafenamide MIHAN, Nagpur,
Maharashtra, 441 108,
India.

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List of HIV/AIDS drugs classified according to the GF QA Policy 25/58
 WHO
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International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

Celltrion Pharm, Inc. 82, 2

Sandan-ro, Ochang-eup,
Cheongwon-gu, Cheongju-si,
Chungcheongbuk-do 28117;
Aizant Drug Research
Dolutegravir + Solutions Pvt. Ltd. Survey No republic of
50mg + 300 mg NDA
A125 Lamivudine + Tenofovir Tablet Celltrion Pharm, Inc. B 172/173, Apparel Park Road, Korea HDPE Bottle 30, 90, 180
+ 300 mg 211912 Dulapally Village,
disoproxil fumarate India
Dundigal-Gandimaisamma
Mandal, Medchal-Malkhajgiri
District,
Hyderabad, 500 100,
Telangana

1) Aurobindo Pharma Limited

Unit VII, SEZ, APIIC Plot No
SI, Survey No 411, 425, 434,
435 and 458, Green Industrial
Park, Village Polepally,
Mandal Jedcherla, District
Dolutegravir + Mahaboobnagar, Andhra
50mg + 300 mg Aurobindo Pharma NDA
Lamivudine + Tenofovir Tablet B Pradesh; India HDPE Bottle 30, 90, 180
+ 300 mg Ltd 209618 2) APL Health Care limited,
disoproxil fumarate
(UNIT-IV), Plot No.16, APIIC
Multi Product SEZ, Menakuru
Village,
Naidupeta Mandal, Tirupati
District, telangan,
Andhra Pradesh

Mylan Laboratories Limited

(FDF-3)
Dolutegravir + HA688 Plot No. 11, 12 & 13, Indore
50mg + 300 mg Special Economic Zone
Lamivudine + Tenofovir Tablet Mylan laboratories Ltd A-B NDA Pharma Zone, Phase II, Sector India HDPE Bottle 30, 90, 180
+ 300 mg
disoproxil fumarate 209670 III, Pithampur District Dhar –
454775 Madhya Pradesh

1) Cipla Goa (Unit-VII)

Verna Industrial Estate,
Verna,
Salcette, Goa – 403 722
2) Cipla Unit-VII PD II
Dolutegravir + Verna Industrial Estate,
50mg+300mg + India and 28, 30, 84, 90,
Lamivudine + Tenofovir tablet FDC Cipla Ltd A HA702 Verna HDPE Bottle
300mg Salcette, Goa - 403722 Uganda 180, 500
disoproxil fumarate
3) Cipla Quality Chemical
Industries Ltd, PO Box 34871,
Plot No 1-7 Ring Road, Luzira
Industrial Park, Kampala,
Uganda

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 WHO
Global
International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA
Laurus Labs Limited,
(Unit-II),
Plot No:19, 20 & 21,
Dolutegravir + HA707-NDA Western Sector, APSEZ,
50mg+300mg +
Lamivudine + Tenofovir tablet FDC Laurus Lab Ltd A-B 210787 Atchutapuram Mandal, India HDPE Container 30, 90,180
300mg USFDA 2 Visakhapatnam-District-
disoproxil fumarate
531011,
Andhra Pradesh
Village Ganguwala,
Dolutegravir +
50mg+300mg + Sun Pharmaceutical Paonta Sahib, District
Lamivudine + Tenofovir tablet FDC A HA699 India HDPE Bottle 30x1, 90x1, 180x1
300mg Industries Limited Sirmour, Himanchal
disoproxil fumarate Pradesh, 173 025
Unit 5, Survey No 439, 440,
441 & 458 TSIIC Formulation
SEZ, Polepally Village,
Jadcherla (M), Mahaboob
Nagar District, Telangana, 509
301; -

Dolutegravir + HA696/ Unit III, Plot No 22-110 IDA,

50mg+300mg + 30, 60, 90, 100,180,
Lamivudine + Tenofovir tablet FDC Hetero Labs Ltd A-B NDA Jeedimetla, Hyderabad, India HDPE Bottle
300mg Telangana, 500 055; 750
disoproxil fumarate 210880
- I156

Annora Pharma Private

LimitedAnnaram Village,
Gummadidala_Mandal
Sangareddy District,
Telangana State

1) Strides Pharma Science Limited

Oral Solid Dosage Forms Division,
KRS Gardens, 36/7,
Suragajakkanahalli, Indlawadi
Cross, Anekal Taluk Bangalore,
Dolutegravir + Karnataka 562 106 India 28x1, 30x1, 56x1,
50mg+300mg + Strides Pharma
Lamivudine + Tenofovir tablet FDC A HA729 2) Strides Pharma Science Limited India Bottle, HDPE 60x1, 84x1, 90x1,
300mg Science Limited Unit II, RS No 32-34, PIMS Road, 168x1, 180x1
disoproxil fumarate Periyakalapet Puducherry 605 014
India
3) Universal Corporation Ltd
PO Box 1748, Club Road, Plot No
13777 Kikuyu, 902 Kenya

1. Block N 2, Village Theda

(GB1, GB2 and GB3)
P.O. Lodhi Majra, Tehsil
Dolutegravir + HA713 Baddi , Dist.: Solan, Himachal
50mg+300mg + Macleods 30x1, 90x1, 100x1,
Lamivudine + Tenofovir tablet FDC A-B NDA Pradesh, 174101 India India Bottle, HDPE
300mg Pharmaceuticals Ltd 2. Phase III, Unit II 180x1
disoproxil fumarate 210796
Plot No. 25 - 27, Survey No.
366, Premier Industrial
Estate, Kachigam, Daman -
Plot No P-1 & P-2,
Dolutegravir + I.T.B.T., Park Phase II
50mg+300mg + Emcure
Lamivudine + Tenofovir Tablet A HA722 MIDC, Hinjewadi, India Bottle, HDPE 30x1, 90x1, 180x1
300mg Pharmaceuticals Ltd
disoproxil fumarate Pune, Maharashtra,
411057

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 WHO
Global
International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

Lupin Lupin Limited, Unit 1,

Pharmaceuticals, Inc. Plot No. 6A1, 6A2 ,
HA737 30x1, 60x1, 90x1
Dolutegravir + 111 South Calvert Sector-17, Special
50mg+300mg +
Lamivudine + Tenofovir Tablet Street A-B Economic Zone, India Bottle, HDPE
300mg NDA 30x1, 60x1, 90x1
disoproxil fumarate Harborplace Tower, MIHAN, Nagpur,
212303 or 180x1
24th Floor Maharashtra – 441
Baltimore, MD 21202 108, India

1.Aizant Drug Research

Solutions Pvt. Ltd.
Hyderabad- 500100, India.
Dolutegravir + Shanghai Desano Bio-
50mg+300mg + NDA 2. Shanghai Desano Bio-
Lamivudine + Tenofovir Tablet Pharmaceutical Co., B Pharmaceutical Co. Ltd. India Bottle, HDPE 30, 90
300mg 213556
disoproxil fumarate Ltd., China 1479 Zhangheng Road, China
(Shanghai) Pilot Free Trade
Zone,
Shanghai 201203, China

Micro Labs Ltd, Plot

No. S-155 to S-159 &
Dolutegravir +
50mg+300mg + Film Coated N1, Phase III & Phase
Lamivudine + Tenofovir Microlabs Ltd A HA755 India Bottle, HDPE 30, 90, 180
300mg Tablet IV, Verna Industrial
disoproxil fumarate
Estate, Verna, Goa,
403 722, India

Celltrion Pharm, Inc. 82, 2

Dolutegravir + Sandan-ro, Ochang-eup,
50mg+300mg + NDA India
Lamivudine + Tenofovir Tablet Celltrion Pharm, Inc. B Cheongwon-gu , Cheongju-si, Bottle, HDPE 30, 90, 180
300mg 211912 Chungcheongbuk-do, Korea, Korea
disoproxil fumarate 28117

Shanghai Desano Bio-

Pharmaceutical Co Ltd,
1479 Zhangheng Road,
Dolutegravir + Desano
50mg+300mg + China (Shanghai) Pilot
Lamivudine + Tenofovir Tablet Pharmaceuticals A HA746 Free Trade Zone,
China HDPE Bottle 30, 90
300mg
disoproxil fumarate Private Ltd Shanghai, 201203,
China (People's Republic
of)
Patheon Inc.
Oral Merck Sharp & Dohme Canada
A35 Efavirenz (EFV) 30 mg / ml A-B Yes Mississauga, Ontario HDPE Bottle 180ml
Solution Limited Netherlands
Harlem

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 WHO
Global
International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

Merck Sharp & Dohme Manati, Puerto Rico

A36 Efavirenz (EFV) 50 mg Capsule A Yes HDPE bottle 30
Limited Harlem Netherlands

Plot No. S-155 to S- 159

& N1, Phase III & IV ,
NDA
Efavirenz (EFV) 50 mg Tablet Microlabs Ltd Yes Verna Industrial Estate , India HDPE Bottle 30, 60, 90
205389 Verna Salcette , Goa -
403 722
South Granville,
BN Haarlem
Merck Sharp & Dohme
Efavirenz (EFV) 50 mg Tablet A Yes (packager, responsible Australia HDPE bottle 30
Limited
for batch release in the
EU)
Mylan Laboratories Sinnar,Nashik,
Efavirenz (EFV) 50 mg Tablet B Yes India HDPE Bottle 30, 90
Ltd Maharashtra

Mylan Laboratories Sinnar,Nashik,

A38 Efavirenz (EFV) 100mg Tablet B Yes India HDPE Bottle 30, 90
Ltd Maharashtra

Plot No. S-155 to S- 159

& N1, Phase III & IV ,
NDA
Efavirenz (EFV) 100 mg Tablet Microlabs Ltd Yes Verna Industrial Estate , India HDPE Bottle 30,60,90
205389 Verna Salcette , Goa -
403 722
Plot No. L-147, L147-1,
A40 Efavirenz (EFV) 200 mg Capsule Cipla Ltd. A-B Yes India HDPE Bottle 90, 1000
Verna Goa,

Merck Sharp & Dohme Manati, Puerto Rico

Efavirenz (EFV) 200 mg Capsule A Yes HDPE bottle 90
Limited Harlem Netherlands

Unit III, Survey No. 313

&314 Bachupally,
Quthubullapur Mandal
Aurobindo Pharma HDPE bottle; 30, 90;
Efavirenz (EFV) 200 mg Capsule B Yes Hyderabad, Andhra India
Ltd Pradesh
Blister 10
Unit-VII (SEZ),
Mahaboob Nagar (DT),

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 WHO
Global
International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

Plot No. S-155 to S- 159

& N1, Phase III & IV ,
NDA
Efavirenz (EFV) 200 mg Tablet Microlabs Ltd Yes Verna Industrial Estate , India HDPE Bottle 30,60,90
205389 Verna Salcette , Goa -
403 722

36/7,
Film coated Strides Arcolab Suragajakkanahalli
Efavirenz (EFV) 200 mg A-B Yes India HDPE bottle 90
Tablet Limited Indlavadi cross Anekal
Taluk Bangalore

South Granville,
BN Haarlem
Merck Sharp & Dohme
Efavirenz (EFV) 200 mg Tablet A Yes (packager, responsible Australia HDPE bottle 90
Limited
for batch release in the
EU)

Mylan Laboratories Sinnar,Nashik,

Efavirenz (EFV) 200 mg Tablet B Yes India HDPE Bottle 30, 90
Ltd Maharashtra

Bristol-Myers Squibb
Pharma, Manati, Puerto
Rico;
Merck Sharp & Dohme
Australia Pty. Ltd, South Puerto Rico
Merck Sharp & Dohme Granville, Australia; Australia
A42 Efavirenz (EFV) 600 mg Tablet A Yes HDPE bottle 30
Limited Merck Sharp & Dohme, Netherlands
BV Haarlem, The China
Netherlands;
Zhejiang Huahai
Pharmaceutical Co., Ltd,
Zhejiang, China

Sun Pharmaceutical Paonta Sahib, HDPE bottle 30;

Efavirenz (EFV) 600 mg Tablet A Yes India
Industries Ltd Himachal Pradesh Blister; 30

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 WHO
Global
International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

Unit III Survey No.

313, Bachupally,
Quthubullapur
Tablet Film Aurobindo Pharma Mandal, Hyderabad, HDPE Bottle; 30,
Efavirenz (EFV) 600 mg B Yes India
coated Ltd Andhra Pradesh Blister 10
Unit-VII (SEZ),
Mahaboob Nagar
(DT), Andhra Pradesh
Mylan Laboratories Ltd, Plot No H-12 &
H13 MIDC Waluj Industrial Area,
Aurangabad, Maharashtra, 431 136,
India
HA403 28, 30;
Mylan Laboratories Mylan Laboratories Ltd, Plot No 11, 12 HDPE bottle;
Efavirenz (EFV) 600 mg Tablet A-B NDA & 13, Indore Special Economic Zone, India, Kenya
Ltd Pharma Zone, Phase II, Sector III, Blister
078883 Pithampur, District Dhar, Madya 10
Pradesh, 454 775, India
Mylan Laboratories Ltd, F4 & F12
Malegaon MIDC, Sinnar, Nashik
1479 Zhangheng Road,
Shanghai Desano Bio- Zhangjiang Hi-Tech
Efavirenz (EFV) 600 mg Tablet A HA658 China HDPE bottle 30x1
pharmaceutical Co. Park, Shanghai
201203
L-139 to L-146, Verna
Goa India HDPE bottle 30, 500
Efavirenz (EFV) 600 mg Tablet Cipla Ltd. A-B Yes
Quality Chemical Uganda Blister 10
Industries Ltd, Kampala

Strides Shasun Ltd, Oral

Solid Dosage Forms
Film coated Strides Arcolab Division, KRS Gardens,
Efavirenz (EFV) 600 mg A-B HA390 India HDPE bottle 30
Tablet Limited 36/7,
Suragajakkanahalli,
Indlawadi Cross, Anekal
Taluk, Bangalore,
Unit-III, Jeedimetla,
Hyderabad, Andhra
Tablet Film Pradesh, India; HDPE
Efavirenz (EFV) 600 mg Hetero labs limited A-B Yes India 28, 30, 250
coated Unit-V, Mahaboob Container
Nagar, Andhra Pradesh,
India
Macleods
HDPE
Efavirenz (EFV) 600 mg Tablet Pharmaceuticals A-B Yes Himachal Pradesh India 30
container
Limited
Emcure
HDPE bottle; 30, 60;
Efavirenz (EFV) 600 mg Tablet Pharmaceuticals B Yes Hinjwadi, Pune India
Blister 3*10
Limited
HDPE bottle; 30x1
Efavirenz (EFV) 600 mg Tablet Microlabs Ltd A-B HA633 Verna, Goa India
Blister 10x3

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 WHO
Global
International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

Aspen Port Elizabeth ,

Pharmacare (Pty) Ltd, Korsten Port Layflat laminat
Bag(PET/Alu/
Efavirenz (EFV) 600 mg Tablet Ltd.(trading as Aspen A HA649 Elizabeth, South Africa LLDPE)
30 30
Pharmacare) South Africa HDPE Bottle

Lek Pharmaceuticals d.d.,

Ljubljana
or
Salutas Pharma GmbH,
39179 Barleben,
or 10, 28, 30, 50,
LEK S.A., Slovenia White opaque
60, 84, 90, 100 or
Film coated 672 Warszawa Germany PVC/Aclar/Al
Efavirenz (EFV) 600 mg Sandoz Ltd, UK B Yes or 120 30,
Tablet Poland blisters
Salutas Pharma GmbH, 90 (3x30) or 120
Romania HDPE bottles
Dieselstr. 5, 70839 Gerlingen, (4x30)
Germany
or
S.C. Sandoz,
Targu-Mures

The Government
Pharmaceutical
Government Organization (GPO),
Pharmaceutical Rangsit
Organization (GPO), Pharmaceutical
Film coated
Efavirenz (EFV) 600 mg 75/1 Rama VI Road, A HA681 Production Plant 1, Thailand HDPE bottle 30
Tablet
Ratchathewi, 138 Moo 4, Rangsit-
Bangkok, 10400, Nakhonnayok Road,
Thailand Bueng Sanan,
Thanyaburi,
Pathumthani, 12110
36/7,
Efavirenz + [Lamivudine 600 mg + [150 Strides Arcolab Suragajakkanahalli
A42 Tablet B Yes India HDPE bottle 30 + (60)
+ Zidovudine] mg + 300 mg] Limited Indlavadi cross Anekal
Taluk Bangalore

Efavirenz + [Lamivudine 600 mg + [150 Co packed Mylan Laboratories Sinnar, Nashik District 10-day supply (5 two-day blister
B Yes India Blister cards. cards consisting of PVC/PvDC
+ Zidovudine] mg + 300 mg] Tablet Ltd 422 113, Maharashtra film and coated aluminum foil)

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List of HIV/AIDS drugs classified according to the GF QA Policy 32/58
 WHO
Global
International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

Patheon Inc.
Efavirenz + Mississauga, Ontario
600 mg + 200 Merck Sharp & Dohme
A44 Emtricitabine + Tablet B Yes MSD BV Haarlem ( Canada HDPE bottle 30
mg + 300 mg Limited
Tenofovir packaging and batch
release site)

Sinnar,Nashik,
Maharashtra,
Efavirenz + HA444
Waluj, Aurangabad, 30, 28
Emtricitabine + 600 mg + 200 Mylan Laboratories
Tablet A-B Maharashtra; India HDPE bottle
Tenofovir Disoproxil mg + 300 mg Ltd ANDA
Mylan Pithambur, 30, 100
Fumarate 090437
Dhar Dist., Madhya
Pradesh

Efavirenz +
600 mg + 200 Plot No. L-147, L147-1,
Emtricitabine + Tablet Cipla Ltd. A Yes India HDPE Bottle 30
mg + 300 mg Verna Goa,
Tenofovir

Efavirenz + Unit-VII (SEZ),

600 mg + 200 Aurobindo Pharma
Emtricitabine + Tablet B Yes Mahaboob Nagar India HDPE Bottle 30, 100
mg + 300 mg Ltd
Tenofovir (DT), Andhra Pradesh

Hetero Labs Limited,

Efavirenz + Unit-V SEZ Unit I
600 mg + 200 28's, 30's and
Emtricitabine + Tablet Hetero labs limited A-B Yes Survey No. 439, 440, India HDPE Bottle
mg + 300 mg 500's,
Tenofovir 441 & 458 Mahaboob
Nagar.

Macleods Pharmaceuticals
Efavirenz + Macleods HA562 Ltd, Block No. N2, Village
600 mg + 200 Theda, P.O. Lodhi Majra,
Emtricitabine + Tablet Pharmaceuticals A-B ANDA Tehsil Baddi, District Solan, India HDPE Bottle 30, 90, 180
mg + 300 mg
Tenofovir Limited 204287 Himachal Pradesh, 174 101,
India

Efavirenz +
600 mg + 200 Strides Arcolab Anekal Taluk,
Emtricitabine + Tablet A Yes India HDPE Bottle 30
mg + 300 mg Limited Bangalore, India
Tenofovir

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 WHO
Global
International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

Efavirenz + Bristol-Myers Squibb

600 mg+200 Carrigtohill, County
Emtricitabine + Tablet and Gilead Sciences B Yes Ireland HDPE Bottle 30
mg+300 mg Cork
Tenofovir Disoproxil Ltd

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List of HIV/AIDS drugs classified according to the GF QA Policy 34/58
 WHO
Global
International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

Efavirenz +
Emtricitabine + 600 mg+200 Patheon Inc.
Tablet Gilead Sciences, Inc. B Yes Canada HDPE Bottle 30
Tenofovir (Disoproxil mg+300 mg Mississauga, Ontario
Fumarate)

Laurus Labs Limited,

(VSP-2) Plot No. 19,
Efavirenz + 20 and 21, Western
Emtricitabine + 600 mg+200 Film coated ANDA Sector, APSEZ
Laurus Labs Ltd B India HDPE Bottle 30, 90
Tenofovir (Disoproxil mg+300 mg Tablet 213541 Atchutapuram,
Fumarate) Visakhapatnam,
Andhra Pradesh –
531011, India

Remedica Ltd,
Efavirenz +
Aharnon Street,
Emtricitabine + 600 mg+200 Film coated 30,
Remedica B 22699 Limassol Industrial Cyprus HDPE Bottle
Tenofovir (Disoproxil mg+245 mg Tablet 90 (3X30)
Estate, 3056 Limassol,
Succinate)
Cyprus
Sinnar,Nashik,
Maharashtra;
Efavirenz+ Lamivudine + H-12 & H-13, M.I.D.C,
600 mg + 300 Mylan Laboratories HA466
A45 Tenofovir (Disoproxil Tablet A- B Waluj, Aurangabad India HDPE Bottle 30, 100
mg + 300 mg Ltd NDA022142
Fumarate) Maharastra; Mylan
Pithambur, Dhar Dist.,
Madhya Pradesh

Aurobindo Pharma
Efavirenz+ Lamivudine +
600 mg + 300 Aurobindo Pharma Limited Unit-VII
Tenofovir (Disoproxil Tablet B Yes India HDPE Bottle 30, 90& 500
mg + 300 mg Ltd (SEZ) Mahaboob
Fumarate)
Nagar (Dt) AP;

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 WHO
Global
International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA
Plot No 1-7 Ring Road,
Luzira Industrial Park,
Kampala, Uganda
Unit 7, Plot No L-139 to L-
147-1, S-103 to S-105, S-107
to S-112 & M-61 to M-63,
Efavirenz+ Lamivudine + Verna Industrial Estate,
600 mg + 300
Tenofovir (Disoproxil Tablet Cipla Ltd. A-B HA593 Salcette, Goa, 403 722, India HDPE Bottle 30
mg + 300 mg
Fumarate) Unit 2, Plot A-42 MIDC
Industrial Area,
Patalganga, Raigad District,
Maharashtra, 410 220

Macleods
Efavirenz+ Lamivudine + Macleods Pharmaceuticals
600 mg + 300
Tenofovir (Disoproxil Tablet Pharmaceuticals A-B Yes Limited India HDPE Bottle 30
mg + 300 mg
Fumarate) Limited Baddi, District Solan,
Himachal Pradesh
Unit III, Survey No 51,
Plot No 22-110 IDA,
Jeedimetla, Hyderabad,
Telangana
Efavirenz+ Lamivudine + HA549 (Unit-V) S.No. 439,440,
600 mg + 300 HDPE
Tenofovir (Disoproxil Tablet Hetero labs limited A-B NDA 441, & 458, TSIIC India 30, 90, 100
mg + 300 mg Formulation SEZ, Container
Fumarate) 204119
Polepally Village,
Jadcherla (Mandal),
Mahaboobnagar-
(District). Pin-509301
(Unit-2), Plot No:19,
20 & 21, Western
Efavirenz+ Lamivudine + HA727- Sector, APSEZ,
600 mg + 300
Tenofovir (Disoproxil tablet FDC Laurus Labs Limited A-B ANDA Atchutapuram India HDPE Bottle 30x1, 90x1
mg + 300 mg
Fumarate) 212786 Mandal,Visakhapatna
m-District, Andhra
Pradesh, 531011

Micro Labs Ltd, Plot

No. S-155 to S-159 &
Efavirenz+ Lamivudine +
600 mg + 300 N1, Phase III & Phase
Tenofovir (Disoproxil tablet FDC Microlabs Ltd A HA767 India HDPE Bottle 30x1
mg + 300 mg IV, Verna Industrial
Fumarate)
Estate, Verna, Goa,
403 722

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 WHO
Global
International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

Aizant Drug Research

Solutions Pvt. Ltd, Block No.
Efavirenz+ Lamivudine + Desano B, Sy. No. 172 & 173, Apparel
600 mg + 300 Park Rd., Dulapally Village,
Tenofovir (Disoproxil tablet Pharmaceuticals A HA764 Hyderabad, Dundigal- India HDPE Bottle 30, 90
mg + 300 mg
Fumarate) Private Ltd Gandimaisamma Mandal,
Medchal-Malkhajgiri District,
Telangana, 500 100, India

(FDF-3)
Plot No. 11, 12 & 13,
Indore Special
Efavirenz+ Lamivudine + Economic Zone,
400 mg + 300 Mylan Laboratories HDPE Bottle
ARV126 Tenofovir (Disoproxil Tablet A-B HA721 Pharma Zone, Phase - India 30, 90
mg + 300 mg Ltd (white, blue)
Fumarate) II,
Sector -III, Pithampur,
District Dhar - 454775,
Madhya Pradesh

(Unit-2), Plot No:19,

20 & 21, Western
Efavirenz+ Lamivudine + HA732- Sector, APSEZ,
400 mg + 300
Tenofovir (Disoproxil tablet FDC Laurus Labs Limited A-B ANDA Atchutapuram India HDPE Container 30, 90, 180
mg + 300 mg
Fumarate) 213038 Mandal,Visakhapatna
m-District, Andhra
Pradesh, 531011

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 WHO
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International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

Block N-2, Village

HA714- Theda;
Post Office Lodhimajra
Tehshil Baddi,
Distt.Solan, Himachal
Efavirenz+ Lamivudine +
400 mg + 300 Pradesh-174101
Tenofovir (Disoproxil tablet FDC Macleods A-B India HDPE Bottle 30, 90, 180
mg + 300 mg
Fumarate) Survey No 366, Premier
Industrial Estate,
NDA Kachigam Plot No. 25 -
210649 27 Daman, Daman,
India.396210.

Hetero Labs
Limited_UNIT_V
Survey No.: 439, 440,
441 & 458, TSIIC
Efavirenz+ Lamivudine +
400 mg + 300 Formulation SEZ,
Tenofovir (Disoproxil tablet FDC Hetero A HA759 India HDPE Bottle 30, 90, 180
mg + 300 mg Polepally
Fumarate) Village, Jadcherla
(Mandal) Mahabubnagar
(District), Telangana
509301, India (IND)

A46 Emtricitabine 10 mg/ml oral solution Gilead Sciences, Inc. B Yes Country Cork Ireland Bottle 170ml

Plot No. L-147, L147-1,

A47 Emtricitabine 200 mg Capsule Cipla Ltd. A-B Yes India HDPE Bottle 30, 1000
Verna Goa,
Mylan Laboratories Sinnar,Nashik, HDPE Bottle; 30, 100;
Emtricitabine 200 mg Capsule A-B Yes India
Ltd Maharashtra Blister 2*10, 3*10
Emtricitabine 200 mg Capsule Gilead Sciences, Inc. B Yes Foster City USA HDPE Bottle, 30
Plot No.11, 12 & 13,
Indore Special
Economic Zone,
NDA Pharma Zone, Phase -
Emtricitabine 200 mg Capsule Micro Labs Ltd, B India HDPE Bottle 30,60,90
204396 II, Sector - III,
Pithampur – 454775
Dist. Dhar, Madhya
Pradesh.

Emtricitabine +Tenofovir Tablet Film Granta Park Abington, 30, 90(3x30)

A49 200 mg + 245 mg Gilead Sciences, Inc. B Yes UK Bottle (HDPE)
Disoproxil Fumarate coated Cambridge tablets

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 WHO
Global
International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

Remedica Ltd,
Aharnon Street,
Emtricitabine +Tenofovir Tablet Film 30, 90(3x30)
200 mg + 245 mg Remedica B 22347 Limassol Industrial Cyprus Bottle (HDPE)
Disoproxil succinate coated tablets
Estate, 3056 Limassol,
Cyprus

Altana Pharma,
Oranienburg GmbH,
Germany
Emtricitabine + 200 mg + 300 Patheon Inc.
Tablet Gilead Sciences, Inc. A Yes Canada HDPE bottle 30
Tenofovir mg Mississauga, Ontario
South Africa
Aspen Pharmacare,
Port Elizabeth,

Unit - III Survey No. 313

& 314, Bachupally,
Quthubullapur Mandal
Emtricitabine +
200 mg + 300 Aurobindo Pharma Hyderabad, Andhra
Tenofovir disoproxil Tablet B Yes India HDPE bottle 30
mg Ltd Pradesh
fumarate Unit-VII (SEZ),
Mahaboob Nagar (DT),
Andhra Pradesh
1) Mylan Laboratories Ltd
Plot No 11, 12 & 13, Indore
Special Economic Zone,
Pharma Zone, Phase II, Sector
III, District Dhar Pithampur,
Madhya Pradesh 454 775 HDPE bottle; 28, 30,100;
HA417 India
Emtricitabine + Al/Al blister 3x10's
200 mg + 300 Mylan Laboratories 2) Mylan Laboratories Ltd
Tenofovir Disoproxil Tablet A-B F4 & F12 Malegaon MIDC, India
mg Ltd ANDA
Fumarate Nashik District Sinnar, HDPE bottle; 30, 100
090049 Maharashtra 422 113 India blister 2x10's
3) Mylan Laboratories Ltd
Plot No H-12 & H13 MIDC
Waluj Industrial Area
Aurangabad, Maharashtra 431
136 India

Emtricitabine +
200 mg + 300 Plot No. L-147, L147-1,
Tenofovir Disoproxil Tablet Cipla Ltd. A-B Yes India HDPE Bottle 30
mg Verna Goa,
Fumarate

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 WHO
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Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

Unit III 22 - 110,

Emtricitabine + Industrial
200 mg + 300
Tenofovir Disoproxil Tablet Hetero labs limited A-B Yes development Area, India HDPE bottle 28, 30, 56 & 60
mg
Fumarate Jeedimetla,
Hyderabad-500055

36/7,
Emtricitabine +
200 mg + 300 Strides Arcolab Suragajakkanahalli
Tenofovir Disoproxil Tablet A-B Yes India HDPE bottle 30
mg Limited Indlavadi cross Anekal
Fumarate
Taluk Bangalore

Macleods Pharmaceuticals
Ltd, Block No. N2, Village
Theda, P.O. Lodhi Majra,
Tehsil Baddi, District Solan, HDPE bottle
Emtricitabine + Macleods Himachal Pradesh, 174 101, 30;
200 mg + 300
Tenofovir Disoproxil Tablet Pharmaceuticals A HA561 India India
mg Macleods Pharmaceuticals Alu/Alu
Fumarate Limited 10 x 10
Ltd, Unit 2, Plot No 25-27, blister
Survey No 366, Premier
Industrial Estate, Kachigam,
Daman, 396 210, India

Aspen Port Elizabeth ,

Emtricitabine + (Pty) Ltd, Korsten Port
200 mg + 300
Tenofovir Disoproxil Tablet Pharmacare Ltd A HA601 Elizabeth, South Africa HDPE bottle 30
mg
Fumarate South Africa

Shasun
Emtricitabine + Pharmaceuticals
200 mg + 300 Sun Pharmaceutical
Tenofovir Disoproxil Tablet A Yes Limited, India HDPE bottle 30
mg Industries Ltd
Fumarate Periyakalapet,
Puducherry, India

Micro Labs Ltd, Phase

III and Phase IV, Plot
Emtricitabine +
200 mg + 300 No S-155 to S-159 Blister Alu/Alu 10x1 30x1,
Tenofovir Disoproxil Tablet Microlabs Ltd A HA631 India
mg Verna Industrial Bottle HDPE 100x1
Fumarate
Estate, Verna, Goa,
403 722, India

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 WHO
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International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

(Unit-2), Plot No:19, 20

& 21, Western Sector,
Emtricitabine +
200 mg + 300 Tablet Film APSEZ, Atchutapuram
Tenofovir Disoproxil Laurus Lab Ltd A HA717 India 30x1, 90x1
mg coated Mandal,Visakhapatnam- Bottle, HDPE
Fumarate District, Andhra
Pradesh, 531011

Plot No P-2, ITBT

Emtricitabine +
200 mg + 300 Tablet Film Emcure Park, Phase II MIDC,
Tenofovir Disoproxil A HA726 India 30x1
mg coated Pharmaceuticals Ltd Hinjwadi, Pune, Bottle, HDPE
Fumarate
Maharashtra, 411057

APL Healthcare
Limited Unit-IV Plot
No.16, APIIC, M.P.
SEZ, Menakuru
Emtricitabine + Aurobindo Pharma NDA
A139 200mg/25mg Tablet B Village, Naidupeta India HDPE Bottle 30, 90
Tenofovir Alafenamide Ltd 216875
Mandal, Tirupati
District Andhra
Pradesh, 524421 -
India
Laurus Labs Limited,
(VSP-2) Plot No. 19,
20 and 21, Western
Emtricitabine + ANDA Sector, APSEZ,
200mg/25mg Tablet Laurus Labs Limited B India HDPE Bottle 30, 90
Tenofovir Alafenamide 213989 Atchutapuram
Visakhapatnam,
Andhra Pradesh India,
531011
Cartons containing 5 blister
packs (consisting of aluminum-
[Emtricitabine + 200 mg /300 mg
Co packed Mylan Laboratories Sinnar, Nashik District aluminum blisters), each
A50 Tenofovir Disoproxil co-packaged with B Yes India Blister cards. containing two 1-day cards, for
Tablet Ltd 422 113, Maharashtra a 10 day supply. Three cartons
Fumarate]+Nevirapine 200 mg are further packaged together
for a 30 day supply

Edition: Version 175 - 22-Mar-2024

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 WHO
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International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

[Emtricitabine + 200 mg /300 mg Macleods

Co packed
Tenofovir Disoproxil co-packaged with Pharmaceuticals A Yes Kachigam, Daman, India Alu/Alu blister (1 + 2) combipack
Tablet
Fumarate]+Nevirapine 200 mg Limited
60+60 vials of
Hoffmann-La Roche
A51 Enfuvirtide 90mg/ml Injection B Yes Basle Switzerland Vials water for
Inc.
inj+syringe
HA600 (a) Janssen-Cilag SpA
Janssen-Cilag
Via C. Janssen Borgo
A52 Etravirine 25mg Tablet International NV, A-B Italy HDPE Bottle 120
EU/1/08/4 San Michele 04100
Belgium
68/003 Latina, Italy
HA532 (a) Janssen-Cilag SpA
Janssen-Cilag
Via C. Janssen Borgo
A53 Etravirine 100mg Tablet International NV, A-B Italy HDPE Bottle 120
EU/1/08/4 San Michele 04100
Belgium
68/001 Latina, Italy
Janssen-Cilag SpA
Janssen-Cilag
EU/1/08/4 Via C. Janssen Borgo
A54 Etravirine 200mg Tablet International NV, B Italy HDPE Bottle 60
68/002 San Michele 04100
Belgium
Latina, Italy
Glaxo Wellcome
A55 Fosamprenavir (FPV) 700 mg Tablet Glaxo SmithKline Ltd. B Yes UK HDPE bottle 60
Operations

Capsule Merck Sharp & Dohme Hertford Road,

A56 Indinavir (IDV) 200 mg B Yes UK HDPE Bottle 180,270, 360
Hard Limited Hertfordshire

Unit-III, Jeedimetla,
Al/Al strip; 10;
A57 Indinavir (IDV) 400 mg Capsule Hetero Labs Limited A Yes Hyderabad, Andhra India
Pradesh, India HDPE bottle 180
Merck Sharp & Dohme
Indinavir (IDV) 400 mg Capsule A Yes Elkton, Virgina USA HDPE bottle 180
Limited
Capsule Merck Sharp & Dohme Hertford Road,
Indinavir (IDV) 400 mg B Yes UK Bottle (HDPE) 18, 90, 180
Hard Limited Hertfordshire
Oral
A58 Lamivudine (3TC) 10 mg / ml ViiV HealthCare A Yes Mississauga, Ontario Canada HDPE bottle 240ml
Solution
Unit-III 22-110,
Industrial
Oral
Lamivudine (3TC) 10 mg / ml Hetero labs limited B Yes Development Area India HDPE Bottle 240ml
Solution
Jeedimetla,
Hyderabad
Oral Aurobindo Pharma
Lamivudine (3TC) 10 mg / ml B Yes Hyderabad, Telangana India HDPE Bottle 240ml
Solution Ltd
Macleods
Oral Solan, Himachal
Lamivudine (3TC) 10 mg / ml Pharmaceuticals A Yes India HDPE Bottle 100ml, 240ml
Solution Pradesh, India
Limited
A59 Lamivudine (3TC) 30mg Tablet Cipla Ltd. A Yes Goa India HDPE Bottle 60

Edition: Version 175 - 22-Mar-2024

List of HIV/AIDS drugs classified according to the GF QA Policy 42/58
 WHO
Global
International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

PVC/PVdC/Al
10
Lamivudine (3TC) 30mg Tablet Microlabs Ltd A Yes Verna, Goa India u blister ;
60,100,500,1000
HDPE bottle
Tablet Film
A61 Lamivudine (3TC) 100 mg Glaxo SmithKline Ltd. B Yes Ware, Hartfordshire UK Blister; Bottle 28, 84
coated
Macleods
Tablet Film Kachigam, Daman HDPE Bottle; 60;
A62 Lamivudine (3TC) 150 mg Pharmaceuticals A-B Yes India
Coated Baddi, H.P. Blister 6*10
Limited

36/7,
Film coated Strides Arcolab Suragajakkanahalli HDPE bottle; 30, 60;
Lamivudine (3TC) 150 mg A-B Yes India
Tablet Limited Indlavadi cross Anekal Blister 10
Taluk Bangalore

Metallised lay
Aspen Pharmacare Port Elizabeth,
Lamivudine (3TC) 150 mg Tablet A Yes South Africa flat pack, PP 60
Ltd. Korsten
bottle
Goa;
Lamivudine (3TC) 150 mg Tablet Cipla Ltd. A Yes Meditab Specialities India HDPE Bottle 30, 60
Ltd, Goa

Glaxo Operations UK,

Ltd, Ware,
Hertfordshire, UK; GSK,
Tablet Film UK
Lamivudine (3TC) 150 mg ViiV HealthCare A-B Yes Poznan (packaging and HDPE bottle 60
coated release), Poland South Africa
Pharmacare (ASPEN),
Port Elizabeth,

Unit-III, Jeedimetla,
Hyderabad, Andhra
Pradesh, India;
India HDPE Bottle 60, 600
Lamivudine (3TC) 150 mg Tablet Hetero labs limited A-B Yes STADA-VN Joint
Vietnam Blister, 10;
Venture Co, Ltd,
Duong Province,
Vietnam
Alu/PVC/PvdC
Lamivudine (3TC) 150 mg Tablet Microlabs Ltd A-B HA644 Verna, Goa India blister HDPE 6x10 60
Bottle

Alkem Laboratories
Lamivudine (3TC) 150 mg Tablet B Yes Amaliya, Daman India HDPE Bottle 60
Ltd

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List of HIV/AIDS drugs classified according to the GF QA Policy 43/58
 WHO
Global
International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

Centaur Biotech Park

Lamivudine (3TC) 150 mg Tablet Pharmaceutical B Yes Hinjewadi Phase II India HDPE bottle 60
Private Limited Pune, Maharashtra

Mylan Laboratories
Limited, Blister
NDA# F- 4 & F-12, MIDC, PVC/PVDC/Al
Lamivudine (3TC) 150 mg Tablet MYLAN B India 10x1 ; 60x1
078545 Malegaon, uminium)
Sinnar, Nashik - 422 113 HDPE bottle
Maharashtra

Mylan Laboratories
Limited,
Blister
ANDA F- 4 & F-12, MIDC,
PVC/PVDC/Al
A63 Lamivudine (3TC) 300 mg Tablet MYLAN A-B 078545 Malegaon, India 10x1 ; 60x1
uminium);
USFDA 2 Sinnar, Nashik - 422
HDPE bottle
113
Maharashtra
Lamivudine (3TC) 300 mg Tablet Cipla Ltd. A Yes Goa India HDPE Bottle 30,60
36/7,
Film coated Strides Arcolab Suragajakkanahalli
Lamivudine (3TC) 300 mg B Yes India HDPE Bottle, 30; 60
Tablet Limited Indlavadi cross Anekal
Taluk Bangalore

Macleods
HDPE Bottle; 30;
Lamivudine (3TC) 300 mg Tablet Pharmaceuticals A-B Yes Kachigam, Daman India
Blister 3* 10; 6*10
Limited
High density
Lamivudine (3TC) 300 mg Tablet Glaxo SmithKline Ltd. B Yes Greenford, Middlesex UK polyethylene 30
(HDPE) bottle
Unit III 22-110, I.D.A.,
Lamivudine (3TC) 300 mg Tablet Hetero labs limited B Yes Jeedimetla Jeedimeta, India HDPE bottle 30, 600
Hyderabad

HDPE bottle 30, 60, 90

Lamivudine (3TC) 300 mg Tablet Microlabs Ltd B Yes Verna, Goa India
Blister 10

Edition: Version 175 - 22-Mar-2024

List of HIV/AIDS drugs classified according to the GF QA Policy 44/58
 WHO
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International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

Track-II, 126,
Beximco
Film-coated Kathaldia, Auchpara,
Lamivudine (3TC) 300 mg Pharmaceuticals A HA668 Bangladesh HDPE Bottle 30x1
Tablet Tongi-1711, Gazipur,
Limited
Bangladesh

Sinnar, Nashik District,

Lamivudine + Nevirapine 30mg+ 50mg Dispersible Mylan Laboratories Maharashtra, India;
A67 A -B Yes India HDPE Bottle 60
+ Zidovudine +60mg Tablet Ltd Waluj, Aurangabad,
Maharashtra, India
Strides Pharma Science
Limited, Strides house,
Tablet for
Lamivudine + Nevirapine 30mg+ 50mg Strides Pharma Opp. IIMB, Bilekahali,
Oral A-B HA557 India HDPE Bottle 60
+ Zidovudine +60mg Science Limited Bannerghatta Road,
Suspension Bangalore, Karnataka,
560 076, India

Plot No. L-147, L147-1

Tablet for
Lamivudine + Nevirapine 30mg+ 50mg (Unit VII), Verna
Oral Cipla Ltd. B Yes India HDPE Bottle 60, 1000
+ Zidovudine +60mg Industrial Estate, Verna
Suspension Salcette Goa, 403 722

Unit III
Plot No. 22-110,
Lamivudine + Tenofovir NDA
A127 75 mg + 75 mg Tablet Hetero labs limited B I.D.A., Jeedimetla, India HDPE Bottle 30
disoproxil fumarate 207315
Hyderabad – 500 055,
Telangana

Unit-III, 22-110,
Industrial Development
Area, Jeedimetla,
Lamivudine + Tenofovir 300 mg + 300
A70 Tablet Hetero labs limited A-B Yes Hyderabad; India HDPE Bottle 30, 60, 100, 500
disoproxil fumarate mg and
Unit V Mahaboob Nagar
Dist, Andhra Pradesh.

Celltrion Pharm, Inc.

82, 2Sandan-ro,
HA712-
Lamivudine + Tenofovir 300 mg + 300 Ochang-eup, Republic of
Tablet Celltrion Pharm, Inc. A-B NDA HDPE Bottle 30, 60, 100
disoproxil fumarate mg Cheongwon-gu, Korea
211284
Cheongju-si,
Chungcheongbuk-do

Edition: Version 175 - 22-Mar-2024

List of HIV/AIDS drugs classified according to the GF QA Policy 45/58
 WHO
Global
International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA
Mylan Laboratories Ltd, Plot
No 11, 12 & 13, Indore Special
Economic Zone, Pharma Zone,
Phase II, Sector III,
Pithampur, District Dhar,
Madya Pradesh, 454 775,
India
Mylan Laboratories Ltd, F4 &
Lamivudine + Tenofovir 300 mg + 300 Mylan Laboratories HA414 F12 Malegaon MIDC, Sinnar,
Tablet A-B Nashik District, Maharashtra, India HDPE bottle 30, 100
disoproxil fumarate mg Ltd NDA022141 422 113;
Mylan Laboratories Ltd, Plot
No H-12 & H13 MIDC Waluj
Industrial Area, Aurangabad,
Maharashtra, 431 136;

Unit-VII (SEZ),
Lamivudine + Tenofovir 300 mg + 300 Aurobindo Pharma
Tablet B Yes Mahaboob Nagar India HDPE bottle 30
disoproxil fumarate mg Ltd
(DT), Andhra Pradesh

D-7 MIDC Kurkumbh;

Quality 30, 500
Lamivudine + Tenofovir 300 mg + 300 HDPE Bottle
Tablet Cipla Ltd. A- B HA666 Chemical Industries Ltd, India
disoproxil fumarate mg Kampala,
Blister
10
Uganda

Sun Pharmaceutical
Industries Limited,
Lamivudine + Tenofovir 300 mg + 300 Sun Pharmaceutical Village Ganguwala,
Tablet A HA525 India HDPE Bottle 30, 90
disoproxil fumarate mg Industries Ltd Paonta Sahib, District
Sirmour, Himachal
Pradesh, 173 025, India
Macleods Kachigam- Daman
Lamivudine + Tenofovir 300 mg + 300 HDPE Bottle 30
Tablet Pharmaceuticals A-B Yes Baddi- Himachal India
disoproxil fumarate mg Blister 10
Limited Pradesh
Plot No: S-155 to S-
159, Phase III,
Lamivudine + Tenofovir 300 mg + 300
Tablet Microlabs Ltd A HA620 Verna Industrial India HDPE Bottle 30, 100
disoproxil fumarate mg
Estate, Verna, Goa-
403722

Edition: Version 175 - 22-Mar-2024

List of HIV/AIDS drugs classified according to the GF QA Policy 46/58
 WHO
Global
International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

Lupin Limited, Unit 1,

Plot No. 6A1, 6A2 ,
Sector-17, Special
Lamivudine + Tenofovir 300 mg + 300
Tablet Lupin Ltd A HA703 Economic Zone, India HDPE Bottle 30
disoproxil fumarate mg
MIHAN, Nagpur,
Maharashtra – 441
108, India
CELLTRION PHARM,
Inc., 82, 2 Sandan-ro,
Ochang-eup,
Lamivudine + Tenofovir 300 mg + 300 Film coated Cheongwon-gu, Republic of
Celltrion Pharm, Inc. A HA712 HDPE Bottle 30, 60, 100
disoproxil fumarate mg Tablet Cheongju-si, Korea
Chungcheongbuk-do,
28117, Republic of
Korea
(1+1+1) per
Capsules+ Sinnar,Nashik, Alu/Alu Blister
[Lamivudine+Tenofovir] [300mg+300mg] Mylan Laboratories coblister; 3
A71 Tablets+ A Yes Maharashtra India per co packed
+Atazanavir+ Ritonavir +300mg+100mg Ltd blisters in a
Tablets blister
carton
1) Mylan Laboratories Ltd
Plot No 11, 12 & 13, Indore
Special Economic Zone,
Pharma Zone, Phase II, Sector
III, District Dhar Pithampur,
Madhya Pradesh 454 775
HA572 India
2) Mylan Laboratories Ltd
Plot No H-12 & H13 MIDC
Lamivudine + Dispersible Mylan Laboratories
A73 30 mg + 60 mg A -B Waluj Industrial Area India HDPE 60
Zidovudine Tablet Ltd Aurangabad, Maharashtra 431
ANDA 136 India
200748 3) Mylan Laboratories Limited
(FDF-1) Plot No. F-4 and F-12
Malegaon M.I.D.C., Sinnar
Nashik District, Maharashtra,
India. 422113

L-147 to L-147.1 (Unit

VII),
Verna Industrial
Lamivudine + Dispersible NDA HDPE bottle; 60; 1000
30 mg + 60 mg Cipla Ltd. B Estate, India
Zidovudine Tablet 202814 Blister 10
Verna Salcette, Goa
403 722
India

Edition: Version 175 - 22-Mar-2024

List of HIV/AIDS drugs classified according to the GF QA Policy 47/58
 WHO
Global
International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

Plot No 11, 12 & 13, Indore

Special Economic Zone,
Pharma Zone, Phase II, Sector
III, Pithampur, District Dhar,
Lamivudine + Dispersible Mylan Laboratories HA572;
30 mg + 60 mg A -B Madya Pradesh, 454 775: India HDPE 60
Zidovudine Tablet Ltd NDA Plot No H-12 & H13 MIDC
Waluj Industrial Area,
Aurangabad, Maharashtra,
431 136

Sinnar-Nashik,
Lamivudine + Mylan Laboratories
A74 30 mg + 60 mg Tablet A -B Yes Maharashtra India HDPE bottle 60
Zidovudine Ltd
Waluj, Aurangabad

6 x 10;
Lamivudine + PVC/PVdC/Al
30 mg + 60 mg Tablet Microlabs Ltd A Yes Verna, Goa India
Zidovudine u blister HDPE
60, 100, 1000

Shanghai Desano Bio-

Pharmac+H309eutical
Co Ltd, 1479
Lamivudine + Shanghai Desano Bio-
A128 150 mg + 300 mg Tablet A HA655 Zhangheng Road, China HDPE bottle 60'
Zidovudine Pharmaceutical Co Ltd
China (Shanghai) Pilot
Free Trade Zone,
Shanghai, 201203

Plot No. L-147, L147-1,

Verna Goa,
Indore, SEZ, Pithampur,
Dist Dhar (M.P.), India;
Quality Chemical
Lamivudine + Industries Ltd, Kampala, India HDPE bottle ; 60, 1000 ;
150 mg + 300 mg Tablet Cipla Ltd. A-B Yes
Zidovudine Uganda; Uganda Blister 10, 14
Cipla Ltd Baddi,
Himachal Pradesh, India
Meditab Specialities Pvt
Ltd, Kundaim,
Goa

Edition: Version 175 - 22-Mar-2024

List of HIV/AIDS drugs classified according to the GF QA Policy 48/58
 WHO
Global
International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

Unit-III, 22-110,
Lamivudine + Jeedimetla, HDPE bottle 60, 500
150 mg + 300 mg Tablet Hetero Labs Limited A-B Yes India
Zidovudine Hyderabad Blister; 10;
Unit-V, Hyderabad

Sinnar,Nashik,
Maharashtra; Mylan
Laboratories Limited,
Plot No.11, 12 & 13,
Lamivudine + Mylan Laboratories Indore Special Economic HDPE bottle ; 60;
150 mg + 300 mg Tablet A-B Yes India
Zidovudine Ltd Zone, Pharma Zone, Blister 10
Phase - II, Sector - III,
Pithampur – 454775
Dist. Dhar, Madhya
Pradesh.

Glaxo Operations UK,

Ltd, Ware,
Lamivudine + Hertfordshire, UK; Bottle 60,
150 mg + 300 mg Tablet ViiV HealthCare A Yes UK
Zidovudine GSK, Poznan Blister, 60
(packaging and release),
Poland
HDPE bottle;
Alu/PA/PVC
Lamivudine + Sun Pharmaceutical Paonta Sahib, 60;
150 mg + 300 mg Tablet A Yes India Blister;
Zidovudine Industries Ltd Himachal Pradesh 10
PVdC/PVC
blister

Anhui Biochem Bio-

pharmaceutical Co.,
Anhui Biochem Bio- Ltd., No. 30 Hongfeng China
Lamivudine + Film coated
150 mg + 300 mg pharmaceutical Co., A HA656 Road, Hi-Tech (People's HDPE bottle 60
Zidovudine Tablet
Ltd., Development Zone, Republic of)
Hefei City, Anhui
Province

36/7,
Lamivudine + Film coated Strides Arcolab Suragajakkanahalli
150 mg + 300 mg A-B Yes India HDPE bottle 60
Zidovudine Tablet Limited Indlavadi cross Anekal
Taluk Bangalore

Edition: Version 175 - 22-Mar-2024

List of HIV/AIDS drugs classified according to the GF QA Policy 49/58
 WHO
Global
International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

HDPE bottle;
Lamivudine + 30, 60, 90;
150 mg + 300 mg Tablet Microlabs Ltd A Yes Verna, Goa India PVDC/PVC/Al
Zidovudine 10*10;
u blister;
Lamivudine + Port Elizabeth,
150 mg + 300 mg Tablet Pharmacare Ltd. B Yes South Africa Blister 60
Zidovudine Korsten
Macleods
Lamivudine + Kachigam, Daman HDPE Bottle; 60;
150 mg + 300 mg Tablet Pharmaceuticals A -B Yes India
Zidovudine Baddi, H.P. Blister 6*10, 12*10
Limited

Emcure
Lamivudine + HDPE bottle 60
150 mg + 300 mg Tablet Pharmaceuticals B Yes Hinjwadi, Pune India
Zidovudine Blister 10
Limited

Dhar, Pithampur,
Lamivudine +
150 mg + 300 mg Tablet Lupin A Yes Madhya Pradesh; India HDPE bottle 60
Zidovudine
Verna, Salcette Goa,

Aurobindo Pharma
Limited, Unit-III,
Survey No. 313 & 314,
Bachupally,
Lamivudine + Aurobindo Pharma NDA Bachupally Mandal,
150 mg + 300 mg Tablet B India HDPE bottle 60
Zidovudine Ltd 077558 Medchal-Malkajgiri
District,
Telangana State,
INDIA.
Zip Code: 500090

Edition: Version 175 - 22-Mar-2024

List of HIV/AIDS drugs classified according to the GF QA Policy 50/58
 WHO
Global
International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

Universal Corporation Ltd

Lamivudine + Universal Corporation
150 mg + 300 mg Tablet A HA490 PO Box 1748, Club Road, Plot Kenya HDPE bottle 60
Zidovudine Ltd No 13777 Kikuyu, 902 Kenya

AbbVie Inc., 1 N
Waukegan Road, IL
60064, North Chicago,
Aesica Queenborough
Lopinavir (LPV) + (80 mg + 20 mg) Oral HA098ND Limited, North Road, USA, UK,
A78 AbbVie Ltd A -B Queenborough, Kent, Netherlands
PET bottle 160ml
Ritonavir (RTV) / ml Solution A 021251
ME11 5EL,
UPS SCS B.V., Marco
Poloweg 22-24, 5928 LE
Venlo, Netherlands
Plot L147 to L-147-1,
Pellets in NDA Verna Industrial
A79 Lopinavir+Ritonavir 40mg/10mg Cipla Ltd. B India HDPE Bottle 120
Capsule 205425 Estate,
Verna, Goa
Mylan Laboratories
Limited (FDF-1)
Plot # F/4 & F/12,
Malegaon MIDC Sinnar,
Nashik District- 422113
Maharashtra; Mylan
HA697- Laboratories Limited,
Oral Mylan Laboratories aluminum foil
Lopinavir+Ritonavir 40mg/10mg A-B NDA Plot No.11, 12 & 13, India 120
Granules Limited Indore Special Economic sachets
210540
Zone, Pharma Zone,
Phase - II, Sector - III,
Pithampur – 454775
Dist. Dhar, Madhya
Pradesh.

Lopinavir (LPV) + EMA Art 58

A129 100 mg + 25 mg Tablet AbbVie Ltd B Ludwigshafen Germany HDPE bottle 60
Ritonavir (RTV) H-W-764-2
Lopinavir (LPV) + Bottle (HDPE)
100 mg + 25 mg Tablet AbbVie Ltd B NDA21906 North Chicago USA 60
Ritonavir (RTV) Bottle (PVC)

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 WHO
Global
International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA
Mylan Laboratories Limited,
F-4, F-12, Malegaon M.I.D.C,
Sinnar, Nashik – 422113,
Maharashtra state, India
Lopinavir (LPV) + Mylan Laboratories HA429 ;Mylan Laboratories Limited,
100 mg + 25 mg Tablet A-B ANDA#79074 Plot No.11, 12 & 13, Indore India HDPE Bottle 60, 120
Ritonavir (RTV) Ltd
Special Economic Zone,
Pharma Zone, Phase - II,
Sector - III, Pithampur –
454775 Dist. Dhar, Madhya
Unit III Survey No. 313
and 314 Bachupally
Lopinavir (LPV) + Aurobindo Pharma HDPE Bottle; 60;
100 mg + 25 mg Tablet B Yes Quthubullapur Mandal, India
Ritonavir (RTV) Ltd Hyderabad Andhra Blister 6*10
Pradesh
Macleods
Lopinavir (LPV) + Solan, Himachal
100 mg + 25 mg Tablet Pharmaceuticals A Yes India HDPE bottle 60
Ritonavir (RTV) Pradesh
Limited

Unit III, Plot No 22-

ANDA
Lopinavir (LPV) + 110 IDA, Jeedimetla,
100 mg + 25 mg Tablet Hetero labs limited A-B 091677 India HDPE bottle 60; 120
Ritonavir (RTV) Hyderabad,
HA650
Telangana, 500 055

Laurus Labs Limited (VSP-2),

Plot No. 19, 20 and 21,
Lopinavir (LPV) + ANDA Western Sector, APSEZ,
100 mg + 25 mg Tablet Laurus Labs Limited B Atchutapuram, India HDPE bottle 60; 120
Ritonavir (RTV) 213857
Visakhapatnam, Andhra
Pradesh, India 531011

Sinnar,Nashik,
Maharashtra; Mylan
Laboratories Limited,
Plot No.11, 12 & 13,
Lopinavir (LPV) + Mylan Laboratories Indore Special Economic HDPE Bottle; 120;
A82 200 mg + 50 mg Tablet A-B Yes India
Ritonavir (RTV) Ltd Zone, Pharma Zone, Blister 6. 12
Phase - II, Sector - III,
Pithampur – 454775
Dist. Dhar, Madhya
Pradesh.

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 WHO
Global
International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

AbbVie LTD., Deutschland

GmbH and Com KG,
Knollstrasse 67061,
Ludwigshafen,
AbbVie LTD., KM 58
Lopinavir (LPV) + HA381, Carretera, 2 Cruce Davilla, Germany,
200 mg + 50 mg Tablet AbbVie Ltd A-B Barceloneta 00617, Puerto Bottle HDPE, 120x1
Ritonavir (RTV) NDA21906 Ireland
Rico
Fournier Laboratories Ireland
Limited, Carrigtwohill
business park, Anngrove,
Carrigtwohill, Co. Cork

Unit III Survey No. 313

and 314 Bachupally
Lopinavir (LPV) + Aurobindo Pharma HDPE Bottle; 120;
200 mg + 50 mg Tablet B Yes Quthubullapur Mandal, India
Ritonavir (RTV) Ltd Hyderabad Andhra Blister 6*10
Pradesh
Lopinavir (LPV) + A-42, MIDC HDPE Bottle 120,
200 mg + 50 mg Tablet Cipla Ltd. B Yes India
Ritonavir (RTV) Patalganga Blister 10
Unit III 22 - 110,
HDPE
Industrial
Lopinavir (LPV) + Alu/Alu Blister 60, 120
200 mg + 50 mg Tablet Hetero labs limited A-B Yes development Area, India
Ritonavir (RTV) Alu/PVC/PVd 10
Jeedimetla,
C blister
Hyderabad

Macleods
Lopinavir (LPV) + Solan, Himachal
200 mg + 50 mg Tablet Pharmaceuticals A Yes India HDPE bottle 120
Ritonavir (RTV) Pradesh
Limited

Laurus Labs Limited (VSP-2),

Plot No. 19, 20 and 21,
Lopinavir (LPV) + ANDA Western Sector, APSEZ,
200 mg + 50 mg Tablet Laurus Labs Limited B Atchutapuram, India HDPE bottle 60; 120
Ritonavir (RTV) 213857
Visakhapatnam, Andhra
Pradesh, India 531011

Oral HDPE bottle+

A83 Nevirapine (NVP) 10 mg / ml Boehringer Ingelheim A Yes Roxane, Columbus, USA 240ml + 5ml
Suspension syringe

Cipla Ltd, Goa, India; Amber

Meditab Specialties Pvt coloured PET
100ml, 240
Oral Ltd, Maharashtra, India; Bottle
Nevirapine (NVP) 10 mg / ml Cipla Ltd. A Yes Indore, SEZ,
India
Suspension Amber
Pithampur, Dist Dhar 25ml, 10ml
coloured glass
(M.P.) bottle

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 WHO
Global
International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

Unit III Survey No. 313

and 314 Bachupally
Oral Aurobindo Pharma 240ml
A130 Nevirapine (NVP) 50 mg /5 ml B Yes Quthubullapur Mandal, India HDPE bottle
Suspension Ltd Hyderabad Andhra
100ml
Pradesh

Tablet 60, 1000

A-42, MIDC, HDPE bottle
A131 Nevirapine (NVP) 50mg for Oral Cipla Ltd. A-B Yes India
Patalganga Blister
Suspension 10

Unit III Survey No.

Dispersible Aurobindo Pharma 313 and 314
Nevirapine (NVP) 50mg B NDA 22299 India HDPE bottle 30
tablet Ltd Bachupally Mandal,
Telangana

Plot No: S-155 to S-

159, Phase III, HDPE bottle 30,60,90
A86 Nevirapine 50mg Tablet Microlabs Ltd A Yes Verna Industrial India
Estate, Verna, Goa- Blister 10
403722

Plot No: S-155 to S-

HA570, 159, Phase III, HDPE bottle 60,
A132 Nevirapine 200mg Tablet Microlabs Ltd A-B ANDA Verna Industrial India
203080 Estate, Verna, Goa- Blister 10's
403722
NDA 022145
EU/1/07/43 Merck Sharp & Dohme
Film-coated 6/001 B. V. Waarderweg 39
A91 Raltegravir 400mg Merck & Co, USA B Netherlands Bottle 60
tablet 2031 BN Haarlem
Netherlands

Unit III 22 - 110,

Industrial 60, 120
Bottle
Raltegravir 400mg Tablet Hetero labs limited B Yes development Area, India 10'sx10
Blister
Jeedimetla, 10'sx14
Hyderabad

Merck Sharp & Dohme

USA
Chewable B. V. Waarderweg 39
A92 Raltegravir 100mg Merck & Co, USA B Yes Bottle 60
tablet 2031 BN Haarlem
China
Pays-Bas

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List of HIV/AIDS drugs classified according to the GF QA Policy 54/58
 WHO
Global
International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

PATHEON PHARM
Merck Sharp & Dohme
Granules for INC., 2110 East child resistant
B. V. Waarderweg 39 NDA
Raltegravir ( Potassium) 100mg Oral B Galbraith Road, USA single-use foil 60 packets+kit
2031 BN Haarlem 205784
Suspension OH45237-1625 – packet
Pays-Bas
Cincinnati -USA

Merck Sharp & Dohme

Chewable B. V. Waarderweg 39
A93 Raltegravir 25mg Merck & Co, USA B Yes Netherland Bottle 60
tablet 2031 BN Haarlem
Pays-Bas
Oral
A94 Ritonavir (RTV) 80 mg / ml AbbVie Ltd HA096 Yes Queenborough, Kent UK PET bottle 90ml
Solution
NDA A-42, MIDC,
A95 Ritonavir (RTV) 25 mg Tablet Cipla Ltd. B India HDPE Bottle 60
205040 Patalganga
Mylan Laboratories Sinnar, Nashik,
Ritonavir (RTV) 25 mg Tablet A Yes India HDPE Bottle 30
Ltd Maharashtra
NDA A-42, MIDC,
A96 Ritonavir (RTV) 50 mg Tablet Cipla Ltd. B India HDPE Bottle 60
205040 Patalganga

Mylan Laboratories Sinnar,Nashik,

A133 Ritonavir (RTV) 100 mg Tablet A Yes India HDPE Bottle 30, 120
Ltd Maharashtra

Mylan Laboratories Limited, F-

Mylan Laboratories EU/1/17/12 4 & F-12, Malegaon MIDC,
Ritonavir (RTV) 100 mg Tablet B Sinnar,Nashik -422113, India HDPE Bottle 30
Ltd 42/003
Maharashtra, India.
Ritonavir (RTV) 100 mg Tablet AbbVie Ltd HA491 Yes Luwigshafen, Germany HDPE Bottle 30, 60

A-42, MIDC,
Ritonavir (RTV) 100 mg Tablet Cipla Ltd. A-B Yes India HDPE Bottle 30
Patalganga,

Unit III, Survey No 51,

ANDA2045 Plot No 22-110 IDA,
Ritonavir (RTV) 100 mg Tablet Hetero labs limited B India HDPE Bottle 30x1; 120x1
87 Jeedimetla, Hyderabad,
Telangana, 500 055
A99 Saquinavir 500mg Tablet F.Hoffman-La Roche A Yes Madrid Spain HDPE Bottle 120

40mg/gm( Eq to
Tenofovir Disoproxil 33mg/gm of Takeda GmbH Germany
A104 granule Gilead Sciences, Inc. B Yes HDPE bottle 60g
Fumarate Tenofovir Country Cork Ireland
Disoproxil

Edition: Version 175 - 22-Mar-2024

List of HIV/AIDS drugs classified according to the GF QA Policy 55/58
 WHO
Global
International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

Patheon Inc.
Mississauga, Ontario Canada
Tenofovir Disoproxil Tablet Film HDPE
A105 300mg Gilead Sciences, Inc. B Yes Nycomed Oranienburg Germany 30
Fumarate coated GmbH Granta Park
container
UK
Abington, Cambridge
Tenofovir Disoproxil Plot No. L-147, L147-1,
300 mg Tablet Cipla Ltd. A-B Yes India HDPE bottle 30, 1000
Fumarate Verna Goa

Tenofovir Disoproxil Mylan Laboratories Sinnar,Nashik, HDPE Bottle; 30,100;

300 mg Tablet A-B Yes India
Fumarate Ltd Maharashtra Blister 2*10

36/7,
Tenofovir Disoproxil Strides Arcolab Suragajakkanahalli HDPE Bottle 30
300 mg Tablet A-B Yes India
Fumarate Limited Indlavadi cross Anekal Blister 10
Taluk Bangalore

Unit - III Survey No. 313

& 314, Bachupally,
Quthubullapur Mandal
Tenofovir Disoproxil Aurobindo Pharma Hyderabad, Andhra
300 mg Tablet B Yes India HDPE bottle 30,
Fumarate Ltd Pradesh
Unit-VII (SEZ),
Mahaboob Nagar (DT),
Andhra Pradesh
Unit III 22-110
Industrial
Tenofovir Disoproxil 30, 60, 100, 500,
300 mg Tablet Hetero labs limited A-B Yes development Area India HDPE Bottle
Fumarate 1000
Jeedimetla,
Hyderabad
Aspen Port Elizabeth ,
(Pty) Ltd, Korsten Port
Elizabeth,
South Africa
HA588
Tenofovir Disoproxil
300 mg Tablet Pharmacare Ltd. A-B ANDA South Africa HDPE Bottle 30
Fumarate
203470

Edition: Version 175 - 22-Mar-2024

List of HIV/AIDS drugs classified according to the GF QA Policy 56/58
 WHO
Global
International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

(Unit-2), Plot No:19,

20 & 21, Western
Sector, APSEZ,
Tenofovir Disoproxil Atchutapuram
300 mg Tablet Laurus Labs Limited A HA679 India HDPE Bottle 30x1, 500x1
Fumarate Mandal,Visakhapatna
m-District, Andhra
Pradesh, 531011
Macleods Pharmaceuticals
Ltd, Block No. N2, Village
Theda, P.O. Lodhi Majra,
Tehsil Baddi, District Solan,
Himachal Pradesh, 174 101,
India
Macleods Pharmaceutical
Macleods limited, Plot No. M-50 to 54-
Tenofovir Disoproxil
300 mg Tablet Pharmaceuticals A HA516 A, SEZ, Phase II, Pithampur, India HDPE bottle 30
Fumarate Dist.-Dhar, Madhya Pradesh,
Limited
454774, India
Macleods Pharmaceuticals
Ltd, Unit 2, Plot No 25-27,
Survey No 366, Premier
Industrial Estate, Kachigam,
Daman, 396 210, India

Laurus Labs Limited (Unit-2)

Plot No: 19, 20 & 21, Western
Sector,
ANDA
A135 Tenofovir Alafenamide 25 mg Tablet Laurus Labs Limited B APSEZ, Gurajapalem Village, India HDPE bottle 30
214030 Rambilli Mandal,
Anakapalli-District-531011,
Andhra Pradesh, India.

PVC/PVdC/Al 10x10
A106 Zidovudine 60mg Tablet Microlabs Ltd A Yes South Africa India u blister 60, 100, 500,
HDPE bottle 1000
Infusion Barnard Castle,
A108 Zidovudine 10mg/ml ViiV HealthCare A Yes UK Glass vial 20ml
solution County Durham
Macleods
Solan, Himachal
Zidovudine 10mg/ml Oral solution Pharmaceuticals A HA526 India HDPE Bottle 100ml, 240ml
Pradesh
Limited

A109 Zidovudine 50mg/5ml Oral solution ViiV HealthCare A Yes Mississauga, Ontario Canada PET bottle 200ml

Unit-III, Jeedimetla,
Zidovudine 50mg/5ml Oral solution Hetero labs limited A Yes Hyderabad, Andhra India HDPE Bottle 240ml
Pradesh, India
Cipla Limited L-139 to
L-146, Verna Goa, HDPE bottle; 100ml, 240ml
Zidovudine 50mg/5ml Oral solution Cipla Ltd. A-B Yes India
Meditab Specialities PET Bottle 100ml;
Ltd
Edition: Version 175 - 22-Mar-2024
List of HIV/AIDS drugs classified according to the GF QA Policy 57/58
 WHO
Global
International Non- Supplier/ Prequalificati
Ref.No Strength/ Dose Dosage form Fund QA on/
Manufacturing site Country Material Pack
proprietary name Manufacturer(s)
Standard SRA/WLA

Unit III Survey No.

313, Bachupally, HDPE bottle,
Aurobindo Pharma
Zidovudine 50mg/5ml Oral solution B Yes Quthubullapur India with dose 240ml
Ltd
Mandal, Hyderabad, delivery device
Andhra Pradesh

Mylan Laboratories Sinnar,Nashik,

A110 Zidovudine 100mg Tablet A-B Yes India HDPE Bottle 60
Ltd Maharashtra

L138-147 L150 s103-

105 VernaGoa;
Zidovudine 100mg Capsules Cipla Ltd. A-B Yes Indore, SEZ, India HDPE Bottle 100; 1000
Pithampur, District
Dhar (M.P.)
S.C. Europharm, Bottle 100;
Zidovudine 100mg Capsules ViiV HealthCare A Yes Romania
Brasov Blister 100
S. C. Europharm,
A112 Zidovudine 250mg Capsules ViiV HealthCare A Yes Romania Blister 40
Brasov

Unit-III, 22-110,
Industrial
A134 Zidovudine 300mg Tablets Hetero labs limited A-B Yes Development Area, India HDPE bottle 60, 500, 600
Jeedimetla,
Hyderabad

Glaxo Operations UK,

Ltd, Ware,
Hertfordshire, UK; UK Bottle 28
Zidovudine 300mg Tablets ViiV HealthCare A Yes
Glaxo Wellcome SA, Blister 28, 60;
Aranda (packaging
and release), Spain
Mylan Laboratories Sinnar,Nashik,
HDPE bottle; 56, 60;
Zidovudine 300mg Tablets A -B Yes India
Ltd Maharashtra Blister 2 x 10
Plot No. L-147, L147-1,
HDPE Bottle; 30, 60, 1000 ;
Zidovudine 300mg Tablets Cipla Ltd. A-B Yes India
Verna Goa Blister 10
PVDC/PVC/Al
10;
Zidovudine 300mg Tablets Microlabs Ltd A yes Verna, Goa India u blister;
30, 60, 90
HDPE bottle
RAL-based regimens may be recommended as first line regimens for neonates (conditional recommendation) and for children >3kg, as an alternative to DTG-based regimens when
lopinavir/ritonavir solid formulations not available.
End of A or B or C products List

Edition: Version 175 - 22-Mar-2024

List of HIV/AIDS drugs classified according to the GF QA Policy 58/58
 List Of ARV Pharmaceutical Products
classified according to the Global Fund Quality Assurance Policy
Edition: Version 175 - 22-Mar-2024
List of ERP ( Expert Review Panel) Reviewed Products which are permitted for time limited procurement:

If there is no or only one A or B or C product available ( supply of the product cannot be done within 90 days after the receipt of the Purchase Order by the manufacturer) , grant
funds may be used to procure a ERP reviewed product eligible for procurement for limited time (12 months) period. The PR must send the “notification form” (available at
https://www.theglobalfund.org/media/5863/psm_notification_form_en.doc) to the Global Fund and upon receiving the “ No Objection” letter form the Global Fund, the
procurement can proceed. Please note that the QC test of the selected ERP product will be performed by the Global Fund.

Period
International Non-proprietary Dosage Supplier/ Global Fund
Ref. Strength/ Dose Validity for Manufacturing site Country Material Pack
name form Manufacturer(s) QA Standard
No ERP Review

End of ERP Reviewed products list

Edition: Version 175 - 22-Mar-2024

List of HIV/AIDS drugs classified according to the GF QA Policy
1/1