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Dr Reddys Cps Presentation Linked In Aug 2011

Dr. Reddy's Laboratories provides affordable and innovative medicines through pharmaceutical services, active ingredients, and generics. It has 14,000+ employees across 16 manufacturing sites. The company has a strong pipeline of over 200 projects in development across APIs, finished dosages, biosimilars, and specialty products. It aims to leverage its science, technology, and customer service to provide affordable medicines through organic growth and strategic acquisitions. Its custom pharmaceutical services division provides end-to-end capabilities from discovery to commercial launch for a broad base of large pharma, mid-sized pharma, and emerging biotech clients.

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Rising to the Pharma Challenge Introduction to CPS (Custom Pharmaceutical Services) For LinkedIn Christian Jones European Sales & Business Development Manager 30-Aug-11 1
Content  Corporate Overview  Custom Pharmaceutical Services (CPS) Overview  API – Development Capabilities  API – Commercial Manufacturing  Dosage Form Capabilities  Project Execution 2
Corporate Overview Purpose: “Providing affordable and innovative medicines for healthier lives” Strategy: Leverage industry-leading science & technology, product offering, and customer service with execution excellence to provide affordable and innovative medicines for healthier lives. 3
Dr. Reddy’s Today Business Mix Size •Pharma Services & Active •FY11 ~ $1.7 Billion in revenues Ingredients contributing 1/3rd of revenues Business Size •Global Generics contributing Mix balance 2/3rd •Proprietary products business in incubation mode $1.7 BN People & Infrastructure Product Portfolio •14,000+ employees; ~ 2,000 in •100+ APIs, 150+ Finished in international workforce Dosages Infra Product •20 Billion units in finished structure Portfolio •2 biosimilars launched in India dosage manufacturing •69 ANDAs pending approval capacities •200+ DMFs filed globally •16 manufacturing facilities (9 Chemicals, 6 Finished Dosages •8 biosimilars in development & 1 Biologics) •Over 200 projects under development 4
Our Businesses Pharmaceutical Global Proprietary Services and Active Products Ingredients Generics • Active Pharmaceutical • Biologics • NA Ingredients • Specialty Pharmaceuticals • Custom Pharmaceutical • EU (Germany, UK) Services (CPS) • India, Russia, Ukraine/CIS & Venezuela 5
The Last Decade: Achieved Scale and Global Presence Built the foundations for a strong business. Moved up the value chain. Strengthened capabilities. Achieved scale and global presence. Growth aided by acquisitions. 1800 379 1,700 EBITDA ($ Mn) 1600 1,563 1,510 243 1400 1,365 351 369 1,250 121 285 1200 94 75 68 37 50 26 1000 FY00 FY02 FY04 FY06 FY08 FY10 800 600 546 463 447 380 400 338 234 183 200 0 FY00 FY01 FY02 FY03 FY04 FY05 FY06 FY07 FY08 FY09 FY10 FY11 6
Strong Product Development Platform Strong and Growing Pipeline Segment Pipeline Total Filings 126 (including partnered ANDAs) Pending ANDAs 69 (including partnered ANDAs) US DMFs 176 EU DMFs 78 European Products >60 (pending registration) Dossiers 150+ pending registration (Rest Of the World) Specialty (US 3 ready to market products + Dermatology) several others in development Biologics 8 in development 7
Track Record 2010 Agreement for acquisition of GSK’s Penicillin Facility (USA) 2009 Partnership deal with GSK in emerging markets 2008 Acquisition of BASF facility at Shreveport, US Aquisiton of Dowpharma Small Molecules business associated with 2008 Dow’s Mirfield and Cambridge, UK Sites World’s first biosimilar monoclonal anti-body ,Reditux (rituximab) 2007 launched 2008 2007 Fastest Indian Pharma Company to cross $1billion in annual revenue 2007 2006 1st Indian manufacturing company to be Sarbanes-Oxley certified 2006 2006 1st authorized generic deal with multinational pharma 2005 2001 2006 Key acquisition betapharm (Germany) 1997 2005 Key acquisition “Falcon” (Mexico) 1993 1st Indian pharma company to be listed on the New York Stock 2001 Exchange 1997 1st Indian company to out-license an NCE to a multinational pharma 8
Care for Environment and Society Triple Bottom Line Approach… Society • Dr.Reddy’s Foundation – Livelihoods & Education Communities • Community Development– Health/Education/Livelihoods/Employability • Patient Assistance Programs & DRHFE Business Operations • Employee Engagement- Volunteer Program & Power of Ten • Environment: ISO 14001 & OHSAS 18001certified facilities; Zero Liquid Discharge & SHE technologies Core Purpose • Customer: FDA approved, Product safety (Pharmcovigilance) • Suppliers: Vikreta- B2B portal,GBS • Corporate Governance • Employees: Policies / Talent Mgmt Board / Leadership dev/ BPE To help people lead healthier lives through Access & Affordability 9
Achievements Aon-Hewitt 25 best Employers in India 2011 Dun & Bradstreet American Express Business Leader in the Pharmaceutical Sector Corporate Awards 2007 Pharma Excellence Awards 2006-07 for Forbes 2010 Asia Fab 50 companies 2011 sustained Growth First time featured on the list The Indian Express Best Corporate Social Responsibility Initiative Asia-Pacific HRM Congress 2007 2007 Global HR Excellence Award for Innovative HR BSE - India Practices 10
Overview – Custom Pharmaceutical Services 11
Background  One of the largest Custom Pharma businesses from India  End-to-end capabilities Discovery Process Clinical Commercial Chemistry Development Development Launch Process Intermediates Intermediates Development APIs & APIs & Kilolab Dosage Commercial quantities Supplies for drug product clinical trials  3 dedicated R&D facilities (2 in Hyderabad and 1 in Cambridge)  Broad Client Base: 39%  Large Pharma – 10+  Mid Sized Pharma – 5+  Emerging Pharma and Biotech – 30+ 12
Custom Pharmaceutical Services To be the preferred supplier of APIs, Intermediates and Formulations to ‘Innovators’ worldwide Delivering cost-effective and cGMP compliant products and services Managing intellectual property consistent with Global standards Emphasizing safety, health and environment cGMP Speed Competitive Innovation Pricing 13 13
History 2003 2004 2005 2006-7 2008-10 Expanded Acquired Dow Technology Initiated customer base Pharma’s technology Acquired Development contracts with to about 30 platforms and facility Business Roche’s Centre Big Pharma with several in the UK, BASF Facility in commissioned repeat business Dosage site in the Mexico. US. Manpower 70 110 800 950 Focus on API Integrated offer Offer contract Offer niche Services Development of services with Development & technology and scale up Dosage Form Manufacture of solutions in Development Niche API’s (High complex Chiral and Supplies Potent - Cytotoxic, molecules, PEG’s, Hormonal etc) Peptides, prostaglandins, carbohydrates 14
Custom Pharmaceutical Services A Global Organization Custom Pharmaceutical Services Sales & Marketing Technology Dev. Centers Manufacturing North America R&D Chemical Plants Hyderabad, India Hyderabad, India Cambridge, UK Cuernavaca, Mexico Europe Mirfield, UK Pilot Plant Asia Pacific Hyderabad, India Formulation Plants Mirfield, UK Hyderabad, India Louisiana, USA 15
CPS Value Proposition Technology: Cost-effective: ► Chiral Capabilities – Chemo and Bio Catalysis ► Geographic advantage ► PEGylation Technology ► Fit-to-purpose scale of production ► Continuous Processing ► Global supply chain ► Steroid and HPAI capabilities ► Carbohydrate Chemistry (Ex.Fondaparinux) Track Record & Quality: ► Traditional Chemistry ► Large base of customers with several ► Peptide, Prostaglandins & Oligo building blocks repeat business ► High quality products and services Manufacturing & Security of Supply: ► Corporate philosophy supports global ► Extensive, flexible capacity markets ► Geographical versatility -India/UK/Mexico ► cGMP compliant, USFDA inspected ► Large portfolio of DMF’s available off the shelf facilities ► More than 100 tech transfers of ► ISO 27001 certification (IP and Innovator projects Documentation standard) ► Competent technical staff ► Dedicated project management teams through product life cycle 16 16
API – Product Development Capabilities 17
Technology Development Center (Hyderabad, IN) Dedicated R&D facility for CPS with ~300 chemists and engineers Kilo Lab / Pilot Plant with about 10,000 sq ft Class 100,000 clean room Discovery Chemistry & Process R&D 21 Chemistry Labs 5 Analytical Labs Class 100, 000 Cytotoxic suite 18 18
Analytical Capabilities Method development and validation Impurity profile: Established expertise in isolation, identification and characterization Certified, qualified and validated equipment: DSC/TG, GC/LC-MS, LC-MS- MS, powder XRD, single crystal XRD, NMR, LC-NMR, FT-IR, CHN analyzer 19 19
Technology Development Center (Cambridge, UK) Biocatalysis • Discovery and development of Industrial biocatalysts and their application in bio-catalytic manufacture of fine chemical intermediates • In-house culture collection of more than 2000 microorganisms in 96 well plate format Chemocatalysis Mirfield • Technologies with utility in large scale manufacturing • World leader in asymmetric hydrogenation • Other capabilities for fine chemical applications such as Cambridge • Achiral • Asymmetric hydro-formylation Complex Synthesis • Have experience of more than 120 customer projects over the last 12 years • Capability to develop efficient processes to manufacture complex target molecules including • Sugars • Prostoglandin analogues • Oxa-prostoglandins 20 20
Activated PEG Offering ► mPEG-X –Linear architecture –Molecular Weights: 5, 10, 20, 30, 40, 60 kDa –Narrow polydispersity –Low levels of difunctional PEG: < 1-5% depending on MW ► Functional Groups –p-nitrophenyl carbonate –propionaldehyde –Maleimide –Amine ► Custom PEGs 21 21
API – Commercial Manufacturing Capabilities 22
API Production Facilities - India Six commercial production units – All inspected by USFDA Six Pilot Plants, Two Kilo Labs Over 2 million liters of reaction volume Over 500 GL and SS reactors that can handle temperature range of –75 to 300 oC Operations fully integrated through SAP and global supply chain practices 23 23
Highly Potent API Production Blocks - India Contained Blocks 1&2: ► Fully contained cGMP compliant facility ► Range of reactor capacity – 63 L to 630 L, 250 L to 2000 L ► Occupational Exposure Limits (OEL) 0.2µg/m3 for 8 h TWA ► Containment practiced through Air Handling, Pressure Zoning, Isolators and Personal Protective Equipment 24 24
API Manufacturing Network: India CTO IV – 1984 CTO V – 1987 CTO III – 1995 Vizag Hyderabad Miryalguda CTO II – 1986 CTO VI – 1990 CTO I – 1985 25
Regulatory Experience Type Number USDMF 176 EDMF 78 CEP 22 Canada 51 Japan 18 Korea 23 China 14 Turkey 12 Singapore 5 26
USFDA Inspections Unit Date Unit Date Unit II & III March 2003 Unit IV November 1987 Unit VI May 2004 Unit IV March 1996 Unit V March 2005 Unit V March 1997 Unit I & II Nov 2005 Unit I & IV June 1999 Unit III & IV March 2007 Unit II, III & VI February 2000 Unit VI April 2008 Unit V November 2000 Unit I & Unit 5 Feb 2009 Unit IV November 2002 Unit III September 2010 27 27
API Production Facilities – Cuernavaca, Mexico USA Mexico City Toluca Belize Cuernavaca Guatemala 28
Quality Centre Incinerator Main Tank Farm Offices Warehouses Utilities Production 29
API Production Facilities – Cuernavaca, Mexico Installed production capacity : 3350 MT 7 Reactor Bays with reactor volume ranging from 100L to 20KL 1000L and 3000L Cryogenic reactors capable of -110 oC 20 Steroidal API’s and several Steroid Intermediates currently produced Unit audited by FDA 125 Multi-disciplinary professionals • 25 post-graduates (Ph.D. and Masters) • 100 graduates (chemists, engineers, accountants) 30 30
Product Lines - Mexico Facility Naproxen: • 32 Years of experience in producing Naproxen • Installed capacities: Naproxen & Naproxen Sodium – 1000+ TPA History of Supplying of Naproxen globally including USA, EU and Japan • Inspected & approved by USFDA Steroids: • Expertise in development of NCE steroids • Dedicated, refurbished bay at a cost of ~ $29 M • 3 Flexible manufacturing trains • Containment for Offloading & Milling • Class 100,000 • More than 20 DMF’s, 80% on exclusive basis on behalf of customers 31
Dosage Form Capabilities 32
Seamless Formulation Services Covering the Entire Product Development Chain Analytical Preformulation Formulation CT Commercial Development Development Development Manufacturing Manufacturing Preclinical Clinical Supply Market Launch • Preformulation • Analytical and Bioanalytical Development • Formulation Development • Pilot Scale-up • Clinical Trial (CT) Supplies Manufacturing • Commercial Scale Contract Manufacturing 33
NCE Product Development - Capabilities Preformulation Studies: Solution stability studies Chemical Physical properties Solid-state characterization Solubility and reactivity and forced degradation studies Formulation Development; Formulation development for safety assessment studies Prototype formulations for clinical evaluation Process development Formulations for comparator studies Commercial formulation development 34
NCE Product Development - Capabilities Clinical Trials Supplies Manufacturing and Packaging:  Process optimisation, scale-up and technology transfer  Clinical trials supplies manufacturing and release testing  NDA stability and registration batches  CMC documentation for IND submission Analytical Development:  Method development and validation  Cleaning method development and validation  Dissolution and drug release profiling  Forced degradation studies  Specification development  Stability studies per ICH guidelines 35
Clinical Trial (CT) Supplies Manufacturing  cGMP Manufacturing of CT supplies for Phase I, II and III.  Scales of 1/100, 1/10 and 1 in similar equipment.  Seamless scale-up and technology transfer to commercial site.  Drug product supplies for comparator trials (DB encapsulation).  Packaging for clinical studies, comparator trials and commercial supplies.  IND and NDA support documentation.  Experienced Product Development teams 36
Product Registration Support Support Includes:  Manufacturing, packaging and release testing of registration batches  Stability studies per ICH guidelines and monitoring  Process validation plan, protocol and validation reports  Documentation: • CMC for IND and NDA • Technical reports  Experienced PAI teams 37
NCE Product Development - Experience  Rapid prototyping for “quick” first time in human (FTIH) studies  Clinical product development integrating formula, process and analytical development minimizing costly reformulation o Solubilization Technology;  Nanoparticulate Formulations  Cyclodextrin-based Formulations o Injectables: Small volume parenterals Lyophilization o Cytotoxic Product Development; IV Oral o CMC for Regulatory Submission 38
Product Development Capabilities New Drug Delivery Systems 39
Drug Delivery Technologies Apart from standard oral solid dose formulations, specialized technology platforms and IP have been developed to target:  Delivery of drugs with tailored release profile  Combination product with multiple incompatible DS  Combination product with sequential release  Solubility, dissolution and bioavailability enhancement  Taste masking and stabilization 40 40
Novel Drug Delivery Systems (NDDS) - Capabilities • Explore drug delivery approaches for life cycle management (LCM) to enhance therapeutic outcome and improve patient compliance. • Delivery System Based: • Gastro-Retentive Systems • Colon Specific Drug Delivery systems • Small Drug particles • Solid-Lipid particles • Orally Disintegrating Tablets 41
Technologies practiced at Dr Reddy’s…..  Pellets/ beads  Gastro-retentive  Zein Coating  Muco-adhesive  Combination product  Liquid API in solid dosage form  Nanotechnology  Cyclodextrin Complexes  ODT  Ion exchange resins  Ultra sound particle sizing 42 42
Dosage Forms Commercial Manufacturing Sites • FTO 1 - Bollaram, Hyderabad • FTO 2 - Bachupalli, Hyderabad Vyzag Hyderabad • FTO 3 - Bachupalli, Hyderabad Yanam including R/D and pilot plant • FTO 4 - Yanam Baddi • FTO 5 - Recently divested • FTO 6 - Baddi (started up April 1 2006) • FTO 7 - Vishakapatanam ~800km from Hyderabad (Vyzag) 43
FTO-3 Capabilities Main site for the development and manufacturing of standard oral dosage forms and specialized dosage forms Modular concept - All batches follow linear flow movement and one product at a time Total of 11 modular manufacturing suites: •9 Modules for Tablet Manufacturing ~ 4’750 mn units/year •2 Modules for Hard Gelatin Capsules Manufacturing ~ 650 mn units/year •3 Pilot Plants (10 suites + 2 pkg) Integrated development services 44
Processes and Equipments: Fully aligned from Laboratory to Pilot Scale Process Equipment Make Capacity Solubilization Bead Mill Netzsch 100 mL – 2 Ltr Labstar Granulation High Shear Kevin 100 mL – 250 Ltr Fluid Bed Glatt 1 Ltr – 125 Ltr Blending Double Cone and Adams 1 Ltr – 425 Ltr Octagonal Compression Rotary Compression Cadmach 8 – 20 Station Press Pelletization Extruder Fuji Paudel 1 kg/hr – 20 kg/hr Spheroidizer Fuji Paudel 1 kg – 2.5 kg Drug Layering Glatt 150 g – 35 kg Coatings (Tablets Side Vented Pans Gansons 500 g – 30 kg / lot and Pellets) Fluid Bed (Wurster) Glatt 1 Ltr – 125 Ltr Coater Capsule Filling Tamp Filling Machine PAM 5 K/hr – 40 K/hr Lyophilization Lyophilizer Vertis 200 – 2000 vials Spray Drying Spray Dryer Buchi / Hemraj 100 mL – 5 Ltr / hr 45 45
Granulation, Blending and Tablet Manufacturing Capabilities Different batch sizes (20 kg – 1800 kg) Granulation (low and high shear, FBP) Aqueous-based Solvent-based (x-proof) Blending (60 L to 5000 L) Compression: Sejong, Cadmach, Manesty (8 – 75 stations), bi-layer- tablets Coating: Accela-cota equivalent (24’’ up to 66” from 15 kg – 450 kg) Fluidized Bed Coating (125 to 500 Liters) Aqueous coating (Functional and non-functional coating) Organic solvent-based coatings 46
Capsule Manufacturing • Different Batch Size • Bead Manufacturing (Pelletization or non pareil seeds, dry powder loading). • Fluid Bed Drying (15 kg – 300 kg) • Blending (60 L – 5000 L) • Coating (24’’ up to 66” from 15 kg – 450 kg) • Encapsulation tamping and dosator - from 40 K/hour up to 120 K/hour 47
Dosage Forms Primary Packaging Conversion of dosage forms to finished packs of HDPE Bottles, Blisters (PVC/Alu, PVC-PVdC/Alu, Alu-Alu, including cold form, PVC/ACLAR or Aluminium Pouches Total of 10 Lines  4 Bottle Lines  6 Blister-cartonators 48
Dosage Form Secondary Packaging Capabilities Automated equipment designed and constructed as per cGMP requirements BossPack (Aus), Swiftpack(UK), Countec (Korea) BQS, BP-602, Cartonator (IMA) 49
Highly Potent Formulation Facility • Will comply with USFDA and MHRA requirements • Containment practiced through Air Handling, Pressure Zoning, Isolators and Personal Protective Equipment • Three modules for • Hormonal Tablets – 40 mn units/yr • Cyto Capsules – 15 mn units/yr • Cyto Injectable (Liquid/Lyophilized) – 3 mn units/yr • Being commissioned 50
Project Execution 51
Well Knit Support Structure Regulatory Affairs QA Supply Chain Management Planning QC Project Management Capacity & Infrastructure Process & Production Formulation R&D 52
Confidentiality • Global Standards practiced for Confidential Disclosure Agreements • IP ownership and rights clearly defined at project initiation • Complete data protection for customers. Firewalls within various Project Teams • Non disclosure and confidentiality agreement executed by all employees • ISO 27001:2005 certified for information security management © 53
R&D Support for R&D Work CHEMISTRY FORMULATION 350 Chemists and Engineers across 3 Preformulation centers Analytical & Bioanalytical Access to Kilo-Labs for piloting development Multiple Analytical Labs for process Formulation development research support Pilot scale-up DSC/TG, GC/LC-MS, LC-MS-MS, LC-MS/MS, Prep-HPLC, Capillary-HPLC, powder XRD, single crystal XRD, NMR, GC, FTIR, NIR, p-XRD, Photo Stability LC-NMR, FT-IR, CHN analyzer, ICP-MS Chamber , Dissolution Apparatus (Type I, II, III & IV) 54
Project Path – Functional Involvement Feasibility Optimization Hazop Studies Lab Validation Piloting Trial Production Comm. Production R&D AR&D PE QA QC MFG 55
Communication Process  Project manager is single point of contact  Communication between functional departments of CPS & clients  Regular e-mail updates & periodic progress reports  Use of web-based communication channels like Groove  Weekly / Fortnightly teleconferences & videoconferences  Face to face meetings  Proactive communication of deviations for joint problem solving  Campaign reports  Reduces re-work leading to better control on cost, quality and time  Establishes strong customer orientation 56
Uniquely Positioned to meet pharma challenges… Assets (Dossiers, DMFs, IP, Manufacturing) Life Cycle Mgmt Service Portfolio Mgmt Niche Orientation Capabilities Tech-Transfer Niche Offerings 57
CPS uniquely poised to meet pharma challenges… 58
…By leveraging organizational strengths 59
CPS Group in Dr. Reddy’s – A Summary • Wide experience and use of several Technology solutions • Breadth of experience in process R&D, scale-up and commercial contract manufacturing • Intellectual property managed as per global standards • Well-trained man power, quality systems and excellent infrastructure • Well-versed with API & Formulation development, scale up, technology transfer, Regulatory requirements and CMC Documentation needs Our Value Proposition: Excellent speed and cost advantage without compromising quality 60
For more information or to discuss your specific interest please contact: Christian Jones European Sales and Business Development Manager Dr Reddy’s CPS ChiroTech Technology Limited, 410 Cambridge Science Park, Cambridge, UK CB4 0PE T:+44(0)1223 728 030 M:+44(0)7827 157 247 E: cjones@drreddys.com 61

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Dr Reddys Cps Presentation Linked In Aug 2011

  • 1.
    Rising to thePharma Challenge Introduction to CPS (Custom Pharmaceutical Services) For LinkedIn Christian Jones European Sales & Business Development Manager 30-Aug-11 1
  • 2.
    Content  Corporate Overview Custom Pharmaceutical Services (CPS) Overview  API – Development Capabilities  API – Commercial Manufacturing  Dosage Form Capabilities  Project Execution 2
  • 3.
    Corporate Overview Purpose: “Providing affordableand innovative medicines for healthier lives” Strategy: Leverage industry-leading science & technology, product offering, and customer service with execution excellence to provide affordable and innovative medicines for healthier lives. 3
  • 4.
    Dr. Reddy’s Today BusinessMix Size •Pharma Services & Active •FY11 ~ $1.7 Billion in revenues Ingredients contributing 1/3rd of revenues Business Size •Global Generics contributing Mix balance 2/3rd •Proprietary products business in incubation mode $1.7 BN People & Infrastructure Product Portfolio •14,000+ employees; ~ 2,000 in •100+ APIs, 150+ Finished in international workforce Dosages Infra Product •20 Billion units in finished structure Portfolio •2 biosimilars launched in India dosage manufacturing •69 ANDAs pending approval capacities •200+ DMFs filed globally •16 manufacturing facilities (9 Chemicals, 6 Finished Dosages •8 biosimilars in development & 1 Biologics) •Over 200 projects under development 4
  • 5.
    Our Businesses Pharmaceutical Global Proprietary Services and Active Products Ingredients Generics • Active Pharmaceutical • Biologics • NA Ingredients • Specialty Pharmaceuticals • Custom Pharmaceutical • EU (Germany, UK) Services (CPS) • India, Russia, Ukraine/CIS & Venezuela 5
  • 6.
    The Last Decade: AchievedScale and Global Presence Built the foundations for a strong business. Moved up the value chain. Strengthened capabilities. Achieved scale and global presence. Growth aided by acquisitions. 1800 379 1,700 EBITDA ($ Mn) 1600 1,563 1,510 243 1400 1,365 351 369 1,250 121 285 1200 94 75 68 37 50 26 1000 FY00 FY02 FY04 FY06 FY08 FY10 800 600 546 463 447 380 400 338 234 183 200 0 FY00 FY01 FY02 FY03 FY04 FY05 FY06 FY07 FY08 FY09 FY10 FY11 6
  • 7.
    Strong Product DevelopmentPlatform Strong and Growing Pipeline Segment Pipeline Total Filings 126 (including partnered ANDAs) Pending ANDAs 69 (including partnered ANDAs) US DMFs 176 EU DMFs 78 European Products >60 (pending registration) Dossiers 150+ pending registration (Rest Of the World) Specialty (US 3 ready to market products + Dermatology) several others in development Biologics 8 in development 7
  • 8.
    Track Record 2010 Agreement for acquisition of GSK’s Penicillin Facility (USA) 2009 Partnership deal with GSK in emerging markets 2008 Acquisition of BASF facility at Shreveport, US Aquisiton of Dowpharma Small Molecules business associated with 2008 Dow’s Mirfield and Cambridge, UK Sites World’s first biosimilar monoclonal anti-body ,Reditux (rituximab) 2007 launched 2008 2007 Fastest Indian Pharma Company to cross $1billion in annual revenue 2007 2006 1st Indian manufacturing company to be Sarbanes-Oxley certified 2006 2006 1st authorized generic deal with multinational pharma 2005 2001 2006 Key acquisition betapharm (Germany) 1997 2005 Key acquisition “Falcon” (Mexico) 1993 1st Indian pharma company to be listed on the New York Stock 2001 Exchange 1997 1st Indian company to out-license an NCE to a multinational pharma 8
  • 9.
    Care for Environmentand Society Triple Bottom Line Approach… Society • Dr.Reddy’s Foundation – Livelihoods & Education Communities • Community Development– Health/Education/Livelihoods/Employability • Patient Assistance Programs & DRHFE Business Operations • Employee Engagement- Volunteer Program & Power of Ten • Environment: ISO 14001 & OHSAS 18001certified facilities; Zero Liquid Discharge & SHE technologies Core Purpose • Customer: FDA approved, Product safety (Pharmcovigilance) • Suppliers: Vikreta- B2B portal,GBS • Corporate Governance • Employees: Policies / Talent Mgmt Board / Leadership dev/ BPE To help people lead healthier lives through Access & Affordability 9
  • 10.
    Achievements Aon-Hewitt 25 best Employers in India 2011 Dun & Bradstreet American Express Business Leader in the Pharmaceutical Sector Corporate Awards 2007 Pharma Excellence Awards 2006-07 for Forbes 2010 Asia Fab 50 companies 2011 sustained Growth First time featured on the list The Indian Express Best Corporate Social Responsibility Initiative Asia-Pacific HRM Congress 2007 2007 Global HR Excellence Award for Innovative HR BSE - India Practices 10
  • 11.
    Overview – CustomPharmaceutical Services 11
  • 12.
    Background  One ofthe largest Custom Pharma businesses from India  End-to-end capabilities Discovery Process Clinical Commercial Chemistry Development Development Launch Process Intermediates Intermediates Development APIs & APIs & Kilolab Dosage Commercial quantities Supplies for drug product clinical trials  3 dedicated R&D facilities (2 in Hyderabad and 1 in Cambridge)  Broad Client Base: 39%  Large Pharma – 10+  Mid Sized Pharma – 5+  Emerging Pharma and Biotech – 30+ 12
  • 13.
    Custom Pharmaceutical Services To be the preferred supplier of APIs, Intermediates and Formulations to ‘Innovators’ worldwide Delivering cost-effective and cGMP compliant products and services Managing intellectual property consistent with Global standards Emphasizing safety, health and environment cGMP Speed Competitive Innovation Pricing 13 13
  • 14.
    History 2003 2004 2005 2006-7 2008-10 Expanded Acquired Dow Technology Initiated customer base Pharma’s technology Acquired Development contracts with to about 30 platforms and facility Business Roche’s Centre Big Pharma with several in the UK, BASF Facility in commissioned repeat business Dosage site in the Mexico. US. Manpower 70 110 800 950 Focus on API Integrated offer Offer contract Offer niche Services Development of services with Development & technology and scale up Dosage Form Manufacture of solutions in Development Niche API’s (High complex Chiral and Supplies Potent - Cytotoxic, molecules, PEG’s, Hormonal etc) Peptides, prostaglandins, carbohydrates 14
  • 15.
    Custom Pharmaceutical Services AGlobal Organization Custom Pharmaceutical Services Sales & Marketing Technology Dev. Centers Manufacturing North America R&D Chemical Plants Hyderabad, India Hyderabad, India Cambridge, UK Cuernavaca, Mexico Europe Mirfield, UK Pilot Plant Asia Pacific Hyderabad, India Formulation Plants Mirfield, UK Hyderabad, India Louisiana, USA 15
  • 16.
    CPS Value Proposition Technology: Cost-effective: ► Chiral Capabilities – Chemo and Bio Catalysis ► Geographic advantage ► PEGylation Technology ► Fit-to-purpose scale of production ► Continuous Processing ► Global supply chain ► Steroid and HPAI capabilities ► Carbohydrate Chemistry (Ex.Fondaparinux) Track Record & Quality: ► Traditional Chemistry ► Large base of customers with several ► Peptide, Prostaglandins & Oligo building blocks repeat business ► High quality products and services Manufacturing & Security of Supply: ► Corporate philosophy supports global ► Extensive, flexible capacity markets ► Geographical versatility -India/UK/Mexico ► cGMP compliant, USFDA inspected ► Large portfolio of DMF’s available off the shelf facilities ► More than 100 tech transfers of ► ISO 27001 certification (IP and Innovator projects Documentation standard) ► Competent technical staff ► Dedicated project management teams through product life cycle 16 16
  • 17.
    API – ProductDevelopment Capabilities 17
  • 18.
    Technology Development Center(Hyderabad, IN) Dedicated R&D facility for CPS with ~300 chemists and engineers Kilo Lab / Pilot Plant with about 10,000 sq ft Class 100,000 clean room Discovery Chemistry & Process R&D 21 Chemistry Labs 5 Analytical Labs Class 100, 000 Cytotoxic suite 18 18
  • 19.
    Analytical Capabilities Method development and validation Impurity profile: Established expertise in isolation, identification and characterization Certified, qualified and validated equipment: DSC/TG, GC/LC-MS, LC-MS- MS, powder XRD, single crystal XRD, NMR, LC-NMR, FT-IR, CHN analyzer 19 19
  • 20.
    Technology Development Center(Cambridge, UK) Biocatalysis • Discovery and development of Industrial biocatalysts and their application in bio-catalytic manufacture of fine chemical intermediates • In-house culture collection of more than 2000 microorganisms in 96 well plate format Chemocatalysis Mirfield • Technologies with utility in large scale manufacturing • World leader in asymmetric hydrogenation • Other capabilities for fine chemical applications such as Cambridge • Achiral • Asymmetric hydro-formylation Complex Synthesis • Have experience of more than 120 customer projects over the last 12 years • Capability to develop efficient processes to manufacture complex target molecules including • Sugars • Prostoglandin analogues • Oxa-prostoglandins 20 20
  • 21.
    Activated PEG Offering ► mPEG-X –Linear architecture –Molecular Weights: 5, 10, 20, 30, 40, 60 kDa –Narrow polydispersity –Low levels of difunctional PEG: < 1-5% depending on MW ► Functional Groups –p-nitrophenyl carbonate –propionaldehyde –Maleimide –Amine ► Custom PEGs 21 21
  • 22.
    API – CommercialManufacturing Capabilities 22
  • 23.
    API Production Facilities- India Six commercial production units – All inspected by USFDA Six Pilot Plants, Two Kilo Labs Over 2 million liters of reaction volume Over 500 GL and SS reactors that can handle temperature range of –75 to 300 oC Operations fully integrated through SAP and global supply chain practices 23 23
  • 24.
    Highly Potent APIProduction Blocks - India Contained Blocks 1&2: ► Fully contained cGMP compliant facility ► Range of reactor capacity – 63 L to 630 L, 250 L to 2000 L ► Occupational Exposure Limits (OEL) 0.2µg/m3 for 8 h TWA ► Containment practiced through Air Handling, Pressure Zoning, Isolators and Personal Protective Equipment 24 24
  • 25.
    API Manufacturing Network:India CTO IV – 1984 CTO V – 1987 CTO III – 1995 Vizag Hyderabad Miryalguda CTO II – 1986 CTO VI – 1990 CTO I – 1985 25
  • 26.
    Regulatory Experience Type Number USDMF 176 EDMF 78 CEP 22 Canada 51 Japan 18 Korea 23 China 14 Turkey 12 Singapore 5 26
  • 27.
    USFDA Inspections Unit Date Unit Date Unit II & III March 2003 Unit IV November 1987 Unit VI May 2004 Unit IV March 1996 Unit V March 2005 Unit V March 1997 Unit I & II Nov 2005 Unit I & IV June 1999 Unit III & IV March 2007 Unit II, III & VI February 2000 Unit VI April 2008 Unit V November 2000 Unit I & Unit 5 Feb 2009 Unit IV November 2002 Unit III September 2010 27 27
  • 28.
    API Production Facilities– Cuernavaca, Mexico USA Mexico City Toluca Belize Cuernavaca Guatemala 28
  • 29.
    Quality Centre Incinerator Main Tank Farm Offices Warehouses Utilities Production 29
  • 30.
    API Production Facilities– Cuernavaca, Mexico Installed production capacity : 3350 MT 7 Reactor Bays with reactor volume ranging from 100L to 20KL 1000L and 3000L Cryogenic reactors capable of -110 oC 20 Steroidal API’s and several Steroid Intermediates currently produced Unit audited by FDA 125 Multi-disciplinary professionals • 25 post-graduates (Ph.D. and Masters) • 100 graduates (chemists, engineers, accountants) 30 30
  • 31.
    Product Lines -Mexico Facility Naproxen: • 32 Years of experience in producing Naproxen • Installed capacities: Naproxen & Naproxen Sodium – 1000+ TPA History of Supplying of Naproxen globally including USA, EU and Japan • Inspected & approved by USFDA Steroids: • Expertise in development of NCE steroids • Dedicated, refurbished bay at a cost of ~ $29 M • 3 Flexible manufacturing trains • Containment for Offloading & Milling • Class 100,000 • More than 20 DMF’s, 80% on exclusive basis on behalf of customers 31
  • 32.
  • 33.
    Seamless Formulation Services Coveringthe Entire Product Development Chain Analytical Preformulation Formulation CT Commercial Development Development Development Manufacturing Manufacturing Preclinical Clinical Supply Market Launch • Preformulation • Analytical and Bioanalytical Development • Formulation Development • Pilot Scale-up • Clinical Trial (CT) Supplies Manufacturing • Commercial Scale Contract Manufacturing 33
  • 34.
    NCE Product Development- Capabilities Preformulation Studies: Solution stability studies Chemical Physical properties Solid-state characterization Solubility and reactivity and forced degradation studies Formulation Development; Formulation development for safety assessment studies Prototype formulations for clinical evaluation Process development Formulations for comparator studies Commercial formulation development 34
  • 35.
    NCE Product Development- Capabilities Clinical Trials Supplies Manufacturing and Packaging:  Process optimisation, scale-up and technology transfer  Clinical trials supplies manufacturing and release testing  NDA stability and registration batches  CMC documentation for IND submission Analytical Development:  Method development and validation  Cleaning method development and validation  Dissolution and drug release profiling  Forced degradation studies  Specification development  Stability studies per ICH guidelines 35
  • 36.
    Clinical Trial (CT)Supplies Manufacturing  cGMP Manufacturing of CT supplies for Phase I, II and III.  Scales of 1/100, 1/10 and 1 in similar equipment.  Seamless scale-up and technology transfer to commercial site.  Drug product supplies for comparator trials (DB encapsulation).  Packaging for clinical studies, comparator trials and commercial supplies.  IND and NDA support documentation.  Experienced Product Development teams 36
  • 37.
    Product Registration Support SupportIncludes:  Manufacturing, packaging and release testing of registration batches  Stability studies per ICH guidelines and monitoring  Process validation plan, protocol and validation reports  Documentation: • CMC for IND and NDA • Technical reports  Experienced PAI teams 37
  • 38.
    NCE Product Development- Experience  Rapid prototyping for “quick” first time in human (FTIH) studies  Clinical product development integrating formula, process and analytical development minimizing costly reformulation o Solubilization Technology;  Nanoparticulate Formulations  Cyclodextrin-based Formulations o Injectables: Small volume parenterals Lyophilization o Cytotoxic Product Development; IV Oral o CMC for Regulatory Submission 38
  • 39.
    Product Development Capabilities New Drug Delivery Systems 39
  • 40.
    Drug Delivery Technologies Apartfrom standard oral solid dose formulations, specialized technology platforms and IP have been developed to target:  Delivery of drugs with tailored release profile  Combination product with multiple incompatible DS  Combination product with sequential release  Solubility, dissolution and bioavailability enhancement  Taste masking and stabilization 40 40
  • 41.
    Novel Drug DeliverySystems (NDDS) - Capabilities • Explore drug delivery approaches for life cycle management (LCM) to enhance therapeutic outcome and improve patient compliance. • Delivery System Based: • Gastro-Retentive Systems • Colon Specific Drug Delivery systems • Small Drug particles • Solid-Lipid particles • Orally Disintegrating Tablets 41
  • 42.
    Technologies practiced atDr Reddy’s…..  Pellets/ beads  Gastro-retentive  Zein Coating  Muco-adhesive  Combination product  Liquid API in solid dosage form  Nanotechnology  Cyclodextrin Complexes  ODT  Ion exchange resins  Ultra sound particle sizing 42 42
  • 43.
    Dosage Forms CommercialManufacturing Sites • FTO 1 - Bollaram, Hyderabad • FTO 2 - Bachupalli, Hyderabad Vyzag Hyderabad • FTO 3 - Bachupalli, Hyderabad Yanam including R/D and pilot plant • FTO 4 - Yanam Baddi • FTO 5 - Recently divested • FTO 6 - Baddi (started up April 1 2006) • FTO 7 - Vishakapatanam ~800km from Hyderabad (Vyzag) 43
  • 44.
    FTO-3 Capabilities Main sitefor the development and manufacturing of standard oral dosage forms and specialized dosage forms Modular concept - All batches follow linear flow movement and one product at a time Total of 11 modular manufacturing suites: •9 Modules for Tablet Manufacturing ~ 4’750 mn units/year •2 Modules for Hard Gelatin Capsules Manufacturing ~ 650 mn units/year •3 Pilot Plants (10 suites + 2 pkg) Integrated development services 44
  • 45.
    Processes and Equipments: Fullyaligned from Laboratory to Pilot Scale Process Equipment Make Capacity Solubilization Bead Mill Netzsch 100 mL – 2 Ltr Labstar Granulation High Shear Kevin 100 mL – 250 Ltr Fluid Bed Glatt 1 Ltr – 125 Ltr Blending Double Cone and Adams 1 Ltr – 425 Ltr Octagonal Compression Rotary Compression Cadmach 8 – 20 Station Press Pelletization Extruder Fuji Paudel 1 kg/hr – 20 kg/hr Spheroidizer Fuji Paudel 1 kg – 2.5 kg Drug Layering Glatt 150 g – 35 kg Coatings (Tablets Side Vented Pans Gansons 500 g – 30 kg / lot and Pellets) Fluid Bed (Wurster) Glatt 1 Ltr – 125 Ltr Coater Capsule Filling Tamp Filling Machine PAM 5 K/hr – 40 K/hr Lyophilization Lyophilizer Vertis 200 – 2000 vials Spray Drying Spray Dryer Buchi / Hemraj 100 mL – 5 Ltr / hr 45 45
  • 46.
    Granulation, Blending andTablet Manufacturing Capabilities Different batch sizes (20 kg – 1800 kg) Granulation (low and high shear, FBP) Aqueous-based Solvent-based (x-proof) Blending (60 L to 5000 L) Compression: Sejong, Cadmach, Manesty (8 – 75 stations), bi-layer- tablets Coating: Accela-cota equivalent (24’’ up to 66” from 15 kg – 450 kg) Fluidized Bed Coating (125 to 500 Liters) Aqueous coating (Functional and non-functional coating) Organic solvent-based coatings 46
  • 47.
    Capsule Manufacturing • DifferentBatch Size • Bead Manufacturing (Pelletization or non pareil seeds, dry powder loading). • Fluid Bed Drying (15 kg – 300 kg) • Blending (60 L – 5000 L) • Coating (24’’ up to 66” from 15 kg – 450 kg) • Encapsulation tamping and dosator - from 40 K/hour up to 120 K/hour 47
  • 48.
    Dosage Forms PrimaryPackaging Conversion of dosage forms to finished packs of HDPE Bottles, Blisters (PVC/Alu, PVC-PVdC/Alu, Alu-Alu, including cold form, PVC/ACLAR or Aluminium Pouches Total of 10 Lines  4 Bottle Lines  6 Blister-cartonators 48
  • 49.
    Dosage Form SecondaryPackaging Capabilities Automated equipment designed and constructed as per cGMP requirements BossPack (Aus), Swiftpack(UK), Countec (Korea) BQS, BP-602, Cartonator (IMA) 49
  • 50.
    Highly Potent FormulationFacility • Will comply with USFDA and MHRA requirements • Containment practiced through Air Handling, Pressure Zoning, Isolators and Personal Protective Equipment • Three modules for • Hormonal Tablets – 40 mn units/yr • Cyto Capsules – 15 mn units/yr • Cyto Injectable (Liquid/Lyophilized) – 3 mn units/yr • Being commissioned 50
  • 51.
  • 52.
    Well Knit SupportStructure Regulatory Affairs QA Supply Chain Management Planning QC Project Management Capacity & Infrastructure Process & Production Formulation R&D 52
  • 53.
    Confidentiality • Global Standardspracticed for Confidential Disclosure Agreements • IP ownership and rights clearly defined at project initiation • Complete data protection for customers. Firewalls within various Project Teams • Non disclosure and confidentiality agreement executed by all employees • ISO 27001:2005 certified for information security management © 53
  • 54.
    R&D Support forR&D Work CHEMISTRY FORMULATION 350 Chemists and Engineers across 3 Preformulation centers Analytical & Bioanalytical Access to Kilo-Labs for piloting development Multiple Analytical Labs for process Formulation development research support Pilot scale-up DSC/TG, GC/LC-MS, LC-MS-MS, LC-MS/MS, Prep-HPLC, Capillary-HPLC, powder XRD, single crystal XRD, NMR, GC, FTIR, NIR, p-XRD, Photo Stability LC-NMR, FT-IR, CHN analyzer, ICP-MS Chamber , Dissolution Apparatus (Type I, II, III & IV) 54
  • 55.
    Project Path –Functional Involvement Feasibility Optimization Hazop Studies Lab Validation Piloting Trial Production Comm. Production R&D AR&D PE QA QC MFG 55
  • 56.
    Communication Process  Project manager is single point of contact  Communication between functional departments of CPS & clients  Regular e-mail updates & periodic progress reports  Use of web-based communication channels like Groove  Weekly / Fortnightly teleconferences & videoconferences  Face to face meetings  Proactive communication of deviations for joint problem solving  Campaign reports  Reduces re-work leading to better control on cost, quality and time  Establishes strong customer orientation 56
  • 57.
    Uniquely Positioned tomeet pharma challenges… Assets (Dossiers, DMFs, IP, Manufacturing) Life Cycle Mgmt Service Portfolio Mgmt Niche Orientation Capabilities Tech-Transfer Niche Offerings 57
  • 58.
    CPS uniquely poisedto meet pharma challenges… 58
  • 59.
  • 60.
    CPS Group inDr. Reddy’s – A Summary • Wide experience and use of several Technology solutions • Breadth of experience in process R&D, scale-up and commercial contract manufacturing • Intellectual property managed as per global standards • Well-trained man power, quality systems and excellent infrastructure • Well-versed with API & Formulation development, scale up, technology transfer, Regulatory requirements and CMC Documentation needs Our Value Proposition: Excellent speed and cost advantage without compromising quality 60
  • 61.
    For more informationor to discuss your specific interest please contact: Christian Jones European Sales and Business Development Manager Dr Reddy’s CPS ChiroTech Technology Limited, 410 Cambridge Science Park, Cambridge, UK CB4 0PE T:+44(0)1223 728 030 M:+44(0)7827 157 247 E: [email protected] 61