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WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day. The Wockhardt Advantage. World-class Contract Manufacturing Organisation 40 years of experience ‘Full-Turnkey’ service from API production to packaging Network of 12 co-ordinated facilities in Europe, Asia, US

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WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

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  1. WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

  2. The Wockhardt Advantage • World-class Contract Manufacturing Organisation • 40 years of experience • ‘Full-Turnkey’ service from API production to packaging • Network of 12 co-ordinated facilities in Europe, Asia, US • (over 1.5 million sq ft high-quality manufacturing capacity) • Cost-effective services where and when you need them • Excellent project management skills • The experience of our key asset - people • 7,000+ strong team • 500 scientists, 150 PhDs

  3. The Wockhardt Advantage • Value-added services to make your life easier • Security of supply • Quality assured • Regulatory compliance • Financial stability & significant company growth • Breakthrough, rapid service • On-time delivery • Responsiveness • Cost-effective manufacturing • Special Economic Zones • low cost geographies • continuous process optimisation and improvement • Differentiates ‘you’ as our client

  4. Our Stability and Growth • Global market capitalization of $1.3 billion • A growth company +24% (CAGR Global – 2000 to 2007) • Our dedicated and established Contract Manufacturing Division is growing rapidly, in line with global initiatives • New investment in lyophilisation facilities • Lyophilisation upgrade in Wrexham, UK and in Aurangabad, India • Focus on our global capabilities to nurture and expand the business

  5. Our Stability and Growth – Acquisitions

  6. Our Know How – 4 Pillars • Our Manufacturing & Packaging • Our API Manufacturing • Our Services • Our People

  7. Our Know How - Manufacturing & Packaging • ‘Full-Turnkey’ service from API Manufacture to product distribution • 40+ clients • 70+ products delivered globally for Contract Manufacturing clients • Flexible, end-to-end service • Low volume clinical batches through to high volume commercial output • High quality • Fast turnaround

  8. Our Global Manufacturing Capabilities Click here for larger view

  9. Our Global Manufacturing Network UK India Ireland France USA All with state-of-the-art manufacturing facilities

  10. Our European Facilities Pinewood, Ireland MHRA/IMB Approval Specialised & Standard Dosage Forms Wrexham, UK MHRA/FDA Approval Lyophilisation, Sterile Injectables, Cartridges, Specialised & Standard Dosage Forms Quimper, France EMEA Approval Standard Dosage Forms

  11. Our Indian Facilities Site under qualification Biotech Park, Aurangabad MHRA/FDA ApprovalSterile Injectables Chikalthana, Aurangabad MHRA/FDA Approval Sterile Injectables, Specialised & Standard Dosage Forms Eou, Aurangabad MHRA/FDA Approval Specialised & Standard Dosage Forms SEZ, Aurangabad MHRA/FDA Approvable Completion end of 2008 Lyophilisation, Large and Small Volume Parenteral Injectables

  12. Our Indian Facilities Baddi, Himachal Pradesh MHRA/FDA Approval Specialised & Standard Dosage Forms Daman1, Bhimpore MHRA Approval Standard Dosage Forms Daman2, Kadaiya MHRA Approval Specialised & Standard Dosage Forms Waluj, Aurangabad MHRA/FDA Approval Sterile Injectables, Specialised Dosage Forms

  13. Our US Facility Morton Grove, Illinois FDA Approval Standard Dosage Forms

  14. Lyophilisation Liquids, Gels, Ointments & Creams Sachets & Powders Our Manufacturing Capabilities Sterile Injectables Specialised Products Solid Dose

  15. Sterile Injectables

  16. Sterile Injectables (SVP & LVP) • State-of-the-art technology • Aseptic procedures throughout • Partner of choice - major new patented US drug • Global scale biotechnology plant • Four-fold expansion of cartridge capacity • Volume capability by form: • Vials 2mL to 100mL (UK, Biotech Park, Waluj Cephalosporins) • Ampoules 1mL to 20mL (UK) • Ophthalmic Solutions, various sizes (Biotech Park) • Cartridges 1.2, 1.5, 2.7 & 3mL (UK, Biotech Park) • PFS 0.5 to 5mL (Biotech Park) • LVP 100mL to 500mL (Shendra - SEZ)

  17. Lyophilisation • Significant investment to upgrade our lyophilisation capabilities • Wrexham, UK upgrade from 10m2 to 100m2 capacity (+3 x 30m2 freeze driers) to be completed Qtr 2 2011 • Aurangabad, India upgrade to add 60m2 capacityto be completed early in 2009 • Purpose built, fully automated lyophilisation facilities • Both new facilities will be fully compliant with FDA and MHRA requirements • Vial sizes from 2mL to 100mL • Development & commercial scale manufacturing • Large scale permanent refrigerated storage

  18. Specialised Products

  19. Specialised Products • High potency products, non-beta-lactams and cytotoxics (UK, Daman Kadaiya) • Controlled drug handling authorisation (UK Home Office Schedule 1, Baddi, EoU, Chikalthana • MHRA ‘specials’ license for unlicensed products (UK) • Cephalosporins (Waluj)

  20. Solid Dose Products

  21. Solid Dose Products • Over twenty five years experience from small scale batches to high volume production • Manufacturing across 5 Indian facilities: • Plain/film/sugar coated tablets • Press coating (tablet in tablet) • Sustained release tablets (matrix/enteric coated and granules) • Sustained release capsules(coated granules/wurster coating) • Combined formulations • Bi layer tablets • Effervescent tablets

  22. Sachets and Powders

  23. Sachets and Powders • State-of-the-art facility acquired: Pinewood, Ireland, employing 350+ people • Non-beta-lactam (penicillin) sachets • Chikalthana • Negma Laboratories, France • Non-beta-lactam powders • Chikalthana • Pinewood

  24. Liquids, Gels, Ointments and Creams

  25. Liquids, Gels, Ointments and Creams • Long standing expertise in the formulation of semi-solids • Recently acquired facility, Morton Grove, US, for oral and topical liquid formulations • Recently acquired facility, Pinewood, Ireland, expanded Wockhardt's production capabilities by 50 million finished packs per year

  26. Packaging • Flexibility to customise primary and secondary packaging options in accordance with client requirements • Inspection and Packaging capabilities include: • fully automatic and semi-automatic visual inspection methods • automatic leak detection • high speed labelling • PVC tray thermoforming & cartoning • Quality Assurance packaging and labelling controls

  27. Our Know How - API Manufacturing • FDA and MHRA approved, cGMP compliant API manufacturing facility • Multipurpose plant manufactures several products at a time • State-of-the-art facility dedicated to cephalosporin APIs • Flexible manufacture - high value/low volume products through to high volume • Excellent history of precise and timely project implementation • Equilibrium between low cost and high value-added work

  28. Our Know How - API Manufacturing • 150+ APIs developed to date, 50+ in the last 3 years • 30+ DMFs filed during the last 3 years • 70+ R&D scientists, with 20+ PhDs • Supported by a dedicated analytical group of 40 scientists, with 5 PhDs • High pressure, high temperature (to 250ºC) & low temperature (to -70ºC) reactions handled • Macrolide production

  29. Our Know How - Services Bulk Drug Substance Analytical Method Development Pre-formulation Formulation Development Commercial Manufacturing Scale Up & Validation Tech Transfer Clinical Trial Materials Manufacturing Registration Stability

  30. Our Know How - Services Our highly responsive CM team are experts in: • Drug Development & Analytical support • Manufacturing • Quality Assurance & Quality Control • Regulatory Compliance • Logistics • Planning • Engineering • Purchasing Business & Project Management Technical Development Scale-up and Technology Transfer

  31. Our Know How - Business & Project Management • Projects are managed by our dedicated UK-based Contract Manufacturing team, fully supported by local teams at each facility. UK Headquarters provides: • Access and proximity to US/EU clients • Co-ordination of time zones • Understanding of US/EU regulatory, quality and IP standards • Business & Project Managers are the window to our company • Work closely with development and operational groups to ensure your timelines are met • Responsible for ensuring communication is consistent and effective throughout the project life cycle and beyond

  32. Our Know How - Business & Project Management • Key responsibilities include: • Overall project management and collaboration • Ensuring client timelines and budget are achieved • Speedy response to questions and enquiries • Robust and effective process achievements to support clients supply chain needs • Cost saving initiatives

  33. Our Know How - Technical Development • Focus on the commercialisation of your productfor fast market placement • Optimisation of your molecule's developmentin line with marketing and time-line requirements • Synchronisation of formulation development withprocess and analytical requirements Pre-Formulation & Formulation Development services: • Characterisation of physical properties • Chemical reactivity and forced degradation studies • Excipient compatibility studies • Preliminary process identification • Commercial formulation development • Process development optimisation

  34. Our Know How - Technical Development • Fast development of validation methods to meet testing requirements • In-house global analytical development capabilities • Molecule stability and scalability optimised to provide constant method utilisation Analytical Development services: • Molecule characterisation • Method development and validation • Cleaning residuals development and validation • Dissolution and drug release profiling • Forced degradation studies • Specifications development • Stability monitoring to ICH guidelines

  35. Our Know How - Scale-up and Technology Transfer Our process is second to none in delivering exceptional quality • Robust • Repeatable • Meets and exceeds predefined acceptance criteria • Meets and improves on pre-defined timelines • Meets pre-defined costs Our average time to completion of Technology Transfer is six months – we’ve even completed some projects in just two

  36. Our Quality Assurance • Validated document management system • Regulatory submission support (CMC) • Production and process system controls • Vendor and material management • Quality improvement via continuous audits • Quality management review, internally and by client • Corrective/preventative action • Internal self-assessment audits • Qualified Person product release to client

  37. Our Quality Control • Analytical Laboratory • Raw material testing • In-process and finished product testing • Stability storage and testing • Cleaning validation and testing • Microbiology Laboratory • Environmental monitoring • Water (for injection) and critical systems testing • Validation support testing • Sterility, bio-burden and endotoxin testing

  38. Why Wockhardt? - Your Partner of Choice • Proven ability to manage long-term supply contracts • Understand the importance of quality and reliability • Understand the dynamics of being a service provider • Proven financial performance and stability • Ability to manage growth and integrate operations • Ability to maximise your cost efficiency • Flexible global operations keep costs highly competitive From quality-driven processes to proven problem-solving strategies, our end-to-end service is redefining Contract Manufacture

  39. Why Wockhardt? - Our People Our extraordinary service is down to our experienced team who excel every day • 7,000+ Employees world-wide • Insight and Experience – Senior scientific staff bring an average of 15 years experience to your projects • Knowledgeable • Responsive • Professional • At the centre of our success

  40. Our Promise We’ll work in partnership with you to deliver outstanding quality products, efficiently and reliably through a highly responsive and flexible service at a very competitive cost in a shorter than industry-standard time period

  41. Any Questions? Because there are some people in business you can’t afford to ignore

  42. WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

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