WORLDCLASS 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 – (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 Ph. Ds

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

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

Our Stability and Growth – Acquisitions

Our Know How – 4 Pillars = = Our Manufacturing & Packaging Our API Manufacturing Our Services Our People

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

Our Global Manufacturing Capabilities Click here for larger view

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

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

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

Our Indian Facilities Baddi, Himachal Pradesh Daman 1, Bhimpore Daman 2, Kadaiya Waluj, Aurangabad MHRA/FDA Approval Specialised & Standard Dosage Forms MHRA Approval Specialised & Standard Dosage MHRA/FDA Approval Sterile Injectables, Specialised Dosage Forms

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

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

Sterile Injectables

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 2 m. L to 100 m. L (UK, Biotech Park, Waluj Cephalosporins) – Ampoules 1 m. L to 20 m. L (UK) – Ophthalmic Solutions, various sizes (Biotech Park) – Cartridges 1. 2, 1. 5, 2. 7 & 3 m. L (UK, Biotech Park) – PFS 0. 5 to 5 m. L (Biotech Park) – LVP 100 m. L to 500 m. L (Shendra - SEZ)

Lyophilisation = Significant investment to upgrade our lyophilisation capabilities – Wrexham, UK upgrade from 10 m 2 to 100 m 2 capacity (+3 x 30 m 2 freeze driers) to be completed Qtr 2 2011 – Aurangabad, India upgrade to add 60 m 2 capacity to 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 2 m. L to 100 m. L = Development & commercial scale manufacturing = Large scale permanent refrigerated storage

Specialised Products

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

Solid Dose Products

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

Sachets and Powders

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

Liquids, Gels, Ointments and Creams

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

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

Our Know How - API Manufacturing = FDA and MHRA approved, c. GMP 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

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+ Ph. Ds = Supported by a dedicated analytical group of 40 scientists, with 5 Ph. Ds = High pressure, high temperature (to 250ºC) & low temperature (to -70ºC) reactions handled = Macrolide production

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

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

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

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

Our Know How - Technical Development = Focus on the commercialisation of your product for fast market placement = Optimisation of your molecule's development in line with marketing and time-line requirements = Synchronisation of formulation development with process 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

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

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

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

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

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

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

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

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

WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day