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 PhDs

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

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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
MHRA/FDA Approval Sterile 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

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

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 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)

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 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 2mL to 100mL 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, EoU, 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, 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

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 250C) & low temperature (to -70C) reactions handled

Macrolide production

Our Know How - Services

Bulk Drug Substance

Analytical Method Development

Pre-formulation

Formulation Development

Scale Up & Validation Tech Transfer

Commercial Manufacturing

Clinical Trial Materials Manufacturing

Registration Stability

Our Know How - Services

Business & Project Management Technical Development Scale-up and Technology Transfer

Our highly responsive CM team are experts in:

Drug Development & Analytical support Manufacturing Quality Assurance & Quality Control Regulatory Compliance Logistics Planning Engineering Purchasing

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 weve 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
Well 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 cant afford to ignore

WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION

Extraordinary service every day