WORLD-CLASS%20CONTRACT%20MANUFACTURING%20ORGANISATION

1
(No Transcript)
2
(No Transcript)
3
(No Transcript)
4
(No Transcript)
5
(No Transcript)
6
(No Transcript)
7
(No Transcript)
8
(No Transcript)
9

• WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION
• Extraordinary service every day

10
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

11
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

12
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

13
Our Stability and Growth Acquisitions
14
Our Know How 4 Pillars

• Our Manufacturing Packaging
• Our API Manufacturing
• Our Services
• Our People

15
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

16
Our Global Manufacturing Capabilities
Click here for larger view
17
Our Global Manufacturing Network
UK India Ireland France USA
All with state-of-the-art manufacturing facilities
18
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
19
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
20
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
21
Our US Facility
Morton Grove, Illinois FDA Approval Standard
Dosage Forms
22
Our Manufacturing Capabilities
Sterile Injectables
Specialised Products
Solid Dose
23
Sterile Injectables
24
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)

25
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

26
Specialised Products
27
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)

28
Solid Dose Products
29
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

30
Sachets and Powders
31
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

32
Liquids, Gels, Ointments and Creams
33
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

34
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

35
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

36
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 RD 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

37
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
38
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

39
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

40
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

41
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

42
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

43
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

44
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

45
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

46
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
47
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

48

• 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

49
Any Questions?

• Because there are some people in business you
  cant afford to ignore

50

• WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION
• Extraordinary service every day

51
(No Transcript)