Transcript Document

WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION
Extraordinary service every day
The Wockhardt Advantage
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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
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Our Manufacturing & Packaging
Our API Manufacturing
Our Services
Our People
Our Know How - Manufacturing & Packaging
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‘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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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
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
Daman1, Bhimpore
Daman2, Kadaiya
Waluj, Aurangabad
MHRA/FDA Approval
Specialised & Standard Dosage
Forms
MHRA Approval
Standard Dosage Forms
MHRA Approval
Specialised & Standard Dosage
MHRA/FDA Approval
Sterile Injectables, Specialised
Dosage Forms
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)
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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:
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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 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:
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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
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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:
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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:
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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
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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
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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
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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