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WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

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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 - PowerPoint PPT Presentation
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Page 1: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day
Page 2: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day
Page 3: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day
Page 4: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day
Page 5: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day
Page 6: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day
Page 7: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day
Page 8: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day
Page 9: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION

Extraordinary service every day

Page 10: 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

Page 11: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

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

Page 12: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

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

Page 13: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

Our Stability and Growth – Acquisitions

Page 14: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

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

Page 15: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

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

Page 16: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

Our Global Manufacturing Capabilities

Click here for larger view

Page 17: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

Our Global Manufacturing Network

All with state-of-the-art manufacturing facilities

UKIndia

IrelandFranceUSA

Page 18: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

Our European Facilities

Wrexham, UKMHRA/FDA Approval Lyophilisation, Sterile Injectables, Cartridges, Specialised & Standard Dosage Forms

Pinewood, IrelandMHRA/IMB Approval Specialised & Standard Dosage Forms

Quimper, France EMEA Approval Standard Dosage Forms

Page 19: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

Our Indian Facilities

Biotech Park, Aurangabad MHRA/FDA ApprovalSterile Injectables

Chikalthana, AurangabadMHRA/FDA Approval Sterile Injectables, Specialised & Standard Dosage Forms

Eou, Aurangabad MHRA/FDA ApprovalSpecialised & Standard Dosage Forms

SEZ, AurangabadMHRA/FDA ApprovableCompletion end of 2008Lyophilisation, Large and Small Volume Parenteral Injectables

Site under qualification

Page 20: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

Our Indian Facilities

Baddi, Himachal PradeshMHRA/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 ApprovalSterile Injectables, Specialised Dosage Forms

Page 21: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

Our US Facility

Morton Grove, Illinois FDA ApprovalStandard Dosage Forms

Page 22: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

Our Manufacturing Capabilities

LyophilisationSterile Injectables

Sachets & PowdersSolid Dose Liquids, Gels, Ointments & Creams

Specialised Products

Page 23: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

Sterile Injectables

Page 24: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

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)

Page 25: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

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

Page 26: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

Specialised Products

Page 27: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

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)

Page 28: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

Solid Dose Products

Page 29: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

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

Page 30: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

Sachets and Powders

Page 31: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

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

Page 32: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

Liquids, Gels, Ointments and Creams

Page 33: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

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

Page 34: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

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

Page 35: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

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

Page 36: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

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

Page 37: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

Our Know How - Services

Bulk Drug Substance

Analytical Method Development Pre-formulation

Formulation Development

Scale Up & ValidationTech Transfer

Clinical Trial Materials Manufacturing Registration Stability

CommercialManufacturing

Page 38: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

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

Page 39: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

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

Page 40: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

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

Page 41: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

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

Page 42: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

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

Page 43: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

Our Know How - Scale-up and Technology TransferOur 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

Page 44: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

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

Page 45: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

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

Page 46: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

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

Page 47: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

Why Wockhardt? - Our PeopleOur 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

Page 48: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

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

Page 49: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

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

Page 50: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION

Extraordinary service every day

Page 51: WORLD-CLASS CONTRACT MANUFACTURING ORGANISATION Extraordinary service every day

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