world-class contract manufacturing organisation extraordinary service every day
DESCRIPTION
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 PresentationTRANSCRIPT
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
Click here for larger view
Our Global Manufacturing Network
All with state-of-the-art manufacturing facilities
UKIndia
IrelandFranceUSA
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
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
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
Our US Facility
Morton Grove, Illinois FDA ApprovalStandard Dosage Forms
Our Manufacturing Capabilities
LyophilisationSterile Injectables
Sachets & PowdersSolid Dose Liquids, Gels, Ointments & Creams
Specialised Products
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 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
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 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 & ValidationTech Transfer
Clinical Trial Materials Manufacturing Registration Stability
CommercialManufacturing
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
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 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
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 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
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