Chemwerth - A Generic API Supply Company
Sep 14, 2014
Chemwerth is an Active Pharmaceutical Ingredient or API Supply Company headquartered in Woodbridge, CT, USA. We provide generic pharmaceutical companies worldwide with safe and compliant ingredients for their finished dosage pharmaceuticals.
Welcome message from author
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
The Business Objective
1. Company Overview
2. Why ChemWerth
3. Our Services
4. The Future – Industry & ChemWerth
To be a valued full-service global developer of Active Pharmaceutical
Ingredients.
• ChemWerth established 1982.
• First-rate API Facilities Approved in 11 Countries.
• Regulatory filings in 20 Countries.
• 100+ Successful FDA Inspections in the past 10 years.
• Over 30 approvals with no “form 483.”
Company Overview
World Wide Customer Locations
USA Headquarters in Woodbridge, Connecticut Shanghai, China Regulatory Office & FDA approved analytical laboratory
Hyderabad, India Office • Freiburg, Germany Sales Office
Canada
United States
Brazil
Argentina
Spain
Austria
Belgium
Italy
Greece
Jordan
UnitedKingdom
Netherlands Germany
Turkey
Croatia
Ukraine
Russia
SaudiArabia
India
Australia
Bangladesh
Taiwan
Japan
Korea
Switzerland Hungary
Ireland
Poland
Armenia
Business Objective
Why CWhy CHEMHEMWWERTHERTH??
High Quality API
FDA Approved Factories
Investing in Compliance
Competitively Priced
Confidentiality Agreements
Fast to Market
Why ChemWerth – Fast to Market
● Over 200+ DMF Approvals.
● More than 45 First to Market generic approvals.
● Average 24 months in bringing new products to market.
Why ChemWerth - FDA Inspections Since 2009
52 Successful FDA Inspections: 18 Zero 483s, 34 Minor Deficiencies, & 0 Failures.
2011: 19 Passed, 7 Zero 483s.
2010: 10 Passed.
2009: 8 Passed, 1 Zero 483s.
2012: 5 Passed, 4 Zero 483s.
2013: 10 Passed, 6 Zero 483s.
What We Do – A Full Service API Supplier
New Product Development
New Product R&D, QA and Production Patent Review Services
Compliance & Regulatory Support Customs & Logistics Support Product Launch
Offering Full Service Support from product development
to product launch.
New Product Development Team
The Idea The Support
The Process
Product Evaluation•Competitive landscape•Identify manufacturer
Patent Analysis•Intellectual Property Review•On-going Technical Support
Stages of Development•Qualify Processes
•PVB/Exhibit Batches
Regulatory and Compliance Team
In house regulatory expertise•U.S. Team•China Team•Former FDA Inspector
Six System Audit Program.
200+ DMFs filed.
150+ FDA Inspections.
Past 5 years – 500+ regulatory filings in over 20 countries.
Supply Chain Management
Skilled Project Managers
All APIs meet RLD, ICH & FDA criteria
Customs-Trade Partnership Against Terrorism (C-TPAT) & Dangerous Goods (DG) Certified
Average 3 day customs clearance
Offices in India, China & U.S. = Local logistics support
One World. One Quality● International Marketplace. Local Inspections.● GDUFA: FDA Approval Fees Imposed in USA● EU Directive 62: Local Government GMP Certification● FDA, WHO, EDQM: Must Meet all Regulatory Standards
Your One Company. . . . ChemWerth● Investing in GMP Compliance & Regulatory Documentation● All API Partners are GDUFA Registered for 2014● Strong Industry Reputation – Done Right, the First Time
30+ years FDA experience.
All facilities cGMP compliant.
APIs meet highest criteria.
Impeccable inspection history.
Recognized worldwide for compliance expertise. ChemWerth HQ1764 Litchfield TurnpikeWoodbridge, CT 06525
Related Documents
