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Company Profile

Since 1982 Chemwerth, Inc. has been a quality API supplier to the generic, proprietary, and vet markets.

Working with Chemwerth offers you the following experience:

Over 150 DMFs filed in the US, 14 in 2003, 16 in 2004

2 NDA approvals, 6 pending NDA approvals

42 FDA inspections in the last 5 years

28 FDA inspected & approved Chemwerth-represented manufacturers located in China, Europe, India, and United States

The key to Chemwerth's success lies in our compliance. Chemwerth's experienced in-house regulatory group maintains an active channel of communication with both the FDA and the USP committees. We have 16 full-time Chemwerth regulatory employees based in Connecticut and Shanghai conducting audits of our factories twice a year using Chemwerth's FDA Quality Systems program. We don't hire outside consultants because Chemwerth has a vested interest in ensuring that both our API manufacturers and Finished Dosage customers obtain the necessary results to meet FDA - cGMP compliance.

We eliminate any problems our customers may have when they file their NDA or ANDA because we understand what the FDA requires through our 25 years of experience of working together.

There are many companies in India and China that give favorable quotes to US customers. Many times they are lower because the material is CP grade instead of USP grade. The larger risk is the factory's lack of ability and experience in passing the FDA inspection. There are over 4200 pharmaceutical plants in China and only 51 plants have passed US FDA inspections, only 1.2% of the total. Of the 51 FDA inspected plants, 26 were inspected through Chemwerth. This represents 51% of the total.

Chemwerth's 20 plus years of experience shows it takes 2 to 5 years to get a factory cGMP compliant and first product FDA approved. Chemwerth spends an average of 115 to 120 'man days' preparing Procedures/Protocols/SOPs with each factory prior to their product validation and performs frequent on-site audits. Substantial investment of both time and money is paramount to ensuring success. In Chemwerth's early days, it took 7 to 8 years. Chemwerth reduces the time by 12 to 18 months versus other API suppliers for a quicker approval of your ANDA/NDA through our proven efficiencies in answering 483's and deficiencies to the FDA. In this business, regulatory compliance and speed is vital and chemwerth leads the pack.

Chemwerth's capabilities are fully described on our web site at www.chemwerth.com