A Full Service Active Pharmaceutical Ingredient Supplier

Regulatory Strength

Regulatory Strength Image 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 do not 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 requirements.

Working with chemwerth offers you the following successful experience:

Over 175 DMFs filed in the US, EU, Canada, and Australia (Over 40 in 2005 – 2007)
Over 35 first-to-market generic approvals
3 NDA approvals, 6 pending NDA approvals
Over 130 FDA Inspections – Over 50 since 2002
65% of FDA inspections in the last 4 years passed with no 483 issued.
28 FDA inspected & approved chemwerth-represented manufacturers located
in China, Europe, India, and United States
7 chemwerth-represented factories with FDA approvals on Fermentation products
25 years of successful experience in working with manufacturers in China plus our own R & D and Analytical Laboratory at our offices based in Shanghai



		Regulatory Strength 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 do not 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 requirements. Working with chemwerth offers you the following successful experience: Over 175 DMFs filed in the US, EU, Canada, and Australia (Over 40 in 2005 – 2007) Over 35 first-to-market generic approvals 3 NDA approvals, 6 pending NDA approvals Over 130 FDA Inspections – Over 50 since 2002 65% of FDA inspections in the last 4 years passed with no 483 issued. 28 FDA inspected & approved chemwerth-represented manufacturers located in China, Europe, India, and United States 7 chemwerth-represented factories with FDA approvals on Fermentation products 25 years of successful experience in working with manufacturers in China plus our own R & D and Analytical Laboratory at our offices based in Shanghai