Asymchem Dunhua manufacturing facility successfully completes U.S. FDA pre-approval inspection.

Asymchem Laboratories (Tianjin) Co., Ltd. announced that its API facility in Dunhua city, Jilin province, P. R. China (Dunhua), has successfully passed a pre-approval inspection (PAI) by the U.S. Food and Drug Administration (FDA). The five-day inspection was conducted between March 27-31, 2017, triggered by a customer’s New Drug Application (NDA) filing of a cGMP intermediate.

The Dunhua site was found to be compliant with the principles and guidelines of Good Manufacturing Practice (GMP) for commercial activities, and resulted in no Form 483 observations. This was Asymchem Dunhua’s first U.S. FDA inspection. 

Previous PAI and cGMP inspections by the U.S. FDA were conducted in 2014 at Asymchem’s Tianjin 1, Tianjin 2, and Fuxin sites (one week for each site), of which only one Form 483 was issued to the Fuxin site with a minor observation.

Dr. Hao Hong, CEO and chairman of the board of Asymchem Group, states, “We are very pleased with the positive results from this U.S. FDA PAI of Asymchem’s Dunhua manufacturing facility. We are committed to and believe that our compliance history demonstrates our commitment to constantly improve our quality and compliance program to meet the highest quality standards in the manufacture of API’s.”

About Asymchem 

Asymchem is a USFDA and TGA inspected CMC CDMO with over 20 years’ expertise in developing innovative and sustainable processes for development to commercial APIs and HPAPIs.

The company operates out of six facilities in China and proficient in a number of niche technologies, including biotransformation, flow chemistry, highly-potent compounds, asymmetric synthesis, high-pressure, and low-temperature chemistry.

(Source: Asymchem Laboratories (Tianjin) Co., Ltd., PR Newswire)