Asymchem, a China-headquartered contract development and manufacturing organization (CDMO), announced that its dedicated carbapenem active pharmaceutical ingredient (API) manufacturing facility (DH2) successfully completed its first U.S. FDA inspection for a short-notice Pre-Approval Inspection (PAI).

The PAI was conducted in support of a commercial API using continuous raw material feeding and reaction technology, according to the announcement. It also represents a regulatory milestone for the DH2 carbapenem site commissioned in 2020.

Asymchem’s DH2 facility provides custom carbapenem intermediates to API’s supporting clinical into commercial supply. The site houses continuous flow ozonolysis capabilities, designed and built in-house by Asymchem’s engineering team, with capacity into tonnage scale in support of new chemical entities (NCE). Asymchem highlights the implementation of continuous flow technologies across all of its sites as an imperative for heightened operational safety.

“I am proud to continue on a successful track record of approvals from regulatory agencies in the U.S, European Union, Japan, China, Australia, Korea, Canada, Brazil and others,” Asymchem CEO Hao Hong said in a statement. “This first inspection of Asymchem’s Dunhua 2 facility confirms our unwavering commitment in achieving the highest quality standards.”

The CDMO says it successfully undergoes around 200 customer audits each year, globally, and has completed more than 100 regulatory inspections to date. With R&D and manufacturing sites in China, Europe, and the U.S., Asymchem employs more than 10,000 professionals worldwide for a range of services that include small molecule, TIDES, biologics, synthetic biology, and more.