Asymchem, a China-based global contract development and manufacturing organisation (CDMO), announced on Friday that its dedicated carbapenem active pharmaceutical ingredient (API) manufacturing facility has successfully completed its first US Food and Drug Administration (FDA) inspection for a short-notice Pre-Approval Inspection (PAI).

This inspection of Jilin Asymchem Pharmaceuticals Co Ltd, also known as Dunhua 2 (DH2), was conducted in support of a commercial API using continuous raw material feeding and reaction technology, marking a regulatory milestone for the 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).

Across its global operations, Asymchem has completed more than 100 regulatory inspections to date.