- Asymchem announced that its DH2 carbapenem API manufacturing facility in Jilin, China, successfully completed its first U.S. FDA Pre-Approval Inspection (PAI) for a commercial API.
- The inspection supports a commercial API manufactured using continuous raw material feeding and reaction technology and marks the first regulatory milestone for the facility commissioned in 2020.
Asymchem announced that its dedicated carbapenem active pharmaceutical ingredient (API) manufacturing facility, Jilin Asymchem Pharmaceuticals Co. Ltd. (DH2), successfully completed its first U.S. Food and Drug Administration (USFDA) Pre-Approval Inspection (PAI). The short-notice inspection took place from April 27–30, 2026, and was completed on June 22, 2026.
The inspection supported a commercial API manufactured using continuous raw material feeding and reaction technology, representing the first regulatory milestone for the DH2 carbapenem facility, which was commissioned in 2020. The site provides custom carbapenem intermediates for APIs supporting clinical through commercial supply and forms part of Asymchem’s CDMO and contract manufacturing operations.
The company said the facility is equipped with in-house designed continuous flow ozonolysis capabilities with tonnage-scale capacity to support new chemical entities (NCEs). According to Asymchem, expanding continuous flow technologies across its manufacturing network is intended to enhance operational safety while reducing its carbon footprint.
“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. This first inspection of Asymchem’s Dunhua 2 facility confirms our unwavering commitment in achieving the highest quality standards.”
Dr. Hao Hong, Chairman and CEO of Asymchem Group
Asymchem said it completes around 200 customer audits annually across its global operations and has undergone more than 100 regulatory inspections to date. The company added that it continues to apply its Quality by Design (QbD) framework, using science- and risk-based approaches, data-driven decision-making, and integrated control strategies throughout the product lifecycle.
