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Asymchem’s Dunhua 2 carbapenem facility clears first FDA inspection
The milestone represents a first regulatory achievement for Asymchem’s DH2 carbapenem site
- By IPP Bureau
| July 27, 2026
Jilin Asymchem Pharmaceuticals Co. Ltd
Asymchem Laboratories has achieved a significant regulatory breakthrough in the US.
This, after its Dunhua 2 (DH2) carbapenem active pharmaceutical ingredient (API) manufacturing facility successfully completed its first US FDA inspection, reinforcing the company’s growing role in advanced pharmaceutical manufacturing.
The milestone represents a first regulatory achievement for Asymchem’s DH2 carbapenem site, which was commissioned in 2020 and is designed to support the transition of critical pharmaceutical intermediates from clinical development through commercial supply.
Located at Jilin Asymchem Pharmaceuticals Co. Ltd., the DH2 facility features advanced continuous flow ozonolysis capabilities developed and built internally by Asymchem’s engineering team.
The technology operates at ton-scale capacity and supports the production needs of new chemical entities (NCEs), while advancing the company’s broader strategy to improve manufacturing safety and reduce environmental impact.
"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," stated Hao Hong, Chairman and CEO of Asymchem Group. "This first inspection of Asymchem's Dunhua 2 facility confirms our unwavering commitment in achieving the highest quality standards".
