Asymchem Carbapenem API Site in China Successfully Completes First FDA Inspection

Editor’s Take: Implementing continuous flow will heighten the company’s operational safety, while also reducing its carbon footprint.

The U.S. FDA conducted a successful, short-notice Pre-Approval Inspection of Asymchem’s carbapenem API manufacturing facility in China in April.

The site, known as Dunhua 2 (DH2, Jilin Asymchem Pharmaceuticals Co.) received notification of the inspection’s success in June. Asymchem says the inspection supported a commercial API using continuous raw material feeding and reaction technology.

Carbapenem API Capabilities

More specifically, the DH2 site provides custom carbapenem intermediates to APIs, supporting clinical to commercial supply. On-site are cutting-edge continuous flow ozonolysis capabilities, built in-house.

Capacity reaches into tonnage scale, in support of new chemical entities.

Dating back to when the site was commissioned in 2020, this marks its first regulatory milestone.

Asymchem CEO Offers Thoughts

Hao Hong, PhD, Chairman and CEO of Asymchem Group, reflected on the significance of the successful inspection. Hong said the U.S. joins the European Union, Japan, China, Australia, Korea, Canada, and Brazil in validating Asymchem facilities.

“This first inspection of Asymchem’s Dunhua 2 facility confirms our unwavering commitment in achieving the highest quality standards,” Hong added.

To that end, Asymchem believes that implementing continuous flow across all its sites prioritizes heightened operational safety. It also, according to the company, will reduce its carbon footprint.

Asymchem, a global CDMO, says it successfully completes approximately 200 customer audits per year across all operations. Additionally, the company’s facilities have completed more than 100 regulatory inspections to date.

Worldwide, Asymchem employs more than 10,000 professionals. The company is committed to a Quality by Design framework that utilizes science- and risk-based approaches, and data-driven decision-making.