Commissioned in 2020, the DH2 site serves as a cornerstone for Asymchem’s carbapenem manufacturing, scaling from clinical supply to commercial tonnage. The facility integrates proprietary continuous flow ozonolysis capabilities, an engineering feat designed to improve safety profiles and minimize the company's carbon footprint. This shift toward continuous flow manufacturing remains a strategic priority across the organization's global network.
In section Releases
Asymchem Clears First FDA Inspection for Continuous API Manufacturing
The Dunhua 2 carbapenem facility in Jilin, China, has passed its inaugural U.S. Food and Drug Administration pre-approval inspection. This regulatory milestone, finalized on June 22 following a late April assessment, validates the site's specialized continuous raw material feeding and reaction technology used for commercial API production.
Dr. Hao Hong, Chairman and CEO of Asymchem Group, noted that the successful audit reinforces the company’s adherence to global quality standards, adding to a track record that spans regulators in the European Union, Japan, Australia, and North America. The firm currently manages a rigorous quality control environment, conducting over 100 regulatory inspections and roughly 200 customer audits annually. By leveraging a Quality by Design framework, the company maintains its focus on risk-based, data-driven manufacturing processes to support its international pharmaceutical and biotech clients.
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