S&P 500 5,235.18 +1.02%EUR/USD 1.0840 +0.21%GBP/USD 1.2710 +0.14%USD/JPY 149.50 −0.18%BRENT $82.40 −0.81%BTC $67,800 −0.21%GOLD $2,341 +0.55%NASDAQ 16,420.55 +0.74%S&P 500 5,235.18 +1.02%EUR/USD 1.0840 +0.21%GBP/USD 1.2710 +0.14%USD/JPY 149.50 −0.18%BRENT $82.40 −0.81%BTC $67,800 −0.21%GOLD $2,341 +0.55%NASDAQ 16,420.55 +0.74%
A daily business newspaper · Founded in 2026

Money Talk

Finance and markets: business, quotes, gold, energy and 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.

Asymchem Clears First FDA Inspection for Continuous API Manufacturing
Photo: Bio & News

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.

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.

Share article
TelegramXFacebook

When reusing this material a link to Money Talk is required.

Comments (0)

Leave a comment

No comments yet. Be the first!