Asymchem's Carbapenem API Facility Passes First USFDA Pre-Approval Inspection
核心洞察
Asymchem (搜索)'s dedicated carbapenem (搜索) API manufacturing facility (DH2) successfully completed its first USFDA Pre-Approval Inspection on June 22, 2026, following an on-site review conducted April 27-30, 2026.
The PAI supported a commercial API utilizing continuous raw material feeding and reaction technology, marking a regulatory milestone for the DH2 site commissioned in 2020.
The facility houses in-house-designed continuous flow ozonolysis capabilities at tonnage scale, reflecting Asymchem (搜索)'s commitment to operational safety and reduced carbon footprint.
Asymchem (搜索), a leading global contract development and manufacturing organization (CDMO), announced that its dedicated carbapenem (搜索) active pharmaceutical ingredient (API) manufacturing facility—Jilin Asymchem Pharmaceuticals Co. Ltd., also known as "DH2"—successfully completed its first U.S. Food and Drug Administration (FDA) inspection on June 22, 2026. The short-notice Pre-Approval Inspection (PAI) took place between April 27 and April 30, 2026, and was conducted in support of a commercial API employing continuous raw material feeding and reaction technology.
The successful inspection represents a significant regulatory milestone for the DH2 carbapenem (搜索) site, which was commissioned in 2020. Carbapenems are a critical class of broad-spectrum beta-lactam antibiotics used to treat severe bacterial infections, and maintaining robust manufacturing quality standards for these APIs is essential to global public health supply chains.
Facility Capabilities and Technology
Asymchem (搜索)'s DH2 facility provides custom carbapenem (搜索) intermediates to APIs, supporting the full spectrum from clinical development through commercial supply. The site features cutting-edge continuous flow ozonolysis capabilities, designed and built in-house by Asymchem's world-class engineering team, with capacity reaching tonnage scale in support of new chemical entities (NCEs).
The company emphasized that implementing continuous flow technologies across all its sites is a strategic priority for heightened operational safety while simultaneously reducing its carbon footprint. Continuous flow manufacturing offers advantages over traditional batch processing, including improved process control, enhanced safety profiles for hazardous reactions, and greater efficiency in scaling from development to commercial production.
Leadership Commentary
"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 Dr. Hao Hong, Chairman and CEO of Asymchem (搜索) Group. "This first inspection of Asymchem's Dunhua 2 facility confirms our unwavering commitment in achieving the highest quality standards."
Global Regulatory Track Record
Across its global operations, Asymchem (搜索) successfully undergoes approximately 200 customer audits each year and has completed more than 100 regulatory inspections to date. The company remains committed to its Quality by Design (QbD) framework, utilizing science- and risk-based approaches, data-driven decision-making, and integrated control strategies to maintain high-standard quality management throughout the product lifecycle.
With research and development and manufacturing sites in China, Europe, and the United States, Asymchem (搜索) employs more than 10,000 professionals worldwide, offering a range of services that include small molecule manufacturing, TIDES (peptides and oligonucleotides), biologics, synthetic biology, and more.