 |
TIANJIN, China, Oct. 29, 2026 /PRNewswire/ — Asymchem successfully completed its first U.S. Food and Drug Administration (USFDA) Pre-Approval Inspection (PAI) of Asymchem Life Science (Tianjin) Co., Ltd.’s TIDES development and manufacturing facility (“TJ4”), which took place between June 29th to July 2nd, 2026.
This marks the first western regulatory agency inspection of the Tianjin 4 site, which houses extensive modalities including peptides, oligonucleotides, drug product, payload linkers, excipients and small molecule API manufacturing capabilities. The PAI for a small molecule entity involved a comprehensive review of the site’s facility’s quality systems, data integrity measures, and manufacturing operations, and confirmed the rigorous quality structure in place.
“This milestone reflects the standards we hold ourselves to every day. Our systems, people and culture are built to deliver at the highest level, putting us in a position to successfully bring our valued partners through to commercialization.” stated Dr. Hao Hong, Chairman and CEO of Asymchem Group.
The purpose-built TJ4 facility covering 41 acres integrates highly automated production for solid and liquid phase synthesis of both oligonucleotides and peptides, enzymatic ligation, prep-HPLC, TFF, as well as isolation capabilities including lyophilization, precipitation and spray drying capacity for both injectable and oral indications, with a fit-for-purpose design compliant with both NDA and BLA requirements.
This FDA milestone reinforces Asymchem’s consistent regulatory performance, evidenced by roughly 200 annual global customer audits and over 100 regulatory inspections.
About Asymchem
Founded in 1995, Asymchem is a leading global CDMO specializing in integrated solutions for the pharmaceutical and biotech sectors. With advanced R&D and manufacturing sites in China, the US, and Europe, Asymchem employs more than 10,000 professionals worldwide, delivers a broad range of services including small molecule, TIDES, biologics, synthetic biology, and more. The company’s ongoing investments in innovation and sustainability continue to drive value for its global client base.
For more information on Asymchem capabilities and capacities, visit www.asymchem.com
