Asymchem’s API plant gets passing grade from Australian regulators

China flag
Asymchem Laboratories’ API plant in Dunhua successfully passed an inspection by Australian drug regulators.

Chinese drugmaker Asymchem Laboratories’ API plant in Dunhua successfully passed an inspection by Australian drug regulators for a second consecutive time, the company said.

Inspectors from the Australian Therapeutic Goods Administration (TGA) conducted a 4-day inspection of the plant in June as part of a reinspection to extend a GMP certificate for an Asymchem client’s NDA filing. The previous TGA inspection was done in May.

The June inspection at Dunhua resulted in an A1 compliance rating. The plant was visited by FDA inspectors in March and no Form 483 was issued, the company said.


Simplify and Accelerate Drug R&D With the MarkLogic Data Hub Service for Pharma R&D

Researchers are often unable to access the information they need. And, even when data does get consolidated, researchers find it difficult to sift through it all and make sense of it in order to confidently draw the right conclusions and share the right results. Discover how to quickly and easily find, synthesize, and share information—accelerating and improving R&D.

The site produces small-molecule advanced intermediate and API for the pharmaceuticals market as well as handling hazardous chemicals on an industrial scale.

The passing grade reaffirms “our continuous investment in infrastructure and compliance towards meeting the highest quality standards in the API manufacturing arena,” Hao Hong, Ph.D., Asymchem’s CEO and chairman, said in a statement.

The company operates six facilities in China that specialize in areas that include biotransformation, flow chemistry, highly potent compounds, asymmetric synthesis, high-pressure and low-temperature chemistry.

Suggested Articles

Sanofi, which has moved purposefully into high technologies to get more from its manufacturing, will lean even more on that strategy to save costs.

Just months after a C-suite shakeup at Amneal, the generics company has struck a $220 million deal for AvKare, known on the street as R&S Northeast. 

Fujifilm has completed the first manufacturing facility in Japan to make drug-delivering liposomes to use for cancer fighting drugs it is developing.