Asymchem’s API plant gets passing grade from Australian regulators

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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.

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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.

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