Shanghai Shyndec Pharmaceutical's API Unit Gets FDA Certification
Tang Shihua
/SOURCE : Yicai
Shanghai Shyndec Pharmaceutical's API Unit Gets FDA Certification

(Yicai Global) Feb. 12 -- Shanghai Shyndec Pharmaceutical Co.'s active pharmaceutical ingredient (API) unit recently received a favorable report from the U.S. Food and Drug Administration (FDA).

The agency also certified two of the APIs produced at the plant for entry into the U.S.

The wholly-owned subsidiary Shanghai Shyndec Pharmaceutical (Haimen) Co. received the FDA's Establishment Inspection Report (EIR) after the agency conducted an on-site inspection of its API production site, which shows the plant is up to snuff, the Shanghai-based drug maker said recently.

The plant mainly produces antibiotic raw material azithromycin and zidovudine, an AIDS-therapy drug. It has annual output of 400 tons and 100 tons, respectively, per the statement.

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Keywords: Active Pharmaceutical Ingredient (API) , FDA Inspection , U.S. Market , Shanghai Shyndec Pharmaceutical