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Hisun Braces For Hit From US FDA Import Alert

 
• By Ying Huang

Zhejiang Hisun Pharmaceutical has already seen its net profit slump this year, and now has to face a US import alert for APIs made at one of its Chinese plants on top of a voluntarily quarantine by importers in Canada. The company is nevertheless pushing ahead with the reconstruction of its business model, eyeing global partners for future markets.

SHANGHAI - Zhejiang Hisun Pharmaceutical Co. Ltd. has been put on the import alert list of the US Food and Drug Administration (FDA) after issues were found for 15 active pharmaceutical ingredients (APIs) made at one of its Chinese facilities. The warning letter came three months after a quarantine request from Health Canada for a similar problem caused by data integrity concerns.

According to a company statement, Hisun said it received a warning letter from the FDA in September on APIs for human and animal drugs manufactured at its Taizhou production plant....

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