WuXi AppTec subsidiary passes third US FDA inspection

By Melissa Fassbender contact

- Last updated on GMT

(Image: iStock/Sky_Blue)
(Image: iStock/Sky_Blue)

Related tags: Pharmaceutical drug, United states

WuXi AppTec has announced that its Jinshan Shanghai-based small molecule active pharmaceutical ingredient (API) and advanced intermediate manufacturing facility has passed its third US FDA inspection.

The facility is part of WuXi’s subsidiary, Shanghai SynTheAll Pharmaceutical Co., Ltd.​ (STA), a contract development and manufacturing organization (CDMO) focusing on small molecule API process development and manufacturing.

WuXi raised $80m for the subsidiary via the private placement of 7.16m share of STA stock last July.

According to the company, the facility successfully passed a general GMP and Pre-Approval Inspection from the US Food and Drug Administration (FDA) with no Form 483s issued.

STA has also received approvals to supply APIs and GMP intermediates for branded commercial drugs from regulatory agencies in the United States, Canada, the European Union, Switzerland, China, Japan, Australia, and New Zealand.

The successful inspection is good news for the company, as many API firms have come under fire recently after failing to meet GMP compliance.

Last month, the FDA added four API manufacturers​ to its “Red List,” effectively banning the companies from importing APIs to the US. However, with the crack down on compliance, many are focusing on rectifying the issues.

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