This is the third time that Shanghai SynTheAll Pharmaceutical (STA)'s active pharmaceutical ingredient (API) and advanced intermediates facility in Jinshan, Shanghai, China has passed an inspection by the US regulator.
STA, a contract manufacturing and development organisation (CDMO) with operations in China and the US, has received multiple approvals to supply APIs and GMP intermediates for branded commercial drugs from regulatory agencies in the US, Canada, the European Union, Switzerland, China, Japan, Australia, and New Zealand.
'Passing the third US FDA inspection with no observations once again demonstrates our commitment and ability to provide the highest quality services to the global life science community,' said Dr Minzhang Chen, CEO of STA.
STA is currently constructing a new manufacturing plant in Changzhou, China.
The administration building, R&D building, one large-scale manufacturing plant and supporting units have been operating since February operating, with other buildings to follow.
Once completed, the site will employ more than 500 scientists and will add more than 1000 m3 of reactor volume, doubling STA's existing R&D capacity and quadrupling its manufacturing capacity.
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