WuXi STA’s facility passes first inspection by EMA

By Ben Hargreaves

- Last updated on GMT

(Image: Getty/Master1305)
(Image: Getty/Master1305)

Related tags WuXi STA China Ema

The company’s Shanghai facility passes the European regulator’s inspection with no ‘critical’ or ‘major’ findings regarding the commercial products produced at the site.

WuXi STA’s Jinshan, China, facility is involved in the production of 11 products that were approved by the European Medicines Agency (EMA) in recent years, according to the company’s VP of quality, Mei Hao.

Five inspectors from the European agency visited the site, in an inspection that lasted five days, with WuXi STA, a subsidiary of WuXi AppTec, reporting that no critical or major findings were noted.

The 14-acre manufacturing site contains a kilo lab, two pilot plants, and one commercial-scale plant possessing reactors ranging from 5L to 20,000L. In addition, the Shanghai site also includes a highly potent active pharmaceutical ingredient (HPAPI) facility.

With the EMA’s nod of approval, the site has now been approved by the US Food and Drug Administration (FDA), as well as regulators from Japan, Canada, Switzerland, Australia, New Zealand, and China.

The company will also open an API process R&D center next to the Jinshan site, which will add 30,000-square-meters of laboratories and 800 scientists.

WuXi STA's Jinshan facility. Image: WuXi STA

The passing of the inspection was announced prior to this year’s CPhI Worldwide; during the previous year’s event, WuXi STA’s VP of business operations, Yu Lu, told us that it is focused on an aggressive build-out plan to expand its capacity. In line with the additions of the API process R&D center, Lu stated that the company plans to build one API plant each year to achieve growth.

As such, the speed of the company’s growth has hit a number of milestones in recent years, including passing the first FDA inspection​ of one of its manufacturing facilities in China, and becoming the first contract development and manufacturing organization to produce a treatment approved by China’s marketing authorization holder pilot program​.

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