AsianScientist (Aug. 8, 2018) – WuXi STA has announced that its active pharmaceutical ingredient (API) manufacturing facility at Jinshan District in Shanghai, China, has successfully passed its fourth inspection by the US Food and Drug Administration (USFDA).
WuXi STA is the first contract development and manufacturing organization in China that is approved by regulatory agencies in the US, China, EU, Canada, Switzerland, Australia and New Zealand to supply commercial APIs for innovative drugs. The Jinshan site—opened in 2004—is equipped with more than 100 modern reactors ranging from 5 to 20,000 liters for drug manufacturing. It also houses industry-leading technology platforms for flow chemistry and biocatalysis, among other applications.
The Jinshan facility is dedicated to the manufacture of small molecule APIs and advanced intermediates, from kilo- to metric-ton scale, with projects ranging from preclinical and clinical development through to global commercial launch. Furthermore, WuXi STA recently announced that it intends to expand the facility at Jinshan, adding more than 30,000 square meters of laboratory space and 500 scientists.
“It is an integral part of the company’s culture to exceed global standards. We will continue to put quality first for all of our worldwide partners, offering them integrated, efficient and flexible solutions, thereby accelerating the process of new drug launches,” said Dr. Minzhang Chen, CEO of WuXi STA.
Source: WuXi AppTec; Photo: Shutterstock.
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