The STA Pharmaceutical Co., Ltd. Active Pharmaceutical Ingredient (API) manufacturing facility at Jinshan in Shanghai, China, has successfully passed its fourth inspection from the U.S. Food and Drug Administration (FDA)—with no Form 483s issued. The site previously passed three FDA inspections in 2013, 2014 and 2016. STA Pharmaceutical, also referred to as WuXi STA, is a subsidiary of WuXi AppTec.
WuXi STA is the first CDMO in China that is approved to supply commercial APIs for innovative drugs by regulatory agencies in the U.S., China, EU, Canada, Switzerland, Australia, and New Zealand.
The Jinshan site, which opened in 2004, is equipped with 100+ modern reactors ranging from 5L to 20,000L, as well as technology platforms such as flow chemistry, biocatalysis, and high potency APIs. The Jinshan facility is dedicated to the manufacture of small molecule APIs and advanced intermediates, from kilo to metric ton scale—from preclinical and clinical development through to global commercial launch.
In addition, WuXi STA recently initiated the site expansion project in Jinshan, adding more than 30,000 square meters of laboratory space and 500 scientists. Upon completion, the expanded campus will be able to offer one-site process development and manufacturing of APIs and advanced intermediates, according to the company.
The WuXi subsidiary has operations in China and the U.S. along with global partnerships.