IHS Chemical Week

Markets :: Fine Chemicals/Biotech :: Pharmaceutical ingredients

Pharma/fine chemicals roundup—27 May 2014

12:40 AM MDT | May 27, 2014 | Deepti Ramesh

FDA issues warning letter to Sun Pharma's API plant in India FDA issued a warning letter on 7 May to the active pharmaceutical ingredient (API) and finished pharmaceutical manufacturing facilities of Sun Pharmaceutical Industries (Sun Pharma; Mumbai)—located at Karkhadi, Vadodara District, India—for violations of cGMP. The warning letter was published on the FDA Web site on 20 May. An FDA inspection from 13–16 November 2013 at the Karkhadi facility identified deviations from cGMP for the manufacture of APIs and the violation of cGMP regulations...

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