IHS Chemical Week

Markets :: Fine Chemicals/Biotech :: Pharmaceutical ingredients

FDA bans imports of Sun Pharma's products from plant in India

4:56 AM MDT | March 13, 2014 | Natasha Alperowicz

The FDA has imposed a ban on imports from Sun Pharma’s (Mumbai) Karkhadi, Gujarat plant in India. The facility makes APIs and formulations.  The FDA has issued an import alert on the plant. The ban is the latest in a series of FDA clampdowns on Indian drug makers. It follows FDA’s ban on all Ranbaxy Laboratories plants in India over production quality lapses.   India is a leading drug exporter to the United States, supplying about 40% of generic and over-the-counter drugs. The ban on the Sun Pharma unit indicates that it has not met cGMP...

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