IHS Chemical Week

Markets :: Fine Chemicals/Biotech :: Pharmaceutical ingredients

Ranbaxy receives FDA notice of possible API plant violations

5:38 AM MST | January 13, 2014 | Natasha Alperowicz

Ranbaxy Laboratories (Gurgaon, India), India’s largest drugs maker and member of the Daiichi Sankyo Group (Tokyo), has been notified by the US Food and Drug Administration (FDA) that a recent inspection found possible violations at Ranbaxy’s APIs plant at Toansa, India. Ranbaxy says that on 11 January it received Form 483 with certain observations following the recent US FDA inspection at the plant. Ranbaxy “is assessing the observations, and will respond to the FDA in accordance with the agency's procedure to resolve the concerns at the...

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