IHS Chemical Week

Markets :: Fine Chemicals/Biotech :: Pharmaceutical ingredients

FDA issues import alert against Ranbaxy plant

7:28 AM MDT | September 17, 2013 | Deepti Ramesh

On 16 September, FDA issued an import alert for a Ranbaxy Laboratories (Gurgaon, India) facility at Mohali, India, for violating US drug cGMP requirements. Under the alert, US officials may detain at the US border drug products manufactured at the Mohali facility, and the company will remain on the import alert until it complies with cGMP, FDA says. FDA says it does not anticipate that this action will cause a supply disruption or shortage of drugs in the United States. FDA inspections, in September and December 2012, identified significant cGMP violations...

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