FDA Warns Largest Indian Drugmaker | Chemical & Engineering News
Volume 94 Issue 1 | p. 16 | Concentrates
Issue Date: January 4, 2016

FDA Warns Largest Indian Drugmaker

Department: Government & Policy
Keywords: pharmaceuticals, FDA, enforcement

FDA last month issued a warning to India’s largest drugmaker, Sun Pharmaceutical Industries, for violating manufacturing standards at its Halol plant, in the western state of Gujarat. In part, FDA says, the company “failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile.” The Halol facility is among the largest and important for Sun Pharma and produces multiple formulations, including injectable products, which are mainly exported to the U.S., its largest market, which makes up about 15% of its sales. In a statement, the company says it has been implementing corrective measures since September 2014, when FDA first inspected the facility.

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