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US FDA issues observations for Natco Pharma’s Indian plants

pharmafile | March 29, 2016 | News story | Manufacturing and Production, Research and Development, Sales and Marketing  

Shares in India-based Natco Pharma (BOM: 524816) dropped on the Bombay Stock Exchange following news the US Food and Drug Administration (FDA) issued 483 observations regarding two of its manufacturing facilities.

The drug maker said the US regulators visited its active pharmaceutical ingredients facility in Manali and its pharmaceutical formulations plant at Kothur, between February and March.

Shares in the company dropped nearly 15% on the Bombay Stock Exchange Monday.

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The US FDA has made eight observations for the company’s Kothur facility, Natco’s only drug formulations manufacturing plant. Natco said the FDA observations are minor in nature.

The company said it has already sent a response and compliance report for these observations and believes that there would be no adverse impact to its current or future pipeline products coming from these facilities.

Shares in Natco were trading down 3.3% on the Bombay Stock Exchange Tuesday.

Anjali Shukla

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