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Strides Pharma Science Shares Plunge After US Drug Regulator’s Warning Letter

Strides Pharma Science shares fell more than 8 per cent on Wednesday, after the US drug regulator – the US Food and Drug Administration (US FDA) – issued a warning letter to the company for violating its current good manufacturing practice (CGMP) regulations. On the Bombay Stock Exchange (BSE), the Strides Pharma Science share price declined as much as 8.15 per cent to Rs. 347.00 apiece at the day’s weakest point. On the National Stock Exchange, Strides Pharma Science shares dropped 8.13 per cent to an intraday low of Rs.347.10. The US regulator said that the company was involved in destruction of CGMP documents.

In a letter to Strides Pharma Science, the United States’ Food and Drug Administration (FDA) said: “Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated.”

The US regulator, which had inspected Strides Pharma’s drug manufacturing facility in Puducherry from January 28 to February 5, 2019, said the company was caught trying to dispose quality-control records. “Our investigator observed discarded CGMP documents and evidence of uncontrolled shredding of documents,” it said.

The destruction of quality-control paperwork and a lack of adequate documentation that its medicines are safe “raise questions about the effectiveness” of Strides’ quality unit “and the integrity and accuracy” of its data, Francis Godwin, director of the FDA’s Office of Manufacturing Quality, wrote in the letter.

The regulator asked Strides Pharma to respond to the warning letter within 15 working days. – NDTV Profit

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