INSUBCONTINENT EXCLUSIVE:
Strides Pharma Science share price fell as much as 8.15 per cent to Rs 347.00.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
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
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 FDA further said that till the time violations at
the Bengaluru-based Strides Pharma's Puducherry plant are addressed and confirmed by the regulator, no new applications or supplements
will be allowed into the United States.The regulator asked Strides Pharma to respond to the warning letter within 15 working days.Strides
Pharma shares ended 3.08 per cent lower at Rs 366.15 on the BSE, underperforming the benchmark Sensex index which finished up 0.22 per
per cent lower at Rs 365.10 apiece.Get Breaking news, live coverage, and Latest News from India and around the world on
TheIndianSubcontinent.com
Catch all the Live TV action on TheIndianSubcontinent 24x7 and TheIndianSubcontinent India
Like us on Facebook or follow us on Twitter and Instagram for latest news and live news updates.
