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Strides Pharma Puducherry unit receives warning letter from US FDA

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The drug firm, however, did not provide any details of the contents of the warning letter received from the regulator

Drug firm Strides Pharma Science reported that the US health regulator has issued a warning letter to the company for its Puducherry facility.

The company has now received a warning letter from the United States Food and Drug Administration (US FDA) relating to the Puducherry facility, Strides Pharma Science said in a BSE filing.

The drug firm, however, did not provide any details of the contents of the warning letter received from the regulator.

The company said its Puducherry site currently produces six products which will not get impacted by the current development.

However, the 10 abbreviated new drug applications (ANDAs) pending approval from the Puducherry facility will get deferred till the site is reclassified, the company added.

Strides said it is committed to the highest standards of quality and compliance, and will work collaboratively with the US FDA to resolve all issues addressed in the warning letter.

The company said it retains its growth guidance for the US market.

Earlier, in May 6, 2019, the company had said that the US health regulator had classified its inspection of the company’s Puducherry facility as “Official Action Indicated”.

Shares of Strides Pharma Science were trading 4.35 per cent lower at Rs 394 apiece on the BSE.

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