Express Pharma

US FDA issues warning letter to Glenmark for its Baddi facility

US FDA had inspected the facility between April 15 and April 20 and earlier classified the inspection as an official action indicated, Glenmark said in a filing to the BSE

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Drug firm Glenmark Pharmaceuticals said it has received a warning letter from the US health regulator for its Baddi facility in Himachal Pradesh. The United States Food and Drug Administration (US FDA) had inspected the facility between April 15 and April 20 and earlier classified the inspection as an official action indicated, Glenmark said in a filing to the BSE.

The warning letter issued is regarding the same inspection, it added. “The company is committed to work along with the US FDA to implement all the necessary corrective actions required to address the concerns raised in the letter and is in the process of preparing a detailed response to the US FDA within 15 working days,” Glenmark said.

The company believes that the existing manufacturing and the sale of products from this facility will not be impacted, it added.

The Baddi facility is expected to contribute USD 30 million in total sales for this financial year which is about 7 per cent of the total US sales, Glenmark said. “There are no major pending approvals from this facility in the next 12 months. There will be no financial impact on the organisation on account of this development,” it added.

Currently, the company has eight manufacturing facilities approved by the US FDA — five formulations’ facilities and three API facilities under Glenmark Life Sciences Ltd. None of these facilities except Baddi has any outstanding issues with the US FDA at this point in time, Glenmark said.

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