US FDA issues warning letter for Glenmark Pharmaceuticals facility in Baddi

The US Food and Drug Administration (US FDA) has issued a warning letter to Glenmark Pharmaceuticals for breach of norms at its facility at Baddi in Himachal Pradesh.

The US FDA had conducted an inspection between April 15 and 20 and classified it as ‘official action indicated’. With regards to the same inspection, the US FDA has now issued a ‘warning letter’ to the Baddi facility, Glenmark said in a statement.

“The company is committed to working 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.”

However, Glenmark said the existing manufacturing and sale of products from this facility will not be impacted. The Baddi facility is expected to contribute 30 million dollars in total sales for this financial year which is about 7 per cent of the total US sales.

There are no major pending approvals from this facility in the next 12 months, said the pharma major. “There will be no financial impact on the organisation on account of this development.”

Glenmark currently has eight manufacturing facilities approved by the US FDA — five formulations facilities and three active pharmaceutical ingredient (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, it added.

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