Glenmark Pharma hits 52-week low on USFDA warning letter for Baddi facility

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Shares of Glenmark Pharmaceuticals touched a 52-week low of Rs 300, falling 4.7 percent in the early trade on October 7 after the US Food & Drug Administration issued a warning letter to the company’s Baddi facility.

USFDA inspected the Baddi facility in Himachal Pradesh between April 15 and April 20. The company had earlier informed that the inspection was classified as ‘Official Action Indicated’ vide a letter by USFDA.

The management said it is committed to work along with USFDA to implement all necessary corrective actions required to address the concerns raised in the letter and is in the process of preparing a detailed response to USFDA within 15 working days. “Existing manufacturing and the sale of products from this facility will not be impacted,” the company said in a release.

Baddi facility is expected to contribute $30 million in total sales for this fiscal, which is around seven percent of total US sales.

There are no major pending approvals from this facility for the next 12 months and there will be no financial impact on account of this development, the company stated.

The company currently has eight manufacturing facilities approved by the USFDA – five formulations facilities and three API facilities under Glenmark Life Sciences and none of these facilities except Baddi has any outstanding issues with the USFDA at this point in time.

At 09:17 hrs Glenmark Pharma was quoting at Rs 304.90, down Rs 10.75, or 3.41 percent on the BSE. Get access to India’s fastest growing financial subscriptions service Moneycontrol Pro for as little as Rs 599 for first year. Use the code “GETPRO”. Moneycontrol Pro offers you all the information you need for wealth creation including actionable investment ideas, independent research and insights & analysis For more information, check out the Moneycontrol website or mobile app.