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Glenmark Pharma slips 7% after US FDA issues warning letter for Baddi unit

The USFDA had inspected the company's Baddi facility between April 15 and April 20 and had earlier classified the inspection as an "Official Action Indicated".

SI Reporter  |  Mumbai 

Glenmark Pharmaceuticals

Shares of Glenmark Pharmaceuticals slipped 7 per cent on the BSE to hit an over seven-year low of Rs 294 in the morning deals on Monday after the drug firm said it has received a warning letter from the US health regulator for its Baddi facility in Himachal Pradesh. The stock was trading at its lowest level since March 15, 2012 on the BSE.

"The United States Food and Drug Administration (US FDA) had inspected the company’s Baddi facility between April 15 and April 20 and earlier classified the inspection as an 'Official Action Indicated (OAI)'. With regards to the same inspection, the US FDA has now issued a 'warning letter' to the Baddi facility," Glenmark said in a filing to the BSE. READ FILING HERE

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

In the past six months, the stock underperformed the market by falling 54 per cent, as compared to a 3 per cent decline in the S&P BSE Sensex. A combined 1.74 million equity shares have changed hands on the counter on the NSE and BSE so far.

First Published: Mon, October 07 2019. 10:38 IST
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