Glenmark Pharmaceuticals plummets on US FDA warning letter
Glenmark Pharmaceuticals has informed the bourses that US FDA has issued a warning letter for its Baddi facility at Himachal Pradesh. The said facility was inspected by US FDA during 15th to 20th April of 2019. At that time it was classified as ‘Official Action Indicated’ implying regulatory/administrative actions will be recommended. Now, US FDA has issued this warning letter for the same facility.
The company in its exchange filing said that it is in the process of preparing a detailed response to the USFDA within 15 working days. It has also clarified that this warning letter would not disrupt its existing manufacturing and sales of products from Baddi plant.
Glenmark has generated nearly 7 per cent of its US sales (USD 30 million) from this facility. Furthermore, in the next one year there are no major pending approvals from this facility. Besides, in the recent quarter (Q1FY20), the company has generated nearly 31.5 per cent of its consolidated sales from US.
At present the company has eight US FDA approved manufacturing facilities of which five are formulations facilities and three are API facilities under Glenmark Life Sciences Limited. As of now, Glenmark has been reported with issues only for Baddi facility.
With response to this development, the stock of Glenmark Pharma reacted negatively and tanked nearly 15 per cent to touch intra-day low of Rs. 269.75 apiece.