Glenmark Pharmaceuticals Ltd has announced in relation to an inspection conducted by the USFDA between April 15, 2019 to April 20, 2019 at the company's Baddi facility in Himachal Pradesh, India. The company had earlier announced that the inspection was classified as an "Official Action Indicated" vide a letter by the USFDA. With regards to the same inspection, the USFDA has now issued a "Warning Letter" to the Baddi facility. The company is committed to work along with the USFDA 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 USFDA within 15 working days.
The existing manufacturing and the sale of products from this facility will not be impacted. The Baddi facility is expected to contribute USD 30mn in total sales for this financial year which is approximately 7% of the total US sales. 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. Glenmark currently has eight manufacturing facilities approved by the USFDA - five formulations facilities and three API facilities under Glenmark Life Sciences Limited. None of these facilities except Baddi has any outstanding issues with the USFDA at this point in time.
Shares of GLENMARK PHARMACEUTICALS LTD. was last trading in BSE at Rs.315.65 as compared to the previous close of Rs. 319.5. The total number of shares traded during the day was 32862 in over 771 trades.
The stock hit an intraday high of Rs. 329 and intraday low of 314.95. The net turnover during the day was Rs. 10535880.