The share price of Glenmark Pharmaceuticals fell 8.64 % to hit a new 52-week low of Rs 457 on the BSE after US health regulator USFDA issued a Complete Response Letter (CRL) to the drug maker, regarding the new drug application for Ryaltris.
Glenmark Pharma's shares opened 5 points down at Rs 495 after forming a gap down chart pattern at the opening bell, against the last close of Rs 500.
Later, the stock touched a new 52-week low of Rs 457, at a loss of 8.64% or 43.2 points on BSE. On NSE, the stock fell 8.19% to the day's low of Rs 459, also its new 52-week low.
Glenmark Pharma share price closed at Rs 460, down by 39 points or 7.92% on BSE. It ended at Rs 461 on NSE.
Overall, 80.38 lakh shares and 2.8 lakh shares changed hands on NSE and BSE, both above the 5, 10 and 30-day average volume traded. The Pharma stock has fell 10.86% in the last 2 trading days.
As per the company's filing on Saturday, "The CRL cites deficiencies in the Drug Master File (DMF) for Ryaltris (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg]), Nasal Spray, pertaining to one of the active pharmaceutical ingredients (APIs) and in the manufacturing facilities."
The pharma giant replied to the observation saying, "We feel confident that we should be able to resolve these issues within the next 6 to 9 months and shall continue to pursue regulatory approval for Ryaltris and work closely with the FDA to determine the appropriate next steps."