Glenmark Pharma Gets USFDA Approval For Anti-Fungal Ointment

In a press release to the regulatory bodies, Glenmark Pharma announced that it has received final approval from the US health regulator for the anti-fungal ointment nystatin and triamcinolone acetonide. Glenmark Pharmaceuticals USA has been awarded the final approval by the US Food & Drug Administration (USFDA) for the "nystatin and triamcinolone acetonide cream USP, 100,000 units/gram and 1 mg/g," the pharma company said in a filing to the BSE.

The product is the generic version of Mycolog-II cream of Declor Asset Corporation, it further added. According to the IMS Health sales data for the 12 month period ending August of 2016, Mycolog-II cream achieved annual sales of around USD 120.9 million, Glenmark commented. The company's current portfolio consists of 111 products authorized for distribution in the US marketplace and 60 Abbreviated New Drug Applications (ANDA) pending approval with the USFDA.

Glenmark share price is currently trading at Rs 929.15, down by 0.59 per cent or 5.50 points. The share price opened at Rs 945.00 from the previous closing of Rs 934.65. The intraday high of the share price is Rs 945.00 and the intraday low is Rs 928.80.

Glenmark Pharmaceuticals is a pharmaceutical firm headquartered in the city of Mumbai, Maharashtra, India. It is a research driven global pharmaceutical company focused on discovering novel molecules as well as developing high-quality generics and specialty products for markets across the globe. 

Glenmark has seventeen manufacturing facilities across five countries including US, Switzerland, Argentina, Czech Republic and India. Glenmark has five research and development centers around the world engaged in discovery of novel biological and chemical entities.

Glenmark share price made a 52 week high of Rs 1035.10 on 26 October 2015 and a 52 week low of Rs 671.10 on 12th February 2016. The lifetime high of the share is Rs 1262.90 made on 21st August 2015 and the lifetime low of the share is Rs 4.53 made on 17th August 2001.