Glenmark Pharma gains on final ANDA nod for skin drug

Glenmark Pharmaceuticals rose 1.73% to Rs 548.50 at 11:08 IST on BSE after the company said its US-based unit received final approval for Fluocinonide cream from the US drug regulator.

The company made the announcement during trading hours today, 15 July 2014.

Meanwhile, the BSE Sensex was up 194.24 points, or 0.78%, to 25,201.22.

On BSE, so far 28,000 shares were traded in the counter, compared with an average volume of 56,020 shares in the past one quarter.

The stock hit a high of Rs 557 and a low of Rs 542 so far during the day. The stock hit a 52-week high of Rs 640.35 on 2 May 2014. The stock hit a 52-week low of Rs 489.10 on 27 November 2013.

The stock had underperformed the market over the past one month till 14 July 2014, falling 6.71% compared with 0.88% fall in the Sensex. The scrip had also underperformed the market in past one quarter, falling 6.12% as against Sensex's 10.51% rise.

The large-cap company has an equity capital of Rs 27.12 crore. Face value per share is Re 1.

Glenmark Generics Inc., USA, the subsidiary of Glenmark Generics, has been granted final approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Fluocinonide cream USP 0.1%, the generic version of Vanos cream by Medicis.

Fluocinonide cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. According to IMS Health sales data for the 12 month period ending March 2014, Fluocinonide cream garnered annual sales of approximately $103 million.

Glenmark's current portfolio consists of 93 products authorized for distribution in the US marketplace and 71 ANDA's pending approval with the USFDA. In addition to these internal filings, Glenmark Generics continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio, the company said in a statement.

Glenmark Pharmaceuticals' consolidated net profit slumped 75% to Rs 43.07 crore on 27.1% increase in total income to Rs 1691.49 crore in Q4 March 2014 over Q4 March 2013.

Glenmark Pharmaceuticals has a significant presence in branded generics markets across emerging economies including India. GPL along with its subsidiary has 14 manufacturing facilities in four countries and has six R&D centers. Its subsidiary, Glenmark Generics Limited services the requirements of the US and Western Europe generics markets. The API business sells its products in over 80 countries, including the US, various countries in the EU, South America and India.

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