Glenmark Pharma gains after receiving tentative approval from USFDA for a drug

Glenmark Pharmaceuticals rose 0.54% to Rs 836 at 10:05 IST on BSE after the company received tentative approval from the USFDA for a drug, which is a generic version of Lo Loestrin Fe Tablets.

The announcement was made before market hours today, 25 April 2016.

Meanwhile, the BSE Sensex was down 76.35 points, or 0.3%, to 25,602.58.

On BSE, so far 11,912 shares were traded in the counter, compared with an average volume of 53,911 shares in the past two weeks. The stock hit a high of Rs 845 and a low of Rs 835.95 so far during the day. The stock hit a record high of Rs 1,261.95 on 21 August 2015. The stock hit a 52-week low of Rs 671.50 on 12 February 2016. The stock had underperformed the market over the past one month till 25 April 2016, rising 1.14% compared with 1.35% rise in the Sensex. The scrip had, however, outperformed the market in past one quarter, gaining 10.27% as against Sensex's 4.87% rise.

The large-cap company has an equity capital of Rs 28.22 crore. Face value per share is Re 1.

Glenmark Pharmaceuticals said that its US arm, Glenmark Pharmaceuticals Inc., USA has been granted tentative approval by the United States Food & Drug Administration (USFDA) for Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.01 mg, Ethinyl Estradiol Tablets USP, 0.01 mg and Ferrous Fumarate Tablets, 75 mg. The drug is a generic version of Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate) Tablets of Allergan Pharms Intl.

Glenmark will market this product upon receiving final approval of its Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.01 mg, Ethinyl Estradiol Tablets USP, 0.01 mg and Ferrous Fumarate Tablets, 75 mg Abbreviated New Drug Application (ANDA). The patent listed in the Orange Book for Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate) Tablets is scheduled to expire on 2 February 2029. According to IMS Health sales data for the 12 month period ended February 2016, the Lo Loestrin Fe achieved annual sales in US of approximately $432.2 million.

On a consolidated basis, Glenmark Pharmaceuticals' net profit rose 48.1% to Rs 169.95 crore on 1.9% growth in net sales to Rs 1724.46 crore in Q3 December 2015 over Q3 December 2014.

Glenmark Pharmaceuticals is a research-driven, global, integrated pharmaceutical organization headquartered at Mumbai, India. Glenmark has several molecules in various stages of clinical development and is primarily focused in the areas of Inflammation (asthma/COPD, rheumatoid arthritis etc.) and pain (neuropathic pain and inflammatory pain).

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