Unichem Laboratories gains after USFDA approval for drug

Unichem Laboratories rose 1.01% to Rs 310.40 at 15:06 IST on BSE after the company said it received approval from US drug regulator for Montelukast sodium tablets.

The announcement was made during trading hours today, 9 October 2015.

Meanwhile, the BSE Sensex was up 278.33 points, or 1.04%, to 27,124.14.

On BSE, so far 1.40 lakh shares were traded in the counter, compared with an average volume of 58,751 shares in the past one quarter.

The stock hit a high of Rs 320.90 and a low of Rs 305 so far during the day. The stock hit a record high of Rs 334 on 6 October 2015. The stock hit a 52-week low of Rs 174 on 8 June 2015.

The stock had outperformed the market over the past one month till 8 October 2015, rising 18.69% compared with 6.04% rise in the Sensex. The scrip had also outperformed the market in past one quarter, rising 50.12% as against Sensex's 3.04% decline.

The small-cap company has an equity capital of Rs 18.16 crore. Face value per share is Rs 2.

Unichem Laboratories announced that it has received Abbreviated New Drug Application (ANDA) approval from the United States Food and Drug Administration (USFDA) for Montelukast sodium tablets in the US market.

Montelukast sodium tablets 10 milligram (mg) are therapeutically equivalent to Singulair tablets 10mg of Merck Sharp & Dohme Corp.

Montelukast is a leukotriene receptor antagonist (LTRA) which is indicated for prophylaxis and chronic treatment of asthma in adults and adolescents patients over 15 years of age. It is also indicated for prevention of exercise-induced bronchoconstriction (EIB) adults and adolescents patients over 15 years of age. It is also prescribed for relief of symptoms of allergic rhinitis in adults and adolescents patients over 15 years of age.

The product will be commercialized from Unichem's Goa plant. Unichem Laboratories now has total of 19 ANDA approvals (Including 3 Tentative Approvals) from USFDA.

Net profit of Unichem Laboratories declined 4.70% to Rs 28.78 crore on 5.64% rise in net sales to Rs 304.76 crore in Q1 June 2015 over Q1 June 2014.

Unichem Laboratories is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India and several other markets across the world. In India, the company is a leader in niche therapy areas of cardiology, neurology, orthopedics and anti-infectives. The company has strong skills in product development, process chemistry and manufacturing of complex API as well as dosage forms.

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