Unichem Lab jumps after receiving final approval for dementia drug from USFDA

Unichem Laboratories rose 3.48% to Rs 312 at 14:08 IST on BSE after the company said it received final approval from the US drug regulator for dementia drug.

The announcement was made during trading hours today, 14 October 2015.

Meanwhile, the BSE Sensex was up 12.40 points, or 0.05%, to 26,858.93.

On BSE, so far 1.64 lakh shares were traded in the counter, compared with an average volume of 60,466 shares in the past one quarter.

The stock hit a high of Rs 319.70 and a low of Rs 300.25 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 13 October 2015, rising 8.69% compared with 4.83% rise in the Sensex. The scrip had also outperformed the market in past one quarter, rising 35.38% as against Sensex's 3.99% 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 final abbreviated new drug application (ANDA) approval (tentative approval was received earlier) from the United States Food and Drug Administration (USFDA) for Memantine Hydrochloride tablets USP.

Memantine Hydrochloride tablets USP 5mg & 10mg are therapeutically equivalent to Namenda Tablets, 5mg & 10mg of Forest Laboratories, Inc.

Memantine Hydrochloride is an N-methyl-D-aspartate (NMDA) receptor antagonist which is indicated for the treatment of moderate to severe dementia of the Alzheimer's type.

The product will be commercialized from Unichem's Goa plant. Active Pharmaceutical Ingredient will also be made in house at Pithampur API Plant.

Unichem Laboratories now has total of 19 ANDA approvals (including 2 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-infectiies. The company has strong skills in product deveIopment process chemistry and manufacturing of complex API as well as dosage forms.

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