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

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Unichem Laboratories rose 3.41% to Rs 285 at 13:09 IST on BSE after the company said it received final approval from the US drug regulator for hypertension drug.

The announcement was made during trading hours today, 8 December 2015.

Meanwhile, the BSE Sensex was down 129.53 points, or 0.51%, to 25,400.58.

On BSE, so far 45,000 shares were traded in the counter, compared with an average volume of 53,463 shares in the past one quarter.

The stock hit a high of Rs 291 and a low of Rs 273 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 7 December 2015, rising 1.75% compared with 2.80% decline in the Sensex. The scrip had, however, underperformed the market in past one quarter, rising 1.17% as against Sensex's 2.56% rise.

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 from the United States Food and Drug Administration (USFDA) for Irbesartan tablets USP. Irbesartan Tablets USP 75 milligram (mg), 150mg and 300mg are therapeutically equivalent to Avapro tablets, 75mg, 150mg and 300mg of Sanofi-aventis U.S.LLC.

Irbesartan is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. Irbesartan is also indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (>300 mg/day) in patients with type 2 diabetes and hypertension. In this population, Irbesartan reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end-stage renal disease (need for dialysis or renal transplantation).

The product will be commercialized from Unichem's Ghaziabad plant. Active Pharmaceutical Ingredient (APIs) will also be made in house at Pithampur API plant, the company said in a statement.

Net profit of Unichem Laboratories rose 3.45% to Rs 23.09 crore on 10.39% rise in net sales to Rs 303.52 crore in Q2 September 2015 over Q2 September 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 APIs as well as dosage forms.

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First Published: Tue, December 08 2015. 13:13 IST