Unichem Laboratories gets USFDA approval for Irbesartan Tablets USP

Irbesartan Tablets USP 75mg, 150mg and 300mg are therapeutically equivalent to Avapro Tablets, 75mg, 150mg and 300 mg of Sanofi-aventis U.S.LLC.

Unichem Laboratories Limited has announce that it has received Final ANDA approval (Tentative Approval was received earlier) from the United States Food and Drug Administration (USFDA) for Irbesartan Tablets USP.

Irbesartan Tablets USP 75mg, 150mg and 300mg are therapeutically equivalent to Avapro Tablets, 75mg, 150mg and 300 mg 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 will also be made in house at Pithampur API Plant.

Unichem Laboratories Ltd is currently trading at Rs. 286.7, up by Rs. 11.1 or 4.03% from its previous closing of Rs. 275.6 on the BSE.

The scrip opened at Rs. 276.8 and has touched a high and low of Rs. 287.8 and Rs. 273 respectively. So far 31446(NSE+BSE) shares were traded on the counter. The current market cap of the company is Rs. 2503.11 crore.

The BSE group 'B' stock of face value Rs. 2 has touched a 52 week high of Rs. 334 on 06-Oct-2015 and a 52 week low of Rs. 174 on 08-Jun-2015. Last one week high and low of the scrip stood at Rs. 288.2 and Rs. 274.2 respectively.

The promoters holding in the company stood at 50.11 % while Institutions and Non-Institutions held 18.36 % and 31.53 % respectively.

The stock is currently trading above its 50 DMA.