Unichem Labs gets USFDA nod for Solifenacin Succinate Tablets

Specialty pharmaceutical company, Unichem Laboratories informed the bourses that it has received United States Food and Drug Administration (USFDA) approval for Solifenacin Succinate Tablets. The product will be commercialised from company's Goa plant.

The company received ANDA approval from the USFDA for Solifenacin Succinate Tablets, 5 mg and 10 mg to market a generic version of Vesicare Tablets, 5 mg and 10 mg, of Astellas Pharma US, Inc. The said medicine is used in the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Unichem Laboratories is an international, integrated, specialty pharmaceutical company. The company is involved in producing a basket of pharmaceutical formulations such as branded generics as well as generics in India and several other markets across the world.

Recently, company had received observation from USFDA for Ghaziabad facility. Company will provide the response and corrective action plan within next 15 working days to address the USFDA observation.

Earlier this month, the company had received ANDA approval from USFDA for Unichem's Tramadol Hydrochloride Tablets USP, 50 mg. to market a generic version of Ultram Tablets, 50 mg, of Janssen Pharmaceuticals, Inc. which are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Also, it had received ANDA approval from USFDA for its Chlorthalidone Tablets USP, 25 mg and 50 mg to market a generic version of Hygroton Tablets, 25 mg and 50 mg of Sanofi Aventis US, LLC.

In today's trading session, the stock finally settled at Rs. 167.55, down by 3.23 per cent or Rs. 5.60 on the BSE.