Strides Pharma gets approval for Solifenacin SuccinateTablets

The company informed on Friday that Stride Pharma Global Pte Limited, Singapore, has received approval from the United States Food and Drug Administration (USFDA) for manufacturing Solifenacin SuccinateTablets, 5 mg and 10 mg.

The Solifenacin Succinate Tablet will be manufactured at Alathur facility in Chennai and will be marketed by Strides Pharma Inc. in the US market. The product is a generic version of Vesicare Tablet, 5 mg and 10 mg, of Astellas Pharma US, Inc. The tablet is used in treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Meanwhile, the stock fell more than 7 per cent on Friday after Strides pharma received an Information Request from USFDA to provide test data related to N-nitrosodimethylamine (NDMA) impurities in Ranitidine tablets. For ranitidine tablets, the company will conduct the relevant tests mandated by the USFDA and has suspended sales of ranitidine in US market until the company gets clarity of next step from USFDA.

Strides Pharma Science Limited is a Pharmaceutical company with a major focus on development and manufacture of IP-led niche finished dosage formulations. Strides is engaged in the development, manufacture, and marketing of pharmaceutical products for regulated and emerging markets.

On Friday, the stock of Strides Pharma Science Limited opened at Rs. 332.00 per share and made an intraday high and low of Rs. 332.00 and Rs. 297.05, respectively on the BSE. The stock closed at Rs.304.20, down by 7.43 per cent.