Strides receives USFDA approval for Naproxen Sodium OTC Softgel Capsules

Strides Pharma Science Limited (Strides) today announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Naproxen Sodium Softgel Capsules, 220 mg (OTC) from the United States Food & Drug Administration (USFDA). The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Naproxen Sodium Capsules, 220 mg, of Bionpharma Inc.

Strides is focusing on building a private label business in the US by leveraging its portfolio of products across soft gels, tablets, capsules and other formats. The approval for Naproxen Sodium OTC Softgel Capsules further strengthens Strides OTC portfolio for the US markets. The US OTC market for Naproxen Sodium Softgel Capsules, 220 mg (OTC) is approximately ~US$100 Mn. The product will be manufactured at the company's facility at Bengaluru.

The company has 279 cumulative ANDA filings (including recently acquired portfolio from Endo at Chestnut Ridge) with USFDA of which 260 ANDAs have been approved and 19 are pending approval. The company has set a target to launch ~ 20 new products every year in the US.

Shares of Strides Pharma Science Limited was last trading in BSE at Rs. 357.90 as compared to the previous close of Rs. 356.30. The total number of shares traded during the day was 21157 in over 1857 trades.

The stock hit an intraday high of Rs. 362.75 and intraday low of 348.85. The net turnover during the day was Rs. 7509392.00.

Source : Equity Bulls

Keywords

StridesPharmaScience INE939A01011 Singapore NaproxenSodiumSoftgelCapsules USFDA Approval OTC