Strides Pharma's Naproxen Sodium OTC Softgel Capsules gets approval from USFDA; Stock dips 2%

19 Aug 2022 , 11:49 AM

Strides Pharma Science Limited has announced that its Singapore-led step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited has received approval for Naproxen Sodium Softgel Capsules, 220 mg (OTC) from the United States Food & Drug Administration (USFDA).

As per the filing, this product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Naproxen Sodium Capsules, 220 mg, of Bionpharma Inc.

The Company is focusing on building a private label business in the US by leveraging its portfolio of products on all formats. Further, the US OTC market for Naproxen Sodium Softgel Capsules, 220 mg (OTC) is approximately ~US$100 million and it will be manufactured at the company’s facility located at Bengaluru.

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

At around 11:50 AM, Strides Pharma Science Ltd was trading at Rs349.15 per share down by Rs8.75 or 2.44% from its previous closing of Rs357.90 per share on the BSE.