The pharma major announced that it has received approval from the United States Food and Drug Administration (USFDA) for Naproxen Sodium Softgel Capsules.
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Naproxen Sodium Capsules of Bionpharma Inc.Naproxen Sodium Softgel Capsules is a nonsteroidal anti-inflammatory drug used to treat pain or inflammation caused by conditions such as arthritis, ankylosing spondylitis, tendinitis, bursitis, gout, or menstrual cramps. It can also be used to treat acute pain caused by other conditions.
Strides Pharma said that the product will be manufactured at its facility in Bengaluru.
The US OTC market for Naproxen Sodium Softgel Capsules is approximately $100 million.
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.
Bengaluru-based Strides Pharma Science is a global pharmaceutical company. It mainly operates in the regulated markets and has an "in Africa for Africa" strategy and an institutional business to service donor-funded markets. The company focuses on "difficult to manufacture" products sold in over 100 countries.
The drug maker reported a net loss of Rs 135.89 crore as against a net loss of Rs 205.20 crore in Q1 FY23 over Q1 FY22. Net sales rose 36.6% YoY to Rs 940.07 crore in the quarter ended 30 June 2022.
Shares of Strides Pharma Science closed 0.28% lower at Rs 355.30 on the BSE.
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