Strides Pharma Science’s arm receives USFDA approval for Naproxen Sodium OTC Softgel Capsules

18 Aug 2022 Evaluate

Strides Pharma Science’s step-down wholly owned subsidiary -- Strides Pharma Global Pte., 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 $100 Million. 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.

Strides Pharma Science (Formerly Strides Shasun) is a pharmaceutical company with a major focus on development and manufacture of IP-led niche finished dosage formulations. It is also among the world’s largest manufacturers of soft gelatin capsules.

Strides Pharma Scien Share Price

795.55 -0.65 (-0.08%)
27-Jan-2026 14:47 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1632.20
Dr. Reddys Lab 1237.30
Cipla 1310.60
Zydus Lifesciences 891.35
Lupin 2132.50
View more..
Register Now to get our Free Newsletter & much more!

© 2026 The Alchemists Ark Pvt. Ltd. All rights reserved. MoneyWorks4Me ® is a registered trademark of The Alchemists Ark Pvt. Ltd.

×