Strides Pharma Science gets USFDA approval for generic naproxen sodium softgel capsules

Strides Pharma Science Ltd on Thursday said its wholly-owned arm, Strides Pharma Global Pte Ltd, has received approval from the US health regulator for generic naproxen sodium softgel capsules, used to treat pain or inflammation. The approval by the US Food & Drug Administration (USFDA) is for naproxen sodium softgel capsules of 220 mg strength (over the counter), the firm said in a regulatory filing.

It is bioequivalent and therapeutically equivalent to the reference-listed drug, naproxen sodium capsules, 220 mg of Bionpharma Inc, it added. The product will be manufactured at the company's Bengaluru facility. 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, the company said. Strides said it 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 US over the counter (OTC) market for naproxen sodium softgel capsules, 220 mg, is approximately USD 100 million, the firm said.