Strides Pharma secures USFDA nod for pain relief drug

Bengaluru: Strides Pharma Science Limited 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.

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 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 company stated.

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.

Read also: Strides Pharma Science arm bags USFDA nod for Cyclosporine Softgel Capsules

Strides is a global pharmaceutical company headquartered in Bengaluru, India. The Company mainly operates in the regulated markets and has an "in Africa for Africa" strategy along with an institutional business to service donor-funded markets.

The Company's global manufacturing sites are located in India (Chennai, Puducherry and two locations in Bengaluru), Singapore, Italy (Milan), Kenya (Nairobi) and the United States (Florida).

Read also: Board of Strides Pharma Science to consider fund raising through securities issuance