New Delhi: Drug firm Strides Pharma Science on Wednesday said it has got tentative approval from US health regulator for Diclofenac Potassium Softgel Capsules, a drug used to relieve pain. Strides Pharma Global Pte Ltd, Singapore, has received tentative approval for Diclofenac Potassium Softgel Capsules, 25 mg from the United States Food & Drug Administration (USFDA), Strides Pharma Science said in a regulatory filing.
Strides Pharma Global Pte Ltd is a step-down wholly owned subsidiary of Strides Pharma Science. The product is a generic version of Zipsor Capsules in the strength of 25 mg, of Assertio Therapeutics, Inc.
Diclofenac Potassium Softgel Capsule is a nonsteroidal anti-Inflammatory drug used to relieve pain and swelling. It is used to treat muscle aches, backaches, dental pain, menstrual cramps, and sports injuries.
Diclofenac Potassium Softgel Capsules is part of Strides niche and small volume product portfolio with limited competition in the US market.
According to IQVIA MAT data, the US market for Diclofenac Potassium Softgel Capsules, 25 mg is approximately USD 30 million.
Strides can launch the product earliest by September 2022 based on terms of settlement.
On receiving full approval, the product will be manufactured at the company’s Oral dosage facility in Bengaluru and marketed by Strides Pharma Inc in the US Market. Shares of Strides Pharma Science were trading at Rs 381.40, higher by 1.31 per cent on BSE.