Strides Pharma Science’s step?down wholly owned subsidiary, Strides Pharma Global Pte, Singapore, has received tentative approval for Diclofenac Potassium Softgel Capsules, 25 mg from the United States Food & Drug Administration (USFDA). The product is a generic version of Zipsor Capsules, 25 mg, of Assertio Therapeutics, Inc. 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 $30 million.
The company has 102 cumulative ANDA filings with USFDA of which 67 ANDAs have been approved and 35 are pending approval.
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.
