Strides Pharma Science announced that it's step-down wholly-owned subsidiary, Strides Pharma Global Pte. Limited, 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.
According to IQVIA MAT data, the US market for Diclofenac Potassium Softgel Capsules, 25 mg is approximately US$ 30 Mn.
Strides can launch the product earliest by September 2022 based on terms of the settlement. On receiving full approval, the product will be manufactured at the company’s Oral dosage facility at Bangalore and marketed by Strides Pharma Inc in the US Market.
The company has 102 cumulative ANDA filings with USFDA of which 67 ANDAs have been approved and 35 are pending approval.
Strides Pharma Science Ltd is currently trading at Rs381 up by Rs3.85 or 1.02% from its previous closing of Rs377.15 on the BSE. The scrip opened at Rs379.20 and has touched a high and low of Rs382.60 and Rs375.50 respectively.
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