Strides gets USFDA tentative nod for Diclofenac Potassium Softgel Capsules

Strides gets USFDA tentative nod for Diclofenac Potassium Softgel Capsules

by admin- Wednesday, December 4th, 2019 05:00:53 PM

Strides Pharma Science has announced that its step‐down totally owned subsidiary, Strides Pharma Global Pte. Ltd, Singapore, has received tentative acclaim for Diclofenac Potassium Softgel Capsules, 25 mg from the US Food & Drug Administration (USFDA). The product is a accepted version of Zipsor Capsules, 25 mg, of Assertio Therapeutics, Inc.

Strides makes a speciality of softgel domain and is a international chief inside the Rx space. Strides now has a huge portfolio of softgel merchandise which contains of eleven accepted products for the USA markets together with a sturdy product pipeline slicing across numerous healing segments. Diclofenac Potassium Softgel Capsules is a part of Strides niche and small extent product portfolio with confined competition inside the US market. According to IQVIA MAT statistics, the United States market for Diclofenac Potassium Softgel Capsules, 25 mg is approximately US$ 30 Mn. Strides can release the product earliest with the aid of September 2022 based on phrases of agreement. On receiving complete approval, the product could be manufactured at the corporation’s Oral dosage facility at Bangalore and marketed with the aid of Strides Pharma Inc within the US Market.

The enterprise has 102 cumulative ANDA filings with USFDA of which 67 ANDAs were approved and 35 are pending approval.

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