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Strides receives USFDA tentative approval for Diclofenac Potassium Softgel Capsules

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Strides Pharma Science announced that its step]down wholly owned subsidiary, Strides Pharma Global, 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 US$ 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 companyfs Oral dosage facility at Bangalore and marketed by Strides Pharma Inc in the US Market.

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(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Wed, December 04 2019. 11:20 IST