Strides Pharma gets USFDA tentative approval for Diclofenac Potassium Softgel Capsules

According to IQVIA MAT data, the US market for Diclofenac Potassium Softgel Capsules, 25 mg is ~US$ 30mn.

Dec 04, 2019 05:12 IST India Infoline News Service

Strides
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.    

Strides specialize in softgel domain and is a global leader in the Rx space. Strides now have a   large portfolio of softgel products which comprises of 11 approved products for the US markets along with a strong product pipeline cutting across several therapeutic segments.  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 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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