Strides Secures US FDA Appoval For Generic Surprep

By: India Pharma Outlook Team | Friday, 24 November 2023

 India Pharma Outlook Team

Strides Pharma Science's step-down fully owned subsidiary, Strides Pharma Global Pte. Singapore, has acquired FDA clearance for sodium sulphate, potassium sulphate, and magnesium sulphate oral solution 17.5g/ 3.13g/ 1.6g per 6 ounces (product).

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug, Suprep Bowel Prep Kit oral solution 17.5g/ 3.13g/ 1.6g per 6 ounces of Braintree Laboratories Inc. (Braintree). The approval bolsters the company's portfolio of products in bowel preparation that spans both prescription and over the counter offerings, as per pharmabiz.    According to IQVIA, the medicine has a market value of US$143 million and will be produced at the company's Bengaluru plant. The business has 260 cumulative ANDA applications with the US FDA (including the newly acquired portfolio from Endo at Chestnut Ridge), with 230+ ANDAs approved. The corporation has set a goal of launching 60 new goods in the United States during the next three years.   The product is part of a class of medications recommended to those who need to have a colon cleanse before having a colonoscopy. The package comes in a box with two 6 ounce bottles of the liquid and a mixing container.

Strides Pharma Science Limited is an Indian pharmaceutical firm based in Bangalore. The Company operates in two business segments: Regulated Markets and Emerging Markets. Strides has a worldwide production footprint with eight manufacturing sites distributed across four continents, including five FDA-approved facilities in the United States and two in the rest of the globe. The company has a specialized R&D center in India, as well as worldwide filing capabilities and a significant presence in more than 100 countries.

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