Strides Pharma subsidiary receives FDA approval for bowel prep solution

Strides Pharma Science Limited, through its subsidiary Strides Pharma Global Pte. Limited, Singapore, has recently achieved a significant milestone by receiving approval from the United States Food & Drug Administration (USFDA) for its Sodium Sulphate, Potassium Sulphate, and Magnesium Sulphate Oral Solution. This product, designed for bowel preparation, is bioequivalent and therapeutically equivalent to Braintree Laboratories Inc.’s Suprep Bowel Prep Kit.

Strides Pharma’s Market Expansion with Newly Approved Product

The approval of this oral solution significantly bolsters Strides Pharma Science Limited’s portfolio in the bowel preparation market, encompassing both prescription and over-the-counter offerings. The product, with an estimated market size of approximately US$143 million according to IQVIA, will be manufactured at the company’s facility in Bengaluru. Strides Pharma has a robust pipeline of 260 cumulative ANDA filings with the USFDA, of which over 230 have already been approved.

Manufacturing and Application of the Bowel Preparation Solution

The newly approved solution is a vital medicine for patients required to undergo colon cleansing before a colonoscopy. It comes in a kit containing two 6 ounce bottles of the liquid and a mixing container. Strides Pharma Science Limited aims to launch around 60 new products in the US over the next three years, marking a significant expansion in its product offerings in the healthcare sector.

This recent approval from the USFDA not only enhances Strides Pharma Science Limited’s standing in the pharmaceutical market but also represents an important development in medical preparations for colonoscopy procedures.