Strides Pharma’s Singapore Subsidiary Received FDA Approval for an Oral Solution to Empty the Intestines

On Thursday, Strides Pharma Science Ltd announced that its Singapore subsidiary has received approval from the USFDA for the generic Suprep Bowel Prep Kit oral solution. The kit contains three ingredients: sodium sulfate, potassium sulfate, and magnesium sulfate in the strength of 17.5g/3.13g/1.6g per 6 ounces. The newly approved product is considered bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Suprep Bowel Prep Kit Oral Solution from Braintree Laboratories Inc.

The oral solution is used to clean out the intestines before bowel exam procedures, such as colonoscopy. It facilitates colon cleansing, inducing bowel movements to make colonoscopy procedures more manageable. The manufacturing of the product will take place at Strides Pharma’s facility in Bengaluru.

The USFDA clearance was granted to Strides Pharma Global Pte. Ltd, the company’s step-down wholly-owned subsidiary based in Singapore. Strides Pharma is now the second generic company to receive approval for this product, strengthening its portfolio of bowel preparation products that encompass both prescription and over-the-counter offerings.

According to IQVIA data, the new drug has a market size of $143 million. Strides Pharma currently boasts 260 cumulative ANDA filings, including the recently acquired portfolio from Endo at Chestnut Ridge with the USFDA. Over 230 ANDAs have already been cleared. The company has set a target to launch 60 new products over a three-year period in the US.

Shares of Strides Pharma Science Ltd were trading 1.31% higher at ₹492.8 apiece on the BSE at 9:30 AM. This development showcases the company’s commitment to expanding its product offerings in the pharmaceutical market and obtaining regulatory approvals for its generics.