Strides Pharma Science Limited (Strides) today announced that its stepdown wholly owned subsidiary, StridesPharma Global Pte. Limited, Singapore, has received approval for Sodium Sulphate, Potassium Sulphate and Magnesium Sulphate Oral Solution 17.5g/ 3.13g/ 1.6g per 6 ounces (Product) from the United States Food & Drug Administration (USFDA).
The Product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), 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.
The Product has a market size of ~US$143 Mn per IQVIA. The Product will be manufactured at the company’sfacility in Bengaluru.
The company has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with USFDA, of which 230+ ANDAs have been approved. The company has set a target to launch ~ 60 new products over three years in the US.
About Sodium Sulphate, Potassium Sulphate and Magnesium Sulphate Oral Solution 17.5g/ 3.13g/ 1.6g per 6 ounces
The Product belongs to a group of medicines prescribed to those who are required to undergo a colon cleanse prior to a colonoscopy. The kit is available in a carton containing two 6-ounce bottles of the liquid and a mixing container.