Strides Pharma Science Ltd on Thursday said its Singapore subsidiary has received the USFDA approval for the generic Suprep Bowel Prep Kit oral solution.
Suprep Bowel Prep contains three ingredients, sodium sulfate, potassium sulfate, and magnesium sulfate in the strength of 17.5g/ 3.13g/ 1.6g per 6 ounces (product), Strides Pharma said in stock exchange filing. The new product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Suprep Bowel Prep Kit Oral Solution of Braintree Laboratories Inc.
The oral solution is used to clean out the intestines before bowel exam procedures such as colonoscopy. The kit is used in the cleansing of the colon to induce bowel movement, which helps in carrying out colonoscopy easily.
The product will be manufactured at the company’s facility in Bengaluru. The USFDA clearance has been granted to the company'step‐down wholly owned subsidiary, Strides Pharma Global Pte. Ltd, Singapore.
Strides is the second generic to get clearance for this product and the approval boosts the firm's portfolio of products in bowel preparation that spans both prescription and over-the-counter offerings.
The new drug has a market size of $143 million, as per IQVIA data.
Currently, the company has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with USFDA, of which over 230 ANDAs have been cleared.
Also, the pharma major said that it 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 BSE at 9.30 AM.
(Edited by : Shloka Badkar)
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