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 USD 143 Mn per IQVIA. The Product will be manufactured at the company's facility 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.