Granules gets USFDA approval for ANDAGRANULES - 387 Change: 9.20 (2.43 %)
News: Granules India has received USFDA approval for ANDA, Bupropion Hydrochloride Extended-Release Tablets in strengths of 150mg and 300mg (USRLD: Wellbutrin XL Extended-Release Tablets of Bausch Health). The approved drug is used as an antidepressant medication and has an estimated market size of ~ US$661 million (IQVIA, MAT Dec 21).
Views: The approval for Bupropion Hydrochloride Extended-Release Tablets is a high value launch but in a competitive space with existing players. Granules strategy to focus on select small but high value launches in US bodes well for the company with US formulations contributing 52% to the top-line FY21 and we expect it grow at CAGR of 20% over FY21-23E.