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Amphetamine Mixed Salts (IR Tablets) receives ANDA approval

News: Granules India has received USFDA approval for its ANDA for Amphetamine mixed salts, in strengths of 1.25 mg, 1.875 mg, 2.5 mg, 3.125 mg, 3.75 mg, 5 mg and 7.5 mg immediate-release tablets (USRLD: Adderall of Teva Women’s Health). Market size for the approved drug is ~ US$335 million (MAT October 2021, IQVIA/IMS Health).

Views: The approval for Amphetamine mixed salts is a high value launch with limited competitive scenario. This is in line with Granules' strategy to focus on select small but high value launches where competition is less and bodes well in a crowded generics market. Formulations contributed 52% to the topline of Granules in FY21. We expect it grow at a CAGR of 20% in FY21-23E.

Impact: Positive