Alembic Pharma Receives USFDA Approval for Bupropion HCL Tablets

Alembic Pharmaceuticals Limited announced that the company has received approval from the USFDA for its abbreviated new drug application (ANDA) Bupropion Hydrochloride Tablets USP, 75 mg and 100 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Wellbutrin Tablets, 75 mg and 100 mg is indicated for the treatment of major depressive disorder.

Bupropion Hydrochloride Tablets USP, 75 mg and 100 mg, have an estimated market size of USD 37 million for twelve months ending December 2017 according to IMS. Alembic now has a total of 72 ANDA approvals (64 final approvals and 8 tentative approvals) from USFDA. – Medical Buyer Bureau

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