Alembic Pharmaceuticals Limited on Monday announced that it has received US Food & Drug Administration (USFDA) approvals on five of its Abbreviated New Drug Application (ANDA) in Q1 of FY 23-24.
In a press statement, the Company announced that it has received 4 final approvals that include Bepotastine Besilate Ophthalmic Solution, 1.5%, Nadolol Tablets USP, 20 mg, 40 mg, and 80 mg, Carboprost Tromethamine Injection USP, 250 mcg/mL Single-Dose Vials, Doxercalciferol Injection, 4 mcg/2 mL (2 mcg/mL) Multiple-Dose Vials.
Besides these, the Company has received one tentative USFDA approval for Doxycycline Capsules, 40 mg, it added.
Alembic has received a cumulative total of 184 ANDA approvals (159 final approvals and 25 tentative approvals) from the US FDA.
