Drug firm Alembic Pharmaceuticals on Thursday said it has received approval from the US health regulator for Desipramine Hydrochloride tablets used in the treatment of depression. The approved product is therapeutically equivalent to the reference listed drug product Norpramin tablets of Validus Pharmaceuticals LLC. The company has received approval from the US Food and Drug …
7th January, 2022, Mumbai: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Vortioxetine Tablets 5 mg, 10 mg, 15 mg, and 20 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug …
Alembic Pharmaceuticals Limited (Alembic) announced that it has received Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Divalproex Sodium Delayed-Release Capsules USP, 125 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Depakote Sprinkle Capsules, 125 mg, of AbbVie Inc. Alembic …
Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Rivaroxaban Tablets USP, 2.5 mg, 10 mg, 15 mg, and 20 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Xarelto Tablets, 2.5 …
Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Amlodipine and Atorvastatin Tablets USP, 2.5 mg/10 mg, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 …
30th June, 2025 Mumbai: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Doxorubicin Hydrochloride Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) Single-Dose Vials. The approved ANDA is therapeutically equivalent …
Alembic Pharmaceuticals Limited has received the Establishment Inspection Report (EIR) for the inspection conducted by the US Food and Drug Administration (USFDA) at its API-I and API-II facilities in Panelav. The inspection was carried out between May 26, 2025 and May 31, 2025. About Alembic Pharmaceuticals Limited Alembic Pharmaceuticals Limited, a vertically integrated research and …
