Alembic Pharma gets USFDA endorsement for anti-depressant drug Kumar Jeetendra | July 8, 2021 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 …
Alembic Pharmaceuticals receives USFDA Tentative Approval for Vortioxetine Tablets 5 mg, 10 mg, 15 mg, and 20 mg. Kumar Jeetendra | January 7, 2022 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 Pharma Gets USFDA Approval for Divalproex Sodium Capsules, 125 mg Kumar Jeetendra | December 20, 2024 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 Pharma Gets USFDA Nod for Rivaroxaban Tablets Kumar Jeetendra | May 15, 2025 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 Pharma Gets USFDA Nod for Amlodipine-Atorvastatin Tablets Kumar Jeetendra | May 23, 2025 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 …
Alembic Gets USFDA Nod for Doxorubicin Liposome Injection Kumar Jeetendra | June 30, 2025 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 Pharma Gets EIR for API-I & II Facility at Panelav Kumar Jeetendra | September 15, 2025 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 …
Alembic Gets USFDA Nod for Sumatriptan Injection Autoinjector Kumar Jeetendra | November 10, 2025 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) Sumatriptan Injection USP, 4 mg/0.5 mL and 6 mg/0.5 mL, Single-Dose Autoinjector System. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Imitrex STATdose System, …
Alembic Pharma Gets USFDA Nod for Diltiazem HCl Tablets Kumar Jeetendra | November 17, 2025 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) Diltiazem Hydrochloride Tablets USP, 30 mg, 60 mg, 90 mg, and 120 mg. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Cardizem Tablets, 30 …
Alembic Pharma Gets USFDA Approval for Paroxetine ER Tablets Kumar Jeetendra | March 30, 2026 Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its supplemental Abbreviated New Drug Application (sANDA) Paroxetine Extended-Release Tablets USP, 12.5 mg. The approved sANDA is therapeutically equivalent to the reference listed drug product (RLD), Paxil CR Tablets, 12.5 mg, of Apotex Inc. …
Alembic Pharma Receives USFDA Approval for Haloperidol Tablets Kumar Jeetendra | June 5, 2026 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) Haloperidol Tablets, USP, 1 mg, 2 mg, 5 mg, 10 mg, and 20 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Haldol …
