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Results For "Alembic-Pharmaceuticals"

123 News Found

Alembic receives USFDA final approval for Loteprednol Etabonate and Tobramycin Ophthalmic suspension
News | December 12, 2025

Alembic receives USFDA final approval for Loteprednol Etabonate and Tobramycin Ophthalmic suspension

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb


Alembic receives USFDA final approval for Dexlansoprazole delayed-release capsules, 30 mg and 60 mg
Drug Approval | November 14, 2025

Alembic receives USFDA final approval for Dexlansoprazole delayed-release capsules, 30 mg and 60 mg

Dexlansoprazole delayed-release capsules are a proton pump inhibitor


Alembic receives FDA final approval for Sumatriptan Injection USP
Drug Approval | November 08, 2025

Alembic receives FDA final approval for Sumatriptan Injection USP

Sumatriptan injection is indicated in adults for the acute treatment of migraine


Alembic announces USFDA final approval for Dasatinib Tablets
Drug Approval | November 08, 2025

Alembic announces USFDA final approval for Dasatinib Tablets

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Sprycel Tablets


FDA approves Alembic's Ticagrelor Tablets, 60 mg
Drug Approval | October 29, 2025

FDA approves Alembic's Ticagrelor Tablets, 60 mg

Ticagrelor tablets are indicated for reducing the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients


FDA approves Alembic’s Triamcinolone Acetonide injectable suspension USP, 40 mg/mL
Drug Approval | October 19, 2025

FDA approves Alembic’s Triamcinolone Acetonide injectable suspension USP, 40 mg/mL

Triamcinolone Acetonide injectable suspension USP is indicated for various autoimmune, inflammatory, and other conditions


Alembic and Amlan launch feed additive solutions for poultry
News | October 07, 2025

Alembic and Amlan launch feed additive solutions for poultry

These products strengthen poultry immunity, improve productivity, and support sustainable farming practices~


FDA approves Alembic’s Paroxetine ER tablets
Drug Approval | September 26, 2025

FDA approves Alembic’s Paroxetine ER tablets

Paroxetine Extended-Release Tablets USP, 25 mg and 37.5 mg, are indicated for the treatment of major depressive disorder


Alembic receives USFDA final approval for Macitentan Tablets, 10 mg
News | August 19, 2025

Alembic receives USFDA final approval for Macitentan Tablets, 10 mg

Macitentan tablets are an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension