Mumbai, 05th June 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 therapeuticallyContinue Reading
Ahmedabad, 16th May: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Darolutamide Tablets, 300 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Nubeqa Tablets,Continue Reading
Ahmedabad, April 28: 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) Fingolimod Capsules, 0.5 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Gilenya Capsules, 0.5Continue Reading
Ahmedabad, April 07th: 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) Dapagliflozin Tablets, 5 mg and 10 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD),Continue Reading
Ahmedabad, March 9: Alembic Pharmaceuticals Limited (“Alembic”) today announced the first prescription-based sale of Pivya (pivmecillinam) tablets, an oral prescription antibiotic, following its recent commercial launch in the United States of America (US). Pivya® is Alembic’s first branded pharmaceutical product in the US and is being marketed through Alembic TherapeuticsContinue Reading
Ahmedabad, February 27th: 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) Lamotrigine Orally Disintegrating Tablets USP, 25 mg, 50 mg, 100 mg and 200 mg. The approved ANDA is therapeutically equivalentContinue Reading
Ahmedabad 11th, December: 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) Loteprednol Etabonate and Tobramycin Ophthalmic Suspension, 0.5%/0.3% (5 mL and 10 mL). The approved ANDA is therapeutically equivalent to theContinue Reading
AHMEDABAD,17TH November: 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 theContinue Reading