News about "Alembic Pharmaceuticals"

Alembic Pharmaceuticals Gains USFDA Approval for Dapagliflozin Tablets ANDA

Alembic Pharmaceuticals receives USFDA approval for Dapagliflozin Tablets ANDA, gaining eligibility for 180-day shared generic drug exclusivity and strengthening its diabetes portfolio.

Alembic Pharmaceuticals | 07/04/2026 | By News Bureau

Alembic Pharmaceuticals Secures US FDA Approval for Paroxetine ER Tablets

U.S. Food and Drug Administration grants final approval to Alembic’s sANDA for paroxetine extended-release tablets, used in treating depression and anxiety-related disorders.

Alembic Pharmaceuticals | 30/03/2026 | By News Bureau

Alembic Pharmaceuticals Records First US Prescription Sale of Pivya, Marking Entry into Branded Drug Market

Alembic Pharmaceuticals reports first prescription sale of Pivya in the US, marking its entry into the branded pharmaceutical segment with a first-line oral antibiotic for uncomplicated urinary tract infections in women.

Alembic Pharmaceuticals | 07/03/2026 | By News Bureau

Alembic Pharmaceuticals Wins US FDA Approval for Generic Efinaconazole Topical Solution

Alembic Pharmaceuticals receives US FDA approval for generic efinaconazole topical solution, targeting a US market estimated at USD 500 million.

Alembic Pharmaceuticals | 24/02/2026 | By News Bureau |  164

Alembic Pharma Secures US FDA Tentative Approval for Bosutinib Tablets

The USFDA’s tentative approval confirms that Alembic Pharmaceuticals’ Bosutinib Tablets, 400 mg, meet therapeutic equivalence requirements with the Reference Listed Drug (RLD) Bosulif, marking an important step towards potential market entry.

Alembic Pharmaceuticals | 12/01/2026 | By News Bureau |  165

Alembic Pharma Wins USFDA Approval for Travoprost Ophthalmic Solution

Alembic Pharmaceuticals has secured USFDA approval for its Travoprost Ophthalmic Solution, with the ANDA deemed therapeutically equivalent to the reference listed drug Travatan Z (0.004%) from Sandoz.

Alembic Pharmaceuticals | 18/12/2025 | By News Bureau |  101

Alembic Pharmaceuticals Receives USFDA Final Approval for Diltiazem Hydrochloride Tablets

Alembic Pharmaceuticals has received final approval from the USFDA for its Diltiazem Hydrochloride Tablets in multiple strengths, a generic version of Cardizem used for managing certain types of angina. The approval adds to the company’s growing US portfolio, bringing its total ANDA count to 230, including 210 final and 20 tentative approvals.

Alembic Pharmaceuticals | 18/11/2025 | By Dineshwori |  130

Alembic Pharmaceuticals Secures Multiple USFDA Approvals; Q2 Revenue Rises 16 Percent

Alembic Pharmaceuticals has announced a series of regulatory milestones, receiving final approval from the US Food & Drug Administration (USFDA) for four Abbreviated New Drug Applications (ANDAs) in the month.

Alembic Pharmaceuticals | 15/11/2025 | By Dineshwori |  185

USFDA Approves Alembic Pharmaceuticals' Sumatriptan Single-Dose Autoinjector

Alembic Pharmaceuticals has received USFDA approval for its Abbreviated New Drug Application (ANDA) for Sumatriptan single-dose autoinjector, deemed therapeutically equivalent to GlaxoSmithKline’s Imitrex STATdose System in 4 mg/0.5 mL and 6 mg/0.5 mL strengths.

Alembic Pharmaceuticals | 10/11/2025 | By Dineshwori |  185

Alembic Pharmaceuticals Receives USFDA Approval for Generic Dasatinib Tablets

Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dasatinib Tablets in strengths of 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg.

Alembic Pharmaceuticals | 07/11/2025 | By Dineshwori |  461