News about "Alembic Pharmaceuticals"

Alembic Pharmaceuticals Receives US FDA Final Approval for Levothyroxine Sodium Tablets

Alembic Pharmaceuticals receives final US Food and Drug Administration (FDA) approval for multiple strengths of Levothyroxine Sodium Tablets USP, expanding its portfolio of generic therapies for thyroid disorder management.

Alembic Pharmaceuticals | 22/05/2026 | By News Bureau

Alembic Pharmaceuticals Gets US FDA Tentative Nod for Darolutamide Tablets

Alembic Pharmaceuticals receives tentative US Food and Drug Administration (FDA) approval for Darolutamide Tablets 300 mg, a generic equivalent to Nubeqa by Bayer.

Alembic Pharmaceuticals | 15/05/2026 | By News Bureau

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 |  128

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 |  111

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 |  121

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 |  268

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 |  191

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 |  125

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 |  152

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 |  213