News about "Alembic Pharmaceuticals"

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

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

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 |  117

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 |  147

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 |  139

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 |  380

Alembic Pharmaceuticals Secures USFDA Approval for Ticagrelor Tablets, 60 mg

Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ticagrelor Tablets, 60 mg. The product is therapeutically equivalent to Brilinta Tablets, 60 mg, from AstraZeneca.

Alembic Pharmaceuticals | 29/10/2025 | By Dineshwori |  196

Alembic Pharmaceuticals Gets USFDA Nod for Triamcinolone Acetonide Injection

The approved ANDA, Triamcinolone Acetonide Injection, is therapeutically equivalent to the Reference Listed Drug (RLD) product, Kenalog-40 Injectable Suspension, of Bristol-Myers Squibb company.

Alembic Pharmaceuticals | 21/10/2025 | By Dineshwori |  224

Alembic Wins USFDA Clearance for Paroxetine ER Tablets for Depression and Anxiety Disorders

Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Paroxetine Extended-Release Tablets USP, 25 mg and 37.5 mg.

Alembic Pharmaceuticals | 25/09/2025 | By Dineshwori |  126

Alembic Pharmaceuticals Receives US FDA Compliance Report for Panelav API Facilities

Alembic Pharmaceuticals has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (US FDA) for the inspection conducted at its API-I and API-II facilities in Panelav, Gujarat.

Alembic Pharmaceuticals | 15/09/2025 | By Dineshwori |  418