News about "Alembic Pharmaceuticals"

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

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

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

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 |  165

Alembic Pharmaceuticals Secures USFDA Final Approval for Phytonadione Injectable Emulsion

Alembic Pharmaceuticals has received final USFDA approval for its Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-Dose Prefilled Syringe, used in treating and preventing vitamin K deficiency-related conditions.

Alembic Pharmaceuticals | 09/09/2025 | By Mrinmoy Dey

Alembic Secures Final USFDA Nod for Tretinoin Cream USP, 0.025%

Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Tretinoin Cream USP, 0.025 percent, indicated for the treatment of acne vulgaris.

Alembic Pharmaceuticals | 16/08/2025 | By Dineshwori |  216

Alembic Pharma Appoints Dr. Sachin Ghosalkar as Senior VP - SCM and Operations

Alembic Pharmaceuticals Ltd. has announced the appointment of Dr. Sachin Ghosalkar as Senior Vice President – Supply Chain Management (SCM) and Operations, designated as Senior Management Personnel of the company.

Alembic Pharmaceuticals | 21/07/2025 | By Dineshwori |  178

Alembic Pharmaceuticals Secures USFDA Nod for Key GERD Injection Drug

The drug is a therapeutic equivalent to Protonix I.V., originally developed by Wyeth Pharmaceuticals, and is used to manage gastroesophageal reflux disease (GERD), erosive esophagitis, and certain rare hypersecretion conditions like Zollinger-Ellison Syndrome in adults.

Alembic Pharmaceuticals | 02/04/2025 | By Aishwarya |  174

Alembic Pharmaceuticals Gets USFDA Final Approval for Divalproex Sodium Delayed-Release Capsules

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Depakote Sprinkle Capsules, 125 mg, of AbbVie Inc.

Alembic Pharmaceuticals | 16/01/2025 | By Aishwarya |  223

Alembic Pharmaceuticals Gets USFDA Final Approval for Ivabradine Tablets

Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated to reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction.

Alembic Pharmaceuticals | 15/11/2024 | By Aishwarya |  206