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Results For "Alembic"

117 News Found

Alembic Pharmaceuticals receives USFDA final approval for Lamotrigine Extended-Release Tablets
Drug Approval | October 03, 2024

Alembic Pharmaceuticals receives USFDA final approval for Lamotrigine Extended-Release Tablets

Lamotrigine extended-release tablets are indicated for adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures


Briefs: Lupin, Alembic Pharmaceuticals and Piramal Pharma
Drug Approval | September 29, 2024

Briefs: Lupin, Alembic Pharmaceuticals and Piramal Pharma

Lupin's Pithampur Unit-1 gets Form 483 from USFDA with 3 observations


Alembic receives USFDA final approval for Paliperidone ER tablets
News | September 27, 2024

Alembic receives USFDA final approval for Paliperidone ER tablets

Paliperidone extended-release tablets are an atypical antipsychotic agent indicated for treatment of schizophrenia


Alembic appoints Sudhakar Pandiyan as Head - Technical Operations
People | September 17, 2024

Alembic appoints Sudhakar Pandiyan as Head - Technical Operations

He has been associated with Caplin Steriles Ltd., Mylan Laboratories Ltd., Caplin Point Laboratories Ltd., Strides Arcolab Ltd. and Novartis Vaccines and Diagnostics


Alembic receives USFDA final approval for Dabigatran Etexilate Capsules, 110 mg
Drug Approval | August 13, 2024

Alembic receives USFDA final approval for Dabigatran Etexilate Capsules, 110 mg

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pradaxa Capsules, 110 mg of Boehringer Ingelheim Pharmaceuticals


Alembic receives USFDA final approval for Nelarabine Injection, 250 mg/50 mL
Drug Approval | August 03, 2024

Alembic receives USFDA final approval for Nelarabine Injection, 250 mg/50 mL

Nelarabine is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia


Briefs: Indoco Remedies and Alembic Pharmaceuticals
Drug Approval | July 29, 2024

Briefs: Indoco Remedies and Alembic Pharmaceuticals

Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe