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Results For "Alembic-Pharma"

113 News Found

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


Alembic announces USFDA tentative approval for Selexipag for Injection, 1,800 mcg/vial
Drug Approval | July 14, 2024

Alembic announces USFDA tentative approval for Selexipag for Injection, 1,800 mcg/vial

Selexipag is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension


Alembic announces USFDA final approval for Icatibant injection
Drug Approval | June 17, 2024

Alembic announces USFDA final approval for Icatibant injection

This is the first peptide product approval from the USFDA received by Alembic Pharmaceuticals


Alembic received 6 USFDA approvals during Q2FY24
Drug Approval | October 05, 2023

Alembic received 6 USFDA approvals during Q2FY24

The company has received six final approvals that includes Chlorpromazine Hydrochloride Tablets


Alembic receives USFDA final approval for Brimonidine Tartrate Ophthalmic Solution
Drug Approval | March 31, 2023

Alembic receives USFDA final approval for Brimonidine Tartrate Ophthalmic Solution

Brimonidine Tartrate Ophthalmic Solution is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure


Briefs: Lupin and Alembic
News | March 14, 2023

Briefs: Lupin and Alembic

Lupin Bioresearch Centre conducts BA/BE, PK/PD, In-vitro BE and biosimilar studies.