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Results For "Azurity-Pharmaceuticals"

6 News Found

Lupin secures 180-day exclusivity for generic Azilsartan Medoxomil tablets in U.S. market
Drug Approval | June 18, 2026

Lupin secures 180-day exclusivity for generic Azilsartan Medoxomil tablets in U.S. market

Company introduces bioequivalent version of Edarbi for hypertension treatment following U.S. FDA approval; product recorded annual U.S. sales of USD 53.5 million


Lupin secures FDA nod for generic Sutab tablets with 180-day exclusivity
Drug Approval | May 30, 2026

Lupin secures FDA nod for generic Sutab tablets with 180-day exclusivity

The approved product is the generic equivalent of Sutab® Tablets developed by Azurity Pharmaceuticals


Lupin wins FDA nod for generic colonoscopy prep drug with first-to-file exclusivity
Drug Approval | May 30, 2026

Lupin wins FDA nod for generic colonoscopy prep drug with first-to-file exclusivity

Crucially, Lupin is the exclusive first-to-file applicant for this product and is eligible for 180-day generic drug exclusivity in the U.S. market


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


Lupin receives approval from U.S. FDA for Azilsartan Medoxomil Tablets
Drug Approval | July 26, 2022

Lupin receives approval from U.S. FDA for Azilsartan Medoxomil Tablets

The product will be manufactured at Lupin's facility in Nagpur, India.


Azurity Pharma gets USFDA approval for Fleqsuvy
Drug Approval | February 08, 2022

Azurity Pharma gets USFDA approval for Fleqsuvy

Nearly 1 million people are living with multiple sclerosis in the United States. Spasticity is a commonly reported symptom for MS, with an estimated prevalence of spasticity of 67%