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Results For "ANDA"

2089 News Found

Briefs: Dr. Agarwal's Eye Hospital and Apitoria Pharma
News | March 20, 2025

Briefs: Dr. Agarwal's Eye Hospital and Apitoria Pharma

Apitoria Pharma’s API manufacturing facility classified as VAI by USFDA


Zydus receives final approval from USFDA for Apalutamide Tablets, 60 mg
Drug Approval | March 19, 2025

Zydus receives final approval from USFDA for Apalutamide Tablets, 60 mg

Apalutamide is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer


Anupriya Patel inaugurates India Innovation Summit – Pioneering Solutions to End TB
Policy | March 19, 2025

Anupriya Patel inaugurates India Innovation Summit – Pioneering Solutions to End TB

TB treatment coverage in India increased by 32% in the last eight years from 53% in 2015 to 85% in 2023


Clariant unveils natural preservation blend for cosmetics 'Nipaguard SCE Vita'
News | March 19, 2025

Clariant unveils natural preservation blend for cosmetics 'Nipaguard SCE Vita'

Nipaguard SCE Vita delivers comprehensive antimicrobial protection for personal care formulations


RedHill Biopharma to submit FDA-approved Talicia for UK marketing authorisation
Drug Approval | March 19, 2025

RedHill Biopharma to submit FDA-approved Talicia for UK marketing authorisation

Talicia is also approved and launched in the UAE and additional countries may accept UK MHRA approvals as a reference for their own marketing approval processes


Zydus receives final approval from USFDA for Eluxadoline Tablets, 75 mg and 100 mg
Drug Approval | March 17, 2025

Zydus receives final approval from USFDA for Eluxadoline Tablets, 75 mg and 100 mg

Eluxadoline is a mu-opioid receptor agonist, indicated in adults for the treatment of irritable bowel syndrome with diarrhoea


Glenmark Pharma launches Empagliflozin and its fixed-drug combinations in India
News | March 13, 2025

Glenmark Pharma launches Empagliflozin and its fixed-drug combinations in India

Empagliflozin and its Fixed Drug Combinations (FDCs) have been launched under the brand names Glempa, Glempa –L and Glempa-M


Zydus receives final approval from USFDA for Methenamine Hippurate Tablets USP, 1 gram
Drug Approval | March 13, 2025

Zydus receives final approval from USFDA for Methenamine Hippurate Tablets USP, 1 gram

Methenamine Hippurate tablets are indicated for prophylactic or suppressive treatment of frequently recurring urinary tract infections


Poly Medicure receives MDR certification for 54 products
News | March 12, 2025

Poly Medicure receives MDR certification for 54 products

The MDR certification reafirms that these products meet the highest safety, quality, and regulatory standards


Nectar Lifesciences receives 7 observations from EDQM for API facility
News | March 12, 2025

Nectar Lifesciences receives 7 observations from EDQM for API facility

The European regulator will conduct a re-inspection of the facility to verify the compliance