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Results For "ANDA"

2358 News Found

FDA expands medtronic MiniMed 780G system
Drug Approval | September 05, 2025

FDA expands medtronic MiniMed 780G system

Now integrates with Abbott’s instinct sensor and approved for type 2 diabetes


Lupin receives FDA approval for Risperidone LAI with 180-day CGT exclusivity
Drug Approval | September 04, 2025

Lupin receives FDA approval for Risperidone LAI with 180-day CGT exclusivity

This is Lupin's first product using proprietary Nanomi's technology and has a 180-day CGT exclusivity


Brenntag Specialties selected European distributor for Kerry’s pharmaceutical-grade acetates
Supply Chain | September 04, 2025

Brenntag Specialties selected European distributor for Kerry’s pharmaceutical-grade acetates

Brenntag Specialties will provide pharmaceutical manufacturers and biopharmaceutical companies with a reliable supply of high-purity, GMP-compliant acetates


Health Minister Nadda to inaugurate India MedTech Expo 2025
News | September 03, 2025

Health Minister Nadda to inaugurate India MedTech Expo 2025

The three-day expo will feature an expansive exhibition showcasing MSMEs, startups, research institutions, future innovation pavilions, state showcases, and government initiatives


iPHEX 2025: Global regulatory conclaves to highlight India’s role in shaping global health
News | September 03, 2025

iPHEX 2025: Global regulatory conclaves to highlight India’s role in shaping global health

This year’s edition will witness participation of over 700 Indian exporters showcasing their products and services; 500+ overseas delegates representing more than 120 countries; 20,000 domestic visitors; and 8,000+ B2B meetings


Metal-free catalysis is transforming future of sustainable pharmaceutical innovation
Opinion | September 03, 2025

Metal-free catalysis is transforming future of sustainable pharmaceutical innovation

It offers clear environmental benefits, lower emissions, reduced hazardous material use, and alignment with circular economy goals


GEA, JGC commission new spray dryer at Chugai Pharmaceutical in Japan
News | August 31, 2025

GEA, JGC commission new spray dryer at Chugai Pharmaceutical in Japan

This PSD-3, the first pharmaceutical spray dryer built by GEA for OEB-5 products, sets new standards for high-containment pharmaceutical spray drying


Roche, Alnylam to initiate Phase 3 cardiovascular outcomes trial of zilebesiran
News | August 31, 2025

Roche, Alnylam to initiate Phase 3 cardiovascular outcomes trial of zilebesiran

Zilebesiran, a potential best-in-disease RNAi anti-hypertensive with twice-yearly subcutaneous dosing, demonstrated encouraging safety when combined with two or more antihypertensives


Apitoria Pharma receives 5 observations from USFDA for API facility
Drug Approval | August 31, 2025

Apitoria Pharma receives 5 observations from USFDA for API facility

At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported