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Results For "GMP"

431 News Found

Croda opens advanced lipids manufacturing facility in Pennsylvania
News | March 19, 2025

Croda opens advanced lipids manufacturing facility in Pennsylvania

This facility represents a significant step in Croda’s Pharma business strategy to ‘Empower biologics delivery’


Shilpa Biologicals partners with mAbTree Biologics AG for a novel immunooncology asset
News | March 18, 2025

Shilpa Biologicals partners with mAbTree Biologics AG for a novel immunooncology asset

This program aims to develop a fully human monoclonal antibody against a novel immune checkpoint protein that enables T cell activation


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


Briefs: Emcure and Relonchem
Drug Approval | February 27, 2025

Briefs: Emcure and Relonchem

USFDA inspection at Emcure Pharmaceuticals API facility


Briefs: Syngene International and Cipla
Drug Approval | February 23, 2025

Briefs: Syngene International and Cipla

Cipla Limited has received final approval from the USFDA for the New Drug Application submitted for ‘Nilotinib Capsules 50, 150 and 200 mg’


Granules India acquires Swiss Senn Chemicals to foray into peptide and CDMO business
News | February 22, 2025

Granules India acquires Swiss Senn Chemicals to foray into peptide and CDMO business

The acquisition aligns with Granules' vision to enter the rapidly expanding peptide-based anti-diabetic and anti-obesity market


USFDA issues Form-483 for Piramal Pharma's facility at Turbhe
Drug Approval | February 21, 2025

USFDA issues Form-483 for Piramal Pharma's facility at Turbhe

Observations are largely around improvement of procedures and practices


Orchid Pharma's Alathur API facility successfully completes USFDA inspection
Drug Approval | February 20, 2025

Orchid Pharma's Alathur API facility successfully completes USFDA inspection

The Alathur facility specializes in the production of Cephalosporin antibiotics


Briefs: Caplin Point Laboratories, Hikal and Cipla
Drug Approval | February 10, 2025

Briefs: Caplin Point Laboratories, Hikal and Cipla

Hikal Limited announces the completion of the US Food and Drug Administration (USFDA) inspection at its Jigani unit, Bengaluru