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Results For "GMP"

507 News Found

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


CuraTeQ Biologics receives positive opinion for biosimilar Dyrupeg from EMA
News | February 03, 2025

CuraTeQ Biologics receives positive opinion for biosimilar Dyrupeg from EMA

Dyrupeg will be available as 6 mg solution for injection in prefilled syringe and is intended for the reduction in the duration of neutropenia


OneSource receives EIR with VAI classification from USFDA for BLD facility
Drug Approval | January 29, 2025

OneSource receives EIR with VAI classification from USFDA for BLD facility

OneSource operates five cGMP facilities and has a strong track record, with 138 successful regulatory and customer audits to date by all major regulatory bodies


USFDA classifies Biocon Biologics Johor Bahru site, Malaysia as VAI
Drug Approval | January 13, 2025

USFDA classifies Biocon Biologics Johor Bahru site, Malaysia as VAI

Biocon Biologics remains committed to global standards of quality and compliance


Carbogen Amcis successfully completed Swissmedic inspection of its Vionnaz facility
News | January 10, 2025

Carbogen Amcis successfully completed Swissmedic inspection of its Vionnaz facility

The site’s GMP Certification has been successfully renewed