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
The Alathur facility specializes in the production of Cephalosporin antibiotics
The inspection was carried out from January 28 to February 1, 2025
The site’s GMP Certification has been successfully renewed
Cenexi is committed to working closely with the ANSM to address the observations
The company will receive GMP compliance certificate which will further help to accelerate the business growth across the globe
Granules has undertaken a proactive, voluntary and comprehensive remediation plan to address the six form 483 observations raised by the USFDA
The inspection concluded with the issuance of Form 483 with four observations which are procedural in nature
The inspection concluded with the issuance of a form 483 with five observations
HSGP is engaged closely with the USFDA and is committed to address the OAI observations through planned remediation measures
Jubilant HollisterStier is a subsidiary of Jubilant Pharma Holding
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