ANVISA inspection received from Brazil Health Regulatory Agency at Wanbury Tanuku facility
The company will receive GMP compliance certificate which will further help to accelerate the business growth across the globe
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
The recent inspection covered both cGMP and PAI processes
The inspection was concluded with zero observations
The inspection scope included 6 separate Biologics manufacturing units comprising 4 Drug Substance and 2 Drug Product manufacturing plants
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