Drug Approval | December 30, 2024
Cenexi's Fontenay manufacturing facility receives 10 observations in ANSM inspection
Cenexi is committed to working closely with the ANSM to address the observations
Cenexi is committed to working closely with the ANSM to address the observations
This facility is considered to be in a minimally acceptable state of compliance with regard to current GMP
The company will receive GMP compliance certificate which will further help to accelerate the business growth across the globe
Zefylti will be available as 30 MU/0.5 mL and 48 MU/0.5 mL and is intended for the treatment of neutropenia and the mobilisation of peripheral progenitor cells
The successful completion of RRA assessment by the USFDA, would enable company to open up its business in the USA market
This acquisition positions Suven as a key player in one of the fastest growing segments of the Pharma CDMO landscape
New research labs and process development services to enable next generation therapeutics
Jagsonpal Pharmaceuticals has received full consideration of Rs. 41 crore towards the sale of the facility and will now be proceeding with registration formalities
The inspection scope had included six separate Biologics manufacturing units comprising of four Drug Substance and two Drug Product manufacturing plants
The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit
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