Drug Approval | December 12, 2024
Briefs: Alembic Pharmaceuticals and Veerhealth Care
The successful completion of RRA assessment by the USFDA, would enable company to open up its business in the USA market
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
Commercial license to Synaffix technologies follows a series of successful initial preclinical proof of concept studies
The US District Court of New Jersey decided to grant a preliminary injunction delaying the launch of LEQSELVI
The inspection concluded with the issuance of Form 483 with four observations which are procedural in nature
Reinforces position as first commercially approved contract development and manufacturing organization (CDMO) for ADCs in North America
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