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
Observations are largely around improvement of procedures and practices
The Alathur facility specializes in the production of Cephalosporin antibiotics
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Hikal Limited announces the completion of the US Food and Drug Administration (USFDA) inspection at its Jigani unit, Bengaluru
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 operates five cGMP facilities and has a strong track record, with 138 successful regulatory and customer audits to date by all major regulatory bodies
Biocon Biologics remains committed to global standards of quality and compliance
The site’s GMP Certification has been successfully renewed
Increases speed to market for drug developers working on nucleic acid therapeutics
This strategic move aims to address the increasing global demand for biologics, enhancing ProBioGen's ability to support partners from cell line development t
The inspection, which is a routine part of the FDA's regulatory oversight, evaluates compliance with Good Manufacturing Practices and other regulatory requirements.
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