CuraTeQ Biologics receives positive opinion for biosimilar Dyrupeg from EMA
Dyrupeg will be available as 6 mg solution for injection in prefilled syringe and is intended for the reduction in the duration of neutropenia
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.
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
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