Drug Approval | September 18, 2024
Briefs: Eugia Steriles and Shelter Pharma
Eugia Steriles receives EIR from USFDA for new injectable facility
Eugia Steriles receives EIR from USFDA for new injectable facility
The recent inspection covered both cGMP and PAI processes
Trazodone tablets are indicated for the treatment of major depressive disorder in adults
Decision on EU marketing authorisation for this population expected by September 2024
The inspection was concluded with two 483 observations
Rusan’s API facility in Ankleshwar is GMP approved by other stringent international agencies as well
Susvimo is a unique therapeutic approach that provides continuous delivery of medicine to the eye through a refillable implant
The company will address these observations within the stipulated timeline
Utidelone can penetrate BBB due to its unique physicochemical characteristics and insusceptibility to P-glycoprotein-mediated efflux
Vabysmo PFS is the first and only syringe prefilled with an FDA-approved bispecific antibody to treat retinal conditions that can cause blindness
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