Drug Approval | October 01, 2024
Apitoria Pharma gets Form 483 with 10 observations from USFDA
The observations are of procedural in nature and will be responded to within the stipulated time
The observations are of procedural in nature and will be responded to within the stipulated time
Lupin's Pithampur Unit-1 gets Form 483 from USFDA with 3 observations
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
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