Drug Approval | September 29, 2023
The company's Bavla site was successfully jointly inspected by the EDQM and Italian Medicines Agency (AIFA)
InvaGen has received 5 inspectional observations in Form 483
Norepinephrine Bitartrate Injection is used for restoration of blood pressure in adult patients
The company has received the Establishment Inspection Report (EIR) from the USFDA for the Pre-Approval Inspection (PAI) at a manufacturing site situated at Savli, Vadodara, Gujarat, with Zero 483 observations
The inspection was a cGMP Inspection and had ended with NIL observations
US FDA approval is in line with de-risking strategy for additional API site to service our global customer base
The inspection was conducted at its Goa, Vema manufacturing facility
The inspection closed with zero observations and a classification of No Action Indicated
The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories
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