Drug Approval | December 26, 2024
Aarti Drugs receives EIR from USFDA for Tarapur API facility
This facility is considered to be in a minimally acceptable state of compliance with regard to current GMP
This facility is considered to be in a minimally acceptable state of compliance with regard to current GMP
Granules has undertaken a proactive, voluntary and comprehensive remediation plan to address the six form 483 observations raised by the USFDA
Indoco is comprehensively working on the remedial action plan
HSGP is engaged closely with the USFDA and is committed to address the OAI observations through planned remediation measures
USFDA has determined that the inspection classification of this facility is "No Action Indicated" (NAI) with zero 483 observation
The facility is a part of Lupin Manufacturing Solutions
Utidelone can penetrate BBB due to its unique physicochemical characteristics and insusceptibility to P-glycoprotein-mediated efflux
FDA has concluded that this inspection is 'closed'
Sun Pharma's Dadra facility receives OAI status from US FDA
The company is strongly committed to enhancing customer satisfaction and catering to the discerning needs of renowned pharmaceutical companies
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