Drug Approval | October 30, 2025
Granules India’s facility secures FDA EIR with 'VAI’
The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection conducted in June 2025
The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection conducted in June 2025
The facility has been classified as Voluntary Action Indicated
Sun Pharma's Halol plant gets OAI classification from US FDA inspection
This facility is capable of manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms
The USFDA has determined the inspection classification status of this warehousing facility as 'Official Action Indicated
Based on DESTINY-Breast06 Phase III trial results which showed Enhertu demonstrated superiority vs. chemotherapy with a median progression-free survival of more than one year
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
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