Inspection outcome reinforces company's compliance track record and strengthens its ability to serve regulated markets including the United States
The inspection is now closed, and no regulatory action has been recommended
This inspection is now closed
The EIR was issued following an inspection of the facility from November 10 to November 21, 2025
Inspection included drug device combinations covering our recent filing in nasal sprays domain
USFDA determines Sun Pharma's Baska facility inspection classification as OAI
The EIR was issued following an inspection of the facility from September 8 to September 16, 2025
This inspection was conducted following the warning letter issued by the USFDA
This relates to the manufacture and supply of Human Recombinant Insulin (rh- Insulin) and Biosimilar Pegfilgrastim Drug Substance to the United States
The positive outcome clears the way for Glenmark to resume commercial manufacturing at the site
Subscribe To Our Newsletter & Stay Updated
