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
The Unit is approved by major regulators like EMA, Europe; Health Canada, Anvisa, Brazil and TGA, Australia
Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe
Grangemouth serves as PPS’s dedicated antibody-drug conjugate development and manufacturing hub
FDA closes inspection at Zydus' oncology injectable manufacturing facility in SEZ1, Ahmedabad with 2 observations
SMDC is a participating authority under Pharmaceutical Inspection Cooperation Scheme (PIC/S)
The observations are procedural in nature and will be responded to within the stipulated time
The EIR follows a product-specific Pre-Approval Inspection from September 1 to September 5, 2025.
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