Biocon Biologics' Drug Substance Facility in Bengaluru cassified as VAI
This relates to the manufacture and supply of Human Recombinant Insulin (rh- Insulin) and Biosimilar Pegfilgrastim Drug Substance to the United States
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
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
Novartis is the only pharmaceutical company with a dedicated commercial RLT portfolio
The EIR follows a product-specific Pre-Approval Inspection from September 1 to September 5, 2025.
New site expands manufacturing footprint to meet future demand; ensures continued on-time delivery rate of >99.9% to patients across western US, Alaska and Hawaii
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