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Results For "Facility"

1627 News Found

Biocon Biologics' Drug Substance Facility in Bengaluru cassified as VAI
Drug Approval | November 29, 2025

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


Glenmark Pharma gets VAI from FDA for Monroe facility
Drug Approval | November 27, 2025

Glenmark Pharma gets VAI from FDA for Monroe facility

The positive outcome clears the way for Glenmark to resume commercial manufacturing at the site


Lupin receives 7 observations from USFDA for Goa manufacturing facility
Drug Approval | November 24, 2025

Lupin receives 7 observations from USFDA for Goa manufacturing facility

Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe


Piramal Pharma Solutions’ UK facility bags updated MHRA GMP certification
News | November 21, 2025

Piramal Pharma Solutions’ UK facility bags updated MHRA GMP certification

Grangemouth serves as PPS’s dedicated antibody-drug conjugate development and manufacturing hub


Novartis opens radioligand therapy facility in Carlsbad, US
News | November 14, 2025

Novartis opens radioligand therapy facility in Carlsbad, US

Novartis is the only pharmaceutical company with a dedicated commercial RLT portfolio


Lupin receives EIR from FDA for its Aurangabad facility
News | November 13, 2025

Lupin receives EIR from FDA for its Aurangabad facility

The EIR follows a product-specific Pre-Approval Inspection from September 1 to September 5, 2025.


Novartis opens radioligand therapy manufacturing facility in California
News | November 12, 2025

Novartis opens radioligand therapy manufacturing facility in California

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