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
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
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