Drug Approval | September 08, 2025
USFDA conducts product specific pre-approval inspection at Lupin’s Aurangabad facility
Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe
Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe
PendraCare Group develops, manufactures and sells innovative cardiology catheter solutions and provides design, development and manufacturing services to other global OEM’s
Zydus will work closely with the USFDA to address and resolve the observations in an expeditious manner
It will focus on interface between API and formulation manufacturing, reducing carbon footprint in formulation production, creating intellectual property, training next-generation scientists, and setting new industry benchmarks
These licenses are given in areas of infectious disease diagnostics, immunodiagnostics, and vaccine development
The U.S. FDA issued a Form 483 with five observations
The partnership will create a first-of-its-kind, fully integrated offering for the development of mRNA drug products
Free cash flow also reached €63 million, representing an 11 percent increase compared to the high benchmark set in 2024
The three-day expo will feature an expansive exhibition showcasing MSMEs, startups, research institutions, future innovation pavilions, state showcases, and government initiatives
It offers clear environmental benefits, lower emissions, reduced hazardous material use, and alignment with circular economy goals
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