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
Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe
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
It will produce a comprehensive range of dosage forms including tablets, hard gelatin capsules, liquids, injectables, topicals, and beta-lactam products
Facility marks cornerstone of $50 billion investment in medicines R&D and manufacturing in America
Furthering?U.S.-based?pharmaceutical?capacity?to?produce?critical respiratory medicines?
The new site enables end-to-end production of viral vector gene therapies
The new Houston site, Lilly's eighth U.S. manufacturing facility announced since 2020, will focus on domestic production of small molecule synthetic medicines
The facility has been classified as Voluntary Action Indicated
Merck opens first climate-neutral manufacturing facility in Ireland
The inspection concluded with zero form 483 observations
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