Drug Approval | December 26, 2024
Aarti Drugs receives EIR from USFDA for Tarapur API facility
This facility is considered to be in a minimally acceptable state of compliance with regard to current GMP
This facility is considered to be in a minimally acceptable state of compliance with regard to current GMP
Univar Solutions' pharmaceutical ingredients portfolio will be strengthened by the addition of a broad range of cellulose ethers and other excipient solutions
Expansion includes a new 5-story, 136k sq. ft. multipurpose building in Sejong
ALS patients experience neuroinflammation and rapid neurodegeneration
USFDA has determined that the inspection classification of this facility is "No Action Indicated" (NAI) with zero 483 observation
The fresh funds will be used to enhance customer relationships, expand operations and develop state-of-the-art service
Observes no adverse impact of non-nutritive sweetener (NNS) - sucralose on glycemic markers
CureVac receives €400 million upfront and up to an additional €1.05 billion in development, regulatory and sales milestone payments as well as tiered royalties; all previous financial considerations from the prior collaboration agreement replaced
ALS is a rare, progressive and fatal neurodegenerative disease, with an average life expectancy of 3 to 5 years from the time of symptom onset
FDA has concluded that this inspection is 'closed'
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