Briefs: Eugia Steriles and Shelter Pharma
Eugia Steriles receives EIR from USFDA for new injectable facility
Eugia Steriles receives EIR from USFDA for new injectable facility
India's bio economy has experienced remarkable growth, skyrocketing from US $10 billion in 2014 to over $130 billion in 2024, with projections to reach $300 billion by 2030
The sANDA was submitted as “Prior Approval Supplement” for addition of an alternate drug product manufacturing, labeling, packaging, and testing facility
ALS patients experience neuroinflammation and rapid neurodegeneration
Ami informs that PMDA Japan has issued Inspection Result Report declaring the Sachin facility as a Good Manufacturing Practices (GMP) compliant.
ForDoz Pharma Corporation, USA (ForDoz) received an approval for its ANDA from the USFDA
First-in-human Phase-1 study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SUVN-I6107 in healthy subjects
Nor UDCA is likely to be a first-in-class treatment option for NAFLD in India
USFDA has determined that the inspection classification of this facility is "No Action Indicated" (NAI) with zero 483 observation
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