Drug Approval | September 18, 2024
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
The USFDA inspection focused on evaluating the facility's adherence to global regulatory requirements and best practices
The sANDA was submitted as “Prior Approval Supplement” for addition of an alternate drug product manufacturing, labeling, packaging, and testing facility
Ami informs that PMDA Japan has issued Inspection Result Report declaring the Sachin facility as a Good Manufacturing Practices (GMP) compliant.
USFDA has determined that the inspection classification of this facility is "No Action Indicated" (NAI) with zero 483 observation
Q1FY25 Revenue from Operations grew by 15% to Rs. 177 crore
The EIR was issued post the last inspection of the facility conducted from May 6-10, 2024 which concluded with zero FDA 483 observations
The drugmaker's net profit slipped 26 per cent on-year to Rs 143.8 crore
Revolutionary technology will further boost OneSource’s scientific services offerings
Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe
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