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 observations are procedural in nature and will be responded to within the stipulated time
The sANDA was submitted as “Prior Approval Supplement” for addition of an alternate drug product manufacturing, labeling, packaging, and testing facility
These facilities are commissioned by Aurobindo's wholly own subsidiary: Lyfius Pharma Private Limited, Qule Pharma Private Limited, Eugia Steriles Private Limited and Auroactive Pharma Private Limited.
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