Drug Approval | May 06, 2024
Briefs: Eugia Pharma Specialities and IOL Chemicals and Pharmaceuticals
Eugia Pharma Specialities receives 7 observations from USFDA for Unit II
Eugia Pharma Specialities receives 7 observations from USFDA for Unit II
Eugia Pharma Specialities restarts production at terminally sterilized product lines
The product is expected to be launched in December 2023
Dasatinib Tablets is indicated for the treatment of (i) newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia
The approved product has an estimated market size of US$ 106 million for the twelve months ending October 2024, according to IQVIA
He did Master’s of Pharmacy (Pharmaceutical Technology, Formulations) from National Institute of Pharmaceutical Education and Research, Mohali and Bachelor of Pharmacy from Osmania University
Eugia Steriles receives EIR from USFDA for new injectable facility
The sANDA was submitted as “Prior Approval Supplement” for addition of an alternate drug product manufacturing, labeling, packaging, and testing facility
The observations are procedural in nature and will be responded to within the stipulated time
The product is expected to be launched in FY25
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