News | November 15, 2025
Aurobindo Pharma gets 9 observations from USFDA for Unit 2 of Eugia Pharma Specialities
The observations are procedural in nature and will be responded to within the stipulated time
The observations are procedural in nature and will be responded to within the stipulated time
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
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
The product is expected to be launched in FY25
This is the 166th ANDA out of Eugia Pharma Speciality Group facilities
The product is being launched in August 2023
The approved product has an estimated market size of around US$ 210 million for the twelve months ending May 2023
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