Drug Approval | August 16, 2023
Eugia Pharma receives USFDA Approval for Icatibant Injection
This is the 166th ANDA out of Eugia Pharma Speciality Group facilities
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
The product will be produced at the Eugia Pharma Specialities, Unit-I, Medchal, Malkajgiri District, Telangana, India
The approved product is indicated for the treatment of adult patients with Multiple myeloma, in combination with Dexamethasone
Supriya Lifescience Limited has informed that the European Directorate for the Quality of Medicines (EDQM) has granted Attestation of Inspection (EU-GMP) for Lote API Facility, Ratnagiri, Maharashtra.
The product is expected to be launched by Q4 FY23.
This is the 142nd ANDA (including 8 tentative approvals received) out of Eugia Pharma Specialty Group (EPSG) facilities, manufacturing both oral and sterile specialty products.
Pemetrexed for injection is indicated for the treatment of Antineoplastics (medications used to treat cancer)
The approved product has a market size of US $ 1172 million for the twelve months ending March 2022, according to IQVIA
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