Drug Approval | July 26, 2023
Eugia Pharma receives USFDA approval for Plerixafor Injection
The approved product has an estimated market size of around US$ 210 million for the twelve months ending May 2023
The approved product has an estimated market size of around US$ 210 million for the twelve months ending May 2023
This request for withdrawal of the two dossiers was made after necessary consultations and receiving guidance from EMA
The product will be produced at the Eugia Pharma Specialities, Unit-I, Medchal, Malkajgiri District, Telangana, India
The product is expected to be launched in June 2023
Venkat Nageswar Chalasani has been appointed as an Independent Director of Apitoria Pharma with effect from April 4, 2023
The approved product is indicated for the treatment of adult patients with Multiple myeloma, in combination with Dexamethasone
The company has been issued ‘Form 483’ with two observations
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 company continue to develop this program for the WHO markets, thereby providing coverage and protection for more infants globally in time to come
Ryzneuta is a novel dimeric G- CSF long-acting fusion protein without pegylation. The Biologics License Application (BLA) of Ryzneuta is currently under late-stage review by the US FDA for Chemotherapy-Induced Neutropenia (CIN)
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