Drug Approval | January 19, 2023
USFDA completes inspection at APL HealthCare
The company has been issued ‘Form 483’ with two observations
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)
The product is expected to be launched by Q4 FY23.
The plant at Raleigh, North Carolina, USA owned by Aurolife Pharma has received an establishment inspection report (EIR)
The approved product has an estimated market size of around US $62 million for the twelve months ending June 2022 according to IQVIA
The approved product has an estimated market size of around US$ 606 million for the twelve months ending June 2022, according to IQVIA.
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.
he approved product has an estimated market size of US$ 83 million for the twelve months ending April 2022, according to IQVIA.
Subscribe To Our Newsletter & Stay Updated
