Drug Approval | April 14, 2025
Aurolife Pharma gets 11 observations from USFDA for Raleigh plant
The company does not expect this development to have any material impact on the current business operations
The company does not expect this development to have any material impact on the current business operations
This study enrolled a total of 204 healthy volunteers into three groups to compare BP16 with the reference products, Prolia, obtained from both the EU and US markets
Prior to joining Neuland, Deshmukh held several key positions at Cipla
Apitoria Pharma’s API manufacturing facility classified as VAI by USFDA
This termination of Agreement will not have any significant impact on the company and/or its subsidiaries or its financials
During the quarter, US formulations revenue decreased by 2.3% YoY to Rs. 3,671 crore.
Dyrupeg will be available as 6 mg solution for injection in prefilled syringe and is intended for the reduction in the duration of neutropenia
Bevqolva 25 mg/mL concentrate for infusion will be available in 4 mL (100 mg) and 16 mL (400 mg) single-use vials for infusion into veins
Zefylti will be available as 30 MU/0.5 mL and 48 MU/0.5 mL and is intended for the treatment of neutropenia and the mobilisation of peripheral progenitor cells
The approved product has an estimated market size of US$ 106 million for the twelve months ending October 2024, according to IQVIA
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