News | December 15, 2022
Briefs: Jubilant Pharmova and Apollo Hospitals Enterprise
The company will submit an action plan on the observations and will engage with US FDA for next steps.
The company will submit an action plan on the observations and will engage with US FDA for next steps.
Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints
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Leuprolide Acetate Injection Depot contains 22.5 mg of leuprolide acetate for 3- month administration given as a single dose injection.
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 company had responded to the agency and carried out the required corrective actions.
Formulation revenue decreased by 7.6% YoY to Rs. 4,770 crore whereas in Q2 FY23, API business posted a growth of 24.2% YoY with revenue of Rs. 969.4 crore
The company currently supplies one product to the US market that contributes low- single digit revenue to Jubilant Pharmova revenue
The inspection concluded with no observation (FDA-483) issued.
The inspection of the facility was conducted from August 16-19, 2022.
Sildenafil for Oral Suspension (RLD Revatio) had estimated annual sales of US $64 million in the US
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