GlobalData’s ‘Pharmaceutical Intelligence Center’ observes that India is still in the nascent stage of developing these potential therapies as currently only four cell/gene therapy molecules are being developed in the country.
According to industry sales data, Yondelis generated annual sales of $49.7 million for the twelve months ending June 2022 in the US market.
The decision is based on the outcome of a prespecified interim analysis of the Phase 3 AMEERA-5 trial
The OAI classification implies that the US FDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved
First PARP inhibitor to demonstrate clinical benefit in radiographic progression-free survival in combination with a new hormonal agent with or without homologous recombination repair gene mutations
Collaboration supports multiple discovery efforts, including vaccines
The estimated capex is to the tune of Rs. 140 crore to be funded through debt and internal accrual
The company has reported total income of Rs. 450.26 crores during the period ended June 30, 2022.
Meclizine Hydrochloride Tablets had estimated annual sales of USD 29 million in the U.S.
The approved product has an estimated market size of around US$ 606 million for the twelve months ending June 2022, according to IQVIA.
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