Alembic receives USFDA final approval for Macitentan Tablets, 10 mg
Macitentan tablets are an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension
Macitentan tablets are an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension
The accelerated approval is supported by results from part 1 of the ESSENCE trial
The PLI scheme focuses on incentivizing a strategic shift towards high-value, innovative products such as biologics, complex generics, and specialty formulations
The projected business potential is around US$ 1 million in the first year
Fourteenth breakthrough therapy designation granted by FDA across the oncology portfolio of Daiichi Sankyo
OGSIVEO is the first and only therapy to receive marketing authorization in the EU for the treatment of desmoid tumors
The company’s virgin PET chips plant in Egypt, commissioned in Q4 FY25, achieved 74.8 per cent capacity utilization in its first full quarter. In India, the Panipat facility operated at 96.6 per cent utilization
Its lead product, Dasynoc, is awaiting FDA approval with a PDUFA date of October 7, 2025
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