Drug Approval | November 23, 2022
USFDA grants priority review of BLA for dengue vaccine TAK-003
If approved, TAK-003 has the potential to become an important dengue prevention option for healthcare providers
If approved, TAK-003 has the potential to become an important dengue prevention option for healthcare providers
Nifedipine Extended-Release Tablets have an estimated market size of US $56 million for twelve months ending September 2022
The pre-approval inspection of USFDA was completed successfully with ZERO 483 observation of the manufacturing facilities of Bajaj Healthcare Limited
The product is expected to be launched by Q4 FY23.
The approval further strengthens the Potassium Chloride franchise for the company.
Cyclophosphamide Capsules, 25 mg and 50 mg, have an estimated market size of US$ 8 million for twelve months ending Sep 2022 according to IQVIA.
PIKA COVID-19 vaccine is currently in Phase 3, multi-country, multi-center clinical trial conducted at Southeast Asian and Middle East countries.
Doxycycline Capsules (RLD Oracea) had estimated annual sales of US $215 million in the US
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India
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