Jubilant receives EIR from USFDA for its radiopharmaceuticals manufacturing facility Montreal Canada
With the receipt of the EIR, the inspection stands successfully closed.
With the receipt of the EIR, the inspection stands successfully closed.
Phase 2 Study of MK-2060 Currently Ongoing in People with End-Stage Renal Disease Receiving Hemodialysis
The approved product has an estimated market size of around US $62 million for the twelve months ending June 2022 according to IQVIA
The company is relieving all its staff who were directly engaged by our US subsidiary in its plant in connection with the manufacturing process in a phased manner
Novavax' vaccine is the first protein-based COVID-19 vaccine authorized in the U.S.
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Naproxen Sodium Capsules, 220 mg, of Bionpharma
The OAI classification implies that the US FDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved
The approved product has an estimated market size of around US$ 606 million for the twelve months ending June 2022, according to IQVIA.
The product will be manufactured at Lupin’s facility in Goa, India.
Xofluza is the first and only single-dose oral medicine for the treatment of influenza to be approved in the US for children as young as five years of age
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