Drug Approval | November 21, 2022
Aurobindo Pharma receives 10 observations for Unit IX
The company had responded to the agency and carried out the required corrective actions.
The company had responded to the agency and carried out the required corrective actions.
The product is expected to be launched by Q4 FY23.
The approval further strengthens the Potassium Chloride franchise for the company.
This is the fifth consecutive year that a Biocon Group company has made it to the Asia lP ELITE list
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.
The core of “LANXESS Biosecurity Solutions” is a portfolio of scientifically formulated, highly effective and versatile biocidal products
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
The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI)
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