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.
This is the fifth consecutive year that a Biocon Group company has made it to the Asia lP ELITE list
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
The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI)
Drospirenone Tablets (RLD Slynd) had estimated annual sales of US $141 million in the US
This is the third major regulatory milestone for the vaccine candidate following acceptance of regulatory submissions in Europe and Japan
The voluntary program is the first time the FDA will allow excipient manufacturers to obtain review of certain novel excipients prior to their use in drug formulations.
Acetaminophen injection had annual sales of US $72 million in the United States according to IQVIA data
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