Drug Approval | November 08, 2022
Zydus receives EIR with VAI from USFDA for Moraiya facility
The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI)
The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI)
Revenue from operations for the half year was Rs. 178.5 crore, declined by 23% whereas net profit for the half year was Rs. 16.9 crore, declined by 70%
This is the third major regulatory milestone for the vaccine candidate following acceptance of regulatory submissions in Europe and Japan
His experience covers a wide range of areas including advisory services in the field of accounting, taxation, corporate and commercial laws, and regulatory matters
The participants discussed the latest developments under ABDM that shall enable true interoperability in the health sector and how effective adoption of ABDM can pave the way towards Universal Health Coverage
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.
The company currently supplies one product to the US market that contributes low- single digit revenue to Jubilant Pharmova revenue
Acetaminophen injection had annual sales of US $72 million in the United States according to IQVIA data
The team will also assist the state health departments in terms of public health measures, management guidelines and protocols to manage the increasing cases of Avian Influenza
Gland Pharma Q2 FY2023 consolidated net profit up at Rs. 241.24 Cr
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