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)
Saroglitazar Mg is an investigational compound in the USA/EU, undergoing Phase 2b/3 clinical trials in patients with Primary Biliary Cholangitis and Phase 2b in patients with Non- alcoholic Steatohepatitis
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
Ketorolac Tromethamine Tablets are indicated to relieve moderately severe pain, usually after surgery.
Micafungin for Injection had annual sales of US $99 million in the United States according to IQVIA data
The new plant will include a wide range of dosage form capabilities for oral solids, liquids, topicals, films, and manufacturing technologies for granulation, film coating, spray drying, tableting
He is a seasoned business leader with a successful track record of over 26 years across local and area roles within the pharmaceutical industry
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