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)
Pantoprazole Sodium Sesquihydrate are proton pump inhibitors used in drugs to suppress the gastric acid secretion
Revenue is up 23% whereas Profit After Tax expands 29% for the company
Drospirenone Tablets (RLD Slynd) had estimated annual sales of US $141 million in the US
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 laboratory is equipped to perform high-volume diagnostic testing services
Innovative Capsugel Enprotect capsule can simplify the manufacturing process to accelerate drug development and expedite first-in-human timelines
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.
NFIL’s ambition is to reach revenues of US$100mn from CDMO by FY25.
The company is committed to addressing the observations at the earliest, and gaining approval for injectable manufacturing for the US
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