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)
The company has successfully developed Methyl salicylate using Flow Chemistry and successfully erected a Flow reactor at Jhagadia plant and expects to start production from Q3 FY23
The acquisition is for an enterprise value of Rs. 218 crores
R&D center would be doing a lot of new product generation projects, process optimization, scale-up and product life cycle management work, full synthetic labs, the kilo labs, the process safety labs, and the population lab
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
Phase III trial also demonstrated a statistically significant reduction (14%) in hospitalization for any cause, bringing potential relief for patients and reducing burden on healthcare systems
H1 FY23 revenues at Rs. 860.1 crore, higher by 40% YoY whereas PAT at Rs. 52.6 crore, higher by 4% YoY
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
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