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%
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
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
Ketorolac Tromethamine is advised for the short-term management of moderately severe acute pain in adult patients
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
Glenmark’s Sodium Phenylbutyrate Tablets USP, 500 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals USA.
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