Drug Approval | November 09, 2022
Lupin receives tentative approval from USFDA for Doxycycline Capsules
Doxycycline Capsules (RLD Oracea) had estimated annual sales of US $215 million in the US
Doxycycline Capsules (RLD Oracea) had estimated annual sales of US $215 million in the US
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India
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
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
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
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