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 USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI)
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
Revenue is up 23% whereas Profit After Tax expands 29% for the company
H1 FY23 revenues at Rs. 860.1 crore, higher by 40% YoY whereas PAT at Rs. 52.6 crore, higher by 4% YoY
API platform to comprise of RA Chem Pharma, ZCL Chemicals and Avra Laboratories
Most of the new growth Capex investments are happening on the Specialty Chemicals and Nutrition side
The participants discussed the latest developments under ABDM that shall enable true interoperability in the health sector and how effective adoption of ABDM can pave the way towards Universal Health Coverage
The company is committed to addressing the observations at the earliest, and gaining approval for injectable manufacturing for the US
India will become a digital health leader, as we have the world’s best technical manpower required and our data is the cheapest in the world, approaching 100 percent coverage
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