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.
The expansion program includes investments in France and the U.S., adding an additional 23,000+ m² of manufacturing footprint.
The approved product has an estimated market size of around US $62 million for the twelve months ending June 2022 according to IQVIA
This is the 142nd ANDA (including 8 tentative approvals received) out of Eugia Pharma Specialty Group (EPSG) facilities, manufacturing both oral and sterile specialty products.
Dr. Reddy's acquired the Eton portfolio for an upfront payment of approximately $5 million in cash, plus contingent payments of up to $45 million.
The inspection was a Pre-Approval cum cGMP inspection and it covered 15 ANDAs
Cabenuva was co-developed as part of a collaboration with ViiV Healthcare and builds on Janssen's decades-long commitment to combatting HIV
Launching Dexamethasone, Azacitidine, Carboprost, and Atropine for the Institutional Market
Given as few as six times per year and demonstrated superior efficacy to a daily oral PrEP option (FTC/TDF tablets) in reducing the risk of HIV acquisition
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