Drug Approval | July 24, 2023
Lupin receives tentative USFDA’s approval for Dolutegravir Lamivudine and Tenofovir Alafenamide Tablets
This product would be manufactured at Lupin's Nagpur facility in India
This product would be manufactured at Lupin's Nagpur facility in India
Chlorpromazine Hydrochloride Tablets USP had an estimated annual sale of USD 45 million in the U.S.
The company has submitted marketing authorization applications for mRNA-1345 with the European Medicines Agency (EMA), Swissmedic in Switzerland, and the Therapeutic Goods Administration (TGA) in Australia
Dolutegravir Tablets for Oral Suspension (RLD Tivicay PD®) had estimated annual sales of USD 1 million in the U.S. (IQVIA MAT March 2023)
Cyanocobalamin Nasal Spray (RLD Nascobal) had estimated annual sales of USD 69 million in the U.S. (IQVIA MAT Mar 2023)
As Caeregen’s CDMO partner for CTR-107, Wacker Biotech will produce drug substance at its site in Halle, Germany, and complete clinical trial drug product production at its site in Amsterdam, the Netherlands
Supply readiness follows months of manufacturing to ensure timely and ample supply
This product will be manufactured at Lupin's Pithampur facility in India
Thiamine Hydrochloride Injection USP had estimated annual sales of USD 35 million in the U.S.
Obeticholic Acid Tablets had estimated annual sales of US$ 262 million in the U.S. (IQVIA MAT Mar 2023).
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