The product will be manufactured at Lupin’s Somerset facility in the US
This is the first peptide product approval from the USFDA received by Alembic Pharmaceuticals
The approval marks a significant milestone for the American pharmaceutical company in the field of UC
Febuxostat Tablets (RLD Uloric) had estimated annual sales of US$ 27 million in the U.S. (IQVIA MAT November 2023)
The company has received six final approvals that includes Chlorpromazine Hydrochloride Tablets
This is the 166th ANDA out of Eugia Pharma Speciality Group facilities
NDA supported by data from global Phase III FRESCO-2 study in the U.S., Europe, Japan and Australia along with data from Phase III FRESCO study conducted in China
Granules now have a total of 53 ANDA approvals from USFDA
 
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