Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries.
Aurobindo Pharma Limited is pleased to announce that it has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Darunavir Tablets, 600 mg and 800 mg, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Prezista Tablets, 600 mg and 800 mg, of Janssen Products, L.P. The product will be launched on November 29, 2023.
The approved product has an estimated market size of USD 274.8 million for the twelve months ending October 2023, according to IQVIA. Aurobindo now has a total of 500 ANDA approvals (478 Final approvals and 22 tentative approvals) from USFDA.
Darunavir Tablets, 600 mg and 800 mg, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and paediatric patients 3 years of age and older.
