 "Pharma, medicine, pharmaceutics")
Aurobindo Pharma Limited (APL) received approval from the US Food and Drug Administration (USFDA) to manufacture and market Darunavir Tablets, 600 mg and 800 mg. The tablet is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Prezista Tablets, 600 mg and 800 mg, of Janssen Products, the company informed in a regulatory filing with the BSE on Wednesday, November 29.
The company said that the approved product could generate an estimated revenue of $274.8 million for the twelve months ending October 2023, according to IQVIA. As things stand, Aurobindo now has a total of 500 ANDA approvals from the USFDA. Among these, 478 are final approvals, and 22 are tentative approvals.
Darunavir Tablets, 600 mg, and 800 mg, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients three years of age and older.
Last week, Evive Biotech and Acrotech Biopharma received the US Food and Drug Administration's (FDA) approval for Ryzeneuta (Efbemalenograstim alfa), which is a subsidiary of a New Jersey-based and a wholly-owned subsidiary of Aurobindo Pharma USA Inc.
Aurobindo Pharma was trading 0.90 per cent in the green at Rs 1025.20 apiece on the BSE at 1224 hours on Wednesday, November 29. Aurobindo Pharma Limited is a global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes generic pharmaceuticals, branded speciality pharmaceuticals, and active pharmaceutical ingredients globally.
