Aurobindo Pharma Limited is pleased to announce that it has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Estradiol Vaginal Inserts USP, 10 mcg, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), VAGIFEM 10 mcg of Novo Nordisk Inc. The product will be launched in Q2 FY25.

The approved product has an estimated market size of US$ 268 million for the twelve months ending June 2024, according to IQVIA. Aurobindo Pharma now has a total of 521 ANDA approvals (504 Final approvals and 17 tentative approvals) from USFDA. Estradiol Vaginal Inserts USP, 10 mcg is indicated for the treatment of atrophic vaginitis due to menopause.

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.

The company has 29 manufacturing and packaging facilities that are approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA. The company’s robust product portfolio is spread over 7 major therapeutic/product areas encompassing CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic, supported by a strong R&D set-up.