Aurobindo Pharma subsidiary earns FDA approval for Testosterone Cypionate Injection

In a significant development for the pharmaceutical industry, Aurobindo Pharma Limited’s dedicated subsidiary, Eugia Pharma Specialities Limited, has triumphantly gained the final nod from the US Food & Drug Administration (USFDA). This monumental approval permits the manufacture and marketing of the Testosterone Cypionate Injection USP in multiple dosage configurations, which stand as bioequivalent and therapeutically equivalent to Pfizer Inc.’s renowned reference listed drug, Depo-Testosterone Injection.

With an imminent launch slated for November 2023, this product is poised to tap into a robust market estimated at a staggering US$ 226.8 million, as per data accumulated by IQVIA up until August 2023.

Delving deeper into this landmark achievement, this represents the 169th ANDA approval, encompassing both tentative and final authorizations, obtained by Eugia Pharma Speciality Group (EPSG). The group, renowned for its versatile manufacturing capabilities, caters to a wide spectrum of both oral and sterile specialty products.

The approved Testosterone Cypionate Injection USP serves as a pivotal replacement therapy for males grappling with conditions characterized by a deficiency or total absence of endogenous testosterone. This encompasses ailments like Primary hypogonadism and Hypogonadotropic hypogonadism, both congenital or acquired in nature.