Aurobindo Pharma Announcement

Hyderabad: Aurobindo Pharma Limited has announced that its wholly owned subsidiary company, Eugia Pharma Specialities Limited, has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Testosterone Cypionate Injection USP 1,000 mg/10 mL (100 mg/mL) and 2,000 mg/10 mL (200 mg/mL) in Multi-Dose Vial and 200 mg/mL in Single-Dose Vial.

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Depo-Testosterone Injection, 100 mg/mL and 200 mg/mL of Pfizer Inc.

Testosterone Cypionate Injection USP is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone, Primary hypogonadism (congenital or acquired) and Hypogonadotropic hypogonadism (congenital or acquired).

The product is expected to be launched in November 2023. The approved product has an estimated market size of US$ 226.8 million for the twelve months ending August 2023, according to IQVIA. This is the 169th ANDA approval (including 9 tentative approvals received) out of Eugia Pharma Speciality Group (EPSG) facilities, manufacturing both oral and sterile specialty products.

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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 25 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, AntiRetroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics, and Anti-Allergic, supported by a strong R&D set-up.

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