Aurobindo Pharma arm gets USFDA’s final nod for Testosterone Cypionate Injection

At 2 pm, the shares of Aurobindo Pharma were trading at Rs 878.45, up by 1.41% from its previous closing of Rs 866.20 on the BSE.

Aurobindo Pharma’s wholly owned subsidiary – Eugia Pharma Specialities 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, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Depo-Testosterone Injection, 100 mg/mL and 200 mg/mL of Pfizer Inc. The product is expected to be launched in November 2023. The approved product has an estimated market size of USD 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 speciality products. Testosterone Cypionate Injection USP is indicated 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).

Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.

On Monday, the stock opened at Rs 865 and touched a high and low of Rs 884.90 and Rs 859.10, respectively.

The BSE group ‘A’ stock of face value of Rs 1 has touched a 52-week high and low of Rs 930.00 and Rs 397.30, respectively. Last one week high and low of the scrip stood at Rs 922 and Rs 859.10 respectively. The current market cap of the company is Rs 50,865.33 crore.

The promoters holding in the company stood at 51.83%, while Institutions and Non-Institutions held 40.74% and 7.42% respectively.

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