Shares of Aurobindo Pharma were trading 1% higher on 23 October after the company’s subsidiary got final approval from the USFDA (US Food & Drug Administration).

In its regulatory filing, the company said Eugia Pharma Specialities, its wholly-owned subsidiary, has received final approval from the USFDA to manufacture and market a drug that treats hypogonadism.

The company added that it has received approval to develop “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 drug is bioequivalent and therapeutically equivalent to the RLD (reference listed drug), Depo-Testosterone injection, 100 mg/mL and 200 mg/mL of Pfizer Inc.

The drug is expected to be released by November 2023 and has an estimated market size of $226.8 million for the twelve months ending August 2023, according to IQVIA.

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

At 3:30 pm, the shares of Aurobindo Pharma closed 0.63% above at Rs 871.70 on NSE.