
Shares of Aurobindo Pharma experienced a robust surge of nearly 2% in response to the US Food and Drug Administration (FDA) granting approval for Efbemalenograstim Alfa Injection.
A significant stride was made by Aurobindo Pharma as its wholly-owned subsidiary, Eugia Pharma Specialities Limited, received the FDA’s final nod to manufacture and market Testosterone Cypionate injection. The approved concentrations include 100 mg/mL and 200 mg/mL in multi-dose vials, along with 200 mg/mL in single-dose vials. The slated launch for this product is set for November 2023.
Research firm IQVIA reports that the estimated market size for the approved product stands at an impressive $226.8 million for the 12 months ending August 2023. This marks the 169th abbreviated new drug application (ANDA) approval secured from Eugia Pharma Speciality Group (EPSG) facilities.
Testosterone Cypionate Injection USP, designed for replacement therapy in males facing conditions linked to deficiency or absence of endogenous testosterone, such as primary hypogonadism and hypogonadotropic hypogonadism, takes center stage in this development.
In a separate occurrence in October, Aurobindo Pharma, in collaboration with Sun Pharmaceutical, initiated a product recall from the US market due to manufacturing issues, as confirmed by the US Food and Drug Administration. Notably, a US-based subsidiary of Mumbai-based Sun Pharma is recalling 69,707 cartons of Cequa (cyclosporine ophthalmic solution) from the US market.
At 10:45 am, the shares continued their ascent, registering a commendable 1.19% increase, reaching ₹1,039.50.