Aurobindo Pharma’s subsidiary — Eugia Pharma Specialities (Eugia) has received a 505(b)(2) NDA approval from the U.S.Food & Drug Administration (USFDA) for its Cyclophosphamide Injection 500 mg/2.5 mL and 1 g/5 mL vials. Aurobindo’s product will be available in ready-to-use (RTU) injection preparation. The product shall be launched in the US market in the near term and will be manufactured in Eugia’s manufacturing facility in India.
The approved product has an addressable market size of $ 170 million for the twelve months ending June 2021 according to IQVIA. This is the 19th product to be approved (including 3 tentative approvals) for Eugia. Aurobindo now has a total of 482 ANDA approvals (453 Final approvals and 29 tentative approvals) from USFDA.
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.