Eugia receives USFDA Approval for Cyclophosphamide Injection

Aurobindo Pharma Limited (along with its subsidiaries together referred to as "Aurobindo") has announced that its subsidiary Eugia Pharma Specialities Ltd. (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.

Aurobindo's Cyclophosphamide Injection is indicated for

- Malignant lymphomas
- Multiple myeloma
- Leukemias
- Mycosis fungoides (advanced disease)
- Neuroblastoma (disseminated disease)
- Adenocarcinoma of the ovary
- Retinoblastoma
- Carcinoma of the breast

The approved product has an addressable market size of US$ 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.

Shares of Aurobindo Pharma Ltd. was last trading in BSE at Rs. 698.1 as compared to the previous close of Rs. 696.6. The total number of shares traded during the day was 1505423 in over 6975 trades.

The stock hit an intraday high of Rs. 707.85 and intraday low of 694. The net turnover during the day was Rs. 1056978099.

Source : Equity Bulls

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