Aurobindo Pharma arm gets USFDA okay for Cyclophosphamide Injection

Written by Ruchika Sharma Published On 2021-08-27T13:19:08+05:30 | Updated On 27 Aug 2021 1:19 PM IST

Aurobindo Pharma arm gets USFDA okay for Cyclophosphamide Injection

Hyderabad: Aurobindo Pharma Limited today announced that the company's subsidiary Eugia Pharma Specialities Ltd. 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.

Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 155 countries.

The company has 27 manufacturing and packaging facilities that are approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA.

Read also: Aurobindo Pharma to channelize efforts for commercializing COVID vaccine

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751