Aurobindo Pharma arm gets USFDA okay for Cyclophosphamide Injection
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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.
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