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Corporate - Regulatory Bodies & Rulings
US nod for Dabur’s cancer injection

New Delhi, Aug. 22

Dabur Pharma has received the US Food and Drug Administration’s approval for the Abbreviated New Drug Application (ANDA) for the chemotherapy injection, Epirubicin. The injection, a generic version of Pfizer’s Ellence, is used in the early treatment of breast cancer, said the company in a statement.

According to Dabur Pharma, the drug has an annual sale of about $ 60 million. The company will sell 50 mg and 200 mg dosages in the US. “We are pleased to announce our third USFDA approval in the last one year. This bears testimony to the strong foundation that we are laying towards becoming one of the leading oncology players across the globe,” said Mr Ajay K Vij, CEO, Dabur Pharma. Dabur Pharma claims to be India’s largest player in the Oncology segment, with a market cap of over Rs 1,000 crore. —

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