Dabur Pharma, India's leading oncology player, has received final approval from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for epirubicin injection 50mg and 200mg.
Epirubicin is the generic equivalent of Pfizer's ellence injection, a chemotherapy drug used to fight early-stage breast cancer and had sales of approximately US$ 60 million (IMS - March 2007) in the US.
Commenting on the approval, Ajay K Vij, CEO, Dabur Pharma Ltd said "We are pleased to announce our third US FDA 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".
Dabur Pharma Ltd is India's largest player in the oncology segment, with a current market cap of over Rs 1000 crore (US $ 290 million). Dabur Pharma is a research and development driven company that develops, manufactures, and markets a wide range of oncology drugs. It offers a complete range of products, from injectable and oral dosage forms to intermediates and APIs across all key oncology segments. Its products are currently available in more than 40 countries, including the US and Europe.