Seoul, South Korea-based drugmaker Dong-A Pharmaceutical says that it has been granted the Certificate of Suitability of Monographs of the European Pharmacopeia (COS) for epirubicin HCl.
The compound, which is an active pharmaceutical ingredient used in some anticancer drugs to inhibit the synthesis of nucleic acids in tumor cells, is a second-generation version of the anticancer agent doxorubicin. The firm added that the two components can be used to treat the same kinds of breast, stomach and lung cancers, but that epirubicin HCl has an improved side effect profile.
The certificate, which indicates approval by the European Directorate for the Quality of Medicines (EDQM), also ensures that the material complies with the relevant section of the European Pharmacopeia. Dong A added that it intends to enter the European market with the compound in the future.
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