Jiangsu Hengrui Medicine Co., Ltd.
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Docetaxel is a well-established anti-mitotic chemotherapy medication that works by interfering with cell division. It is used for treatment of locally advanced or metastatic breast cancer, head and neck cancer, gastric cancer, hormone-refractory prostate cancer and non small-cell lung cancer. Docetaxel can be used as a single agent or in combination with other chemotherapeutic drugs as indicated depending on specific cancer type and stage.
For this API product, Docetaxel Trihydrate, we have got Chinese local GMP certificate, and US-DMF is available.
For Docetaxel Injection, we get Chinese local GMP certificate, and have US-ANDA. Docetaxel Injection Concentrate (two-vial) has Chinese local GMP certificate, and US-ANDA has been submitted.
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