"The Quality System Regulation includes
requirements related to the methods used in, and the facilities and controls
used for, designing, manufacturing, packaging, labeling, storing, installing and
servicing of medical devices intended for human use." - FDA
is specialized in supply high quality 99.5% Paclitaxel as Active Pharmaceutical
We select the best factories, inspecting and keep monitoring their real-time production situation to ensure the high quality of 99.5% Paclitaxel that we provided. These factories have more than 8 years of Paclitaxel production experience. In associate with the universities / institutions, the quality of the product are analyzed by high-technology. There are large yew tree plant fields to ensure the sufficient material resource. The total production capability is >200kg/per year now.
In additional, the 8 year clinical use of Paclitaxel Injection made by it and enormous research works proved its effectiveness and safety.
It needs 10 tons of yew tree leaves to extract and purify (natural extract by HPLC, no any semi-synthesis process) 1 kg 99.5% Paclitaxel. You can imaging the scale and skill implied during its production. Many sectors of factories in different locations are involved in the whole process. 21CEC China Offices (Shanghai and Chengdu) have done excellent work on monitoring this production process.
Since we have pushed its quality improvement along the way, now the Paclitaxel that 21CEC provide is the highest quality & lowest price of its kind in the world. No wonder more and more USA & Europe companies turned to our supply.
Cutting-edge Technology for Control of Paclitaxel Quality:
Good Manufacturing Practices Facilities and Equipments:
Manufacturing Procedure and Drug Master File (FDA):
There are several steps in the Paclitaxel extract & purification process;
(A) Extract from yew tree leaves and bark to obtain 1%
The last step is the most high-tech one.
21CEC selected factories do have DMF files registered in
This is the advantage of 21CEC for being one of the most reliable suppliers of high quality Paclitaxel in the world.
Cultivated Yew Trees Resources - Environment Friendly:
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