Quality Control of 
Paclitaxel Production

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"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

21CEC is specialized in supply high quality 99.5% Paclitaxel as Active Pharmaceutical Ingredients. 
With the
guaranteed highest quality & lowest price

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.

Why buy Paclitaxel from 21CEC? ( "If I contact with the factory directly, may be better deal?" You might think.. . )
(A) High quality
guaranteed -
We looking after the product quality for our clients.
(B) Lowest price guaranteed -  After all, the factories have to export the product through Trading companies. 21CEC China Pharmaceuticals Ltd, (Shanghai) is the Trading Company in China to handle it for you.  
(C) Exclud. VAT - 21CEC Paclitaxel price is Exclud. VAT (save you at least 17,5% - a lot of money), since you pay to China directly .
(D) L/C at sight - 21CEC made it easy for our clients to pay by L/C at sight. - Once the client put the order to 21CEC, we paid the factory by cash in advance and get the product ready and ship it to you by air. You received the product before you pay it. No worry about million dollars cash flow problem.  

 

Cutting-edge Technology for Control of Paclitaxel Quality:

Paclitaxzel - IR Spectrum Pacitaxel - Heavy Water Exchange 1H NMR Spectrum Paclitaxel - 1H NMR Spectrum
Paclitaxel - 13C NMR Spectrum Paclitaxel - EI MASS Spectrum Paclitaxel - FAB MASS Spectrum

 

Good Manufacturing Practices Facilities and Equipments:

Analysis Equipments in the manufacturer
Scientific Instruments in the manufacturer
Control  Laboratories in the manufacturer
Production Facilities in the manufacturer

 

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% Extract.
(B) Purify from 1% Extract to 50% Paclitaxel.
(C) Purification from 50% to 70% Paclitaxel.
(D) Further purification from 70% to 99.5% Paclitaxel.

The last step is the most high-tech one.

21CEC selected factories do have DMF files registered in FDA.
Based on our scientific strength and long term friendship with them, these factories trust 21CEC and provided us the content of DMF files in confidential. We appreciate this trust. Hence we be able to check all the manufacturing procedure and inspect the product quality accordingly.

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:

Yew Tress from Planting to Harvesting

 

 


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