China Manufacturer for Oral Semi-Synthetic Paclitaxel Api - Antitumor Pharmaceutiucal Materials Natural Paclitaxel with FDA CEP GMP certificates – Hande Detail:
Product Informations
Established in 1993, Yunnan Hande bio-tech Co., Ltd. is a leading Paclitaxel APIs manufacturer with a great fame over the world, the company located at Kunming, Yunnan, P.R. China, owned China GMP certificate, CEP, and approved by US FDA and TGA, also entered U.K, India , Japan, Canada, Singapore, South Korea, Taiwan China, Malaysia, Russia, Turkey and Zimbabwe, in the records.
The new manufacture base covers an area of 20 acres with over 10,000 square meters of factory buildings. Equipment includes the international standard testing room, covering liquid, gas, metal elements, infrared, microbes, moisture determination, All inspection items such as stability inspection, using all-in-one testing equipment, complete data integrity IT system, efficient & fully enclosed separation and purification production line, and clean factory buildings. Company production capacity of natural paclitaxel increased to 500kg per year, 10-DAB III increased to 1000kg per year.
The company’s paclitaxel APIs have been widely used in customers’ anti-cancer injections, such as polyoxyethylene castor oil injections, liposome injections, albumin injections, and oral solutions. it is also used in Drug eluting stent and Drug-coated balloons to treat coronary heart disease and peripheral vascular disease. For 28 years, Hande has continuously provided customized product solutions for customers in different stages such as R&D, small test, pilot test, and commercial batch.
Product Parameters
COMPANY PROFILE | |
Product Name | Natural Paclitaxel, APIs |
CAS | 33069-62-4 |
Chemical Formula | C47H51NO14 |
Brand | Hande |
Manufacturer | Yunnan Hande Bio-Tech Co., Ltd. |
Country | Kunming, China |
Established | 1993 |
BASIC INFORMATION | |
Synonyms | TAXOL®Paclitaxel, Taxus sp.Baccatin III N-benzyl-beta-phenylisoserine EsterSCHEMBL12202822.beta.-(Benzoylamino)-.alpha.-hydroxy-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2aR,3,4S,4aS,5,6R,9S,10,11S,12S,12aR,12bS-dodecahydro-4,11-dihydroxy-4a,8,13,13-tetramethyl-5-oxo-7,
11-methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-yl ester, benzenepropanoic acid |
Type | Small Molecule |
Structure | |
Weight | Average: 853.9061Monoisotopic: 853.330955345 |
HS Code | 29329990.21 |
Quality Specification | Ph. Eur, CP, USP, IP |
Certificates | Owned China GMP certificate, CEP, and approved by US FDA and TGA, also entered U.K, India, Japan, Canada, Singapore, South Korea, Taiwan China, Malaysia, Russia, Turkey, and Zimbabwe, in the records. |
Assay | 98.0%-102.0% |
Appearance | White or off-White crystalline Powder |
Method of Extraction | Natural extract from high content Taxus wallichiana Zucc. The paclitaxel effective content of yew is more than 0.3‰. |
Annual Capability | 500kg/year |
Package | Multiple DMF inner packaging: Brown glass bottle, Polyethylene bag, Foil bag |
COA | Customized COA, Meet the quality requirements of different customers |
Logistics | Multiple transports |
Payment Terms | T/T, D/P, D/A |
Other | Accept customer audit all the time; Assist clients with regulatory registration. |
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By John biddlestone from Irish - 2018.06.09 12:42
The company account manager has a wealth of industry knowledge and experience, he could provide appropriate program according our needs and speak English fluently.
By Deirdre from United Arab emirates - 2018.09.23 17:37