Quality Inspection for Active 10-Dab Semi-Synthetic Paclitaxel Pharmaceutical Ingredients - Antitumor Pharmaceutiucal Materials Natural Paclitaxel with FDA CEP GMP certificates – Hande

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.