FDA certification;CoS of EDQM;GMP
cert of CFDA ;Registration in India,
Australia and Japan.
Over 20 years,more than 450 batches of products produced by Hande have no any quality problems, unique purification process, impurity and purity control meet spec of USP, EP and CP.
USP reference standards supplier of Paclitaxel and other taxanes;
The release spec of Paclitaxel controlled by spec of CP/EP/USP. The impurity analytical method covers all impurities in USP/EP/CP, and the impurity contents spec are way beyond that in regulatory standards;
Spec of Residual solvents in Paclitaxel are below spec of regulatory standards;