Cemplete
Regulatory Certification

FDA certification;CoS of EDQM;GMP
cert of CFDA ;Registration in India,
Australia and Japan.

Reliable Quality

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.

Quality System

• Quality Assurance System
  Document control
  Validation system
  Training system
  Internal audit protocol
  Supplier audit system

• Equipment & Facilities System

• Material Control System

• Production Control System

• Packaging & Labeling System

• Laboratory Control System

• Verification & Validation System

• Regulatory Affairs System

Quality Control
Specification

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;

Cooperative
Institutions