Drug Master File cGMP

The manufacture of our Bulk phase CHIRALPAK®AD complies with a drug master files (DMF). In addition, we have worked with many pharmaceutical companies in the scale-up of chiral chromatography processes.

CHIRAL TECHNOLOGIES EUROPE and DAICEL assist in the submission of Drug Master File (DMF) or Validation Activities. If necessary, we can perform all the necessary studies to prove that production on enantiomer pure API does not change the quality of your product.

We can also prove the stability of the process as well assist in demonstrating the absence of release of chiral polymer into the enantiomer.