Module 1 2021

28/06/2021

CMC Items in CTN

Name and location of manufacturer or business office

Formulation of drug product

Manufacturing method

- Drug substance State whether chemical synthesis, extraction, culture, generic recombination, etc. - Drug product Dosage form - Manufacturing in Japan or imported Country and name of manufacturer

Distribution to third parties is not allowed

37

CMC Items in CTN

- Drug substance – Name – CAS No.

– Code number – Molecular formula – Molecular weight – Structural formula – Physicochemical properties

- Drug product – Name

– Code number – Formulation – Storage conditions

Distribution to third parties is not allowed

38

19

Made with FlippingBook - professional solution for displaying marketing and sales documents online