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
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