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25.Entry Barriers (1)

Kampo has a history of more than 1,800 years
The basic ingredients and formulation methods are unprotected by patents
Kampo may be manufactured according to the open recipe. But, to get an approval as medicine, ...

Proof of bioequivalence

Would-be manufacturers need to demonstrate equivalence to established preparations.
Prospective new prescription Kampo preparations are subject to the same stringent evaluation as other pharmaceuticals.

Storing crude drug

Inventories of crude drugs occupy a great deal of space and require rigorous environmental control.

Manufacturing Kampo bulk

The production processes demand larger-scale equipment than is commonly used in manufacturing synthetic pharmaceuticals.