New product [Regulatives / Guidelines]

posted by Ohlbe – France, 2020-03-11 17:54  – Posting: # 21257
Views: 1,942

Dear SKM,

» Both the APIs are registered and marketed as separate formulation. We are mixing these two at same ratio into one formulation without adding any new excipients. I don't know why will it be considered as a new product. Can you guide me please?

Well, you are giving all the arguments yourself: up to now the two active substances are only marketed as separate formulations. You will be mixing them into one new formulation, which has never been tested or marketed before. Sorry, but I can't explain more.

Regards
Ohlbe

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