Immediate release fixed dose combination product [Regulatives / Guidelines]

posted by ping4santosh  – India, 2020-03-11 14:22 (677 d 12:36 ago) – Posting: # 21245
Views: 3,609

Dear Dr Dan,

Please accept my apology for spelling your name wrongly in my last draft.

Please allow me to ask you why you consider this as a new product? Both the APIs are registered as individual products in market and we are just combining both. Why would you call it as a new product that needs Efficacy and Safety data?

Thank you,
SKM

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