Generic submission in India [Regulatives / Guidelines]

posted by jag009  – NJ, 2019-11-11 22:43 (1176 d 10:02 ago) – Posting: # 20785
Views: 3,668

Hi folks,

Can someone direct me to guidance doc(s) for generic submission in India? I would like to get some info on the comparative dissolution testing (is it like FDA where one has to carry out a recommended disso?), potency differences? I got the BE reqts part.

Thx
J

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