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Generic submission in India [Regulatives / Guidelines]

posted by jag009 – NJ, 2019-11-11 22:43 (1620 d 14:03 ago) – Posting: # 20785
Views: 3,950

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

Complete thread:

Generic submission in Indiajag009 2019-11-11 21:43
- Dead silence in India Helmut 2019-11-21 14:01
- Generic submission in India Ajit Thorat 2019-12-09 13:29

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