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RegisterGeneric submission in India [Regulatives / Guidelines]
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
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 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Dead silence in India Helmut 2019-11-21 14:01
- Generic submission in India Ajit Thorat 2019-12-09 13:29
Ing. Helmut Schütz