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Profile comparison requirements [Regulatives / Guidelines]

posted by PriyalAayushi – India, 2018-03-13 05:09 (2230 d 00:12 ago) – Posting: # 18524
Views: 2,329

Dear friends,

Is it must to have matching dissolution profile of all 3 registration batches with RLD for ANDA filing purpose?

If 2 batches have F2 50+ but one below 50, then what?

Please help.

Thanks

Complete thread:

Profile comparison requirementsPriyalAayushi 2018-03-13 04:09 [Regulatives / Guidelines]
- Homework Helmut 2018-03-13 13:36
- Profile comparison requirements jag009 2018-03-15 21:45

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