New product [Regulatives / Guidelines]

posted by ping4santosh  – India, 2020-03-11 15:34 (361 d 23:28 ago) – Posting: # 21256
Views: 3,262

» » 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 [...]
» Because that's what it is. You have to distinguish API and formulation. This will be a new combination of two existing API.

Dear Ohlbe,

Both the APIs are registered and marketed as separate formulation. We are mixing these two at same ratio into one formulation without adding any new excipients. I don't know why will it be considered as a new product. Can you guide me please?

Edit: Please don’t shout[Helmut]

Complete thread:

 Admin contact
21,371 posts in 4,463 threads, 1,495 registered users;
online 2 (0 registered, 2 guests [including 2 identified bots]).
Forum time: Monday 15:03 UTC (Europe/Vienna)

When puzzled, it never hurts to read the primary documents 
a rather simple and self-evident principle that has, nonetheless,
completely disappeared from large sectors
of the American experience.    Stephen Jay Gould

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz