Bioequivalence and Bioavailability Forum • New product

New product [Regulatives / Guidelines]

posted by Ohlbe – France, 2020-03-11 18:54 (1941 d 22:01 ago) – Posting: # 21257
Views: 6,214

Dear SKM,

❝ 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?

Well, you are giving all the arguments yourself: up to now the two active substances are only marketed as separate formulations. You will be mixing them into one new formulation, which has never been tested or marketed before. Sorry, but I can't explain more.

—
Regards
Ohlbe

Complete thread:

Immediate release fixed dose combination product ping4santosh 2020-03-06 09:21 [Regulatives / Guidelines]
- Immediate release fixed dose combination product Ohlbe 2020-03-06 10:35
  - Immediate release fixed dose combination product ping4santosh 2020-03-09 11:50
    - Immediate release fixed dose combination product ping4santosh 2020-03-11 12:22
      - Immediate release fixed dose combination product Ohlbe 2020-03-11 14:24
- Immediate release fixed dose combination product ElMaestro 2020-03-09 13:50
  - Immediate release fixed dose combination product Dr_Dan 2020-03-11 11:47
    - Immediate release fixed dose combination product ping4santosh 2020-03-11 12:21
      - Immediate release fixed dose combination product Dr_Dan 2020-03-11 13:44
        
        Immediate release fixed dose combination product ping4santosh 2020-03-11 14:22
        
        New product Ohlbe 2020-03-11 14:40
        
        New product ping4santosh 2020-03-11 16:34
        
        New productOhlbe 2020-03-11 17:54
        
        New product ping4santosh 2020-03-11 20:52
  - Immediate release fixed dose combination product ping4santosh 2020-03-11 12:18