Bioequivalence and Bioavailability Forum • New product

New product [Regulatives / Guidelines]

posted by ping4santosh – India, 2020-03-11 17:34 (1499 d 12:07 ago) – Posting: # 21256
Views: 4,258

❝ ❝ 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:

Immediate release fixed dose combination product ping4santosh 2020-03-06 09:21
- 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 productping4santosh 2020-03-11 16:34
        
        New product Ohlbe 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