An Approval to manufacture and sale the copy of innovator product in the US Market

  • Posted on: 31 October 2017
  • By: admin

 

Magazine Home


November 2017 ARTICLE LIST >>

PharmaTutor (November - 2017)

 

ISSN: 2347 - 7881
(Volume 5, Issue 11)

 

Received On: 20/06/2017; Accepted On: 10/07/2017; Published On: 01/11/2017

 

AUTHORS:
Munish Thakur*, Anupama Setia, Neetu
Department of Pharmaceutical Management & drug regulatory affairs,
JCDM college of pharmacy,
Sirsa, Haryana, India
* munish.thakur98@gmail.com

 

 

ABSTRACT:
The drug designated for production has to be manufactured in compliance with Current Good Manufacturing Practices (cGMP) following USFDA requirements, EU Directive or International Conference on Harmonization (ICH) Guidelines or Regulatory Authority of respective country. Regulatory authorities bear the responsibility to conduct inspections on pharmaceutical manufacturing plants to ensure they follow cGMP guidelines so that the drug manufactured is safe and effective. A quality system has to be set up such that the drug is manufactured in accordance with approved procedures.

 

 

How to cite this article: Thakur M, Setia A, Neetu; An Approval to manufacture and sale the copy of innovator product in the US Market; PharmaTutor; 2017; 5(11); 9-16

 

[ABSTRACT WITH CITATION]   [VIEW AS HTML