Critical and Comparative Analysis of ANDA Filling of Tablets in India, Europe and US

  • Posted on: 31 October 2017
  • By: admin

 

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November 2017 ARTICLE LIST >>

PharmaTutor (November - 2017)

 

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

 

Received On: 21/07/2017; Accepted On: 21/07/2017; Published On: 01/11/2017

 

AUTHORS:
Neetu*, Anupama Setia, Munish Thakur Department of pharmaceutical management
& drug regulatory affairs,
JCDM College of pharmacy,
Sirsa-haryana, India
* neetu.kaushal11@gmail.com

 

 

ABSTRACT:
Abbreviated New Drug Application (ANDA) is an application used for regulatory submission for the authorization of generics drugs and its entry into a brand drug market. Generic drugs are pharmaceutical equivalent to the brand name drugs and distributed without patent protection. Different countries have different requirements for the registration of generic drugs and its own regulatory authority, which are responsible to enforce the rules and regulations, issue the guidelines to regulate the marketing of drugs. Various government agencies in regulating drugs are CDSCO- India, EDQM-Europe, and USFDA-US. Aim of title was to review the generic drug filing and different aspect of obtaining regulatory approval in order to get the marketing authorization in India, Europe & US.

 

 

How to cite this article: Neetu, Setia A, Thakur M; Critical and Comparative Analysis of ANDA Filling of Tablets in India, Europe and US; PharmaTutor; 2017; 5(11); 17-27

 

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