Assessment of Regulatory Strategies for ANDA Submissions: Case Studies from Generic Drug Manufacturers

Authors

  • Mitul Tilala, Abhip Dilip Chawda, Abhishek Pandurang Benke Author

DOI:

https://doi.org/10.48047/

Keywords:

Generic Drugs, Indian Companies, Marketing, Generic Companies, US-Approved, Pharma Companies, Life Cycle Management (LCM) Strategies, Drug Application.

Abstract

Propose: The regulatory regulations of different nations globally differ from one another. As a result, 
it is difficult for the corporations to create a single medication that can be concurrently filed for 
approval in every country. The various requirements for registration for generic medicine in the US 
were presented by the present research

Downloads

Download data is not yet available.

Downloads

Published

2024-05-14

Issue

Vol. 15 No. 5 (2024): volume 15 issue 5 (2024)

Section

Articles