Author(s) :

Dr. Vandana P. Patil, Ms. Suwarna H. kale.

Volume/Issue :

Abstract :

The Abbreviated New Drug Application (ANDA) drug development process is an important part of the pharmaceutical industry. It's a streamlined process for getting generic drugs approved in the United States. It doesn't require clinical trials or extensive safety studies, making it faster and cheaper than traditional drug approval processes. ANDAs are submitted to the FDA in order to market a generic version of a drug that has already been approved. The ANDA process can take anywhere from 6 months to 2 years. Generic drugs must be bioequivalent to the innovator drug, and they may not be able to make significant changes to the formulation or manufacturing process. There is always the possibility that patent litigation could delay or prevent generic entry into the market.

No. of Downloads :

10