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Approval of Generic Drugs by FDA Process

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The various life-saving important Drugs may be too costly for the common man to purchase. The importance of the Generic Drugs comes into play precisely at this point of time. The Generic Drugs are cheap and affordable medicines having the same ingredients as of the Branded Drugs. The Generic Drugs not only have the same composition but also the similar effect and impact on the body as their branded counterparts. Just like the branded drugs, Generic Drugs also need to undergo the Food and Drug Administration (FDA) Drug Approval in order to be sold throughout the market. For this, the Abbreviated New Drug Application (ANDA) has to be submitted with FDA.

The Testing Of The ANDA Facts

The FDA Drugs Approval is based on the testing of the facts related to the Abbreviated New Drug Application (ANDA) data that is submitted by a Generic Drugs company. The testing of the Generic Drugs is required to check their similarity with the original Drug. In other words, the Generic Drug must have a similar composition, as well as similar active ingredients and effect as the original Drug. The time taken by the Generic Drug to dissolve in the system should also be similar to that of the original Drug.

The testing of the Generic Drugs is not based on the information regarding the Drug’s efficiency or reliability. The Approval Process of the Generic Drugs focuses on their availability by ensuring that they are less expensive.


Some of the reasons for the availability of the Generic Drugs at low cost are as follows:

  • The Generic Drugs are not marketed by the manufacturers.
  • Unlike the manufacturing process of the original Drugs, the production process of the Generic Drugs does not involve comprehensive research.
  • The manufacturers of Generic Drugs do not advertise the drugs.


The Drug Approval Services can be availed to complete the Drug Approval Process in a timely manner. The FDA Drugs Approval can be obtained only after the Basic Research and Preclinical Testing of the Generic Drugs. The Testing and Certification is done after three rounds of testing the Generic Drug.They are equally effective as the original Drugs. The Generic Drugs, if approved by the FDA, are in no way inferior to the original Drugs and are equally effective for the purposes they are meant for.



Manjit Singh Article's Source:
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  • Posted On July 16, 2012
  • Published articles 10

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