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Thursday, June 3, 2010

What is a Generic Drug or Generic Pharmaceutical Products how generic drug is defined

What is a generic drug (generic drugs, short form : generics) :

Pharmaceutical or Drug is considered as a generic drug , where it is not protected by patent protection .It is possible that a generic drug have a patent on the formulation but not on the active ingredient, in such case formulation can not be taken by any one but the active ingredient can be formulated so as to form a suitable dosage form.
A generic Drug or Pharmaceutical should contain the same active ingredients as that of the original or parent formulation.
According to the U.S. Food and Drug Administration (FDA),Generic Pharmaceuticals or generic drugs are identical to or acceptable within an bioequivalent range with respect to pharmacokinetic and pharmacodynamic properties of the to the branded pharmaceutical product. Hence, Generic Pharmaceuticals or generic drugs are considered by US FDA as drugs identical in dose, strength, route of administration, safety, efficacy, and intended use.

US FDA establishes required standards for a generic drug giving a range of acceptable values and range of variations that a generic drug is required to be bioequivalent to a brand name drug .

Generic drugs is likely to differ from original brand name drug with respect to inactive ingredients or excipients, its configuration, release mechanisms, packaging shape , scoring.

In the US, drug patents grant twenty years of protection.

Here is the latest news about two pharmaceutical giant companies dispute on patent and generic drug ,
Pfizer sued Teva Pharmaceutical

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Here are some articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing and regulatory affairs and good manufacturing practice in pharmaceutical industry

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Time limitations in sterile pharmaceuticals processing

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New Drug Application (NDA) how to make a New Drug Application (NDA) to US FDA

Abbreviated New Drug Application (ANDA) What is ANDA , detaied information about ANDA preparation and submission to US FDA

How to make Investigational New Drug (IND) Application to US FDA

Drug applications submission to us fda Over the counter Drugs OTC drugs


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Good manufacturing practice in pharmaceutical industry

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