Similar product of a brand drugs

GENERIC SUBSTITUTION…

Generic substitution is the practice of shifting from a prescribed originator medicine product to an interchangeable medicine that consisting the same active pharmaceutical ingredient-the strength, the same concentration, for the same route of administration. The generic medicine may differ in organoleptic characteristics, labeling and packaging patterns however because of these formulation differences, the generic drug players are required to submit additional paper work to drug regulatory authorities to prove that their product is manufactured in accordance with good manufacturing practices (cGMP) and is similar or as pure and stable as the branded medicine; are generally commercialized under the nonproprietary name or could be marketed as branded generics.

This week our update covers the some of the most common questions that some patient asks about generic products are following:

WHAT ARE GENERIC MEDICINES?

A generic product is a similar product of a brand drug. To be marketed, these products must be “bio identical” to the innovators product. This means that the generic drug must be shown to be the same as the innovator product in the following ways:

• Dosage form
• Strength (same amount of drug in both)
• Safety
• Route of administration
• Quality
• Bioequivalence
• Actions

The generic applicant must prove that their generic product meets these requirements before the drug regulatory agency, will approve it and provide a permission to be introduce in to the market.

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