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THE PHARMA REVIEW (NOVEMBER DECEMBER 2012)

Strategies and Lead Resources for Generic Drug Development

Bayya Subba Rao

Introduction:
 
United States Food and Drug Administration is the whole and sole organization for approval of drugs into the market of United States. At USFDA, drugs are approved as New Drug Application, Abbreviated New Drug Applications (generics), first generics, tentative approvals, New Molecule Entities, Orphan drugs and pediatric drugs. It is necessary to understand drug discovery, drug approval processes with corresponding intellectual property right protection as patents, market exclusivity (data exclusivity) etc. The objective of this article is to bring an awareness so as to be well in hand in the development of products especially by generic manufacturer to release into the US market. It is necessary to understand development and release of a product depends on volume of consumption, quantity already manufactured globally, possible demand to overcome shortage, client’s requirements, patent expiry, data/market exclusivity expiry etc., either as bulk drug, different type of formulation, combination products. The current article mainly reflects to USFDA data as countries like India which is a leading manufacturer of pharmaceutical products, and companies can simultaneously get approved upon fulfilling local other country requirements in addition to United States.

 

 

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