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American Journal of Pharmacy and Health Research

Keyword

Nasal Products

Explore 1 research publication tagged with this keyword

1Publications
4Authors
1Years

Publications Tagged with "Nasal Products"

1 publication found

2014

1 publication

Regulatory Requirements for the Approval of Generic Inhalation And Nasal Products and Its Marketing Scenario in USA, Canada and EU

Pasumarthy N. V. Gopal et al.
11/1/2014

In this study work a comparative and differentiation has been put forwarded to make some recommendations of the regulatory framework. Now a day’s it’s too hard to invent a new drug so, the major pharmaceutical companies mainly depend up on the generic production of drugs. The generic drugs are very cheap when compared to innovator drugs in production cost and these generic products are customer friendly. . In this study the information was extracted from certain journals, text books, and related websites and from the authorized regulated authorities of the particular countries. The Topics covered in this study are introduction to regulatory affairs as well as regulated authorities in USA, CANADA and EUROPEAN UNION. About the data exclusivity and patent protection term information and the comparison among USA, CANADA and EUROPEAN UNION are enlisted in this topic. The comparison between the number of NDA approvals and ANDA approvals of USA, CANADA and European Union are represented statistically from 2006 to 2013 are labeled. The number of total molecule wise approvals in these countries is represented through pie charts and the top most pharmaceutical firms and their brand names of inhalation and nasal products are mentioned.

Keyword Statistics
Total Publications:1
Years Active:1
Latest Publication:2014
Contributing Authors:4