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DECLARATION

I hereby declare that the contents presented in the thesis entitled,

“Analysis of India’s Strengths in Product Registrations with U.S.FDA”

that is being submitted in partial fulfillment for the award of Ph.D. in

Pharmaceutical Sciences to Jawaharlal Nehru Technological university,

Hyderabad is a record of original work carried out by me under the

guidance and supervision of Prof. G. Krishna Mohan and Co Supervision

of Prof. M. Lakshmi Narasu of Jawaharlal Nehru Technological university,

Hyderabad .

Further to this to state that the results embodied in this thesis have not

been submitted to any other University or Institution for the award of any

degree or diploma.

Place: Hyderabad, India. Uma VasireddyDate: December 2011

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Disclaimer

The views expressed in this thesis (Analysis of India’s Strengths in

Product Registrations with U.S.FDA) are based on my personal opinion

and do not represent US FDA and PHARMEXCIL (Pharmaceuticals

Export Promotion Council, Set up by Ministry of Commerce &

Industry, Govt of India) officially.

Uma Vasireddy