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FDA Awards NIPTE Potential $35 Million in Grants to Reform Drug Manufacturing Process
Date:10/4/2011

CHICAGO, Oct. 4, 2011 /PRNewswire-USNewswire/ -- In a move that seeks to cut health care costs, create jobs, and improve drug safety, the U.S. Food and Drug Administration (FDA) has awarded a grant worth up to $35 million over the next five years to the National Institute for Pharmaceutical Technology and Education (NIPTE) to improve drug manufacturing standards. The grant comes at a time when the current cost of bringing a drug to market in the U.S. exceeds $1 billion and an increasing number of drugs and drug ingredients are being imported from abroad. Investment in research of drug development and manufacturing will not only improve America's manufacturing competitiveness and create high-paying jobs at home, but will help to reverse the current outsourcing trends in the pharmaceutical industry in the long term by decreasing the cost of manufacture and by improving quality and safety of our drugs.

"Over the last several years, NIPTE has contributed a great deal of research toward our understanding of quality pharmaceutical manufacturing," said Helen N. Winkle, Director, FDA Office of Pharmaceutical Sciences. "Progress in this area will mean safer, more efficient, and less costly drug production here in the U.S., and we are looking forward to NIPTE's findings."

NIPTE, Inc. is an academic not-for-profit organization dedicated to fundamental research and education in pharmaceutical product development and manufacturing. NIPTE's goal is to increase science and engineering-based understanding of this area so that novel state-of- the-art technologies can be developed and science-based regulations can be implemented. These technologies will also enable new drug discoveries to be brought to market faster with less variability, higher predictability of performance and at a significantly lower cost.

"Outsourcing of drugs and drug intermediates are increasing at an alarming rate, potentially threatening overall quality of our drugs accompanie
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SOURCE National Institute for Pharmaceutical Technology and Education
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