by NR INDRAN / INT

Building on more than a decade of working relationships with Indian government , industry, and academia, the U.S. Pharmacopeial Convention (USP) held inaugural ceremonies today to mark the opening of its new, significantly expanded and state-of-the art facility in the IKP Knowledge Park in Hyderabad.  USP’s new facility expands its presence from 14,000 square feet to over 100,000 square feet; the number of employees will go from 70 to 90 in the coming year.

USP is a private, nonprofit, science-based organization with a mission to improve the health of people around the world through public quality standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.  With headquarters in United States and operating globally, USP opened its first non-U.S. facility in Hyderabad in 2006, based on India’s continuing emergence as a center for worldwide pharmaceutical manufacturing and USP’s developing ties to Indian regulatory agencies and the Indian pharmaceutical industry.

“The new facility is a milestone in our constructive relationships with Indian government and industry,” said Roger L. Williams, M.D., USP’s chief executive officer.  “This expands our scope considerably.  We are now poised to do more collaborative testing, verification testing, pharmacopeial education, customer support, and sourcing of written and physical standards for drugs, much of which we have been doing in concert with Indian manufacturers.  In addition, we are now able to launch new initiatives in synthetic chemistry and, reflecting the increasingly important role worldwide of biologics and biotechnology, in bio-analytic chemistry and testing.”

USP-India plays a key role in the production of the USP Medicines Compendium (MC), launched recently to address gaps in quality standards for medicines distributed around the world.  The laboratories and staff will help produce associated MC reference materials. The facility also will allow the USP India site to play a more active part in USP’s Verification programs, especially for dietary supplements. That is a voluntary testing and auditing program that helps dietary supplement manufacturers ensure and attest to the production of quality products for consumers.

The inauguration ceremony was attended by an array of dignitaries from Indian government and industry, as well as USP executives and members of the USP Board of Trustees, led by Dr. Duane M. Kirking, board chair.  Among Indian officials participating was Dr. B. Suresh, chairman on the Indian Pharmacopoeia Commission’s Scientific Body and a member of the USP Convention as well as president of the Pharmacy Council of India.  Commented Dr. Williams, “Our outreach to Indian manufacturers and regulators has already yielded significant results, which I hope and expect to continue into the future.  This new facility will enable even more extensive and fruitful collaborations.”

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