Rockville, Md.,USA, Feb 10, 2005—The United States Pharmacopeia (USP) announces it will establish a USP-India site. The site will consist of business operations and laboratories and will offer USP’s broad range of pharmacopeial services to Indian pharmaceutical manufacturers in India as well as surrounding countries. This will be the first time the organization has established a USP-based laboratory outside of the U.S. This decision supports USP’s global public health strategy and will help fulfill USP’s mission: to promote the public health by disseminating authoritative standards and information for medicines, other health care technologies, and related practices used to maintain and improve health and promote optimal health care delivery.

The USP-India site will support the activities of Indian and regional constituencies, including the Indian Pharmacopoeia, to promote the manufacture of good quality therapeutic products globally. USP will work with Indian manufacturers, as it does with other U.S. and multinational manufacturers, to supply good quality, safe and effective medicines and dietary supplement ingredients and products for the U.S. market. Currently, Indian pharmaceutical manufacturers supply bulk ingredients and dosage forms to the U.S.

The USP-India site will also meet the same high standards as do the USP facilities in the United States, including relevant International Organization of Standards (ISO) certifications. The USPIndia site will involve experienced Indian scientists in the standards-setting activities of USPwith a focus on U.S. legally marketed, off-patent medicines.

“USP looks forward to working more closely with the Indian Pharmacopeia, the Indian pharmaceutical industry, Indian drug regulatory authorities, and Indian scientists,” said Roger L. Williams, M.D., executive vice president and chief executive officer. “Our mutual commitment to global public health and improving drug quality worldwide will be further enhanced with the establishment of USP’s office and laboratory in India.”