USP awards verified mark to Dr. Reddy's Laboratories, Ltd. i...( Rockville Md. October 2 2007 The Un...)

Rockville, Md., October 2, 2007 The United States Pharmacopeial Convention (USP) today announced the award of a specific verification mark, shown at the conclusion of this announcement, to two drug substances (Active Pharmaceutical Ingredients) manufactured by Dr. Reddys Laboratories, Ltd. in Hyderabad, India. The two drug substances are Ramipril and Finasteride. Dr. Reddys may now use this special mark on its certificate of analyses and other materials to signal to purchasers, regulatory bodies, official medicines control laboratories, independent testing bodies, and others that the two drug substances have undergone a rigorous and independent conformity assessment activity conducted under the auspices of USPs Pharmaceutical Ingredient Verification Program (PIVP). Dr. Reddys was the first manufacturer to enter the USP PIVP. Two more drug substances manufactured by Dr. Reddys are in the final stages of verification by USP.

USPs PIVP is a voluntary program that includes:

• Evaluation of an ingredient manufacturers quality systems through an audit for compliance with Good Manufacturing Practices (GMPs, using ICH Q7 as the standard);

• Review of manufacturing and quality control documents;

• Laboratory testing of ingredient samples from USP-selected lots for compliance with a private or public monograph, including those available in the United States Pharmacopeia (USP);

• Request for follow-on information such as post evaluation change in method or manufacturer that might alter the primary decision; and

• Yearly re-evaluation through testing and other approaches.

USP has verification programs for dietary supplements and dietary supplement ingredients and, based on decisions of its Board of Trustees, expanded these programs last year to include pharmaceutical ingredients, both drug substances and excipients, said Roger L. Williams, M.D., USPs executi
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