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USP awards verified mark to Dr. Reddy's Laboratories, Ltd. ingredients
Date:10/2/2007

ve vice president and CEO. USP believes these programs are critically needed in a world with many thousands of manufacturers making many thousands of pharmaceutical ingredients. Dr. Williams said that many of these ingredients seldom if ever receive inspections, even in advanced countries, and many may be substandard or even counterfeit. While USPs effort is small, Williams noted that it represents a substantial commitment to work with manufacturers who wish to obtain independent documentation of the integrity of their work and the commitment of their employees. Dr. Williams also said that continued vigilance is needed to assure the quality of manufactured ingredients for medicines, even when an ingredient has been verified through USPs PIVP program. He noted that the PIVP mark is not intended to signal a well-manufactured drug product, which is the responsibility of a dosage form manufacturer working with a responsible regulatory agency.

Satish Reddy, COO and managing director of Dr. Reddy's Laboratories, stated, "This certification from a highly respectable body such as the USP is yet another veracious witness of quality systems that are internalised in the operations at Dr.Reddys. We will continue to work closely with USP to expand the coverage of this certification program in Dr. Reddys."

USP will provide a special certificate to Dr. Reddys at the CPhI trade show in Milan on October 2. The certificate will recognize Ramipril and Finasteride as the first drug substances to earn the USP verification mark for pharmaceutical ingredients.

USP looks forward to partnering with regulatory and compendial bodies around the world in advancing its pharmaceutical ingredients verification program. The conformity assessment activity embodied in USPs verification programs, including PIVP, not only assists manufacturers but also helps USP update monographs in USP and National Formulary and allied official USP Reference Standards (reference materials).
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Contact: Sandra Kim
sek@usp.org
301-816-8241
US Pharmacopeia
Source:Eurekalert

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