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

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 executive 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). Despite this opportunity, USP separates entirely the standards-setting activities of the Council of Experts from its PIVP and other verification programs to ensure the continued independence and objectivity of its standard-setting processes.


'/>"/>

Contact: Sandra Kim
sek@usp.org
301-816-8241
US Pharmacopeia
Source:Eurekalert

Related biology news :

1. Prehistoric mystery organism verified as giant fungus
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2017)... N.Y. and ITHACA, N.Y. ... ) and Cornell University, a leader in dairy research, ... with bioinformatics designed to help reduce the chances that ... With the onset of this dairy project, Cornell University ... Consortium for Sequencing the Food Supply Chain, a food ...
(Date:5/23/2017)...  Hunova, the first robotic gym for the rehabilitation and functional motor ... Genoa, Italy . The first 30 robots will be ... USA . The technology was developed and patented at the ... spin-off Movendo Technology thanks to a 10 million euro investment from entrepreneur ... ...
(Date:5/16/2017)... DALLAS , May 16, 2017   ... for health organizations, and MD EMR Systems ... certified development partner for GE, have established a ... Patient Portal product and the GE Centricity™ products, ... Centricity EMR. These new integrations ...
Breaking Biology News(10 mins):
(Date:10/11/2017)... ... October 11, 2017 , ... ComplianceOnline’s Medical Device Summit is back for ... June 2018 in San Francisco, CA. The Summit brings together current and former FDA ... board directors and government officials from around the world to address key issues in ...
(Date:10/11/2017)... a leading provider of patient support solutions, has announced the ... which will launch this week. The VMS CNEs will address ... enhance the patient care experience by delivering peer-to-peer education programs ... to help women who have been diagnosed and are being ... ...
(Date:10/11/2017)... ... ... Disappearing forests and increased emissions are the main causes of the evolving ... those living in larger cities are affected by air pollution related diseases. , That ... countries globally - decided to take action. , “I knew I had to take ...
(Date:10/11/2017)... ... October 11, 2017 , ... Singh ... orphan drug designation to SBT-100, its novel anti-STAT3 (Signal Transducer and Activator of ... SBT-100 is able to cross the cell membrane and bind intracellular STAT3 and ...
Breaking Biology Technology: