Covance Announces New cGMP Melamine Testing Service
— Covance adds cGMP melamine testing in compliance with new FDA pharmaceutical guidance —
PRINCETON, NJ, September 28, 2009 — Covance Inc. today announced that it has added cGMP (current Good Manufacturing Process) melamine testing services in North America to meet recent U.S. Food and Drug Administration (FDA) guidance on melamine testing for pharmaceutical and animal health manufacturers.
Covance developed the new cGMP-compliant method for melamine testing in food and nutritional chemistry products using advanced LC-MS technology to significantly reduce the risk of contamination by melamine and its related analogs in pharmaceutical excipients and products.
Prompted by recent incidents involving food products in China and the United States, the FDA issued Pharmaceutical Industry Guidance on Preventing Melamine Contamination in August 2009 to avoid potential melamine contamination of pharmaceutical products. The guidance recommends melamine testing for certain pharmaceutical ingredients used in the manufacture or preparation of drug products.
"Covance is committed to ensuring the quality of every client product in compliance with the latest regulatory requirements," said John Robson, PhD, president, analytical services, Covance. "Our method has demonstrated a significantly better sensitivity than recommended by the guidance, which provides our global clients greater assurance of product safety and an earlier opportunity for process optimization."
Covance offers a comprehensive portfolio of chemistry, manufacturing, and control (CMC) analytical services to the global pharmaceutical and animal health industry. These services include analytical method development, method validation, stability testing, and product release testing. Covance also offers expertise in inhalation product testing, extractable and leachable testing, and nitrosamine testing.
Covance, with headquarters in Princeton, New Jersey, is one of the world's largest and most comprehensive drug development services companies with annual revenues greater than $1.7 billion, global operations in more than 25 countries, and more than 10,000 employees worldwide. Information on Covance's products and services, recent press releases, and SEC filings can be obtained through its website at www.covance.com.
Statements contained in this press release, which are not historical facts, are forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All such forward-looking statements including the statements contained herein regarding anticipated trends in the Company's business are based largely on management's expectations and are subject to an qualified by risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, competitive factors, outsourcing trends in the pharmaceutical industry, levels of industry research and development spending, the Company's ability to continue to attract and retain qualified personnel, the fixed price nature of contracts or the loss of large contracts, and other factors described in the Company's filings with the Securities and Exchange Commission.