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ChromaDex gets GMP-ready with Alkemists

By Clarisse Douaud, 19-Feb-2007

Related topics: Regulation

Californian testing laboratory ChromaDex has announced it is expanding its phytochemical reference standards and materials through a partnership with Alkemists Pharmaceuticals – a move the company said will allow it to become better prepared for Good Manufacturing Practices (GMPs).

The analytical methods company provides botanical reference materials for use in quality control and research of botanical based extracts and products. ChromaDex said its botanical reference materials (BRMs) give users the tools to determine whether or not their raw botanical material evaluation is comprehensive as well as to examine material composition.

"As the industry prepares for the release of the GMPs, there will be an increasing demand for tools such as BRMs," said ChromaDex president & CEO, Frank Jaksch.

Legislation such as Good Manufacturing Practices or the Adverse Events Reporting bill is expected to spur on more opportunities for third party business, such as for analytical laboratories or call centers, who gear their services to helping companies to comply.

GMPs are part of DSHEA (the 994 Dietary Supplements Health and Education Act), but after 12 years the industry is still waiting for them. Draft current GMPs were published in 2003, but the final version of the guidelines are still going through the Office of Management and Budget.

ChromaDex's botanical reference materials include macro and microscopic information for a specific genus and species of plant as well as thin layer chromatography blueprints of a botanical.

"These BRMs when used, will increase the confidence of all involved …in the final analysis, that 'what is on the label is actually in the bottle'," said Alkemists CEO & director, Sidney Sudberg.