Raw Materials Producer Joins Texas Manufacturing Facility With Top International Quality Rating
IRVING, Texas, Jan. 28 /PRNewswire-FirstCall/ -- Carrington Laboratories, Inc. (Nasdaq: CARN) today announced that its Costa Rica raw materials manufacturing facility has been awarded ISO 9001 certification signifying that it has met stringent international standards for quality. Carrington's Irving, Texas, facility, which processes the raw materials into products for consumers and other manufacturers, achieved ISO 9001 certification in 1998. Carrington also is compliant with Current Good Manufacturing Practice (cGMP) production standards for oral drugs, medical devices, nutraceuticals, etc. as required by the U.S. Food & Drug Administration.
The Costa Rica facility produces all of Carrington's products-by-process raw materials derived from the Aloe vera L. plant: Acemannan Hydrogel(TM), Manapol(R) and Hydrapol(TM). The facility is also producing Carrington's SaliCept(TM) Oral Patch, which is intended for use in tooth extraction sites to manage alveolar osteitis, an often-painful condition also known as dry socket. Additionally, the facility will produce CR1013, the raw material for the GelSite(TM) drug delivery technology used by DelSite Biotechnologies to deliver proteins and peptides.
"This is the latest step in our initiative to enhance production and meet new FDA and ISO guidelines at all our facilities," said Dr. Carlton E. Turner, president and chief executive officer. "These upgrades have been buttressed by process improvements and better staffing and training to ensure that we continue to deliver world-class products to consumers and our partner companies. Over the past year, we have invested more than $2 million to upgrade our operations across the board. In addition to assuring users that our products meet the highest global standards of quality, the ISO 9001 designation, along with our organic and Kosher certifications, will facilitate marketing our products in Europe and other international markets and to global strategic partners targeting those markets."
ISO, an acronym for the International Organization for Standardization located in Switzerland, is widely acknowledged as the most important quality standard in the world. The organization, established in 1947 to develop common international standards in many areas, is made up of members from more than 120 national standards bodies.
"ISO standards of quality are recognized and respected throughout the world and allows us to get the CE mark needed to market our products in countries recognizing the ISO system," Dr. Turner said. "Our certification in Costa Rica is further evidence of the high standards under which we produce products both for ourselves and others utilizing our proprietary 'product by process' methodology."
About The Products
Acemannan Hydrogel (TM) is a highly processed, freeze-dried "product by process" from the inner leaf gel of Aloe vera L. Carrington's patented process ensures batch-to-batch consistency. The raw material is used in human monograph drugs, medical devices and prescription medical devices, primarily related to wound care.
Manapol (R) Powder is protected by patents in more than 26 countries. Its DSHEA (Dietary Supplement Health and Education Act of 1994) claims include that it enhances the immune system. Manapol(R), when used in conjunction with a proper nutrition and exercise program, may also aid in digestion and help maintain healthy cholesterol levels. The product's major end markets include nutritional beverages, dietary supplements, nutraceuticals and cosmetics.
Hydrapol(TM) is a product by process covered under U.S. Patents and is a mixture of naturally-occurring substances rich in Aloe vera L. complex carbohydrates. Product consistency is achieved via patented technology that uses controlled manufacturing parameters and yields lot-to-lot consistency. The product is marketed primarily to cosmetic manufacturers.
Carrington Laboratories, Inc., is an ISO 9001-certified, research-based biopharmaceutical and consumer products company currently utilizing naturally occurring complex carbohydrates to manufacture and market products for mucositis, radiation dermatitis, wound and oral care; manufacture and market the nutraceutical raw material Manapol(R) and the raw material Hydrapol(TM) for use in cosmetic formulations. Carrington also manufactures and markets consumer products sold under its AloeCeuticals(R) brand and manufactures quality products for other companies. Manufacturing operations comply with cGMP standards. The company's DelSite subsidiary is developing its proprietary GelSite(TM) technology designed to provide controlled release of peptide- and protein-based drugs. Carrington's technology is protected by more than 120 patents in 26 countries. Select products are honored with the internationally coveted CE mark, recognized by more than 20 countries around the world.
Certain statements in this release concerning Carrington may be forward- looking. Actual events will be dependent upon a number of factors and risks including, but not limited to: subsequent changes in plans by the company's' management; changes in the regulatory process; changes in market trends; and a number of other factors and risks described from time to time in the Company's filings with the Securities & Exchange Commission, including the Form 10Q filed November 14, 2002.