Articles
DelSite Subsidiary Sabila Industrial In Costa Rica Completes ISO 9001:2000 Inspection
August 6, 2008
DelSite, Inc., a drug delivery technology company, recently announced that its bulk pharmaceutical manufacturing subsidiary, Sábila Industrial, S.A., located in Liberia, Guanacaste, Costa Rica has completed an annual ISO 9001:2000 re-certification inspection by the European Union's notified body, AENOR Internacional, S.A.U. of Madrid, Spain.
During the audit, no major incidences of nonconformance were reported. Mr. José Zúñiga, Carrington's vice president of operations and manager of its South American business, stated, "For many years we have met all quality requirements for ISO and Current Good Manufacturing Practices (cGMP) for the FDA. We are proud of our quality record and the products we produce, whether raw materials or finished products. Our facilities are world-class and our farm is organically certified. Our raw material Manapol is kosher certified, and we take great pride in the GelSite polymer we produce in our facility. The GelVac powder formulation including the H5N1 (bird) flu antigen will be the first pure nasal powder vaccine with no preservatives, cold storage or adjuvant required. The IND for this bird flu vaccine will be filed in August, and our employees are extremely proud of this accomplishment."
About Sábila Industrial
Sábila Industrial, S.A. is a wholly-owned subsidiary of DelSite, Inc. that uses organic-certified plant materials to manufacture GelSite polymer, the raw material key to the drug and vaccine delivery technology developed by DelSite. GelSite is used to make the nasal powder for the H5N1 (bird flu) antigen. In addition to GelSite polymer for DelSite, Sábila Industrial is dedicated to producing raw materials for oral care and consumer products. All naturally-derived, polymeric raw materials are produced under the FDA's cGMP standards for use in human drugs. An injectable biologic raw material to treat fibrosarcoma in companion animals is produced by Sábila under USDA biologic regulations. Sábila Industrial, S.A. operates in a duty-free zone with an adjacent farm, Finca Sábila, which is certified organic by an agency of the Costa Rican government and which is recognized by the USDA and the European Union.
About DelSite
DelSite, Inc. is an ISO 9001-certified, research-based, biopharmaceutical and consumer products company with a core technology based on naturally-occurring complex carbohydrates. DelSite also manufactures and markets consumer products and manufactures quality products for other companies. Manufacturing operations comply with cGMP standards. DelSite is developing its proprietary GelSite technology designed to provide controlled release of peptide and protein-based drugs. Its technology is protected by more than 130 patents in 26 countries. For more information, visit www.delsite.com.
SOURCE: DelSite, Inc.
