News Archive

Anteco Pharma was notified by BSI, an international certifying agency, that it had been certified as ISO 9001:2000 and ISO 13485:2003. This milestone was achieved after a two year effort to expand and modify our operations and quality and operations procedures and practices to meet both cGMP and ISO standards for the manufacture of pharmaceuticals, medical devices and nutritional ingredients.

ISO 9001, by far the world’s most established quality framework, is currently being used by over ¾ million organizations in 161 countries. ISO 9001 sets the standard not only for quality management systems, but management systems in general. This standard helps organizations succeed through improved customer satisfaction, staff motivation and continual improvement.

ISO 13485, applying specifically to manufacture of medical devices, was published in 2003. and is now fully recognized in many countries. This standard is recognized by the Global Harmonization Task Force (GHTF), for compliance with the European Union (EU) CE marking medical device directives, Health Canada CMDCAS, Taiwan Medical Device Regulations, Japan JPAL and other international requirements.

• 2000 Iso Certificate.pdf
• Bsi Certificate.pdf

Anteco Pharma received confirmation of its Drug Establishment Registration and assignment of a Labeler Code from the US Food and Drug Administration today. "This registration, which subjects the company to inspection by the FDA, was possible only through the efforts of the Anteco Pharma management, consultants and staff to develop and implement a conforming facility and a compliant quality system", noted Phoebe Byington, Anteco Pharma‘s Quality Specialist.

Anteco Pharma was named small business of the year by the Columbia County, Wisconsin Economic Development Corporation at its annual awards banquet on November 28, 2007. It was also announced today that the company has been nominated in the small company category for Wisconsin Manufacturer of the Year awards. Winners will be named on February 28, 2008.

Company president, Howard Teeter, announced today that the US Food and Drug Administration has confirmed the registration of Anteco Pharma as a medical device manufacturer. Teeter comments that, "This registration is an important milestone in Anteco Pharma‘s goal to assure its customers full compliance with all US and international regulatory requirements."