For Immediate Release:

Schwabe North America’s Enzymatic Therapy Facility First in USA to Achieve Drug GMP Certification from UK’s Medicines and Healthcare Products Regulatory Agency

Schwabe North America’s Enzymatic Therapy® manufacturing facility has been awarded the Drug Good Manufacturing Practice (GMP) Certification by the UK Medicines and Healthcare Products Regulatory Agency (MHRA)

GREEN BAY, WI (Nov. 24, 2009) — Wisconsin-based, Enzymatic Therapy, Inc. (ETI), a key brand of Schwabe North America, is the first US nutritional supplement company to receive the prestigious Drug Good Manufacturing Practice (GMP) certification from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). The ETI manufacturing facility is also organically certified, an FDA registered drug establishment and has received the NSF GMP Certification by NSF International, the Public Health and Safety Company™. Adding the MHRA Drug GMP allows the facility to manufacture medicine for the European Community. Not only does this widen the scope of the market, it highlights the company’s serious commitment to safety and the highest quality manufacturing standards.

“Enzymatic Therapy has made the commitment to deliver exceptional quality, safety and purity in all the products we manufacture,” said Travis Borchardt, Vice President of Regulatory Affairs and Quality Assurance and Control. “The MHRA Drug GMP Certification reflects our ongoing mission to deliver superior products that people can trust.”

The MHRA is the UK government agency responsible for ensuring that medicines, herbal medicines, homeopathic remedies and medical devices work, and are acceptably safe. The UK has contributed, together with other Member States of the European Economic Community, requirements for the control of medicinal products. MHRA experts assess all applications to ensure they meet the required standards and follows up with a system of inspection, testing and safety monitoring. 

 “Adding the MHRA Drug Certification to our roster of quality manufacturing credentials confirms that our products meet strict requirements,” Borchardt explained. “Our Quality Assurance and Manufacturing Systems are recognized and respected by regulatory agencies at the local, state, federal and international levels.”

Find out more at www.enzymatictherapy.com or www.mhra.gov.uk.