National Enzyme earns GMP thumbs up in Oz

Australia’s Therapeutic Goods Administration (TGA) is considered one of the world’s toughest regulatory regimes, and it is often criticized by dietary supplements manufacturers for applying pharmaceutical standards to products it considers don’t warrant it.

“Our GMP certification by TGA as an overseas manufacturer is an honor shared by few other manufacturers of dietary supplements in the US Compliance with the strict internationally recognized cGMP requirements imposed by the Australian TGA demonstrates the high level of commitment that NEC has in producing complementary medicines on a global front,”​ NEC’s director of Quality Assurance, JoAnn Peterson, said in a statement.

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National Enzyme said the successful completion of the audit took many months and makes it one of the few North American companies to achieve it.

The approval comes under the Australian Code of Good Manufacturing Practice for Medicinal Products and means the company can continue to trade in powdered and encapsulated products as it has done for the past six years.

Australia’s Therapeutic Goods Administration (TGA) is considered one of the world’s toughest regulatory regimes, and it is often criticized by dietary supplements manufacturers for applying pharmaceutical standards to products it considers don’t warrant it.

“Our GMP certification by TGA as an overseas manufacturer is an honor shared by few other manufacturers of dietary supplements in the US Compliance with the strict internationally recognized cGMP requirements imposed by the Australian TGA demonstrates the high level of commitment that NEC has in producing complementary medicines on a global front,”​ NEC’s director of Quality Assurance, JoAnn Peterson, said in a statement.

National Enzyme said the successful completion of the audit took many months and makes it one of the few North American companies to do so.

The approval comes under the Australian Code of Good Manufacturing Practice for Medicinal Products and means the company can continue to trade in the products as it has done for the past six years.

NEC was last audited by the TGA in September, 2003, but was not able to be contacted prior to publication today.

It recently opened a 10,000 square foot manufacturing space in its home state of Missouri, where its encapsulation and blending departments are located.

“This expansion will allow National Enzyme Company to work more effectively and efficiently, as well as allow room for growth within the company. Not only will this new facility fuel the local economy, but it will also allow growth within the supplement industry,”​ said the firm.