Best Formulations gets TGA cert

Located near Los Angeles, Best Formulations is a contract manufacturer of softgels, tablets, capsules, powders, teas, and liquids.

TGA certification is reputed to be of a very high standard, and as such this step represents a significant profile boost for Best Formulations.

Expanding to certification across various markets helps facilitate international trade and Best Formulations is promoting the announcement accordingly.

"…the TGA certificate allows us to grow into the expanding international markets," said Robin Koon, senior vice president sales & marketing.

The Therapeutic Goods Administration covers pharmaceuticals and dietary supplements.

The approval as such means that any product certified under its auspices can be marketed as a "therapeutic good".

In late 2003 the Australian and New Zealand governments signed an agreement for the joint regulation of therapeutic products, including complementary medicines, over-the-counter and prescription medicines, medical devices, blood and blood products and tissues and cellular therapies.

The agreement involves setting up the bi-national Australia New Zealand Therapeutic Products Authority (ANZTPA), which will be accountable to both governments and replace Australia's Therapeutic Goods Administration (TGA) and New Zealand's Medsafe.

The plan has proved controversial since, although complementary therapies and supplements were previously bundled together with prescription drugs under the TGA's bailiwick, historically New Zealand has had a more lenient regulatory structure than its neighbor, meaning that many more products have been available on the market.

In the US, Best Formulations is also a fully licensed drug manufacturing facility and is GMP (Good Manufacturing Practices) certified by the Natural Products Association (NPA).

Best Formulations has been involved in softgel innovation in the North American dietary supplement industry.

This year it announced itself as a licensee for the formulation of FMC BioPolymer's patent-pending SeaGel carrageenan and starch blend - a vegetarian alternative to animal-derived gelatine softgels.

FMC BioPolymer's carrageenan blend it is more expensive than gelatin, though the company claims less of the raw material is required in production.

"Most manufacturers aren't TGA certified because of the effort and expense in doing so," said Koon.

"However, since we already have a drug license and operate under GMP guidelines, the TGA certification process was relatively simple."