Capsugel Obtains Australia’s TGA Certification for it’s Licaps® Liquid-fill Capsule Manufacturing Facility

August 07, 2008

An important pre-requisite for product sales in Australia and beyond

Capsugel, a global leader in dosage form development and manufacturing, has received certification from the Therapeutic Goods Administration (TGA), a division of the Australian Department of Health and Ageing, for its Licaps® liquid-fill capsule production facility in Greenwood, S.C. (USA). The TGA is Australia’s principal regulatory authority for all therapeutic goods, including pharmaceuticals, dietary and nutritional supplements, as well as complementary medicines. Lawful sale of such products in Australia requires that the product is included on the Australian Register of Therapeutic Goods (ARTG). To obtain certification, which is product-specific, a marketer must demonstrate compliance with TGA requirements. One such requirement is that the manufacturing operations used to produce the product meet the current Australian Code of Good Manufacturing Practice (GMP) for Medicinal Products.

"The Australian GMP code is very thorough because it covers all medicines and is highly respected by many regulatory authorities around the world. In conjunction with the growing demand for products that utilize the Licaps liquid delivery system, our customers can now more readily access important global markets. Certainly, our experience is that the important benefits of the Licaps delivery system, which include heightened consumer preference and improved bioavailability, address global needs," said Robert Whitelaw, Director of Sales, Marketing and Business Development for Capsugel’s Americas Region.

With this TGA certification in place for a key manufacturing operation, marketers can more readily expand their product lines delivered via the Licaps technology into the Australian market – as well as elsewhere around the world because of the certification’s high credibility.

"Capsugel is well positioned with the resources to help customers develop TGA certified products," Whitelaw concluded.