Sabinsa Gets TGA OK for ForsLean

EAST WINDSOR, N.J. Sabinsa received product information (PI) numbers from the Therapeutic Goods Administration (TGA), Australia, for its ForsLean® 10 percent and 20 percent grades, allowing the company to sell the ingredient into the Australian market. The numbers are: 11628, Sabinsa Coleus Forslean (1) 26/04/2005; and 107073, Sabinsa Coleus forskohlii extract 10 percent.

PI documentation is reviewed by TGA as part of the approval process before a therapeutic product can be sold in Australia. The product information is designed to provide health professionals with a summary of essential scientific information about a therapeutic product, particularly its safety and efficacious dosage.

As a global company we have become quite familiar with the process of meeting a variety of regulatory requirements in order to sell our products in many different markets, said Shaheen Majeed, marketing director, Sabinsa. Although the processes are never simple, we have extensive documentation on the safety and efficacy of our branded ingredients, so its just a matter of providing the right information in the right form.