Regulations

Kappa Bioscience AS Gains TGA Approval for K2VITAL in Australia

Kappa Bioscience AS, Oslo, Norway, has obtained Therapeutic Goods Australia (TGA) approval for the use of synthetic Vitamin K2 MK-7 in complementary medicines in Australia.
 
With immediate effect, Australian manufacturers and brand marketers will be permitted to use K2VITAL, the company’s proprietary vitamin K2 MK-7, as an ingredient to boost bone and cardiovascular-based health claims. The ingredient will be brought to market through our Australian & New Zealand agent, Nutrition Connect Pty Ltd.
 
This approval is a result of a file submission wholly owned, prepared and supported by Kappa Bioscience AS and is restricted to organic synthesis and high purity profile vitamin K2 MK-7, as is achieved with K2VITAL.
 
Kappa Bioscience AS has teamed up with Alpha Laboratories (NZ) Ltd as the 3rd party manufacturer for formulations containing Vitamin K2 MK-7 to allow a quick adoption into the market place. Alpha Laboratories have several complementary medicine formulations ready to be marketed. All of those come fully documented and are currently undergoing shelf-life studies, including selected formulations in zone iv b trials.
 

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