Kappa Bioscience AS Gains TGA Approval for Synthetic Vitamin K2 MK-7 in a Australia
19 Jun 2014 --- Kappa Bioscience AS, Oslo, Norway, is pleased to announce that today we have obtained Therapeutic Goods Australia (TGA) approval on the use of synthetic Vitamin K2 MK-7 in complementary medicine for Australian use.
With immediate effect, Australian manufacturers and brand marketers will be permitted to use K2VITAL, our proprietary vitamin K2 MK-7, as an ingredient to boost bone & 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.
“The approval of our proprietary K2VITAL vitamin K2 MK-7 for use in complementary medicine in Australia is a significant milestone in Kappa’s ambition to globalise the use and adoption of vitamin K2 MK-7, and with great benefits for Australian consumers” comments Dr Egil Greve, CEO & President of Kappa Bioscience AS. “Together with market ready products developed by one of the leading 3rd party manufacturers – Alpha Laboratories – a quick and cost effective introduction into the market place has been secured” Dr Greve further concludes.
“We are delighted to partner with Kappa Bioscience on the launch of this exciting new complementary medicine in our region. K2VITAL has undergone pilot development and stability studies across many single active and complex formulations in several dosage forms, all of which are now ready for immediate launch into Australia, New Zealand, Singapore and other selective Asia Pacific markets. Registration packages for Malaysia, Thailand and Indonesia are also now open for discussion” comments Warwick Mills, Innovation Manager of Alpha Laboratories.
