Brandon Griffin, CEO of Ingredient Identity, said Bio-gen is working with his firm on a broad-based expansion strategy. The plan is carve out a wider footprint for the company both in terms of the global reach of its direct sales efforts but also to more efficiently commercialize new ingredients in the company’s development pipeline.
“What they are interested in doing in the U.S. and some other markets is understanding what the regulatory landscape would be for their new ingredients that they have already developed or are developing,” Griffin told NutraIngredients-USA.
One strategy for many markets
Griffin said Ingredient Identity will help Bio-gen develop an integrated strategy for bringing new ingredients into a variety of the world’s markets. Having a comprehensive overview of all fo the regulatory requirements of the various countries or unified markets that the company is looking at will provide synergies in the regulatory review. Information developed to satisfy one regulatory body could be submitted to another with minor tweaks if the various requirements are on the table from the outset, he said. Ingredient Identity will help Bio-gen with entry into South American markets as well as the U.S., Canada and Mexico.
“We will be packaging that up as an indepedent ingredient strategy,” he said. “Each country has its own regulatory framework. What might be acceptable for one country, like GRAS is here in the U.S., might not translate to another. Canada, for example, has its registration requirement.”
Bio-gen is a privately held ingredient manufacturer with headquarters in the southern Indian city of Bangalore, a hotbed of dietary ingredient production. The company, founded in 2000, supplies food and dietary ingredients, all produced at facilities the company claims are GMP compliant.
Bio-Gen operates a 40,000 sqft manufacturing & research facility in Dobbaspet, an industrial area northwest of Bangalore. The company claims the follow certifications for the facility: ISO, GMP, HACCP, OHSAS, FSSAI, Halal and Kosher. The company currently lists dozens of products and claims to be developing new or novel ingredients at the clip of about seven per year. Bio-gen produces lutein and zeaxanthin ingredients, beta-carotene and other carotenoid products and a variety of oils, food ingredients and colors and Ayurvedic extracts.
Grittith said that Bio-gen is looking to establish a captive sales presence in the markets of interest. Bio-gen has been selling into some of these markets already, but at a small scale and only through ingredient brokers. In addition, he said the company is looking to conduct research that will support the benefits of the ingredients for the relevant populations.
“The majority of their studies, both analytical and clinical, have been done in India on Indian populations. Part of our agreement is to help them conduct their activities here in the U.S. There is a slight preference, if you will, to have data supporting efficicacy from a population that is similar to the one using your prduct. A study conducted in Australia, for example, would probably suffice to support a claim here in the U.S.,”he said.
Cleaning up Ayurvedic supply
Griffin said the new agreement with Bio-gen mirrors the overall trend in the market. While in his view there has not been explosive growth in Ayurvedic ingredients, the expansion has been steady. And newer players in the game are stepping up to try to boost trust and transparency and to make the supply chain more direct, he said, rather than just being a name on a shipping label on a few totes in the back of some distributor’s warehouse. (Established companies like Sabinsa and Omniactive have been touting their transparency and traceability for years, but there are is a plethora of smaller, less visible companies in the market.)
“I think there has been steady growth in Ayurvedic ingredients. We are trying to help in that process of dismantling the mystery around this category of products. What is interesting is that a lot of these folks are taking a lot more active role in getting these ingredients into the marketplace and are looking to partner much earlier in the development process with U.S. companies,”Griffin said.
“That’s one of the challenges that we are constantly brought in to address for our clients who make finished products. If they don’t have all information on the ingredients they are using then it becomes a guessing game. What we have found in the past is there have been a lot of middlemen,” he said.