Based in Florida, CareMundi describes itself as a company with a mission of providing access to the “newest and most modern medicines and supplements approved by the main regulatory bodies worldwide” to Latin American buyers.
Brazil has a vitamin and dietary supplement market worth $652 million in 2017, according to market research firm Euromonitor. It’s expected to grow to $695.9 million by 2022.
The top performing players in the market are brands by multinational pharmaceutical giants like Pfizer, Bayer, and Sanofi, according to Euromonitor's report. Perhaps not coincidentally, these also happen to be companies with coffers of cash and a large workforce to help navigate regulations of Brazil’s health authority, ANVISA.
Currently, there aren’t regulations surrounding dietary supplements as its own category. Instead, manufacturers and importers have to consider a diverse set of laws related to food as well as medicine and have to decide where their ingredient or finished product fits best within that scheme.
“Compared to other countries, the Brazilian regulatory authority is very strict. So we found a way to bring products using an ANVISA regulation that allows patients to import directly if he or she has a prescription,” André Di Donato, co-founder and co-CEO of CareMundi, told NutraIngredients-USA.
“So now with our model established, we are allowed to bring any products from the US or any other countries to the Brazilian market. We bring the product with the timeframe of 15 days from any location in the US to any location in Brazil.”
Entering Brazil, not such an easy task for supplement companies
According to Di Donato, non-Brazilian supplement makers that want to enter a product to the country may need to change the formula, wait around two years for its registration process to complete, and spend around $100,000 per product to get it registered.
The company uses a provision which allows Brazilian patients to order foreign brands directly using a doctor’s prescription. Within CareMundi’s model, the company isn’t the importer but a facilitator, and the patient is the importer.
Di Donato has had 21 years of experience in the pharmaceutical industry, having worked in companies like Novartis and Abbott Medical Optics, familiarizing him with the lengthy process healthcare companies go through under the current regulatory structure.
CareMundi was established by him and co-founder Felipe Negri as a way to make it easier for Brazilians to access both dietary supplements and pharmaceutical products not yet available in the country. Pharmaceuticals will come next, he added. Originally funded by angel investors, Di Donato said the company is now financed by its own cash flow.
“We started with supplements because the gap here in Brazil is huge,” he said. “If you have a supplement in the US and you want it to enter Brazil, you would have to change the formula. With our model, you wouldn’t have to change the formula and the product can still come through legally.”
Hence, the company specializes in brands that are sold through healthcare practitioners, such as Metagenics. “We now have a sales force to visit doctors to create the demand. We have specific suppliers in the US and we’ll have to be able to talk about their products in Brazil,” he said.
Headquartered in Florida to serve Latin America
The company is headquartered in Florida, but its web platform is entirely in Portuguese. “To serve legally the products, we have to have an American company, so we founded the company in the US. The website domain is located in the US. But the Brazilian market is the first to be targeted,” Di Donato said.
He added that they are aiming to expand to other Latin American countries, and further down the line, to other countries with a regulatory structure similar to Brazil’s.
Because of how ANVISA regulates dietary supplements, Di Donato believes there isn’t much start-up activity in the space.
“Health and nutrition isn’t as popular for start-ups. Maybe for diagnostic tests, but not for entering specific niches,” he said.
“What’s very common here in Brazil is to develop apps for communication between patients and doctors. But specifically for nutritional supplements, we don’t see a lot of movement for start-ups. Our center of thought is on pharmaceutical-grade supplements. So we are very unique on this side.”