Pressemitteilung -
Certmedica enters the Mexican market after COFEPRIS approved formoline L112 as class III medical device
Certmedica International has received approval for its formoline L112 product series by the Mexican regulatory authorities COFEPRIS. The series comprises two doses, formoline L112 (500 mg) and formoline L112 extra (750 mg), classified as Class III medical devices to support the treatment of overweight and obesity.
The obesity pandemic in Mexico
In Mexico, seven out of ten are at least overweight and more than a third are clinically obese. Following trends already seen in other parts of the world, Mexicans have abandoned the traditional Mexican diet, which is high in whole grains, fruits, legumes and vegetables, in favour of a diet with more animal products and highly processed foods. This has led to an increase in energy intake and the number of overweight and obese people.
Among the Organization for Economic Cooperation and Development (OECD) countries, Mexico has the second highest obesity rate, only six points below that of the United States (42.8%). The OECD has released a hard-hitting report that examines the health outlook for 2023. It states that Mexicans have the highest rate of diabetes, a disease that affects 16.9% of the population. As a result, Mexicans live on average 4.2 years less due to overweight, the largest reductions in life expectancy of all countries analyzed by the OECD. The impact on the economy is large: overweight accounts for 8.9% of health expenditure. Only seven out of 10 people in Mexico had access to the basic healthcare system in 2020. With the levels in Mexico, the challenges for the health system is going to worsen.
formoline L112 – an effective and safe treatment option
Certmedica International is now with formoline L112 providing solutions to the Mexican people. The company has chosen an experienced distribution partner who will distribute the formoline L112 product series in selected Mexican states with the market launch in the second quarter of 2025 in over six thousand pharmacies and 70 clinics, including a large number of specialized overweight clinics. As a non-prescription product, it gives the general public direct access to an effective weight-loss support. For the upcoming market launch, Certmedica International has undertaken the largest stockpiling to date in a market outside Europe.
Dr. Marcus Furch, COO further confirms: „Mexico is an important market for Certmedica. In fact, the socio-economic and epidemiological parameters are favourable for the rapid market penetration of the formoline L112 product series. COFEPRIS has recognized the medical product for its excellent efficacy and safety profile. “
Links
Themen
Kategorien
About formoline L112
formoline L112 is a substance-based medical product in tablet form, the first of its kind approved according to novel European legislative (EU) 2017/745 (MDR). It contains the active ingredient polyglucosamine L112, a dietary fiber that binds significant amount of dietary fat and thus reduces its resorption from the intestine. It can also capture oxidized fats and cholesterol. Thus, formoline L112 supports weight reduction and weight control and has an LDL cholesterol-lowering side effect. In a year-long study, the addition of formoline L112 to two daily meals resulted in more substantial weight reduction compared to lifestyle changes alone. On average, those taking formoline L112 lost 12 kilograms over the year. The clinical study evidence also shows positive effects and improvements of systemic inflammation (hsCRP), insulin levels, insulin resistance, HbA1c and blood pressure. Certmedica is continuosly investing in clinical trials to expand the medical use of the formoline product series and to target new patient groups. Cornelli et al.: Long-term treatment of overweight and obesity with polyglucosamine (PG L112)… Current developments in nutrition (2017) 1:e000919.
About Certmedica International
Certmedica International GmbH is a privately-owned healthcare company operating since 2005 in Aschaffenburg, greater Frankfurt area, Germany. It strives to become a global leader in the medical fields of overweight and obesity and related diseases and linked to the metabolic syndrome. As such, the company develops, manufactures and distributes medical devices, nutritional supplements and cosmetics following the standards of ISO 13485 and Regulation (EU) 2017/745 (MDR), and others. In addition, Certmedica trades in pharmaceuticals as a pharmaceutical wholesaler according to §52a AMG (German Medicines Act). Today, Certmedica is through its own pharmacy distribution in Germany and Austria and its international distribution network successfully operating in some 40 countries worldwide. With the company‘s strong own brands formoline® and aldiamed®, Certmedica has the number 1 OTC anti-obesity product in its home market and other high-quality products in its portfolio, whose effectiveness and benefits are proven by clinical studies. Under the slogan "metabolic health for a better lifestyle and longevity", we want to enable our customers to positively influence their own health.
Contact:
Certmedica International GmbH
Magnolienweg 17
63741 Aschaffenburg
+49 6021 15093 0
PR@certmedica.de
www.certmedica.de // www.L112.com
