Mexico becomes the first country in the world to use Danish insulin pen
Danish GO-Pen ApS has received approval from the Mexican health authorities to market the world's first insulin pen for insulin in vials. This makes Mexico the first country in the world where people with diabetes will be able to use GO-PEN®.
GO-PEN is the world's first insulin pen that can be used with insulin in vials. Photo: GO-Pen ApS
Copenhagen, Denmark – 26 October 2026. The Danish medtech company GO-Pen ApS has received approval from the Mexican health authority, COFEPRIS, to introduce the product GO-PEN in Mexico. With this approval, Mexico becomes the first country in the world where people with diabetes will be able to use GO-PEN — the world's first insulin pen for vials.
The approval in Mexico is a significant first step in the company's mission to bring insulin pens to the millions of people with diabetes who today have no access to injecting their daily insulin with a modern pen. More than 20 million people with diabetes worldwide currently rely on insulin in vials and disposable syringes for their daily injections. That is one third of all insulin users.
Modern insulin pens are the standard in high-income countries, but they remain out of reach for most people with diabetes. GO-PEN, by contrast, is a reusable insulin pen that is filled directly with the affordable insulin in vials that is already available in public health systems. GO-PEN is designed to improve diabetes care by combining the well-known benefits of pen technology with the affordable price of vial insulin.
"With more than 13 million adults living with diabetes, Mexico faces one of the greatest health challenges in the world. We would be pleased to see GO-PEN contribute to better treatment for many of these people," says Ole Kjerkegaard Nielsen, CEO and co-founder of GO-Pen ApS.
The approval in Mexico follows a successful financing round that will support the commercial launch in Mexico and the company's continued growth. GO-PEN will enter the Mexican market in partnership with the Mexican company Grupo Lybb, which specialises in securing market access and distribution in the Mexican health system.
The commercial launch of GO-PEN® in Mexico is planned for early 2027. The insulin pen is designed for subcutaneous (i.e., under-the-skin) self-injection of insulin from a standard vial in doses from 1 to 60 units, and is expected to give users more precise dosing, less pain and greater discretion compared with injection using a syringe and vial.
"We see our solution as globally scalable beyond Mexico. Any market with a high proportion of vial-based insulin use is a potential future GO-PEN market," says Ole Kjerkegaard Nielsen, CEO and co-founder of GO-Pen ApS.
Facts: GO-PEN® and the marketing authorisation in Mexico
Marketing authorisation (registro sanitario) No. 1817C2026 SSA has been granted by COFEPRIS, the Mexican health authority, in September 2026 and is valid for five years, until September 2031
Formal holder: Grupo Lybb, GO-Pen's market access and distribution partner in Mexico
Product: reusable insulin pen filled from standard insulin vials; doses 1–60 units; for subcutaneous self-injection of insulin
Commercial launch in Mexico: early 2027
Mexico: 13.6 million adults (20–79) are living with diabetes, equivalent to one in six adult Mexicans (IDF Diabetes Atlas, 11th edition)
Globally: more than 20 million insulin users have no access to insulin pens and inject with syringes
About Go-Pen ApS
GO-Pen ApS is a Danish medtech company founded in 2019 with a mission to ensure equal access to good diabetes care. The product GO-PEN is the world's first insulin pen for vials. It is designed to give the more than 20 million vial-and-syringe users worldwide access to the benefits of insulin pens. www.go-pen.com
About Grupo Lybb
Grupo Lybb is a Mexican company specialising in market access and distribution of health innovation in the public sector. Grupo Lybb is the registered holder, with COFEPRIS, the Mexican health authority, of the marketing authorisation for GO-PEN® in Mexico. www.lybb.mx
Press contact
Brit Larsen, Director of Communications
brit@go-pen.com, ph. +45 22822842
