GO-PEN reusable insulin pen approved in Mexico, Digi Mart USA News (Mexico): The Federal Commission for Protection against Sanitary Risks (Cofepris) has granted sanitary registration to GO-PEN, a reusable pen developed in Denmark that allows insulin to be administered directly from a compatible vial. The device uses a disposable cartridge and a dose selector as an alternative to conventional syringes.
Mexico will be the first country where the device is marketed. It was developed by the Danish company GO-Pen ApS, while Grupo LYBB will be responsible for its import and exclusive distribution in national territory.
The authorization comes in a country where 13.6 million adults aged 20 to 79 were living with diabetes in 2024, including diagnosed and undiagnosed cases, according to estimates from the International Diabetes Federation’s Diabetes Atlas.
The device is aimed at patients who require insulin from a vial. It consists of a reusable dosing unit with a disposable cartridge that the user fills with compatible insulin.
Unlike traditional syringes, it allows the prescribed dose to be selected through an integrated mechanism, while the pen itself is kept and only the cartridge is replaced.
Ole Kjerkegaard Nielsen, chief executive and co-founder of GO-Pen, said the goal is to expand insulin delivery options for people who still depend on conventional syringes. “We developed GO-PEN with the conviction that innovation in insulin delivery must also consider access, ease of use and the needs of people who still rely on traditional syringes,” he said.
According to international estimates cited by the company, more than 20 million people worldwide still use syringes to inject insulin. The pen received 510(k) clearance from the U.S.
Food and Drug Administration (FDA) on April 24, 2025, and CE marking as a class IIb medical device in the European Union in November of the same year.
The company also reported that an assessment conducted with the Technical University of Denmark found a carbon footprint 73 percent lower than that of one-milliliter disposable syringes, under a scenario of 1,460 injections per year. The company noted that the result depends on usage conditions and practices.
GO-PEN must be used exclusively with the insulin formulations included in its authorized labeling in Mexico and according to the instructions of the treating physician. Although it already holds sanitary registration, the company’s statement does not specify the date sales will begin or the price the device will have in the Mexican market.
