Looking to expand into Latin America? Mexico is not only the region’s second-largest market—it’s also evolving into a gateway for international companies, thanks to its streamlined regulatory environment. With the right strategy, your OTC, Rx, or medical device product could reach Mexican shelves in as little as 12 months. Discover what it takes to navigate COFEPRIS and unlock the full potential of this dynamic market
Mexico stands out as the second-largest Consumer Health and Pharma market in Latin America, with the market projected to reach US$40 billion by 2040. This presents substantial growth opportunities for companies aiming to expand in the region. Thanks to increasingly streamlined regulatory pathways and a growing openness to international products, Mexico has become a highly attractive destination for manufacturers of OTC, Rx, Phyto, and medical device products.
Figure 1: Mexican Pharma & OTC Market in 2030-2040
Market entry in Mexico has become more accessible, and a well-prepared strategy can accelerate product registration. In some cases, a Fast Track option allows companies to complete the process within approximately 12 months.
Our experts highlight the key aspects of the registration process with COFEPRIS (Mexico’s Ministry of Health), including:
- Requirements for Consumer Health & Pharma registration in Mexico
- Costs and timelines for registering OTC, food supplements (FS), Rx, cosmetics, and medical devices
- How the Fast Track registration process works and what to consider
- When bioequivalence studies are required—and when they may not be necessary
- Expert tips for conducting a smooth and efficient registration process
- Key differences in registering OTCs, generics, and new molecules
With the right market entry and registration strategy, your product could be available to Mexican consumers in as little as 12 months.
Figure 2: Mexico Drug Registration Process with CPC
Interested in registering your product in Mexico?
Chameleon Pharma Consulting Group (CPC) has over 20 years of experience in supporting Pharma, OTC, Medical Devices, Phyto, and Aesthetic Medicine companies. Having established own offices & local hubs across Latin America, Europe, Asia, the US/Canada, the Middle East, and the CEE/CIS regions is another advantage of CPC. With this local network and expertise gained from 300+ international projects and a team of 25 experts we offer our clients:
- Business Development, M&A, and Due Diligence
- Market Entry & Expansion: Systematic product and country analysis, market reports
- Strategic Partnering: Identifying local partners, acquisitions, or setting up own offices
- Regulatory & Registration: for drugs, MD, Derma, Aesthetic Medicine, etc.
- Market Authorization & Compliance: Holding MAs, conducting pharmacovigilance
- Quality & Certification: GMP certification, pre-GMP audits
Contact us today for your individual request at service@chameleon-pharma.com!
