Medicines - Mexico

*With our services, marketing authorizations are achieved in the countries where we operate, we provide regulatory services, we do not manufacture products


Mexico with an estimated population of 130.8 MM, is the second largest pharmaceutical market in Latin America, in the country it is the fifth largest manufacturing industry. The estimated market size is US$10-13 MM, with growth expectations at a level of US$20.1 billion by 2025 given that the pharmaceutical sector

The generic market was US$2.88 MM in 2017 and is estimated to increase to US$8.39 MM in 2027 (representing 47% of the total sales of pharmaceutical products in the country).

Mexico has the highest penetration of generic drugs in the world, with more than 80% market share in recent years.

That is why the AMLO Government has sought from the beginning, free medical care and medicines, for which it has changed the rules for the purchase and distribution of medicines and other health supplies; has increased the number of keys with reverse auction (subsequent discount offer); it has prioritized a permanent and continuous analysis of market intelligence in relation to the products, volume, price of medicines by therapeutic area; and has promoted a series of regulatory changes in recent years aimed at facilitating access to low-cost generic drugs, eliminating the main barriers to product entry into the Mexican market, which maintained a hegemony with brand name drugs and local protection against to the national generic pharmaceutical industry.

This variation has impacted the market in many ways and, in our case, the country’s regulatory management, through Cofepris.

For these reasons, and given the increasing behavior from the regulatory point of view in the last 4 years, in terms of the gradual removal of regulatory obstacles that initially prevented the introduction of foreign products to the Mexican market; This is what explains a projection and growth of penetration of the foreign pharmaceutical industry, given the facilitation in the recognition of the approval of products in other markets, in terms of new guidelines for active pharmaceutical APIs, and the entry of synthetic and biotechnological drugs from foreign manufacturing, without the requirement of clinical studies in the Mexican population and the approval and recognition of Good Manufacturing Practices from other international regulatory agencies.

Arunamex SC is able to accompany you in this process of introducing products to the Mexican market, taking advantage of the regulatory provisions and regulations developed by this Government, to achieve an intelligent and correct penetration of the Mexican market with products of the highest quality and low cost.

  • Allopathic Medicines
  • Biological Products and Vaccines and Blood Products
  • Specialized Enteral Feeding Formulas of National or Foreign Manufacture
  • Herbal Medicines
  • Vitamin Medications
  • Permit for Narcotics and Psychotropic Control Books

Check with our professionals online or get frequent questions about registration processes in different countries

Check with our professionals online or get frequent questions about registration processes in different countries