Overview of Mexican Pharmaceutical Industry’s Expansion
Mexican pharmaceutical companies are making significant strides in preparing to export their products to the United States, with the aim of obtaining FDA certification and adapting their facilities to meet regulatory standards. Juan de Villafranca, the CEO of the Mexican Pharmaceutical Association (Amelaf), highlighted the progress being made in this area.
Current Status and Objectives
Although some Mexican pharmaceutical companies already export medications to the U.S., Amelaf is actively working towards increasing this number. The president of AMELAF emphasized the benefits of diversifying and growing in this market, reducing risks, creating jobs, and tapping into the world’s largest market.
The U.S. pharmaceutical market accounts for 48% of the global market value, equivalent to over 650 billion dollars, and is growing at an annual average rate of 11%. In contrast, the Mexican pharmaceutical market represents only 3% of the U.S. market value, with half of it being public sector-driven.
Mexico’s Export Potential
De Villafranca pointed out that Mexico’s current participation in the U.S. pharmaceutical market is minimal, accounting for around 1.5% of total U.S. medication imports. However, there is immense growth potential for Mexican pharmaceutical companies to become a significant exporter of medications, including oncology drugs and treatments for conditions like diabetes and obesity.
Collaboration with U.S. Authorities
Amelaf has been diligently working with U.S. authorities for the past three years to achieve these goals.
“We have been actively engaging with U.S. authorities for three years now, being members of the Pharmacopeia, and collaborating with American companies to help Mexican labs comply with FDA regulations,” explained de Villafranca.
The United States Pharmacopeia (USP) is an organization that establishes standards to ensure medications and supplements are safe, pure, and of high quality.
APIS Production Development
Amelaf aims to develop Active Pharmaceutical Ingredients (APIS) for the North American market, reducing dependence on China and India. De Villafranca mentioned that at least two or three APIS could be produced in Mexico, further strengthening its position as a key pharmaceutical exporter.
Key Questions and Answers
- What is the current status of Mexican pharmaceutical companies exporting to the U.S.? Some companies already export, but Amelaf is working to increase this number by obtaining FDA certification and adapting facilities.
- Why is the U.S. market important for Mexican pharmaceutical companies? The U.S. represents 48% of the global pharmaceutical market value, offering significant growth opportunities.
- What specific medications are Mexican companies planning to export? Oncology drugs and treatments for diabetes and obesity are key areas of focus.
- How is Mexico collaborating with U.S. authorities to facilitate exports? Amelaf is working closely with USP and American companies to ensure Mexican labs meet FDA regulations.
- What is the goal regarding APIS production in Mexico? Amelaf aims to produce at least two or three APIS for the North American market, reducing reliance on China and India.
