Mexican Drugmakers Aim to Enter US Market: AMELAF

Mexican pharmaceutical companies are advancing efforts to enter the United States by seeking certification from the US Food and Drug Administration (FDA), reports the Mexican Association of Pharmaceutical Laboratories (AMELAF). The move forms part of a broader strategy to expand the presence of Mexican-made generic medicines internationally.

“Progress with the United States is significant. We are working to ensure Mexican laboratories secure FDA certification so they can export,” says Juan de Villafranca, Executive Director, AMELAF, to El Economista.

Few Mexican laboratories export to the United States, but this country accounts for 48% of the global pharmaceutical market, valued at over US$650 billion, and is growing at an annual average of 11%, according to AMELAF. In contrast, the Mexican pharmaceutical market represents only 3% of the US market value, highlighting the potential for growth.

AMELAF, which represents domestic manufacturers of quality, safe, and effective generic drugs, is supporting member laboratories in upgrading production facilities to meet FDA standards. The association promotes a competitive local industry that can meet both domestic needs and international demand.

Beyond facilitating FDA certification, AMELAF plays a key role in linking companies with the government. The association acts as an intermediary to encourage dialogue and collaboration, particularly given the public sector’s status as both the industry’s primary client and regulator. 

The initiative aligns with AMELAF’s broader mission which is to influence public policy in a way that benefits both Mexico and the pharmaceutical industry. It works to build a reliable pharmaceutical industry made up of Mexican laboratories that manufacture safe, effective, and accessible generic medicines for the Mexican population.