Supplying Medicines and Supplements to Mexico

Mexico is one of Latin America's two largest pharmaceutical markets, and one of the more open ones. A foreign manufacturer can hold a registro sanitario itself, without a plant in Mexico, as long as it has a legal representative with a Mexican address.

Mexico also has some of the region's most generous reliance routes, and since 15 October 2026 products approved by Brazil's ANVISA have joined them. For a manufacturer already registered in Brazil, Mexico just got much closer.

Mexico at a glance

How to supply medicines to Mexico

1. Appoint a legal representative. The registro sanitario can be in the foreign manufacturer's name, with a legal representative at a Mexican address.
2. Prepare the dossier. A CTD dossier, the plant's GMP certificate and a certificate of free sale. For the reliance route, the product must match the reference approval.
3. Choose the route. The 45-working-day reliance route if the product is approved by a listed regulator, the older 60-working-day equivalence route for a wider list of regulators, or the standard route.
4. Supply. Private distributors and pharmacy chains, or public consolidated purchases, where bidders need a registro sanitario and GMP certificates.

COFEPRIS issues free online import permits for unregistered medicines for personal use against a prescription, usually within 10 working days, and there is a route for donations to health facilities. See named-patient and special import and government tender supply.

Supplements

Supplements (suplementos alimenticios) are regulated by COFEPRIS. Labels must be in Spanish, and supplements cannot claim to prevent, treat or cure disease. We help brands get supplements made under their own label by GMP-certified contract manufacturers: see nutraceutical private label.

What people in Mexico search for

Semrush data from October 2026 shows that Mexicans search for omega-3 (about 201,000 searches a month), creatine, ashwagandha, vitamins C and D, gummies (gomitas) and probiotics. Myo-inositol is unusually popular, at about 291,500 searches a month. Among medicines, pain relievers, allergy treatments and antibiotics lead.

Mexicans search in Spanish: “omega 3” gets about 201,000 searches a month, “creatina” and “ashwagandha” 165,000 each, “vitamina C” and “vitamina D” 110,000 each, and “proteínas” and “gomita” (gummy) 90,500 each (Semrush, October 2026). Medicines are typed by their Spanish generic name, led by “ibuprofeno” (about 278,100 a month), “loratadina” (266,900), “metronidazol” (205,500) and “atorvastatina” (190,400).

How importers and distributors in Mexico search

“distribuidora de medicamentos” and “distribuidores de medicamentos” each get about 1,900 searches a month in Mexico, and “private label” about 320 (Semrush, October 2026). Across ten Spanish-speaking markets combined, Google Keyword Planner adds “laboratorio farmacéutico” and “registro sanitario de medicamentos” (1,000 to 10,000 a month) and “laboratorios farmacéuticos en México” and “maquiladora de suplementos alimenticios” (100 to 1,000).

Originator brands searched by name include Mounjaro (tirzepatide), Rybelsus (oral semaglutide), Forxiga (dapagliflozin), Ozempic (semaglutide), Zyrtec (cetirizine) and Tamiflu (oseltamivir). Brand names are trademarks of their owners and are used only to identify the medicine.

Supplements we can help you make

The most searched medicines include ibuprofen (ibuprofeno, about 278,100 a month), loratadine, metronidazole, atorvastatin, celecoxib and pregabalin.

Documents to ask your supplier for

• A Certificate of a Pharmaceutical Product (CoPP) in WHO format.
• The plant's GMP evidence, such as a WHO-GMP, EU-GMP or PIC/S certificate, plus any inspection by your regulator.
• The registration dossier (CTD or ACTD), with bioequivalence data for generics where required.
• Stability data for hot climates.
• A Certificate of Analysis for every batch.

Not sure a supplier is genuine? Read how to verify a pharmaceutical supplier. For the neighbouring markets, see our Latin America and Caribbean import guide.

Frequently asked questions