Start a Pharmaceutical Company in Mexico

Updated on Tuesday 08th May 2018

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A pharmaceutical company, also named a drug company, is a commercial company which is licensed to research, develop, sale and/or distribute medicines, usually in the field of healthcare. 
In this article, our Mexico company formation advisors touch on a few key aspects related to starting a pharmaceutical company in Mexico.

What is the profile of the pharmaceutical industry in Mexico?

Mexico is the 11th global market for pharma, having a net worth of USD 13.2 billion. With a population of 120 million and a steady economic situation, this country has growing healthcare needs, mainly those connected to chronic illnesses like cardiovascular, diabetes and cancer.
The private sector represents 48.3% of the market and 91.5% of this sum is out of pocket expenditure. Major pharmacy chains are continuing to develop and a lot of independent pharmacies have been liquidated.
Our company formation consultants in Mexico can provide further details on the pharmaceutical industry in this country. We can also help you open a company in this industry in Mexico.

What are the main countries in which Mexico exports its pharmaceutical products?

The countries where Mexico exported pharmaceutical products in the last years were:
Country 2012 / million USD 2013 / million USD 2014 / million USD % share in 2014 % in 2014/2013
U.S. 414 452 444 24.03 -1.77
Switzerland 17 17 225 12.21 1252.08
Panama 223 191 206 11.16 7.97
Venezuela 329 263 202 10.92 -23.21
Colombia 111 96 109 5.93 13.94

What are the regulatory strategies for pharmaceutical products in this jurisdiction?

In order to register a pharmaceutical product for sale in this jurisdiction, the product needs an approval from the Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS), which is a section of the Ministry of Health.
Certain pharmaceutical devices which previously received a market authorization in the U.S., Canada or Japan qualify for expedited review by COFEPRIS.
Our Mexico company registration agents can assist entrepreneurs who are interested in obtaining this approval here.

What is the most popular business structure for a pharmaceutical company in Mexico?

One of the most popular business structures for a pharmaceutical company in Mexico is the limited liability company.
For setting up such a company in Mexico, entrepreneurs have to take these steps:
  1. Obtain the name authorization from the Ministry of Economy in Mexico;
  2. Gather the company deed with a notary public: this is the deed of the establishment to be able to get the status of the legal entity;
  3. Register the company deed with the Public Register of Commerce in this jurisdiction;
  4. Other steps: our Mexico company formation representatives can provide all the necessary details on what these other steps consist of.
For further information related to setting up a pharmaceutical company in Mexico, please contact our Mexico company registration agents.