GMP's


In order to satisfy the requirements of the pharmaceutical market, our operation and distribution are based on the highest quality standards. We have the authorization of COFEPRIS (Ministry of Health in Mexico) for the production and distribution of Active Pharmaceutical Principles (API's).

We maintain good manufacturing standards; we have received audits from:

  • COFEPRIS (national)
  • FDA
  • KFDA
  • PMDA
  • Constant audits for our customers (national and international)

Our operations are based in the following standards:

  • Norma Oficial Mexicana NOM-164-SSA1-2015
  • Good Manufacturing Practices for Drug Substances
  • Good Manufacturing Practice Medicinal Products for Human and Veterinary use part II: Basic requirements for Active Substances used as starting material. (ICH-Q7A)