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PHARMACEUTICAL DRUGS

Domestic and foreign establishments that manufacture, repack or re-label, and market drug products in Mexico are required to register with the COFEPRIS.

We will guide you step-by-step through the process of registering your products.

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Generic drugs

Biological/products

New molecules

Orphan drugs

OTCs

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Our expert team will gather the precise information for an agile and successful evaluation of your applications

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We monitor the status of your applications before COFEPRIS to ensure a positive response in a timely manner

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We provide a comprehensive follow up after obtaining your registration to ensure full compliance with current legislation

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