FDA Certificate of Pharmaceutical Product (CPP) Apostille

Issuing agency

U.S. Food and Drug Administration (CDER)

We can obtain it?

No — the exporter requests it from the FDA

Certification first?

No — the FDA-issued certificate is authenticated as issued

Also known as

CPP, CoPP, WHO-format pharmaceutical certificate

A Certificate of a Pharmaceutical Product (CPP) is the document pharmaceutical exporters use to register or import a drug in another country. Issued by the FDA in the World Health Organization (WHO) format, it confirms the drug's U.S. marketing status and that its manufacturer complies with current good manufacturing practice (CGMP). Foreign drug regulators frequently require the CPP to be apostilled before they'll accept it.

What an FDA CPP is

The Certificate of a Pharmaceutical Product is issued by the FDA's Center for Drug Evaluation and Research (CDER) for human drugs. It follows the format established by the World Health Organization, and it communicates verified regulatory information — the product's U.S. authorization status and the manufacturer's CGMP compliance — from the FDA to an importing country's regulator. It is the primary document foreign authorities rely on to approve, license, or register a U.S. drug for their market. CPPs are issued electronically and expire two years from the date of issuance.

Why it needs an apostille abroad

A foreign authority cannot verify a U.S. federal document on its own. The apostille, issued by the U.S. Department of State, certifies it as genuine for use across the 120-plus Hague Convention countries. Non-Hague destinations need that authentication followed by embassy or consulate legalization — the same document, a longer path.

Getting the CPP from the FDA

The CPP is requested by the exporting firm directly from the FDA through its export-certification system; a fee applies (the FDA is authorized to charge up to $175 for a certificate issued within 20 days of the application). We can't request it from the FDA on your behalf, but once you have the FDA-issued certificate in hand, we take it through apostille.

Document preparation requirements

• Submit the FDA-issued certificate exactly as issued — no edits or additions.
• Do not notarize the certificate; notarizing a federal document invalidates it for authentication.
• Do not laminate, staple across the text, or annotate it.
• Confirm the CPP hasn't expired (two-year validity) and matches the destination's current requirement.

The step-by-step process

1. Request the CPP from the FDA

   The exporting firm applies to the FDA for the Certificate of a Pharmaceutical Product through the FDA's export-certification system. We tell you what the destination regulator expects.

2. Receive the certificate

   The FDA issues the CPP. Send us the FDA-issued certificate.

3. We review & submit in D.C.

   We verify it's in a form the Department of State will authenticate, then hand-deliver it to the Office of Authentications.

4. Apostille or authentication issued

   You receive an apostille (Hague) or authentication certificate (non-Hague), affixed to your CPP.

5. Embassy legalization & translation, if required

   For non-Hague destinations we handle embassy legalization, and arrange certified translation where the regulator requires it.

Common rejection reasons — and how to avoid them

Common uses

• Foreign drug registration — registering or licensing a U.S.-made drug with another country's regulator.
• Import licensing — clearing pharmaceutical shipments into a foreign market.
• Government tenders — qualifying products for public health procurement abroad.
• Marketing authorization — supporting an application to market the product overseas.

Hague vs. non-Hague countries

We authenticate for any destination — see all countries we serve.

Official references: FDA — Human Drug Export Certificates · U.S. Department of State — Authenticate Your Document. Government fees are set by these agencies and are separate from our service fee.