FDA Export Certificate · Human Drugs

Certificate of a Pharmaceutical Product (CPP) Apostille

The FDA issues your CPP electronically, in the World Health Organization format, for the country registering your drug. If that country asks for a legalized copy, we take the eCPP you downloaded, have it apostilled or authenticated by the U.S. Department of State, and ship the finished document by FedEx.

FDA Digital Certificate Sample

Simply upload your FDA digital file, and you will receive your apostilled document via FedEx.

Processing time

9 business days
  • We accept credit card payments.
  • Track your order history and expenses online.
  • The U.S. Department of State fee is already included.
  • Submit the files you received from the FDA electronically.
  • We use the State Department minimum processing time.
  • You may update your own FedEx air waybill or purchase a new one.
  • U.S. Department of State Form DS-4194 is not required; we handle it.

Exp. Service fee

US Dept. of State fee

Total:

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FDA Certificate Sample 2

What Is a Certificate of a Pharmaceutical Product?

A CPP is the export certificate a drug regulator abroad relies on when it decides whether to license a U.S. drug for its own market. It follows the WHO Certification Scheme format. That means a ministry of health in Egypt, Jordan, the Philippines or Colombia sees the same familiar layout no matter where the drug was made.

The FDA’s drug center issues CPPs for human drugs that are exported directly from the United States. This covers approved or licensed products, and unapproved drugs that meet the legal requirements for export. Each certificate states the drug’s U.S. marketing status and the manufacturer’s compliance with FDA requirements.

The FDA now issues CPPs as electronic certificates (eCPPs). They are delivered as downloadable PDFs through its export certificate system, CDEReCATS.

CPP key facts

  • Format: WHO Certification Scheme
  • Products: human drugs exported from the U.S.
  • Valid for 24 months from the issue date
  • Cannot be reissued. You need a new application once it expires.
  • FDA fee: up to $175 for the first certificate per country and application, less for additional copies

When a CPP Needs an Apostille or Authentication

Many drug regulators register a product on the eCPP alone. Others, along with importers, tender committees and local agents, need a legalized copy for their dossier, and that copy has to be verified by the U.S. government. Because the FDA is a federal agency, only the U.S. Department of State can verify the signature on a CPP.

Hague Convention countries

Apostille

A single State Department apostille makes the CPP valid in member countries, with no embassy step. Examples include Mexico, Colombia, Peru, Saudi Arabia, South Korea, India and the EU states.

Non-member countries

Authentication + legalization

The State Department authenticates the CPP and the destination country’s embassy legalizes it. This route is common for drug registrations in parts of the Middle East, Asia and Africa.

Look up your destination on our countries page, or tell us the country when you order and we’ll confirm the route.

How We Apostille Your CPP

  1. Download your eCPP

    Once the FDA approves your application, download the certificate PDF from CDEReCATS.

  2. Upload it with the destination

    Send us the unaltered PDF and tell us which country is registering the drug.

  3. We handle the State Department

    We check the certificate, submit it to the Office of Authentications and track it to issuance.

  4. Ship to you or your agent

    The apostilled CPP goes out by FedEx to your office, your regulatory agent or your importer.

CPP Apostille Pricing

ItemAmountNotes
Our service fee$68 / doc.Review, submission, tracking and FedEx dispatch
U.S. Department of State fee$20 / doc.Paid by us on your behalf
Total per CPP$88Standard processing: 9 business days

The FDA’s own CPP fee is invoiced to you separately by the FDA. It is not part of our price.

Avoid Delays in Your Drug Registration

A drug registration can stall for months over one detail on the CPP. Check these points before you order:

Mind the 24-month clock

A CPP expires 24 months after it is issued and cannot be reissued. Many regulators also want a more recent certificate, so apostille it soon after you receive it.

One country per certificate

CPPs are requested for a specific importing country. A certificate issued for one market generally shouldn’t be reused for another.

Product details match the dossier

Check that the active ingredients, strength, dosage form and manufacturing sites match your registration file exactly.

Marketing status is right

The CPP shows whether the drug is marketed in the U.S. Check that this matches what you told the foreign regulator.

Keep the PDF unaltered

Upload the eCPP exactly as downloaded. Don’t merge, compress, re-scan or annotate it.

Ask how many copies

Some authorities want an apostilled original for each submission. Order the number of apostilled copies you’ll actually need.

CPP Apostille FAQs

What is an eCPP?

It is the electronic version of the Certificate of a Pharmaceutical Product. The FDA issues it as a downloadable PDF through CDEReCATS instead of on security paper. It carries the same WHO-format information about the drug’s U.S. status and the manufacturer’s compliance.

Can an electronic CPP be apostilled?

Yes. Upload the eCPP PDF and we take it through U.S. Department of State apostille or authentication. Nothing needs to be mailed to us.

How long is a CPP valid?

24 months from the issue date, according to the FDA. An expired CPP can’t be reissued, so you have to apply again. The importing country may set a shorter acceptance window.

Who apostilles a CPP?

The U.S. Department of State, Office of Authentications. A state Secretary of State cannot apostille an FDA-issued certificate.

How much does it cost and how long does it take?

$88 per certificate, which is our $68 service fee plus the $20 State Department fee. Standard processing takes 9 business days, and expedited options are available.

Do you apostille certificates for medical devices or supplements too?

Yes. Devices typically use a Certificate to a Foreign Government and supplements a Certificate of Free Sale. We apostille both.

Ready to Apostille Your CPP?

Upload your eCPP today. It will be apostilled and on its way by FedEx in 9 business days, for $88 with the State Department fee included.

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