Certificate of a Pharmaceutical Product (CPP)

  • A Certificate of Pharmaceutical Product (CPP) is a document that allows human drug products to be exported (including biological drugs).
  • The World Health Organization (WHO) credential requirements are met by this certificate (CPP). It also includes information on the pharmaceutical regulation or marketing status in the United States.
  • The FDA issues a Certificate of Pharmaceutical Product (CPP) for drugs that are not approved for sale in the United States but can be legally exported to another country. Certification is meant for a drug that fulfills the standards of 801(e)(1) of the Food, Drug, and Cosmetic Act [21 U.S.C. 381(e)(1)] and for a foreign-made drug (i.e. made from outside the U.S. and exported from the U.S.).
  • CPP is valid for twenty-four (24) months from the date of issue. For all certifications, a new CPP application will be submitted.

Apostille Certificate of Pharmaceutical Products

FDA Apostille provides attestation service for Certificate of Pharmaceutical Products issued by US Food & Drug Administration and destined for use in the Hague Convention Participating Countries. We obtain Apostille for Certificate of Pharmaceutical Products from the US Department of State in Washington DC.

Certificate of Pharmaceutical Products Legalization

FDA Apostille assists corporations to authenticate Certificate of Pharmaceutical Products from the US Department of State and the embassy of the destination country in Washington DC. Embassy legalization is required to acknowledge documents destined for use in the Non-Hague Participating Countries.

FDA documents received by mail Regular Service

Fee

Processing time

  • Must be paid by a check or money order.
  • Must include UPS or USPS Return.
  • Must fill the US Department of State form.

FDA documents received by mail Expedited Service

Fee

Processing time

  • Billing is available.
  • Shorter processing time.
  • Credit card payment is OK.
  • No need for the US Department of State form.
  • Return FedEx or UPS is required, or add $12.
  • Track your history and your annual spending online
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FDA documents received online Regular Service

Fee

Processing time

  • Must be paid by a check or money order.
  • Must include UPS or USPS Return.
  • Must fill the US Department of State form.

FDA documents received online Expedited Service

Fee

Processing time

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  • No need to ship your document. You may upload it here.
  • Billing is available.
  • Shorter processing time.
  • Credit card payment is OK.
  • US Department of State fee is included.
  • No need for the US Dept. of State form.
  • Track your history and spending online.