Federal Service · 8–10 Business Days

FDA eCPP Apostille & Legalization

Get your eCPP apostilled or authenticated within 8–10 business days. We federally walk it in and process it for an apostille or authentication — then add the Arab Chamber of Commerce stamp and embassy legalization your ministry requires.

  • Filed in person at the U.S. Department of State — never mailed by you
  • Certificate and approved product label submitted as one complete set
  • Chamber of commerce and consular legalization coordinated end to end
Get Your ECPP See Pricing
5.0
Certificate + product label filed together
$220
Federal apostille
8–10 days
Standard processing
2 parts
eCPP + label
APOSTILLE
(Convention de La Haye du 5 octobre 1961)
1.Country:United States of America
This public document
2.has been signed byChris Ormerod
3.acting in the capacity ofSection Chief, Biometric Services Section
4.bears the seal/stamp ofU.S. Department of Justice, Federal Bureau of Investigation
Certified
5.at Washington, D.C.
6.thetwenty-seventh of July, 2026
7.byAssistant Authentication Officer, United States Department of State
8.No.2026-0418735
9.Seal/Stamp:
10.Signature:
Karen Chongwa
Karen E. Chongwa
Federal Apostille
United States Food and Drug AdministrationCenter for Drug Evaluation and Research10903 New Hampshire Ave, Silver Spring, MD 20993, United States of AmericaCDERExports@fda.hhs.gov · Telephone (301) 796-4950Certificate of a Pharmaceutical Product — Approved Drug Product
Certificate Number: CDER-2026-0473198Certificate Issued Date: 09 JULY 2026Certificate Expiration Date: 09 JULY 2028
Importing Country: KUWAITExporting Country: UNITED STATES OF AMERICA
1.1Drug Trade Name, International or National non-proprietary name (as applicable) & dosage form
1.2Active Ingredient(s) and amount(s) per unit dose (complete quantitative composition is preferred)
1.3Is this product authorized by the certifying authority to be marketed in the certifying country?
1.4Is this product actually on the market in the certifying country?
1.4.1Are there restrictions on sale, distribution or administration of the product specified in the marketing authorization?
2.A.1Number of marketing authorization & date of issuance:
2.A.2Marketing authorization holder (name and address):
2.A.3Status of marketing authorization holder:
2.A.4Is a summary basis for approval appended?
2.A.5Is the attached product information, complete and consistent with the marketing authorization?
2.A.6Applicant name & address for certificate (if different than the marketing authorization holder):
2.A.7Center weblinks to marketing authorization:
3.1Manufacturer name & address:
3.2Does the certifying authority arrange for periodic inspection of the manufacturing plant?
3.3Periodicity of routine inspections (years):
3.4Has the manufacture of this type of dosage form been inspected?
3.5Do the facilities and operations conform to GMPs as recommended by the WHO?
3.6Does the information submitted by the applicant satisfy the certifying authority on all aspects of manufacture?
Remarks:
Marguerite A. Halloran, Division DirectorDigitally signed by FDA Center for Drug Evaluation and ResearchReason: eCPPLocation: CDER
To verify the authenticity of the information on this certificate, scan the QR code or visit www.access.fda.gov/fecv/searchCderCertificate to view a copy of the certificate as issued by FDA.This certificate conforms to the format recommended by the World Health Organization, revised March 25, 2021.
SAMPLE · FICTIONAL PRODUCT INFORMATION
FDA eCPP

Two-part submission

eCPP plus approved product label

Federal processing

U.S. Department of State, Washington DC

Embassy legalization

Chamber and consular steps coordinated

Certified translations

Arabic, Spanish, French and more

What the eCPP is

A certificate in two required parts

The eCPP is issued by FDA's Center for Drug Evaluation and Research in the format recommended by the World Health Organization. It confirms that a drug product is approved in the United States, identifies the marketing authorization holder and manufacturing site, and confirms that the facility complies with Good Manufacturing Practice.

  • Part one — the FDA eCPP itself, digitally signed by a CDER division director.
  • Part two — the approved product label referenced inside the certificate.
  • Both parts are required for submission; a certificate filed without its label is rejected abroad.
  • We keep the set intact and file it as one packet so the legalization chain stays valid.
Why it is needed

No certificate, no registration

Ministries of health, drug regulatory authorities, and government tender boards use the certificate as proof that a product is genuinely approved and lawfully manufactured in its country of origin. It is required for product registration, license renewals, import permits, and public tenders.

Product registrationNew market applications and renewals
Import permitsCustoms and ministry clearance
Government tendersPublic procurement bids
Distributor agreementsLocal agent and licensing filings
(215) 892-2680
Pricing

Simple, Transparent Pricing

Add the chamber stamp or embassy legalization only when the receiving authority requires it. Each additional set is $99.

Most Requested
Core service

Federal Apostille

$220
product label included

Certificate and label authenticated at the U.S. Department of State.

  • Product label included
  • Federal filing fees included
  • 8–10 business days
  • Completion scans and tracking
Add-on

Apostille + Chamber Stamp

+$75
per stamp

Arab Chamber of Commerce stamp added before consular submission.

  • Everything in Federal Apostille
  • Chamber stamp per document
  • Hand-delivered submission
  • Stamp sequence confirmed first
Non-Hague

Embassy Legalization

At cost
no markup on fees

Consular legalization billed exactly at the embassy's published cost.

  • Embassy fees at cost
  • Requirements confirmed per embassy
  • Certified translation available
  • Courier submission and return

Each additional certificate set is $99. Certified translations are $50 per page. Embassy, consular, and chamber fees are passed through at cost once the receiving authority is confirmed.

Federal processing, start to finish

How your eCPP is processed.

01

Free document review

Send us the eCPP and product label with the destination country. We confirm the certificate is current and complete before anything is filed.

02

Upload both parts

Upload the FDA certificate and the approved product label. Both are required — we keep them together as one packet.

03

Federal filing

The set is filed with the U.S. Department of State Office of Authentications in Washington DC, typically 8–10 business days.

04

Apostille or legalization

Hague countries receive a physical apostille. Non-Hague destinations continue to chamber of commerce and embassy legalization.

05

Translation and return

Any certified translation is attached, then we email scans and ship the original legalized set worldwide.

Destination Requirements

Apostille or embassy legalization?

The chain depends entirely on the authority the certificate is presented to. We confirm the exact sequence with the receiving ministry or embassy before filing.

Hague Convention countries

A single federal apostille from the U.S. Department of State completes the legalization. You receive the physical apostille attached to the certificate and label set.

  • Federal apostille issued in Washington DC
  • No consular step required
  • Certified translation added when the ministry requires it

Non-Hague destinations

Gulf, Middle East, North African, and several Asian markets require full consular legalization. Requirements vary by embassy, so the order of steps is confirmed case by case.

  • U.S. Department of State authentication of the FDA certificate
  • Arab Chamber of Commerce stamp where the embassy requires it
  • Embassy or consular legalization for the destination country
  • Certified Arabic or local-language translation when requested
Start Online

Place your eCPP order.

Upload the certificate and the approved product label, choose your legalization path, and your projected invoice updates as you go.

Card 1

Your eCPP and product label

Both documents are required for submission: the FDA Certificate of a Pharmaceutical Product and the approved product label.

FDA eCPP certificate *

PDF preferred, up to 25 MB. Send the file exactly as issued.

Approved product label *

PDF preferred, up to 25 MB. Send the file exactly as issued.

eCPP Apostille FAQs

Before you file abroad.

Clear answers about federal processing, embassy legalization, translations, and timing.

Pharmaceutical export documentation

Ready to legalize your eCPP?

Upload the certificate and product label, choose apostille or embassy legalization, and track every stage through delivery.

Client Portal

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Track your pennsylvania — document in real time, download completed files, and request changes — all from your secure client portal.

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Service
Pennsylvania — Document
State
Pennsylvania
Documents
1 original
Est. Delivery
May 21, 2026
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