Export-Ready?
We’ll Help You Prove It.
Global expansion can stall over a single document: the FDA Export Certificate. Without it, your drug products risk rejection, costly delays, and lost revenue. Protect your global shipments. Registrar Corp ensures fast, accurate certificate issuance—eliminating red tape, securing full compliance, and keeping your shipments moving. Expand globally with confidence, not hesitation.
3,000+ Drug Manufacturers Trust Registrar Corp
What Is an FDA Export Certificate?
An Export Certificate serves as formal documentation from the FDA confirming that a drug product:
- Is legally marketed or compliant with U.S. regulations
- Is manufactured under current Good Manufacturing Prac
- Is manufactured under current Good Manufacturing Practice (cGMP) tice (cGMP)
For many countries, this certificate is a prerequisite for product registration, importation, or customs clearance. It acts as a seal of regulatory credibility, especially when introducing U.S.-regulated products to global authorities.
Who Needs It?
If you are manufacturing, repacking, relabeling, or distributing any FDA-regulated drug product including APIs, prescription, OTC, or veterinary drugs and plan to export it from the U.S., you likely need an FDA Export Certificate. This applies to:
- U.S.-based drug manufacturers
- Foreign drug companies using a U.S. contract manufacturer
- Private label distributors exporting from the U.S.
We Help You Get It Right the First Time
Securing an FDA Export Certificate involves more than just an application. The FDA expects complete, compliant documentation and precise product and facility information. Registrar Corp ensures:
- Accurate facility and product verification
- Correct formatting of the Certificate request
- Timely submission through the FDA’s CECATS system
- Assistance with follow-ups and corrections if FDA requests changes
Whether you’re applying for a Certificate of a Pharmaceutical Product (CPP) or a Certificate of Exportability, we know what FDA expects and how to meet it.
Why Choose Registrar Corp?
20+ years managing FDA documentation
for global exporters
Real-time support to avoid errors or rejections
Experts in drug listing
and registration to
streamline certificate prep
Trusted by experts in 160+ countries
Deep familiarity with FDA’s CECATS and
compliance criteria
International regulators require FDA Export Certificates — we ensure yours complies.
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