Drug Registration
Register Your Facility to Legally Manufacture, Repack, or Import Drugs into the U.S. Market
Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), specifically Section 510 (21 U.S.C. § 360) and 21 CFR Part 207, all domestic and foreign facilities involved in the manufacture, repacking, relabeling, or distribution of drugs must register with the FDA before entering the U.S. market.
This registration ensures your facility is listed in the FDA’s Drug Establishment Registration database, which is essential for legal marketing, supply chain transparency, and product safety oversight. It’s a critical first step to keep your operations compliant and your products moving without delays.
At Hykkon, we streamline this process by managing your drug establishment registration, obtaining a labeler code, preparing and submitting Structured Product Labeling (SPL), and acting as your U.S. Agent if needed. We can also help review your labels to ensure they meet FDA requirements and assist with your drug listings once registration is complete.
What You’ll Need to Provide:
- Establishment name, address, DUNS number, and contact details
- Type of operation (e.g., manufacturer, repacker, relabeler, API manufacturer, sterilizer, analytical lab, importer)
- Drug status (e.g., OTC, prescription, veterinary, homeopathic, API)
- U.S. importer/distributor information (including FDA registration number and DUNS)
- Contact and submitter details
Service Options:
- Drug Establishment Registration
- Labeler code request
- Drug listing preparation and submission
- Optional: Label review for compliance
Ready to Register Your Drug Establishment?
Complete the form below and let Hykkon handle your FDA submissions quickly and accurately. We’ll help keep your products compliant, avoid costly delays, and open the door to the U.S. market.
