Frequently asked questions

Yes. Under 21 CFR Part 207, every foreign drug establishment that manufactures, repacks, relabels, or tests drug products for U.S. distribution must appoint a U.S. Agent. Without a designated U.S. Agent, your FDA Establishment Registration is considered incomplete, and your products may be refused entry into the United States.

Facility Registration identifies your company—its location, operations, and activities. Drug Listing identifies each product you market in the U.S. Both are required, but they serve different regulatory functions. Facility Registration answers “Who are you?” Drug Listing answers “What are you selling?”

An FEI (FDA Establishment Identifier) is a unique numeric code assigned by the FDA to track inspections, compliance history, and regulatory actions. Most foreign facilities receive their FEI upon registration. We assist with FEI verification, corrections, and linking during the registration process.

Most clients are onboarded within 24–48 hours, depending on how quickly required information is provided. We issue a U.S. Agent Authorization Letter immediately after onboarding to support your FDA filings.

To begin, we require: - Your legal business name and manufacturing site address - A facility contact person - DUNS number (if available; we can assist in obtaining one) - FEI number (if assigned) - Scope of operations (e.g., manufacturing, packing, testing). Once provided, we handle the rest.

We support the entire spectrum of finished dosage forms, including tablets, capsules, injectables, ophthalmics, oral liquids, topicals, inhalation products, APIs, intermediates, dietary supplements, and herbal/nutraceutical products.

Yes. Many CDMOs and independent consultants outsource U.S. Agent duties, SPL preparation, facility registration, labeling submissions, and regulatory documentation to Axentra so they can focus on development and client-facing work. We work quietly in the background and respect all client relationships.