Importing Active Pharmaceutical Ingredients (APIs) and finished drug products into the United States requires strict compliance with U.S. Food and Drug Administration (FDA) and U.S. Customs & Border Protection (CBP) regulations. Any gaps in registration, labeling, or documentation can result in detention, refusal, or costly delays at U.S. ports of entry. To ensure smooth entry, companies must have complete and accurate filings before shipment.

The FDA regulates the importation of pharmaceutical products under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Every foreign manufacturer, repacker, relabeler, or distributor must have a valid Drug Establishment Registration and listed drug products (with assigned National Drug Codes – NDCs). Additionally, a U.S. Agent is required for foreign facilities to handle FDA communications.

Common challenges companies face when importing APIs and drugs include:

• Incomplete Registration – Shipments detained because the manufacturer or product is not registered or listed with FDA.
• Improper Labeling – Labels not meeting FDA 21 CFR 201 requirements can trigger refusal at customs.
• Missing Documentation – Lack of Prior Notice, commercial invoices, or certificates of analysis.
• Customs Hold or Detention – FDA may issue an Import Alert, resulting in significant delays.

At XPRO America, we specialize in import compliance and customs clearance support for pharmaceutical companies worldwide. Our services include:

• FDA Registration & Drug Listing Assistance to ensure all facilities and products are correctly registered.
• U.S. Agent Representation to manage FDA communication on behalf of foreign companies.
• Prior Notice Filing for shipments to ensure timely FDA notification.
• Labeling & Documentation Review to avoid detention at U.S. ports.
• Customs Clearance Support by coordinating with CBP and FDA for smooth entry.
• Import Alert Resolution Guidance in case of detention, refusal, or regulatory enforcement.

By partnering with XPRO America, pharmaceutical manufacturers and exporters can minimize regulatory risks, prevent shipment delays, and ensure a seamless import process into the U.S. market.

XPRO America ensures FDA import compliance & customs clearance for APIs and finished drugs. Avoid shipment detention with expert registration & filing support.