Philippines → US: Drugs U.S. Agent
Philippines-based drug establishments manufacturing or distributing prescription and OTC drugs that export to the United States are required by FDA to designate a U.S. Agent. Assurentry provides fast, reliable U.S. Agent representation for companies in Philippines.
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Why Philippines Companies Need a U.S. Agent
Under U.S. federal law, every foreign facility that manufactures, processes, packs, or holds drugs for export to the United States must designate a person residing or maintaining a place of business in the U.S. as their agent.
For companies in Philippines, this means appointing a U.S.-based representative who can receive FDA communications, assist with inspections, and act as your point of contact with the agency. Without a valid U.S. Agent, your FDA registration is incomplete and your products may be refused entry at U.S. ports.
Assurentry has extensive experience serving drugs companies from Philippines and throughout the southeast asia region. We understand the specific regulatory challenges your business faces and provide responsive, knowledgeable support.
What's Included for $399/year
21 CFR 207.69 — Drugs U.S. Agent Requirement
The FDA regulation 21 CFR 207.69 requires all foreign drugs establishments to designate a U.S. Agent as part of their facility registration. Here is what that means for your Philippines-based business.
Regulatory Authority
The U.S. Agent requirement is established under 21 CFR 207.69 and enforced by the U.S. Food and Drug Administration (FDA). Compliance is mandatory for all foreign facilities in the drugs category.
Agent Responsibilities
Your U.S. Agent receives FDA communications on your behalf, assists with FDA inspections of your facility, helps respond to questions from FDA, and serves as an emergency point of contact for recalls or safety issues.
Consequences of Non-Compliance
Facilities without a valid U.S. Agent cannot complete their FDA registration. This can result in import refusals, shipment detentions at U.S. ports, FDA warning letters, and loss of market access.
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Appoint Assurentry as your U.S. Agent today for just $399 per year. We'll file the designation with FDA and provide your acceptance letter within one business day.
Trusted by 2,800+ companies in 160+ countries