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Articles for exporters dealing with FDA paperwork

Read practical guides about food registration, MoCRA, drug filings, and the paperwork that comes before your products enter the market.

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Drug

FDA Drug Establishment Registration for Foreign Manufacturers: New 2026 Proposed Rule Explained

Jul 15, 2026

The FDA proposed new drug establishment registration rules in July 2026 that would require more foreign manufacturers to register. Here is what the proposed rule means for foreign API and OTC drug producers.

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Drug

OTC Drug Registration for Foreign Manufacturers: What the FDA Requires Before You Can Sell in the US

Jun 28, 2026

Foreign manufacturers of over-the-counter drugs must register their establishment, obtain an NDC Labeler Code, list each product, and comply with the applicable OTC monograph before selling in the United States.

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Drug

FDA Drug Listing: How Foreign Manufacturers Submit Product Information Under 21 CFR Part 207

Jun 27, 2026

Every drug product sold in the United States must be listed with the FDA using the SPL electronic format — here is how foreign manufacturers navigate the drug listing process.

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Drug

FDA Current Good Manufacturing Practice for Drugs: What 21 CFR Parts 210 and 211 Require

Jun 26, 2026

Foreign drug manufacturers must comply with FDA's CGMP regulations under 21 CFR Parts 210 and 211 — covering facility design, equipment, production controls, testing, and recordkeeping.

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Drug

Exporting Homeopathic Products to the United States: FDA Registration and Compliance Requirements

Jun 25, 2026

Homeopathic drugs are regulated as drugs under the FD&C Act and require FDA establishment registration, NDC listing, and compliance with homeopathic manufacturing and labeling standards.

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Drug

FDA OTC Monograph Reform: What the CARES Act Changed for Foreign Drug Manufacturers

Jun 24, 2026

The CARES Act of 2020 overhauled the OTC drug monograph system, replacing decades-old rulemaking with administrative orders and introducing user fees that affect every foreign OTC manufacturer.

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Drug

Drug Master Files: What Foreign API Manufacturers Must Know About DMF Submissions to the FDA

Jun 23, 2026

Drug Master Files allow foreign API manufacturers to share confidential manufacturing and quality information with the FDA without disclosing it to their customers — here is how DMFs work.

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Drug

FDA Drug Establishment Inspection: What Foreign Manufacturers Should Expect During a GMP Audit

Jun 22, 2026

FDA inspections of foreign drug facilities examine every aspect of CGMP compliance — here is what happens before, during, and after an FDA investigator arrives at your manufacturing site.

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Drug

Exporting Hand Sanitizers and Antiseptic Products to the US: Why They Are OTC Drugs, Not Cosmetics

Jun 21, 2026

Hand sanitizers, antiseptic washes, and antibacterial soaps are regulated as OTC drugs in the United States — not as cosmetics — and require drug establishment registration, NDC listing, and monograph compliance.

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Drug

Prescription Drug User Fee Act and Foreign Manufacturers: What PDUFA Fees Mean for Market Entry

Jun 20, 2026

PDUFA establishes annual establishment fees and application fees that every foreign drug manufacturer must pay to maintain FDA registration and submit drug applications.

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Drug

FDA Drug Labeling: OTC Drug Facts Panel vs Prescription Drug Labeling Requirements

Jun 19, 2026

OTC drugs require a Drug Facts panel under 21 CFR 201.66 while prescription drugs follow the Physician Labeling Rule — foreign manufacturers must apply the correct format for their product classification.

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Drug

SPF Products in the United States: Why Sunscreens Are Regulated as OTC Drugs, Not Cosmetics

May 17, 2026

Sunscreens and SPF products are classified as OTC drugs in the US, not cosmetics. Foreign manufacturers who treat them as cosmetics will face import refusals and registration violations.

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Drug

What Is OMUFA and What It Means for Foreign OTC Drug Manufacturers

May 12, 2026

OMUFA created mandatory user fees for OTC monograph drug manufacturers. Foreign facilities that make OTC drugs for the US market pay these fees as part of their FDA obligations.

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Drug

FDA Drug Establishment Registration: What Foreign Manufacturers Must File

May 8, 2026

Foreign drug manufacturers must register their establishments with the FDA before distributing drugs in the US. Here is who must register, what is required, and how the annual cycle works.

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Drug

What Is an NDC Number and How Foreign Drug Manufacturers Obtain One

May 5, 2026

The NDC number is a required identifier for every drug product sold in the US. Foreign manufacturers must obtain one through the FDA drug listing process before their products can be shipped.

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Drug

FDA Drug Labeling Requirements: What Foreign Manufacturers Must Include on US Packaging

May 2, 2026

FDA drug labeling requirements specify exactly what must appear on US drug packaging — from the Drug Facts panel to allergen declarations. Foreign manufacturers must meet every requirement before the first shipment.

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Drug

What drug manufacturers should know before FDA listing

Mar 5, 2026

The key setup items to prepare before you begin establishment registration and drug listing work.

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Articles in foreign languages / Yabancı dilde makaleler / 外国語の記事 / Artículos en otros idiomas →

🇹🇷 Türkçe — Gıda ve Kozmetik İhracatı

FDA gıda tesisi kaydı, US Agent, DUNS numarası ve MoCRA kozmetik kaydı hakkında Türk ihracatçılara yönelik kapsamlı bilgiler.

🇩🇪 Deutsch — FDA-Registrierung für deutsche Exporteure

FDA Lebensmittelregistrierung, US Agent Pflicht, DUNS-Nummer und MoCRA-Kosmetikregistrierung für deutsche Exporteure.

🇫🇷 Français — Enregistrement FDA pour les exportateurs français

Enregistrement d'établissement alimentaire FDA, agent américain, numéro DUNS et enregistrement cosmétiques MoCRA pour les entreprises françaises exportant vers les États-Unis.

🇮🇹 Italiano — Registrazione FDA per esportatori italiani

Registrazione stabilimento alimentare FDA, US Agent, numero DUNS e registrazione cosmetici MoCRA per aziende italiane che esportano negli Stati Uniti.

🇷🇴 Română — Înregistrare FDA pentru exportatorii români

Înregistrare unitate alimentară FDA, Agent SUA, număr DUNS și înregistrare cosmetice MoCRA pentru companiile românești care exportă în Statele Unite.

🇵🇱 Polski — Rejestracja FDA dla polskich eksporterów

Rejestracja zakładu spożywczego FDA, US Agent, numer DUNS i rejestracja kosmetyków MoCRA dla polskich firm eksportujących do Stanów Zjednoczonych.

🇬🇷 Ελληνικά — Εγγραφή FDA για Έλληνες εξαγωγείς

Εγγραφή μονάδας τροφίμων FDA, US Agent, αριθμός DUNS και εγγραφή καλλυντικών MoCRA για ελληνικές εταιρείες που εξάγουν στις Ηνωμένες Πολιτείες.

🇨🇳 中文 — FDA注册服务

中国食品出口FDA注册、FDA化妆品注册（MoCRA）、DUNS编号申请、美国代理人服务。帮助中国制造商顺利进入美国市场。

🇯🇵 日本語 — FDA登録サービス

FDA食品施設登録、USエージェント指定、DUNS番号取得、化粧品MoCRA登録。日本からアメリカへの輸出をサポート。

🇰🇷 한국어 — 한국 수출업체를 위한 FDA 등록

FDA 식품 시설 등록, 미국 대리인(US Agent), DUNS 번호 취득, MoCRA 화장품 등록. 서울, 부산, 인천의 제조업체 지원.

🇻🇳 Tiếng Việt — Đăng ký FDA cho nhà xuất khẩu Việt Nam

Đăng ký cơ sở thực phẩm FDA, US Agent, số DUNS và đăng ký mỹ phẩm MoCRA dành cho nhà xuất khẩu Việt Nam.

🇹🇭 ภาษาไทย — FDA สำหรับผู้ส่งออกไทย

การลงทะเบียนสถานประกอบการอาหาร FDA, ตัวแทนสหรัฐ, หมายเลข DUNS และการลงทะเบียนเครื่องสำอาง MoCRA สำหรับผู้ผลิตไทย

🇲🇾 Bahasa Melayu — Pendaftaran FDA untuk pengeksport Malaysia

Pendaftaran kemudahan makanan FDA, Ejen AS, nombor DUNS dan pendaftaran kosmetik MoCRA untuk syarikat Malaysia yang mengeksport ke Amerika Syarikat.

🇮🇳 हिन्दी — भारतीय निर्यातकों के लिए FDA पंजीकरण

FDA खाद्य सुविधा पंजीकरण, US एजेंट, DUNS नंबर और MoCRA सौंदर्य प्रसाधन पंजीकरण। मुंबई, दिल्ली और बेंगलुरु के निर्माताओं के लिए सहायता।

🇮🇩 Bahasa Indonesia — Pendaftaran FDA untuk eksportir Indonesia

Pendaftaran fasilitas makanan FDA, Agen AS, nomor DUNS, dan pendaftaran kosmetik MoCRA untuk perusahaan Indonesia yang mengekspor ke Amerika Serikat.

🇧🇩 বাংলা — বাংলাদেশি রপ্তানিকারকদের জন্য FDA নিবন্ধন

FDA খাদ্য সুবিধা নিবন্ধন, US Agent, DUNS নম্বর এবং MoCRA কসমেটিক্স নিবন্ধন। ঢাকা, চট্টগ্রাম ও সিলেটের উৎপাদনকারীদের সহায়তা।

🇺🇿 O'zbekcha — O'zbek eksportchilar uchun FDA ro'yxatga olish

FDA oziq-ovqat korxonasini ro'yxatga olish, AQSh agenti, DUNS raqami va MoCRA kosmetika ro'yxatga olish. Toshkent va Samarqand ishlab chiqaruvchilariga yordam.

🇰🇪 Kiswahili — Usajili wa FDA kwa wasafirishaji wa Kenya

Usajili wa kiwanda cha chakula FDA, Wakala wa Marekani, nambari ya DUNS na usajili wa MoCRA. Kusaidia wazalishaji kutoka Nairobi na Mombasa.

🇪🇹 አማርኛ — ለኢትዮጵያ ወጪ ላኪዎች FDA ምዝገባ

FDA የምግብ ተቋም ምዝገባ፣ የአሜሪካ ወኪል፣ DUNS ቁጥር እና MoCRA ምዝገባ። ከአዲስ አበባ እና ድሬዳዋ ላሉ አምራቾች ድጋፍ።

🇸🇦🇦🇪🇪🇬🇲🇦 العربية — تسجيل FDA للمصدِّرين العرب

تسجيل منشأة الأغذية FDA، تعيين وكيل أمريكي، رقم DUNS، وتسجيل مستحضرات التجميل وفق قانون MoCRA للشركات العربية المصدِّرة إلى الولايات المتحدة.

🇵🇰 اردو — پاکستانی برآمد کنندگان کے لیے FDA رجسٹریشن

FDA فوڈ فیسیلیٹی رجسٹریشن، امریکی ایجنٹ، DUNS نمبر اور MoCRA کاسمیٹکس رجسٹریشن۔ کراچی، لاہور اور فیصل آباد کے مینوفیکچررز کی مدد۔

🇵🇭 Filipino — FDA registration para sa mga exporters ng Pilipinas

FDA food facility registration, US Agent, DUNS number at MoCRA cosmetics registration. Tulong sa mga tagagawa mula Maynila, Cebu at Davao.

🇲🇽🇨🇴🇦🇷🇵🇪 Español — Registro FDA para exportadores latinoamericanos

Registro de instalaciones alimentarias FDA, número DUNS, agente estadounidense y registro de cosméticos MoCRA. Servicio completo desde $449 USD.

🇧🇷 Português — Registro FDA para exportadores brasileiros

Registro de estabelecimento alimentar na FDA, US Agent, número DUNS e Registro de cosméticos MoCRA para empresas brasileiras exportando para os EUA.

🇿🇦🇳🇬🇬🇭 English (Africa) — FDA Registration for African Exporters

FDA food facility registration, US Agent, DUNS number and MoCRA cosmetics registration for African companies exporting to the United States.