Shipping drugs to the United States from a foreign pharmaceutical company is a complex process that requires a detailed understanding of the regulations set forth by the U.S. Food and Drug Administration (FDA).

The FDA is the agency charged with protecting public health by ensuring that food, drugs, medical devices, cosmetics and biological products are safe, effective and properly labeled. For pharmaceutical companies, compliance with these regulations is essential not only to avoid legal sanctions, but also to ensure that their products reach the U.S. market efficiently and smoothly.

To ship medicines to the United States from Europe, Asia, Oceania, Africa and other countries in the Americas, a number of steps must be followed to comply with FDA requirements.

1. Research and preparation: It is essential to be familiar with Code of Federal Regulations (CFR) regulations and FDA guidance related to pharmaceuticals. In addition, it is necessary to determine the classification of the drug and whether it requires prior FDA approval.
2. Registration: The pharmaceutical company must be registered with the FDA and have a list of each drug to be exported to the United States.
3. Good manufacturing practice (cGMP) compliance: It is essential to ensure that manufacturing facilities and processes comply with FDA cGMP guidelines. In addition, we must be available for audits and inspections by authorities.
4. New Drug Approval: If you wish to submit a new drug to the United States, you need to file a New Drug Approval (NDA) application. This application must include clinical trial data demonstrating the safety and efficacy of the drug.
5. Correct labeling: It is essential to be rigorous with product labeling. Labeling and packaging must comply with FDA requirements, including clear documentation in English.

Company for transporting medicines to the United States

The shipment of products such as vaccines and analgesic, antacid, anti-ulcer, anti-allergic, anti-diarrheal, laxative, anti-infective, anti-inflammatory, antipyretic, antitussive or mucolytic drugs, among others, requires an efficient, fast, traceable and effective logistics operation. Transportation must be carried out under controlled humidity and temperature conditions to avoid any deterioration of the medicines.

At Airpharm, we help pharmaceutical companies throughout the logistics process. Our facilities are authorized by the Spanish Agency of Medicines and Health Products as a warehouse for medicines under customs control or surveillance.

If you need to ship pharmaceutical products to the United States and want to comply with all FDA requirements, contact Airpharm now. Our team of professionals specialized in pharmaceutical logistics will provide you with personalized advice.