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International Manufacturers

Meaning

International Manufacturers, in the pharmaceutical and wellness context, are companies that produce active pharmaceutical ingredients, excipients, or finished drug products in facilities located outside of the primary market where the product is sold or distributed. These manufacturers are subject to the regulatory oversight of their host country, but also to the quality and safety standards of the importing countries, such as the U.S. FDA or the European Medicines Agency (EMA). For consumers of compounded or generic hormonal therapies, the sourcing and quality control of these international facilities are critical considerations for product consistency and safety.