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FDA Drug Listing & NDC Number Assignment (SPL Submissions) – XPRO America

The US FDA Drug Listing process is a mandatory compliance requirement for all human and veterinary drug products marketed in the United States. Under 21 CFR Part 207, every registered drug establishment must submit detailed information about each drug product they manufacture, repack, relabel, or distribute. This process ensures the [...]

USFDA NDC Code Registration – XPRO America

XPRO America offers expert assistance for USFDA NDC (National Drug Code) Registration, required for companies manufacturing, repacking, relabeling, or distributing drug products in the United States. The process involves detailed submission of product and label information in compliance with FDA regulations. Our team streamlines this process, ensuring accurate registration and faster approval. Our Services [...]