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Active Pharmaceutical Ingredient (API) Importers
Active pharmaceutical ingredient (API) importers provide the raw material for the manufacturing or compounding of drug products. They play an important role as they are additionally responsible for purity and stability testing as well as general quality control (QC) as they operate in an FDA GMP setting.
Reverse distributors play an important role in coordinating returns and credits, as well as the destruction of products in the pharmaceutical supply chain.
Five Rivers RX has assisted reverse distributors with business strategy & consulting, FDA reporting (license reporting), state licensing (assessing and obtaining new licenses and maintaining license renewals), and NABP Drug Distributor Accreditation.
Comparator Drug Exporters
Comparator drug exporters are important in the development of generic drugs. Generic manufacturers around the world need to be supplied with brand drugs in order to show the FDA that their products are equivalent.
Five Rivers RX has assisted comparator drug exporters with business strategy and consulting, DSCSA (serialization/track and trace), FDA reporting (license reporting), operational audits, state licensing (assessing and obtaining new licenses and maintaining license renewals), and NABP Drug Distributor Accreditation.