Active Pharmaceutical Ingredient (API) Listing with FDA
API (Active Pharmaceutical Ingredient) is any substance that is represented for use in a drug and that, when used in the manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug.
All foreign firms that manufacture, prepare, propagate, compound, or process a drug imported or offered for import into the U.S. shall, through electronic means register the name and place of business, designate a U.S. Agent, provide names of each known importer & person who imports or offers for import and list all drug products imported or offered for import into the U.S..
API (Active Pharmaceutical Ingredient) product information through electronic means can be submitted to FDA by creating a SPL (Structured Product Labeling) .
Liberty Management Group Ltd provides assistance in API (Active Pharmaceutical Ingredient) listing, SPL preparation and submission and also provides US Agent service for foreign firms.
|FDA Registration, US Agent, Labeler code||USD 649 (Annually)|
|Drug listing||USD 399 / Drug|
|Label Review||USD 649 / Drug|