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triButyrate® is the trade name for (Sodium) Phenylbutyrate (or 4-phenylbutyric acid sodium salt). triButyrate® was originally developed in the mid 1980's by triple crown america, inc. at the request of Johns Hopkins Hospital as a remedy for inborn errors of urea synthesis (Urea Cycle Disorder). For this indication triButyrate®/(Sodium) Phenylbutyrate is today the Active Pharmaceutical Ingredient (API) of the registered drug to treat Urea Cycle Disorder in the United States of America. All our product tradenames begin with the prefix "tri", from our corporate name, and the "Butyrate"-part comes from the generic/chemical name of this compound. triButyrate® is both an active pharmaceutical ingredient (API)/bulk substance and a finished dosage form (tablets), intended for Research and Development, Clinical Studies, as well as medical treatment of listed indications, where allowed, under professional management and supervision at Research Centers, Hospitals, Clinics and Pharmaceutical Laboratories. It is not to be dispensed for human consumption or used as a drug, unless proper approvals and permits by applicable agency(ies) are held by the user. According to FDA regulations 21 C.F.R.Sections 312.1 et seq., Fyrklövern Scandinavia AB may provide triButyrate® in tablets or powder form, to sponsors of clinical investigations, which are the subject of an Investigational New Drug application (IND). Patents exist and/or may exist in some countries for the usage and treatment of various medical conditions using triButyrate®/(Sodium) Phenylbutyrate, and any infringement may be punishable by law. Information about triButyrate® and the product are made available worldwide by Fyrklövern Scandinavia AB.
All rights to the product and trademark triButyrate® are owned by |
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