Carglumic Acid
Overview
Carglumic acid is an orphan drug for the treatment of hyperammonemia, due to N-acetylglutamate synthase deficiency. It works by activating the enzyme carbamoyl phosphate synthetase, which is a part of the urea cycle.
API suppliers (5)
Suppliers of Carglumic Acid evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.
4 of 5 hold a GMP certificate on record in the EU or UK registers
- RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPAItaly1 active DMF GMP on record
- NOVITIUM PHARMA LLCUnited States1 active DMF
- PROCOS SPAItaly1 active DMF GMP on record
- DIPHARMA SASwitzerland1 active DMF GMP on record
- Scl Lifesciences LimitedIndia1 active DMF GMP on record
Patent & exclusivity (US)
Per the FDA Orange Book (3 approved US products), the latest listed US patent on Carglumic Acid expires — and exclusivity 22 Jan 2028. Generic API sourcing typically opens up once these lapse.
Therapeutic areas
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