Phenobarbital
Overview
Phenobarbital is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL40).
API suppliers (7)
Suppliers of Phenobarbital evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.
Country recorded for 6 of 7 suppliers.
4 of 7 hold a GMP certificate on record in the EU or UK registers
- HARMAN FINOCHEM LTDIndia2 active DMF GMP on record
- Alkaloida Chemical Company Zrt.Hungary2 active DMF GMP on record
- NANTONG JINGHUA PHARMACEUTICAL CO LTDChina1 active DMF
- SHANDONG XINHUA PHARMACEUTICAL CO LTDChina1 active DMF GMP on record
- Siegfried LTDUnited Kingdom1 active DMF
- CHEMISCHE FABRIK BERG GMBHGermany GMP on record
- AMRI RENSSELAER INC
Patent & exclusivity (US)
Per the FDA Orange Book (1 approved US product), the latest listed US patent on Phenobarbital expires 7 Apr 2042 and exclusivity 17 Nov 2029. Generic API sourcing typically opens up once these lapse.
Chemical identity
- IUPAC name
- 5-ethyl-5-phenyl-1,3-diazinane-2,4,6-trione
- Canonical SMILES
- CCC1(C(=O)NC(=O)NC1=O)C2=CC=CC=C2
- InChIKey
- DDBREPKUVSBGFI-UHFFFAOYSA-N
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