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Phenobarbital API from Indian Manufacturers & Suppliers
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Phenobarbital | CAS No: 50-06-6 | GMP-certified suppliers
A medication that supports long-term management of diverse seizure disorders except absence seizures, providing reliable antiseizure control for neurological care in major North American markets.
Therapeutic categories
Anticholinergic AgentsAnticonvulsantsBarbituratesBarbiturates and DerivativesBSEP/ABCB11 inducersCentral Nervous System Agents
Generic name
Phenobarbital
Molecule type
small molecule
CAS number
50-06-6
DrugBank ID
DB01174
Approval status
Approved drug, Investigational drug
ATC code
N05CB01
Primary indications
- For the treatment of all types of seizures except absence seizures
Product Snapshot
- Phenobarbital is a small‑molecule API available in oral, parenteral, and rectal formulations
- It is used for broad seizure control in epilepsy, excluding absence seizures
- It is approved in the US and Canada, with additional investigational status in certain uses
Clinical Overview
Phenobarbital (CAS 50-06-6) is a long‑acting barbituric acid derivative used as a nonselective central nervous system depressant. It is structurally characterized by a substituted perhydropyrimidine ring with three oxo groups. Clinically, it is indicated for the treatment of most seizure types except absence seizures, and remains in use globally where long-term antiseizure therapy is required.
Its pharmacology is defined by anticonvulsant and sedative-hypnotic effects. Phenobarbital enhances inhibitory neurotransmission through GABAA receptor modulation, increasing chloride conductance and raising the seizure threshold. It also suppresses excitatory pathways by inhibiting glutamate-mediated depolarization and may reduce excitatory neurotransmitter release through calcium channel effects. Central sedative actions are attributed to depression of polysynaptic activity within the midbrain reticular formation.
Absorption after oral administration is generally reliable, with slow onset and prolonged duration supporting once-daily dosing in many regimens. The compound undergoes hepatic metabolism, including CYP2C19- and CYP2C9-mediated pathways, and displays extensive induction of multiple CYP450 isoenzymes as well as UGT systems. It is a substrate for several CYP enzymes and P-glycoprotein, contributing to a narrow therapeutic index and extensive drug–drug interaction potential. Elimination occurs through both metabolism and renal excretion of unchanged drug.
Safety considerations include dose-related sedation, cognitive impairment, and potential for dependence with prolonged use. Hepatic enzyme induction can alter metabolism of co-administered agents. Toxicity risk increases with excessive plasma concentrations, and careful monitoring is required during long-term therapy. Phenobarbital has been marketed for decades under various generic formulations and is also used in veterinary seizure management.
For API procurement, sourcing should prioritize evidence of regulatory compliance, validated control of impurities, and consistency in polymorphic form. Given the narrow therapeutic index and interaction profile, manufacturers should ensure robust process control and complete documentation to support global regulatory submissions.
Its pharmacology is defined by anticonvulsant and sedative-hypnotic effects. Phenobarbital enhances inhibitory neurotransmission through GABAA receptor modulation, increasing chloride conductance and raising the seizure threshold. It also suppresses excitatory pathways by inhibiting glutamate-mediated depolarization and may reduce excitatory neurotransmitter release through calcium channel effects. Central sedative actions are attributed to depression of polysynaptic activity within the midbrain reticular formation.
Absorption after oral administration is generally reliable, with slow onset and prolonged duration supporting once-daily dosing in many regimens. The compound undergoes hepatic metabolism, including CYP2C19- and CYP2C9-mediated pathways, and displays extensive induction of multiple CYP450 isoenzymes as well as UGT systems. It is a substrate for several CYP enzymes and P-glycoprotein, contributing to a narrow therapeutic index and extensive drug–drug interaction potential. Elimination occurs through both metabolism and renal excretion of unchanged drug.
Safety considerations include dose-related sedation, cognitive impairment, and potential for dependence with prolonged use. Hepatic enzyme induction can alter metabolism of co-administered agents. Toxicity risk increases with excessive plasma concentrations, and careful monitoring is required during long-term therapy. Phenobarbital has been marketed for decades under various generic formulations and is also used in veterinary seizure management.
For API procurement, sourcing should prioritize evidence of regulatory compliance, validated control of impurities, and consistency in polymorphic form. Given the narrow therapeutic index and interaction profile, manufacturers should ensure robust process control and complete documentation to support global regulatory submissions.
Identification & chemistry
| Generic name | Phenobarbital |
|---|---|
| Molecule type | Small molecule |
| CAS | 50-06-6 |
| UNII | YQE403BP4D |
| DrugBank ID | DB01174 |
Pharmacology
| Summary | Phenobarbital enhances inhibitory neurotransmission primarily by potentiating GABAA‑mediated chloride currents, raising seizure threshold and limiting propagation of epileptiform activity. It may also reduce excitatory signaling through calcium‑channel inhibition and interactions with glutamatergic and cholinergic receptor subtypes. These actions underpin its use as a long‑acting barbiturate with anticonvulsant and sedative‑hypnotic effects in seizure disorders other than absence seizures. |
|---|---|
| Mechanism of action | Phenobarbital acts on GABAA receptors, increasing synaptic inhibition. This has the effect of elevating seizure threshold and reducing the spread of seizure activity from a seizure focus. Phenobarbital may also inhibit calcium channels, resulting in a decrease in excitatory transmitter release. The sedative-hypnotic effects of phenobarbital are likely the result of its effect on the polysynaptic midbrain reticular formation, which controls CNS arousal. |
| Pharmacodynamics | Phenobarbital, the longest-acting barbiturate, is used for its anticonvulsant and sedative-hypnotic properties in the management of all seizure disorders except absence (petit mal). |
Targets
| Target | Organism | Actions |
|---|---|---|
| Gamma-aminobutyric acid receptor subunit alpha-1 | Humans | potentiator |
| Neuronal acetylcholine receptor subunit alpha-4 | Humans | antagonist |
| Neuronal acetylcholine receptor subunit alpha-7 | Humans | antagonist |
ADME / PK
| Absorption | Absorbed in varying degrees following oral, rectal or parenteral administration. The salts are more rapidly absorbed than are the acids. The rate of absorption is increased if the sodium salt is ingested as a dilute solution or taken on an empty stomach. |
|---|---|
| Half-life | 53 to 118 hours (mean 79 hours) |
| Protein binding | 20 to 45% |
| Metabolism | Hepatic (mostly via CYP2C19). |
Formulation & handling
- Oral formulations require attention to its low aqueous solubility and moderate lipophilicity, with food influencing absorption rate but not necessitating specialized delivery systems.
- Parenteral use involves aqueous solutions where pH control and solubility limits are key to maintaining clarity and preventing precipitation.
- As a small‑molecule barbiturate solid, it is chemically stable but hygroscopic handling precautions can support consistent API performance in solid‑dose manufacturing.
Regulatory status
| Lifecycle | The API remains in an early market‑protected stage, with a key U.S. patent expiring in 2042. With current availability limited to the United States and Canada, the product is still in a relatively early phase of its commercial lifecycle. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Phenobarbital is an established API with no active originator exclusivity for the core molecule, and the market is supplied by a large number of repackagers and generic manufacturers, indicating a mature and widely distributed supply base. Branded products appear in the US and Canada, but their presence reflects legacy formulations rather than originator‑driven market control. A listed US patent expiring in 2042 likely covers a specific formulation or use, while the underlying API remains long off‑patent, supporting ongoing generic competition. |
|---|
Safety
| Toxicity | CNS and respiratory depression which may progress to Cheyne-Stokes respiration, areflexia, constriction of the pupils to a slight degree (though in severe poisoning they may wshow paralytic dilation), oliguria, tachycardia, hypotension, lowered body temperature, and coma. Typical shock syndrome (apnea, circulatory collapse, respiratory arrest, and death) may occur. |
|---|
High Level Warnings:
- High-dose exposure is associated with profound CNS and respiratory depression, potentially progressing to Cheyne‑Stokes respiration, areflexia, and coma
- Severe toxicity may involve cardiovascular instability, including tachycardia, hypotension, circulatory collapse, and risk of respiratory arrest
- Pupillary changes (miosis or paralytic mydriasis), oliguria, and lowered body temperature can occur in advanced poisoning states, indicating significant systemic involvement
Phenobarbital is a type of Barbiturates
Barbiturates are a category of pharmaceutical active pharmaceutical ingredients (APIs) that have sedative, hypnotic, and anticonvulsant properties. They belong to the class of drugs called depressants, which slow down the central nervous system (CNS) activity. Barbiturates have been widely used in the medical field for their ability to induce sleep, reduce anxiety, and control seizures.
The mechanism of action of barbiturates involves enhancing the effects of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA) in the brain. GABA inhibits the transmission of signals between nerve cells, leading to relaxation and sedation. Barbiturates bind to specific GABA receptors, increasing the inhibitory effects of GABA and resulting in a calming effect on the CNS.
In the past, barbiturates were commonly prescribed for insomnia, anxiety disorders, and epilepsy. However, their use has decreased significantly due to the emergence of safer and more effective alternatives with fewer side effects. Nonetheless, barbiturates are still utilized in certain medical situations, such as anesthesia induction, emergency seizure control, and in some cases of refractory epilepsy.
Despite their therapeutic benefits, barbiturates carry potential risks and side effects. They can cause drowsiness, impaired coordination, and dependence when used for extended periods. Overdose of barbiturates can be life-threatening, leading to respiratory depression and coma.
In conclusion, barbiturates are a class of API widely known for their sedative, hypnotic, and anticonvulsant properties. While their use has diminished over time, they remain important in specific medical contexts. Proper caution and medical supervision are crucial when using barbiturates to ensure safety and efficacy.
Frequently asked questions about Phenobarbital API
Sourcing
What matters most when sourcing GMP-grade Phenobarbital?
Key considerations include confirmed GMP compliance and complete regulatory documentation suitable for US and Canadian submissions. Because the API is mature and widely supplied, assessing supplier qualification, batch consistency, and traceability is essential. It is also important to confirm that sourced material does not intersect with any formulation‑ or use‑specific patent claims that remain active through 2042.
Which documents are typically required when sourcing Phenobarbital API?
Request the core API documentation set: CoA (9 companies), GMP (7 companies), USDMF (6 companies), CEP (5 companies), WC (3 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Phenobarbital API?
Known or reported manufacturers for Phenobarbital: Chr. Olesen Group, Hänseler AG. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Phenobarbital API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Phenobarbital manufacturers?
Audit reports may be requested for Phenobarbital: 5 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Phenobarbital API on Pharmaoffer?
Reported supplier count for Phenobarbital: 9 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Phenobarbital API?
Production countries reported for Phenobarbital: China (3 producers), Switzerland (1 producer), India (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Phenobarbital usually hold?
Common certifications for Phenobarbital suppliers: CoA (9 companies), GMP (7 companies), USDMF (6 companies), CEP (5 companies), WC (3 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Phenobarbital (CAS 50-06-6) used for?
Phenobarbital is used as a long‑acting anticonvulsant for most seizure types, excluding absence seizures. It provides seizure control by enhancing GABAA‑mediated inhibition and reducing excitatory neurotransmission. It also serves as a central nervous system depressant with sedative‑hypnotic effects and is used in long‑term seizure management, including veterinary applications.
Which therapeutic class does Phenobarbital fall into?
Phenobarbital belongs to the following therapeutic categories: Anticholinergic Agents, Anticonvulsants, Barbiturates, Barbiturates and Derivatives, BSEP/ABCB11 inducers. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Phenobarbital mainly prescribed for?
The primary indications for Phenobarbital: For the treatment of all types of seizures except absence seizures. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Phenobarbital work?
Phenobarbital acts on GABAA receptors, increasing synaptic inhibition. This has the effect of elevating seizure threshold and reducing the spread of seizure activity from a seizure focus. Phenobarbital may also inhibit calcium channels, resulting in a decrease in excitatory transmitter release. The sedative-hypnotic effects of Phenobarbital are likely the result of its effect on the polysynaptic midbrain reticular formation, which controls CNS arousal.
What should someone know about the safety or toxicity profile of Phenobarbital?
Phenobarbital has a narrow therapeutic index, and toxicity is typically dose‑related, leading to pronounced CNS and respiratory depression that can progress to coma and respiratory arrest at high exposure levels. Severe poisoning may also produce cardiovascular instability, pupillary changes, oliguria, and reduced body temperature. Long‑term use carries risks of sedation, cognitive impairment, dependence, and significant drug–drug interactions due to hepatic enzyme induction. Careful monitoring of plasma concentrations is important to minimize these safety concerns.
What are important formulation and handling considerations for Phenobarbital as an API?
Phenobarbital’s low aqueous solubility and moderate lipophilicity require careful management in oral formulations, where dissolution characteristics and the influence of food on absorption rate should be considered. Parenteral preparations rely on controlled pH and solubility limits to maintain solution clarity and avoid precipitation. The API is chemically stable but hygroscopic, so dry‑handling practices support consistent performance during solid‑dose manufacturing.
Is Phenobarbital a small molecule?
Phenobarbital is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Phenobarbital?
Oral Phenobarbital is chemically stable, but its hygroscopic nature warrants controlled handling during solid‑dose manufacturing to maintain consistent performance. Low aqueous solubility and moderate lipophilicity can influence dissolution and require routine formulation attention. Food may alter the rate of absorption but does not create additional stability concerns for the oral product.
Regulatory
Where is Phenobarbital approved or in use globally?
Phenobarbital is reported as approved in the following major regions: US, Canada. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Phenobarbital right now?
In the United States and Canada, Phenobarbital is an established, long‑approved active ingredient with ongoing regulatory oversight consistent with its use as a controlled substance. It is marketed as a generic drug in both jurisdictions. The compound is off‑patent, and no market exclusivities are typically associated with its current generic status.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Phenobarbital procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Phenobarbital. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Phenobarbital included in the PRO Data Insights coverage?
PRO Data Insights coverage for Phenobarbital: 2756 verified transactions across 620 suppliers and 75 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Phenobarbital?
Market report availability for Phenobarbital: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
