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Sumatriptan | CAS No: 103628-46-2 | GMP-certified suppliers
A medication that treats migraines with or without aura in patients aged 12 and older and certain cluster headaches in adults through rapid relief of acute symptoms.
Therapeutic categories
Primary indications
- A combination sumatriptan and [naproxen] tablet is indicated for the treatment of migraines with or without auras in patients 12 years of age and older
- Sumatriptan nasal powder, nasal spray, subcutaneous injection, and tablets are indicated to treat migraines with or without auras in adults
- One of the subcutaneous formulations of sumatriptan is also indicated to treat cluster headaches in adults, while the other subcutaneous formulation is not
Product Snapshot
- Sumatriptan is available in multiple formulation types including nasal sprays, subcutaneous injections, orally disintegrating tablets, and film-coated tablets
- It is primarily indicated for the treatment of migraines with or without auras and cluster headaches in adults
- Sumatriptan products are approved for use in the US and Canada, with certain formulations under investigational status
Clinical Overview
Pharmacologically, sumatriptan acts as an agonist at 5-HT1B and 5-HT1D receptors, which results in cranial vasoconstriction and inhibition of pro-inflammatory neuropeptide release from sensory neurons. These actions contribute to its therapeutic effects in alleviating migraine symptoms. Sumatriptan reduces carotid arterial blood flow while increasing flow velocity in the internal carotid and middle cerebral arteries. Importantly, sumatriptan does not readily cross the blood-brain barrier.
The drug is available in multiple formulations including oral tablets, nasal powders and sprays, and subcutaneous injections, with dosing regimens adjusted accordingly. Generally, no more than two doses per day are recommended to minimize the risk of medication-overuse headaches, a known safety concern with frequent triptan use.
Sumatriptan exhibits rapid absorption following oral and parenteral administration, though the exact pharmacokinetic parameters vary by formulation. Clearance occurs primarily via renal excretion, and the compound is a substrate for various transporters including BCRP/ABCG2 and OATP1B1, factors relevant to drug-drug interaction potential.
Safety considerations include cardiovascular risk due to vasoconstriction, particularly in patients with underlying ischemic heart conditions. Monitoring for adverse effects and contraindications is essential during clinical use.
For pharmaceutical sourcing, it is critical to verify the quality and purity of sumatriptan APIs, ensuring compliance with pharmacopeial standards and regulatory requirements. Consistent manufacturing processes and reliable supplier qualification help maintain product integrity for global supply chains.
Identification & chemistry
| Generic name | Sumatriptan |
|---|---|
| Molecule type | Small molecule |
| CAS | 103628-46-2 |
| UNII | 8R78F6L9VO |
| DrugBank ID | DB00669 |
Pharmacology
| Summary | Sumatriptan is a selective agonist of 5-HT₁B and 5-HT₁D receptors, leading to cranial vasoconstriction and inhibition of pro-inflammatory neuropeptide release. Its action reduces carotid arterial blood flow while enhancing blood flow velocity in cerebral arteries, contributing to its therapeutic effect in migraine and cluster headache. Sumatriptan does not cross the blood-brain barrier and modulates sensory neurons to prevent the release of vasoactive peptides. |
|---|---|
| Mechanism of action | Sumatriptan is an agonist of 5-HT<sub>1B</sub> and 5-HT<sub>1D</sub>. This agonism leads to constriction of cranial blood vessels and inhibits the release of pro-inflammatory neuropeptides. Sumatriptan decreases carotid arterial blood flow, but increases blood flow velocity in the internal carotid artery and middle cerebral artery.[A179734 Agonism of the 5-HT<sub>1B</sub> and 5-HT<sub>1D</sub> receptors also inhibits sensory neurons, preventing the release of vasoactive peptides.[A179734 Sumatriptan does not cross the blood brain barrier. |
| Pharmacodynamics | Sumatriptan constricts cranial blood vessels and prevents the release of vasoactive peptides. The dose of sumatriptan varies widely by route of administration and in most cases, no more than 2 doses should be given daily. Medication overuse headaches may occur in patients who use sumatriptan frequently. |
Targets
| Target | Organism | Actions |
|---|---|---|
| 5-hydroxytryptamine receptor 1A | Humans | agonist |
| 5-hydroxytryptamine receptor 1D | Humans | agonist |
| 5-hydroxytryptamine receptor 1B | Humans | agonist |
ADME / PK
| Absorption | A 6mg subcutaneous injection of sumatriptan reaches a C<sub>max</sub> of 69.5ng/mL (95% CI of 62.8-76.9ng/mL) with a T<sub>max</sub> of 0.17h (95% CI of 0.08-0.33h), an AUC of 9.0h\*ng/mL (95% CI of 7.5-10.9h\*ng/mL), and a bioavailability of 100%. A 25mg oral dose of sumatriptan reaches a C<sub>max</sub> of 16.5ng/mL (95% CI of 13.5-20.1ng/mL) with a T<sub>max</sub> of 1.50h (95% CI of 0.50-2.00h), an AUC of 8.7h\*ng/mL (95% CI of 6.1-12.5h\*ng/mL), and a bioavailability of 14.3% (95% CI of 11.4-17.9%). A 20mg intranasal dose of sumatriptan reaches a C<sub>max</sub> of 12.9ng/mL (95% CI of 10.5-15.9ng/mL) with a T<sub>max</sub> of 1.50h (95% CI of 0.25-3.00h), an AUC of 7.4h\*ng/mL (95% CI of 5.0-10.8h\*ng/mL), and a bioavailability of 15.8% (95% CI of 12.6-19.8%). A 25mg rectal dose of sumatriptan reaches a C<sub>max</sub> of 22.9ng/mL (95% CI of 18.4-28.6ng/mL) with a T<sub>max</sub> of 1.00h (95% CI of 0.75-3.00h), an AUC of 14.6h\*ng/mL (95% CI of 11.3-18.8h\*ng/mL), and a bioavailability of 19.2% (95% CI of 15.3-24.1%). |
|---|---|
| Half-life | Subcutaneous sumatriptan has a half life of 1.9h (95% CI of 1.7-2.0h). Oral sumatriptan has a half life of 1.7h (95% CI of 1.4-1.9h). Rectal sumatriptan has a half life of 1.8h (95% CI of 1.6-2.2h). Intrsnasal sumatriptan has a half life of 1.8h (95% CI of 1.7-2.0h). |
| Protein binding | Sumatriptan is 14%-21% bound to protein in circulation. |
| Metabolism | Sumatriptan is predominantly metabolized by monoamine oxidase A. The main metabolites are the inactive indole acetic acid and indole acetic acid glucuronide. |
| Route of elimination | 22±4% is excreted in the urine as unchanged sumatriptan and 38±7% in urine as indole acetic acid approximately 40% is excreted in the feces. |
| Volume of distribution | Sumatriptan has a volume of distribution of 50±8L for a 6mg subcutaneous dose, or 2.7L/kg. |
| Clearance | Subcutaneous sumatriptan has a clearance of 0.22L/min (95% CI of 0.19-0.25L/min). Oral sumatriptan has a clearance of 0.17L/min (95% CI of 0.14-0.21L/min). Rectal sumatriptan has a clearance of 0.17L/min (95% CI of 0.14-0.21L/min). Intrsnasal sumatriptan has a clearance of 0.21L/min (95% CI of 0.18-0.25L/min). Total plasma clearance of sumatriptan is approximately 1200mL/min. |
Formulation & handling
- Sumatriptan is a small molecule suitable for multiple delivery routes including oral, nasal, subcutaneous injection, inhalation, and transdermal applications.
- Formulations may require consideration of limited water solubility (0.127 g/L) and moderate lipophilicity (LogP 0.74) for optimal bioavailability.
- Handling should account for potential gastrointestinal risks linked to concurrent alcohol use, although food does not significantly affect absorption.
Regulatory status
| Lifecycle | The API is marketed in the United States and Canada, with patent protections in the US extending until 2026 and in Canada until 2022, indicating the product is approaching full market maturity with potential for increased generic competition. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Sumatriptan is produced by multiple originator and generic manufacturers, indicating a well-established supply base with diverse roles including manufacturing and packaging across both the US and Canadian markets. Branded products have a significant presence primarily in North America, with several patent expirations occurring before or around 2026, suggesting that generic competition is either active or likely to increase in the near term. This landscape reflects an established API with ongoing competition from both branded and generic suppliers globally. |
|---|
Safety
| Toxicity | Symptoms of overdose include convulsions, tremor, paralysis, inactivity, ptosis, erythema of the extremities, abnormal respiration, cyanosis, ataxia, mydriasis, salivation, and lacrimation. Overdoses may be fatal and patients should be monitored for 3-5 half lives or while symptoms persist. |
|---|
- Exposure to excessive quantities may result in severe neurotoxic effects including convulsions, paralysis, and respiratory abnormalities
- Handling requires measures to prevent dermal and mucosal contact due to potential for erythema and lacrimation
- In case of accidental overexposure, continuous monitoring over multiple half-lives is advised to observe persistent toxicological symptoms
Sumatriptan Succinate is a type of Selective 5HT1-agonists
Selective 5HT1-agonists are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a crucial role in the treatment of various neurological and psychiatric disorders. These compounds specifically target and activate the 5HT1 receptor subtype, which belongs to the serotonin (5-hydroxytryptamine) receptor family. The 5HT1 receptor is primarily found in the central nervous system and is involved in regulating neurotransmitter release, mood, pain perception, and vasoconstriction.
Selective 5HT1-agonists have demonstrated therapeutic potential in the management of several conditions, including migraines, cluster headaches, and depression. By binding to and activating the 5HT1 receptor, these APIs can modulate serotonin levels in the brain, leading to a cascade of neurochemical events that alleviate symptoms associated with these disorders.
One of the key advantages of selective 5HT1-agonists is their targeted action, focusing specifically on the 5HT1 receptor without significant interactions with other receptor subtypes. This selectivity reduces the risk of adverse effects and improves the overall safety profile of these APIs.
Moreover, selective 5HT1-agonists often exhibit high affinity for the 5HT1 receptor, enhancing their efficacy and therapeutic potential. Through their agonistic activity, these compounds can regulate the release of neurotransmitters and modulate pain pathways, offering relief to patients suffering from debilitating migraines or cluster headaches.
In summary, selective 5HT1-agonists are a valuable subcategory of pharmaceutical APIs that provide targeted and effective treatment options for various neurological and psychiatric disorders. Their ability to selectively activate the 5HT1 receptor offers therapeutic benefits with reduced side effects, making them an essential component in the management of conditions such as migraines, cluster headaches, and depression.
Sumatriptan Succinate (Selective 5HT1-agonists), classified under Central Nervous System Agents
Central Nervous System (CNS) Agents are a crucial category of pharmaceutical Active Pharmaceutical Ingredients (APIs) that specifically target the central nervous system. The CNS encompasses the brain and spinal cord, playing a vital role in regulating and controlling various bodily functions, including cognition, movement, emotions, and sensory perception. These agents are designed to interact with specific receptors, enzymes, or ion channels within the CNS to modulate neural activity and restore normal functioning.
CNS agents comprise a diverse range of pharmaceutical APIs, including analgesics, anesthetics, antipsychotics, sedatives, hypnotics, anti-epileptics, and antidepressants. Each subcategory addresses distinct neurological disorders and conditions. For instance, analgesics alleviate pain by targeting receptors in the brain and spinal cord, while antipsychotics are employed to manage psychosis symptoms in mental illnesses such as schizophrenia.
The development of CNS agents involves rigorous research, molecular modeling, and extensive clinical trials to ensure safety, efficacy, and specific target engagement. Pharmaceutical companies invest significant resources in identifying novel drug targets, synthesizing new compounds, and optimizing their pharmacological properties. These agents undergo rigorous regulatory evaluations and must adhere to stringent quality standards and guidelines.
Given the prevalence of CNS disorders globally, the market demand for effective CNS agents is substantial. The development of innovative CNS APIs not only improves patient outcomes but also provides valuable commercial opportunities for pharmaceutical companies. Continued advancements in CNS agent research and development hold the promise of groundbreaking therapies that can improve the quality of life for individuals affected by neurological conditions.
Sumatriptan Succinate API manufacturers & distributors
Compare qualified Sumatriptan Succinate API suppliers worldwide. We currently have 19 companies offering Sumatriptan Succinate API, with manufacturing taking place in 6 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Aquatic Remedies Pvt Ltd | Producer | India | India | CoA | 35 products |
| Asymchem | Producer | China | China | CoA, USDMF | 10 products |
| Cipla | Producer | India | India | CoA, GMP, USDMF, WC | 164 products |
| Divis Labs. | Producer | India | India | CoA, GMP, WC | 47 products |
| Dr. Reddy's | Producer | India | India | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, JDMF, MSDS, USDMF, WC | 170 products |
| Dr. Sahu's Laboratories | Producer | India | India | CoA, GMP | 70 products |
| Hari Ganesh Pharma Privat... | Distributor | India | India | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, MSDS | 35 products |
| Kolon Life Science | Producer | South Korea | South Korea | CoA, JDMF | 32 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Lupin | Producer | India | India | CoA, GMP, WC | 155 products |
| Moehs | Producer | Spain | Spain | CoA, EDMF/ASMF, GMP, JDMF, USDMF | 50 products |
| MSN Pharma | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 31 products |
| Mylan | Producer | India | India | CEP, CoA, JDMF, USDMF, WC | 201 products |
| Natco Pharma | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 40 products |
| Phalanx Labs | Producer | India | India | CEP, CoA, WC | 5 products |
| Quimica Sintetica | Producer | Spain | Unknown | CEP, CoA, GMP, USDMF | 51 products |
| Sun Pharma | Producer | India | India | CEP, CoA, USDMF, WC | 219 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
| Vamsi Labs | Producer | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS, WC, WHO-GMP | 29 products |
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