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Pramipexole | CAS No: 104632-26-0 | GMP-certified suppliers
A medication that provides symptomatic relief for Parkinson’s disease and moderate to severe primary Restless Legs Syndrome, supporting reliable supply needs for global pharmaceutical manufacturing.
Therapeutic categories
Primary indications
- This drug is indicated for the symptomatic treatment of Parkinson’s disease [FDA label]
- This drug can be administered as monotherapy or in conjunction with levodopa
- It is also indicated for symptomatic treatment of moderate to severe primary Restless Legs Syndrome (RLS) [FDA label]
Product Snapshot
- Oral small‑molecule dopamine agonist supplied mainly as standard, extended‑release, and orally disintegrating tablets
- Used for symptomatic management of Parkinson’s disease and moderate to severe primary Restless Legs Syndrome
- Approved in the US, EU, and Canada with both fully approved and investigational listings depending on the specific presentation
Clinical Overview
Pramipexole acts primarily by stimulating dopamine receptors in the striatum. Although the precise mechanism in human disease remains incompletely defined, its pharmacologic activity reflects high in vitro affinity for D2‑family receptors, with preferential binding at the D3 subtype. Enhanced dopaminergic signaling is associated with improvements in tremor, rigidity, and bradykinesia. Animal studies indicate effects on striatal neuronal transmission and demonstrate reduced dopamine synthesis and turnover, as well as neuroprotective responses in specific injury models; these findings are not directly extrapolated to clinical benefit.
Absorption after oral administration is rapid and extensive, with high systemic bioavailability. Pramipexole displays low plasma protein binding and distributes widely into tissues. Metabolism is minimal, and the drug is eliminated largely unchanged in urine, making renal function an important determinant of exposure. Dose adjustment is generally required in renal impairment. The elimination half‑life lengthens with reduced renal clearance.
Safety considerations include risks characteristic of dopamine agonists, such as somnolence, orthostatic hypotension, hallucinations, and impulse control disorders. Dyskinesia may emerge when used in combination with levodopa. Adverse effects are dose dependent and may be more pronounced in older adults or those with renal dysfunction.
Pramipexole is available globally in immediate‑ and extended‑release oral formulations. Common reference brands include Mirapex and Sifrol, depending on region.
For API procurement, sourcing should prioritize manufacturers with demonstrated control of stereochemistry, impurity profiles, and residual solvent limits, along with current GMP compliance and regulatory documentation suitable for global submissions.
Identification & chemistry
| Generic name | Pramipexole |
|---|---|
| Molecule type | Small molecule |
| CAS | 104632-26-0 |
| UNII | 83619PEU5T |
| DrugBank ID | DB00413 |
Pharmacology
| Summary | Pramipexole is a non‑ergot dopamine agonist that primarily targets D2‑family receptors, with higher affinity for the D3 subtype. It enhances dopaminergic signaling in striatal pathways implicated in Parkinson’s disease and restless legs syndrome, where dopaminergic dysfunction contributes to motor and sensory symptoms. Animal data also show broader effects on dopamine synthesis and neuronal resilience, though the relevance of these findings to clinical outcomes is uncertain. |
|---|---|
| Mechanism of action | The exact mechanism of action of pramipexole as a treatment for Parkinson's disease is unknown at this time. It is thought, however, that the ability of pramipexole to cause stimulation of the dopamine receptors in the striatum of the brain, a region that receives a vast array of neurological input and is responsible for a wide variety of functions, may be involved. Studies performed in animals show that pramipexole influences striatal neuronal transmission rates following activation of dopamine receptors [FDA label]. Pramipexole is considered a non-ergot dopamine agonist that shows specificity and strong activity at the D2 subfamily of dopamine receptors in vitro, binding selectively and dopamine D2 receptors and showing a preference for the dopamine D3 receptor subtype rather than other subtypes . The clinical significance of this binding specificity is unknown [FDA label], . |
| Pharmacodynamics | **Parkinson's Disease** Through the stimulation of dopamine receptors, pramipexole is thought to relieve the symptoms of Parkinson's Disease [FDA label]. The motor symptoms of Parkinson's disease occur partly due to a reduction of dopamine in the substantia nigra of the brain . Dopamine is an essential neurotransmitter that has major effects on motor movements in humans. **Restless Legs Syndrome** Pramipexole likely restores balance to the dopaminergic system, controlling the symptoms of this condition. Restless legs syndrome is thought to occur, in part, through dysfunction of the dopaminergic system, resulting in unpleasant lower extremity symptoms , . **Other effects** In addition to the abovementioned effects, animal studies demonstrate that pramipexole blocks dopamine synthesis, release, and turnover. Additionally, this drug is neuroprotective to dopamine neuron degeneration after ischemia or methamphetamine neurotoxicity . |
Targets
| Target | Organism | Actions |
|---|---|---|
| Dopamine D3 receptor | Humans | agonist |
| Dopamine D2 receptor | Humans | agonist |
| Dopamine D4 receptor | Humans | agonist |
ADME / PK
| Absorption | The bioavailability of pramipexole is higher than 90%, indicating a high level of absorption [FDA label]. |
|---|---|
| Half-life | About 8.5-12 hours [FDA label]. |
| Protein binding | About 15% bound to plasma proteins [FDA label]. |
| Metabolism | This drug undergoes little metabolism in humans [FDA label]. |
| Route of elimination | The main route of pramipexole elimination, with 90% of a pramipexole dose found in the urine, almost entirely as unchanged drug [FDA label]. |
| Volume of distribution | This drug is extensively distributed in the body with a volume of distribution of approximately 500 L [FDA label]. |
| Clearance | Renal clearance is about 400 mL/min, indicating heavy secretion by the renal tubules [FDA label]. |
Formulation & handling
- Oral small‑molecule API suitable for immediate‑ and extended‑release tablets; moderate lipophilicity and low aqueous solubility may require solubility‑enhancing excipients for uniform dissolution.
- Solid, chemically stable aralkylamine that handles well in standard dry blending and compression processes without special environmental controls.
- Food has minimal impact on absorption, allowing flexible administration, though formulations may consider GI tolerability.
Regulatory status
| Lifecycle | Most key patents for the API have expired in the US and Canada, with one later‑expiring US patent extending protection until 2029. As a result, the API is largely in a mature phase across Canada and the EU, while US market maturity is moderated by remaining patent coverage. |
|---|
| Markets | Canada, US, EU |
|---|
Supply Chain
| Supply chain summary | Pramipexole was originally developed by a single originator company, with a wide range of secondary manufacturers and packagers now involved in distribution, reflecting an established generic supply base. Branded and generic products are available across major markets including the United States, Canada, and the European Union. Most core patents have expired, and although one later‑expiring U.S. patent remains, the presence of multiple generic suppliers indicates existing generic competition. |
|---|
Safety
| Toxicity | **LD50** Rat Oral LD 50 >800 mg/kg . **Carcinogenicity, mutagenicity, impact on fertility** Pramipexole was not found to be carcinogenic in 2-year studies on mice and rats at 0.3, 2.2, and 11 times the maximum recommended human dose (MRHD). No increased incidence of tumors was observed [FDA label]. No mutagenicity was detected in various assays, including the Ames test. Finally, pramipexole given to rat models at a dose of 2.5 mg/kg/day (5 times the maximum recommended human dose), increased estrus cycles and inhibited implantation of a fertilized ovum. Decreased levels of prolactin, a hormone necessary for implantation and maintenance of early pregnancy, were measured [FDA label]. The significance of these findings in humans is unknown. **Pregnancy** This drug is considered a pregnancy category C drug, showing teratogenic effects in animals. Currently, there no studies of pramipexole in human pregnancy. Animal reproduction studies are not always predictive of human response. This drug should only be used in pregnancy if the potential benefit outweighs the possible fetal risks [FDA label]. **Nursing** Whether pramipexole is excreted in human milk is unknown. A decision should be made regarding the administration pramipexole during nursing, or whether to discontinue it during nursing, as many drugs are excreted in human milk. The potential exists for risk to the infant if pramipexole is, in fact, excreted in the milk [FDA label]. |
|---|
- Oral acute toxicity is low to moderate, with rat LD50 values exceeding 800 mg/kg
- Long‑term studies show no carcinogenic or mutagenic activity, but high‑dose exposure in rats produced reproductive effects, including altered estrus cycles and implantation inhibition linked to prolactin suppression
- Developmental toxicity has been observed in animal models, indicating potential embryo‑fetal risk at elevated exposure levels
Pramipexole is a type of Dopamine agonists
Dopamine agonists are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that act on the dopamine receptors in the brain. These compounds mimic the effects of dopamine, a neurotransmitter involved in various physiological processes such as movement, cognition, and emotions.
Dopamine agonists are commonly used in the treatment of neurological disorders, particularly Parkinson's disease and restless legs syndrome. They work by binding to dopamine receptors and stimulating them, thereby increasing dopamine activity in the brain. This helps to alleviate the symptoms associated with these conditions, such as tremors, rigidity, and muscle stiffness.
One of the key advantages of dopamine agonists is their ability to provide long-lasting relief compared to other medications. They are available in different formulations, including oral tablets, transdermal patches, and injectable solutions, allowing patients to choose the most suitable administration method.
However, like any medication, dopamine agonists may have side effects. These can include nausea, dizziness, hallucinations, and compulsive behaviors. It is important for healthcare professionals to closely monitor patients using dopamine agonists to minimize the occurrence and severity of these side effects.
In conclusion, dopamine agonists are a vital subcategory of pharmaceutical APIs used to manage Parkinson's disease and restless legs syndrome. They mimic the effects of dopamine in the brain and offer long-lasting relief from symptoms. Although they can have side effects, proper monitoring and dosage adjustments can help optimize their therapeutic benefits.
Pramipexole (Dopamine 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.
Pramipexole API manufacturers & distributors
Compare qualified Pramipexole API suppliers worldwide. We currently have 19 companies offering Pramipexole API, with manufacturing taking place in 9 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 |
|---|---|---|---|---|---|
| Amino Chemicals | Producer | Malta | Malta | CEP, CoA, FDA, GMP, KDMF, USDMF | 20 products |
| Boehringer Ingelheim | Producer | Germany | Unknown | CEP, CoA, FDA, GMP, USDMF | 35 products |
| Chr. Olesen Group | Distributor | Denmark | Denmark | BSE/TSE, CEP, CoA, EDMF/ASMF, GDP, MSDS | 252 products |
| Cipla | Producer | India | Unknown | CEP, CoA, USDMF, WC | 164 products |
| Curia | Producer | United States | Spain | CEP, CoA, GMP, MSDS, USDMF | 106 products |
| Erregierre | Producer | Italy | Italy | CEP, CoA, FDA, GMP, USDMF | 44 products |
| Hetero Drugs | Producer | India | Unknown | CEP, CoA, FDA, GMP, USDMF, WC | 98 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| MSN Labs. | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 119 products |
| Mylan | Producer | India | India | CEP, CoA, JDMF, USDMF, WC | 201 products |
| Piramal Healthcare | Producer | United Kingdom | India | CoA, GMP, WC | 31 products |
| Piramal Pharma Solutions | Producer | India | Unknown | CEP, CoA, FDA, GMP, USDMF, WC | 44 products |
| Sandoz | Producer | Austria | India | CEP, CoA, FDA, GMP, USDMF, WC | 58 products |
| Shandong Boyuan | Producer | China | China | BSE/TSE, CoA, MSDS | 55 products |
| Sun Pharma | Producer | India | India | CoA, GMP, USDMF, WC | 219 products |
| Symbiotec Pharma | Producer | India | India | CoA, GMP, WC | 50 products |
| Torrent Pharma | Producer | India | India | CoA, USDMF | 34 products |
| Unichem Labs. | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 62 products |
| Yonsung Fine Chem. | Producer | South Korea | South Korea | CoA, JDMF | 13 products |
When sending a request, specify which Pramipexole API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Pramipexole API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Pramipexole API
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Technical
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Regulatory
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