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Levodopa | CAS No: 59-92-7 | GMP-certified suppliers
A medication that supports management of Parkinson’s disease and related parkinsonian syndromes, including intermittent off episodes, to help maintain consistent motor symptom control.
Therapeutic categories
Primary indications
- Levodopa on its own is formulated as an oral inhalation powder indicated for intermittent treatment of off episodes in Parkinson's patients who are already being treated with carbidopa and levodopa[FDA Label]
- Levodopa is most commonly formulated as an oral tablet with a peripheral dopa decarboxylase inhibitor indicated for treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism following carbon monoxide intoxication or manganese intoxication
Product Snapshot
- Levodopa is supplied mainly as oral small‑molecule tablets and capsules, with additional enteral gel and inhalation powder formulations
- It is used for management of Parkinson’s disease and related parkinsonism syndromes
- It is approved in the US, EU, and Canada
Clinical Overview
Levodopa crosses the blood–brain barrier via an amino acid transport system, a property dopamine itself lacks. In the central nervous system it is converted by aromatic‑L‑amino‑acid decarboxylase to dopamine, restoring dopaminergic stimulation of striatal pathways. This mechanism compensates for reduced endogenous dopamine synthesis and supports improvement in bradykinesia, rigidity, and related motor symptoms.
Absorption after oral dosing is influenced by gastric emptying and competition with dietary amino acids. Levodopa undergoes extensive peripheral metabolism primarily via decarboxylation and catechol‑O‑methyltransferase. Co‑administration with a decarboxylase inhibitor increases systemic exposure to levodopa and improves central availability. The compound is widely distributed, exhibits a short plasma half‑life, and is eliminated as metabolites in urine.
Safety considerations include dose‑dependent nausea, orthostatic hypotension, dyskinesia, and fluctuations in motor response with chronic therapy. Central neuropsychiatric effects can occur, particularly in advanced disease. Peripheral decarboxylase inhibitors reduce but do not eliminate dopaminergic adverse effects. Inhaled levodopa may cause cough or upper airway discomfort. Levodopa is associated with a risk of serotonin syndrome when combined with serotonergic agents.
Sinemet, a fixed‑dose combination of levodopa and carbidopa, was the first FDA‑approved product containing levodopa. Numerous global formulations now exist with varying release characteristics to support individualized treatment strategies.
For API procurement, sourcing should prioritize control of chiral purity, particle size distribution, and stability under standard storage conditions. Suppliers should provide full regulatory documentation, including impurity profiles aligned with major pharmacopeial specifications.
Identification & chemistry
| Generic name | Levodopa |
|---|---|
| Molecule type | Small molecule |
| CAS | 59-92-7 |
| UNII | 46627O600J |
| DrugBank ID | DB01235 |
Pharmacology
| Summary | Levodopa is a dopamine precursor that crosses the blood–brain barrier and is converted by aromatic‑L‑amino‑acid decarboxylase to dopamine, restoring deficient dopaminergic signaling. The resulting dopamine activates D1–D5 receptors, supporting motor function in conditions characterized by reduced endogenous dopamine. Co‑administration with a peripheral decarboxylase inhibitor limits peripheral metabolism, increasing levodopa availability to the central nervous system. |
|---|---|
| Mechanism of action | Levodopa by various routes crosses the blood brain barrier, is decarboxylated to form dopamine[Label,F4579]. This supplemental dopamine performs the role that endogenous dopamine cannot due to a decrease of natural concentrations and stimulates dopaminergic receptors[Label,F4579]. |
| Pharmacodynamics | Levodopa is able to cross the blood-brain barrier while dopamine is not[FDA Label,F4579]. The addition of a peripheral dopa decarboxylase inhibitor prevents the conversion of levodopa to dopamine in the periphery so that more levodopa can reach the blood-brain barrier[Label,F4579]. Once past the blood-brain barrier, levodopa is converted to dopamine by aromatic-L-amino-acid decarboxylase[Label,F4579]. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Dopamine D1 receptor | Humans | agonist |
| Dopamine D5 receptor | Humans | agonist |
| Dopamine D2 receptor | Humans | agonist |
ADME / PK
| Absorption | Orally inhaled levodopa reaches a peak concentration in 0.5 hours with a bioavailability than is 70% that of the immediate release levodopa tablets with a peripheral dopa decarboxylase inhibitor like carbidopa or benserazide[Label,A177781]. |
|---|---|
| Half-life | 2.3 hours for orally inhaled levodopa[FDA Label]. Oral levodopa has a half life of 50 minutes but when combined with a peripheral dopa decarboxylase inhibitor, the half life is increased to 1.5 hours. |
| Protein binding | Levodopa binding to plasma proteins is negligible. |
| Metabolism | Levodopa is either converted to dopamine by aromatic-L-amino-acid decarboxylase or O-methylated to 3-O-methyldopa by catechol-O-methyltransferase[Label,A177745,A177733]. 3-O-methyldopa cannot be metabolized to dopamine. Once levodopa is converted to dopamine, it is converted to sulfated or glucuronidated metabolites, epinephrine E, or homovanillic acid through various metabolic processes. The primary metabolites are 3,4-dihydroxyphenylacetic acid (13-47%) and homovanillic acid (23-39%). |
| Route of elimination | After 48 hours, 0.17% of an orally administered dose is recovered in stool, 0.28% is exhaled, and 78.4% is recovered in urine |
| Volume of distribution | 168L for orally inhaled levodopa[Label]. |
| Clearance | Intravenously administered levodopa is cleared at a rate of 14.2mL/min/kg in elderly patients and 23.4mL/min/kg in younger patients. When given carbidopa, the clearance of levodopa was 5.8mL/min/kg in elderyly patients and 9.3mL/min/kg in younger patients. |
Formulation & handling
- Levodopa is an oral and enteral small‑molecule API with good aqueous solubility but limited permeability, so formulations often manage variable gastrointestinal absorption and food effects, particularly competition with dietary amino acids.
- The molecule is sensitive to chelation with multivalent cations (eg, iron), so formulations and packaging should avoid such excipients to preserve bioavailability.
- Oxidative degradation is a key stability concern; solid and liquid formulations typically require antioxidant systems and oxygen‑limiting handling to maintain potency.
Regulatory status
| Lifecycle | The API shows mixed lifecycle maturity, with several U.S. patents expired in 2020 and others remaining in force until late 2028. With availability across Canada, the United States, and the EU, the market is partly mature but retains segments of protection in the U.S. until the later expiries. |
|---|
| Markets | Canada, US, EU |
|---|
Supply Chain
| Supply chain summary | Levodopa is a long‑established therapy with originator products supplemented by numerous manufacturers and repackagers, indicating a mature and highly diversified supply base. Branded and generic formulations are widely available across the US, EU, and Canada. With key US patents already expired and remaining formulation patents extending only to 2028, generic competition is well established and expected to continue. |
|---|
Safety
| Toxicity | There is no readily available data for the use of levodopa in pregnancy[Label]. Rabbits treated with levodopa and carbidopa produced smaller litters and their offspring developed visceral and skeletal deformities[Label]. Levodopa may lower prolactin and interfere with lactation but there is limited human data to demonstrate this effect[Label]. Levodopa is present in human breast milk and so the potential effects of nursing while taking levodopa should be considered before prescribing levodopa to nursing mothers[Label]. There is currently a lack of data on the safety and effectiveness of using levodopa in pediatric patients[Label]. Patients over 65 years of age are more likely to experience adverse effects associated with taking levodopa, however this generally is not sufficient to exclude this patient group from treatment[Label]. |
|---|
- Developmental toxicity observed in animal models, including reduced litter size and visceral/skeletal malformations with levodopa–carbidopa exposure
- Levodopa is excreted into human breast milk and can suppress prolactin
- Relevance to human lactation remains insufficiently characterized
US Drug Master File (USDMF)
A US Drug Master File (USDMF) is a confidential document submitted to the U.S. Food and Drug Administration (FDA) that provides detailed information about the manufacturing process of an Active Pharmaceutical Ingredient (API) or a finished pharmaceutical product. This document includes comprehensive details such as chemical properties, manufacturing facilities, production processes, packaging specifications, storage conditions, and more.
The USDMF ensures that proprietary information remains protected while allowing the FDA to review the data as part of drug approval processes. Unlike other types of DMFs used in different regions, the USDMF is specifically designed to meet the regulatory requirements set by the FDA, ensuring compliance with U.S. standards.
Levodopa 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.
Levodopa (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.
Levodopa API manufacturers & distributors
Compare qualified Levodopa API suppliers worldwide. We currently have 15 companies offering Levodopa API, with manufacturing taking place in 8 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 |
|---|---|---|---|---|---|
| Ajinomoto | Producer | Japan | Unknown | CEP, CoA, FDA, GMP, USDMF | 24 products |
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
| Daiichi Sankyo | Producer | Japan | Japan | CoA, JDMF | 9 products |
| Derivados Quimicos | Producer | Spain | Spain | CoA, GMP | 18 products |
| Divis Labs. | Producer | India | India | CEP, CoA, FDA, GMP, ISO9001, Other, JDMF, USDMF, WC | 47 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Glochem | Producer | India | India | CEP, CoA, FDA, GMP, WC | 14 products |
| Guangxi Bonger | Producer | China | China | CEP, CoA, WC | 1 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Shandong Xinhua | Producer | China | China | CEP, CoA, FDA, GMP, JDMF, USDMF, WC | 21 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sicor | Producer | Italy | Italy | CoA, GMP | 47 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, USDMF | 764 products |
| Zhejiang Wild Wind | Producer | China | China | CEP, CoA, GMP, USDMF, WC | 4 products |
When sending a request, specify which Levodopa 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 Levodopa 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 Levodopa API
Sourcing
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Technical
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Regulatory
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