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Colchicine | CAS No: 64-86-8 | GMP-certified suppliers
A medication that prevents and treats gout flares, manages Familial Mediterranean fever, and reduces cardiovascular event risks in patients with atherosclerotic disease or multiple risk factors.
Therapeutic categories
Primary indications
- Colchicine is indicated for the prophylaxis and treatment of gout flares
- It is also indicated in Familial Mediterranean fever (FMF) in children and adults of four years of age and older
- It is also indicated to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease
Product Snapshot
- Colchicine is formulated primarily as oral tablets and capsules, with some topical and solution forms available
- It is mainly used for the prophylaxis and treatment of gout flares, familial Mediterranean fever, and cardiovascular risk reduction in patients with established atherosclerotic disease
- Colchicine is approved for use in key regulatory markets including the United States and Canada
Clinical Overview
Pharmacodynamically, colchicine exerts anti-inflammatory, anti-fibrotic, and cardiovascular protective effects. It is an anti-mitotic agent that disrupts microtubule dynamics by inhibiting the polymerization of β-tubulin into microtubules. This action impairs neutrophil activation, motility, and degranulation, thereby mitigating inflammation. Colchicine’s mechanism likely involves interference with intracellular inflammasome assembly in neutrophils and monocytes, reducing activation of interleukin-1β, a key inflammatory cytokine. Clinically, colchicine lowers levels of high-sensitivity C-reactive protein (hs-CRP), a marker of systemic inflammation. It also modulates neutrophil adhesion, recruitment, and superoxide production.
The drug exhibits a narrow therapeutic window and is extensively metabolized via cytochrome P450 enzymes, notably CYP3A4, and is a substrate for P-glycoprotein. Colchicine is mainly renally eliminated. These factors necessitate careful dose adjustment in patients with renal or hepatic impairment and concomitant use of CYP3A4 or P-glycoprotein inhibitors to avoid toxicity. Common safety concerns include gastrointestinal disturbances, myotoxicity, and bone marrow suppression at higher exposures. Off-label uses have included treatment of Behcet’s syndrome and pericarditis.
Notable formulations include branded and generic colchicine products marketed globally under various trade names. Given its complex pharmacokinetics and toxicity profile, quality control during API sourcing is critical. Suppliers must ensure compliance with stringent purity specifications, consistent polymorphic form, and absence of contaminants. Regulatory guidelines recommend validated analytical methods to guarantee batch-to-batch reproducibility and adherence to pharmacopeial standards.
Identification & chemistry
| Generic name | Colchicine |
|---|---|
| Molecule type | Small molecule |
| CAS | 64-86-8 |
| UNII | SML2Y3J35T |
| DrugBank ID | DB01394 |
Pharmacology
| Summary | Colchicine is an anti-mitotic agent that inhibits β-tubulin polymerization, disrupting microtubule formation and subsequently impairing neutrophil activation, degranulation, and migration. It modulates inflammatory processes by interfering with inflammasome assembly and reducing interleukin-1β activation, leading to anti-inflammatory and cardiovascular protective effects. Primary targets include the tubulin beta chain, supporting its use in gout flare prophylaxis, Familial Mediterranean fever, and cardiovascular risk reduction. |
|---|---|
| Mechanism of action | The exact mechanism of action of colchicine has not been fully established; however, colchicine likely interferes with the intracellular assembly of the inflammasome complex present in neutrophils and monocytes that mediates activation of interleukin-1β, an inflammatory mediator. Colchicine also attenuates neutrophil adhesion and recruitment, as well as superoxide production. Clinical data demonstrate that colchicine reduces high-sensitivity C- reactive protein (hs-CRP). Colchicine is an anti-mitotic drug that disrupts cytoskeletal functions by inhibiting β-tubulin polymerization into microtubules. Consequently, it prevents the activation, degranulation, and migration of neutrophils. This pharmacological action is thought to be related to colchicine ameliorating gout symptoms and preventing major cardiovascular events. Colchicine blocks microtubule growth at low concentrations and causes the depolymerization of microtubules at high concentrations. |
| Pharmacodynamics | Colchicine ameliorates the symptoms of gout and Familial Mediterranean fever. It possesses anti-inflammatory, anti-fibrotic, and cardiovascular protective effects. Colchicine was shown to exhibit anticancer properties, such as the inhibition of cancer cell migration and angiogenesis. Colchicine has a narrow therapeutic window. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Tubulin beta chain | Humans | inhibitor, binder |
ADME / PK
| Absorption | Colchicine is rapidly absorbed after oral administration from the gastrointestinal tract. The bioavailability of colchicine is about 45%: one study suggests that colchicine bioavailability is highly variable, ranging from 24 to 88%. In healthy adults, the mean C<sub>max</sub> of 2.5 ng/mL (range 1.1 to 4.4 ng/mL) was achieved in one to two hours (range 0.5 to 3 hours) after a single dose administered under fasting conditions. In a multiple-dose study of colchicine administration at a dose of 1 mg per day, steady-state concentrations were achieved by day 8 following administration. Administration of colchicine with food does not affect the colchicine absorption rate but decreases the extent of colchicine by approximately 15%. |
|---|---|
| Half-life | After several doses of 0.6 mg twice daily, the average elimination half-life of colchicine ranges from 26.6 to 31.2 hours. Another study reported the elimination half-life ranging to be 20 to 40 hours. |
| Protein binding | The plasma protein binding for colchicine is low to moderate, at 39 ± 5%, and it is mainly bound to albumin regardless of concentration. |
| Metabolism | Colchicine is metabolized in the liver. It undergoes CYP3A4-mediated demethylation into major metabolites, 2-O-demethylcolchicine and 3-O-demethylcolchicine. It also forms one minor metabolite, 10-O-demethylcolchicine ([colchiceine]). Plasma levels of these metabolites are less than 5% of parent drug. |
| Route of elimination | In a pharmacokinetic study of healthy research subjects who received 1 mg of oral colchicine, about 40% to 65% of the dose was recovered in the urine in the form of an unchanged drug. Colchicine undergoes enterohepatic recirculation and biliary excretion. |
| Volume of distribution | The mean apparent volume of distribution in young and healthy patients is about 5-8 L/kg. It is known to cross the placenta and distribute into the breast milk. Colchicine has been found to distribute to various tissues, mainly into the bile, liver, and kidney tissues. Smaller amounts have been detected in the heart, lungs, intestinal tissue, and stomach. |
| Clearance | In one pharmacokinetic study involving patients who received a single oral dose of 0.6 mg colchicine, the clearance was 0.0321 ± 0.0091 mL/min in young, healthy adults and 0.0292 ± 0.0071 mL/min in adults between the ages of 60 and 70 years. Patients with end-stage renal impairment showed a 75% lower clearance of colchicine. In a pharmacokinetic study of patients with Familial Mediterranean Fever (FMF), the apparent mean clearance was calculated at 0.726 ± 0.110 L/h/kg. |
Formulation & handling
- Colchicine is a small molecule suitable for oral and topical formulations, primarily available as tablets, capsules, granules, and oral solutions.
- The low water solubility (0.0276 g/L) and moderate LogP (1.46) suggest consideration for dissolution enhancement in oral dosage forms.
- Absorption is not affected by food intake, allowing flexible dosing with regard to meals.
Regulatory status
| Lifecycle | The API is under patent protection in the United States until early 2029, with market presence in the US and Canada. As a result, it remains in a mature market phase with limited generic competition expected before patent expiry. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | The colchicine supply landscape features multiple originator companies primarily focused on the US and Canadian markets. Branded colchicine products maintain a significant presence in these regions, supported by active patents with expiration dates around early 2029, indicating limited generic competition currently but potential entry post-patent expiry. The broad network of packagers suggests a well-established manufacturing and distribution infrastructure. |
|---|
Safety
| Toxicity | The oral LD<sub>50</sub> of colchicine in mice is 5.87 mg/kg. Acute overdose exceeding 0.5 mg/kg (35 mg for a 70 kg average adult) is usually fatal. Fatalities have been reported with as little as 7 mg. Colchicine poisoning presents in three sequential and usually overlapping phases. The first stage of acute colchicine toxicity typically occurs within 24 hours of ingestion and includes gastrointestinal symptoms such as abdominal pain, nausea, vomiting, diarrhea, and significant fluid loss, leading to volume depletion. Peripheral leukocytosis may also be seen. The second stage develops 24 to 72 hours after ingestion and is characterized by multi-organ failure. Death is usually a result of respiratory depression and cardiovascular collapse. Recovery may be accompanied by rebound leukocytosis about one week after ingestion. No specific antidote is known. Elimination of toxins by gastric lavage followed by activated charcoal should be attempted within 1-2 hours of ingestion. Colchicine is not effectively removed by hemodialysis. |
|---|
- Colchicine exhibits high oral toxicity with an LD50 of 5
- 87 mg/kg in mice
- Acute doses above 0
Colchicine is a type of Anti-Gout
The Anti-Gout category of pharmaceutical active pharmaceutical ingredients (APIs) consists of medications specifically designed to alleviate the symptoms and treat the underlying causes of gout, a common type of arthritis. Gout occurs due to the accumulation of uric acid crystals in the joints, leading to severe pain, inflammation, and swelling.
Anti-Gout APIs primarily target the management of uric acid levels in the body. These APIs include medications such as allopurinol, febuxostat, probenecid, and colchicine. Allopurinol and febuxostat work by inhibiting an enzyme called xanthine oxidase, which is involved in the production of uric acid. Probenecid, on the other hand, enhances the excretion of uric acid from the body by blocking its reabsorption in the kidneys. Colchicine is commonly used to reduce pain and inflammation during gout attacks.
The effectiveness of Anti-Gout APIs in managing gout symptoms and preventing recurrent episodes has made them crucial in the treatment regimen for gout patients. These APIs are typically formulated into oral tablets or capsules for easy administration. The dosage and duration of treatment may vary depending on the severity of the condition and the individual's response to therapy.
It is important to note that the use of Anti-Gout APIs should be guided by healthcare professionals to ensure proper dosing and monitoring of potential side effects. Gout patients are advised to follow a balanced diet, limit the consumption of foods high in purines (which can increase uric acid levels), and maintain a healthy lifestyle to complement the pharmacological treatment.
In conclusion, Anti-Gout APIs play a vital role in managing gout, reducing pain and inflammation, and regulating uric acid levels. These medications provide significant relief to individuals suffering from gout, helping them lead a more comfortable and active life.
Colchicine API manufacturers & distributors
Compare qualified Colchicine API suppliers worldwide. We currently have 13 companies offering Colchicine API, with manufacturing taking place in 3 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 |
|---|---|---|---|---|---|
| Alkaloids Corporation | Producer | India | India | CoA, GMP, USDMF, WC | 11 products |
| Eigenmann & Veronelli | Producer | Italy | Italy | CoA, GMP | 6 products |
| Ennature Biopharma | Producer | India | India | CoA | 1 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| Harman Finochem | Producer | India | India | CoA, GMP, WC | 34 products |
| Honour Lab | Producer | India | India | CoA, GMP, USDMF, WC | 30 products |
| Indena | Producer | Italy | Unknown | CEP, CoA, GMP, JDMF, USDMF | 15 products |
| India Glycol | Producer | India | India | CoA, WC | 2 products |
| Sanmar Speciality Chem. | Producer | India | India | CEP, CoA, USDMF | 1 products |
| Sarv Bio Labs | Producer | India | India | CoA, WC | 2 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
| The Gwalior Forest Produc... | Producer | India | India | CoA, WC | 1 products |
| Vital Laboratories Pvt. L... | Producer | India | India | CoA, USDMF, WC | 22 products |
When sending a request, specify which Colchicine 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 Colchicine 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.
