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Clopidogrel | CAS No: 113665-84-2 | GMP-certified suppliers
A medication that supports reduction of cardiovascular event risk in acute coronary syndrome, recent myocardial infarction or stroke, and established peripheral arterial disease.
Therapeutic categories
Primary indications
- Clopidogrel is indicated to reduce the risk of myocardial infarction for patients with non-ST elevated acute coronary syndrome (ACS), patients with ST-elevated myocardial infarction, and in recent MI, stroke, or established peripheral arterial disease,
Product Snapshot
- Oral small‑molecule API supplied primarily as tablets and capsules
- Used to reduce thrombotic event risk in acute coronary syndromes, prior myocardial infarction or stroke, and established peripheral arterial disease
- Approved in the US, EU, and Canada
Clinical Overview
Clopidogrel is a prodrug belonging to the class of alpha amino acid esters. It requires two sequential metabolic activation steps to generate a thiol-containing metabolite that exerts pharmacological activity. This metabolite irreversibly binds to platelet P2Y12 ADP receptors, preventing ADP-mediated activation of the GPIIb/IIIa complex and inhibiting platelet aggregation for the lifespan of the platelet.
Absorption is followed by extensive hepatic metabolism, involving CYP2C19 and contributions from CYP1A2, CYP2B6, CYP2C9, and CYP3A isoenzymes. Only a small fraction is converted to the active metabolite, while most is hydrolyzed to inactive products. Clopidogrel has once-daily dosing due to irreversible receptor binding rather than long systemic persistence. It is a substrate of P-glycoprotein. Pharmacokinetic variability is affected by CYP2C19 polymorphisms, which can influence antiplatelet response.
Key safety considerations include bleeding risk, particularly gastrointestinal or procedural bleeding. Concomitant use of drugs that inhibit CYP2C19 or CYP3A may reduce active metabolite formation. Hypersensitivity reactions, thrombotic thrombocytopenic purpura, and hematologic abnormalities have been reported but are uncommon. Use in combination with other anticoagulant or antiplatelet agents requires clinical justification and monitoring.
Clopidogrel is marketed internationally, with widely recognized brands such as Plavix. For API procurement, suppliers should provide evidence of consistent stereochemical purity, validated control of process-related impurities, and compliance with pharmacopeial specifications to ensure suitability for global formulation and regulatory requirements.
Identification & chemistry
| Generic name | Clopidogrel |
|---|---|
| Molecule type | Small molecule |
| CAS | 113665-84-2 |
| UNII | A74586SNO7 |
| DrugBank ID | DB00758 |
Pharmacology
| Summary | Clopidogrel is a prodrug that undergoes hepatic bioactivation to a thiol-containing metabolite that irreversibly inhibits the platelet P2Y12 ADP receptor. This blockade prevents ADP‑mediated activation of the GPIIb/IIIa complex and reduces platelet aggregation. Its pharmacologic effect supports sustained inhibition of platelet activation in conditions characterized by elevated thrombotic risk. |
|---|---|
| Mechanism of action | Clopidogrel is activated via a 2 steps reaction to an active thiol-containing metabolite.This active form is a platelet inhibitor that irreversibly binds to P2Y<sub>12</sub> ADP receptors on platelets.This binding prevents ADP binding to P2Y<sub>12</sub> receptors, activation of the glycoprotein GPIIb/IIIa complex, and platelet aggregation. |
| Pharmacodynamics | Clopidogrel is a prodrug of a platelet inhibitor used to reduce the risk of myocardial infarction and stroke.It has a long duration of action as it is taken once daily and a large therapeutic window as it is given in doses of 75-300mg daily. |
Targets
| Target | Organism | Actions |
|---|---|---|
| P2Y purinoceptor 12 | Humans | antagonist |
ADME / PK
| Absorption | A 75mg oral dose of clopidogrel is 50% absorbed from the intestine.Clopidogrel can be taken with or without food.A meal decreases the AUC of the active metabolite by 57%.The active metabolite of clopidogrel reaches a maximum concentration after 30-60 minutes.Clopidogrel reached a C<sub>max</sub> of 2.04±2.0ng/mL in 1.40±1.07h. The AUC for a 300mg oral dose of clopidogrel was 45.1±16.2ng\*h/mL for poor metabolizers, 65.6±19.1ng\*h/mL for intermediate metabolizers, and 104.3±57.3ng\*h/mL for extensive metabolizers.The C<sub>max</sub> was 31.3±13ng/mL for poor metabolizers, 43.9±14ng/mL for intermediate metabolizers, and 60.8±34.3ng/mL for extensive metabolizers. |
|---|---|
| Half-life | That half life of clopidogrel is approximately 6 hours following a 75mg oral dose while the half life of the active metabolite is approximately 30 minutes. |
| Protein binding | Both the active and inactive metabolites of clopidogrel are 98% protein bound in plasma.Studies in cows show clopidogrel 71-85.5% bound to serum albumin. |
| Metabolism | 85-90% of an oral dose undergoes first pass metabolism by carboxylesterase 1 in the liver to an inactive carboxylic acid metabolite.about 2% of clopidogrel is oxidized to 2-oxoclopidogrel.This conversion is 35.8% by CYP1A2, 19.4% by CYP2B6, and 44.9% by CYP2C19though other studies suggest CYP3A4, CYP3A5, and CYP2C9 also contribute.2-oxoclopidogrel is further metabolized to the active metabolite.This conversion is 32.9% by CYP2B6, 6.79% by CYP2C9, 20.6% by CYP2C19, and 39.8% by CYP3A4. |
| Route of elimination | An oral dose of radiolabelled clopidogrel is excreted 50% in the urine and 46% in the feces over 5 days.The remainder of clopidogrel is irreversibly bound to platelets for their lifetime, or approximately 8-11 days. |
| Volume of distribution | The apparent volume of distribution of clopidogrel is 39,240±33,520L. |
| Clearance | The clearance of a 75mg oral dose was 18,960±15,890L/h and for a 300mg oral dose was 16,980±10,410L/h. |
Formulation & handling
- Oral small‑molecule API with low aqueous solubility, typically formulated as film‑coated tablets to aid manufacturability and limit hydrolytic degradation of the ester.
- High logP supports conventional solid‑dose formulations but may require attention to particle size and solid dispersion approaches to improve dissolution.
- Chemically prone to hydrolysis; handle and store as a dry solid with controlled humidity to preserve ester integrity.
Regulatory status
| Lifecycle | Most core patents for the API expired between 2011 and 2019 in the US and Canada, indicating that key protections have lapsed across major markets. With products marketed in Canada, the EU, and the US, the API is in a mature stage with established generic availability. |
|---|
| Markets | Canada, EU, US |
|---|
Supply Chain
| Supply chain summary | Clopidogrel originated from a small number of innovator firms, with current supply sustained by multiple manufacturers and an extensive network of repackagers and distributors. Branded and generic products are established across the US, EU, and Canada, indicating mature global market penetration. Key patent protections expired between 2011 and 2019, supporting the broad availability of generics and ongoing multi‑source competition. |
|---|
Safety
| Toxicity | A single dose of clopidogrel at 1500-2000mg/kg was lethal to mice and rats while 3000mg/kg was lethal to baboons.Symptoms of overdose include vomiting, breathing difficulty, gastrointestinal hemorrhage, and prostration.Clopidogrel is irreversibly bound to platelets for their lifetime, which is approximately 11 days.Overdoses of clopidogrel can be treated with platelet transfusions to restore clotting ability. |
|---|
- Acute toxicity is high in animal models, with lethal single‑dose ranges of 1500–2000 mg/kg in rodents and ~3000 mg/kg in primates
- Overdose manifestations include emesis, respiratory compromise, gastrointestinal bleeding, and marked prostration
- The compound produces irreversible platelet binding with a functional effect duration aligned to the platelet lifespan (~11 days), relevant for assessing bleeding‑risk scenarios in handling or exposure assessments
Certificate of Analysis
A CoA is a document issued by a companies’ QA/QC-department that confirms that a product meets its product specification and is part of the quality control of a product batch. The CoA commonly contains results obtained from laboratory tests of an individual batch of a product. There are different international standards to which a product can be tested, for example: Ph. Eur. | EP – (European Pharmacopoeia) USP – (United States Pharmacopeia)
Clopidogrel is a type of Platelet Aggregation Inhibitors
Platelet Aggregation Inhibitors are a crucial category of pharmaceutical Active Pharmaceutical Ingredients (APIs) used in the field of cardiology and thrombosis management. These inhibitors play a vital role in preventing platelet aggregation, a process responsible for the formation of blood clots. By inhibiting platelet aggregation, these APIs reduce the risk of arterial thrombosis, which can lead to severe cardiovascular events like heart attacks and strokes.
Platelet Aggregation Inhibitors primarily work by targeting specific receptors on platelet cells, thereby impeding their activation and subsequent aggregation. The most commonly utilized APIs in this category include acetylsalicylic acid (aspirin), clopidogrel, ticagrelor, and prasugrel. These drugs are available in various forms, such as tablets, capsules, and intravenous formulations, allowing flexibility in their administration.
The effectiveness of Platelet Aggregation Inhibitors lies in their ability to prevent platelets from adhering to each other and forming clots within blood vessels. This property is especially crucial in patients with a high risk of cardiovascular events, such as those with a history of heart disease, diabetes, or peripheral artery disease.
While Platelet Aggregation Inhibitors are generally safe and effective, they can also carry potential side effects, including bleeding complications. Therefore, their administration requires careful consideration of individual patient characteristics and risk factors.
In conclusion, Platelet Aggregation Inhibitors represent a significant category of pharmaceutical APIs used for the prevention of platelet aggregation and subsequent blood clot formation. By inhibiting this process, they contribute to the management and reduction of cardiovascular events, offering critical benefits to patients at risk.
Clopidogrel API manufacturers & distributors
Compare qualified Clopidogrel API suppliers worldwide. We currently have 44 companies offering Clopidogrel 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 |
|---|---|---|---|---|---|
| Arch Pharmalabs | Producer | India | India | CoA, USDMF | 19 products |
| AXXO GmbH | Distributor | Germany | World | CEP, CoA, GMP, GDP, MSDS, USDMF | 243 products |
| Dr. Reddy's | Producer | India | India | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, JDMF, KDMF, MSDS, USDMF, WC | 170 products |
| Glochem | Producer | India | India | CEP, CoA, FDA, GMP, KDMF, WC | 14 products |
| HEC Pharm | Producer | Germany | Germany | CEP, CoA, FDA, GMP | 31 products |
| Hetero Drugs | Producer | India | India | CoA, GMP, USDMF, WC | 98 products |
| Humble Healthcaare | Producer | India | India | CoA | 30 products |
| Ind-Swift Labs. | Producer | India | India | CEP, CoA, FDA, GMP, KDMF | 27 products |
| Ipca Labs. | Producer | India | India | CoA, GMP, WC | 69 products |
| KRKA | Producer | Slovenia | Unknown | CEP, CoA, GMP | 81 products |
| Kyung Dong Pharm | Producer | South Korea | South Korea | CoA, JDMF | 5 products |
| Laurus Labs | Producer | India | India | CoA, GMP, WC | 50 products |
| Lee Pharma | Producer | India | India | CoA, GMP, WC | 21 products |
| Mahalaxmi Chemi Pharm | Producer | India | India | CoA | 13 products |
| Menovo | Producer | China | China | CEP, CoA, EDMF/ASMF, FDA, GMP, WC | 27 products |
| MSN Labs. | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 119 products |
| MSN Organics | Producer | India | India | CEP, CoA, FDA, USDMF, WC | 21 products |
| MSN Pharma | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 31 products |
| Mylan | Producer | India | India | CEP, CoA, FDA, GMP, WC | 201 products |
| Osaka Synthetic Chemical ... | Producer | Japan | Japan | CoA, JDMF | 16 products |
| Praveen Labs | Producer | India | India | CEP, CoA, KDMF, WC | 3 products |
| Raks Pharma | Producer | India | India | CoA, USDMF | 58 products |
| Rpg Life Sciences | Producer | India | India | CoA, GMP, WC | 13 products |
| Sandoz | Producer | Austria | India | CoA, GMP, WC | 58 products |
| Sanofi | Producer | France | Unknown | CoA, JDMF, USDMF | 93 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Shenzhen Salubris | Producer | China | China | CEP, CoA | 5 products |
| Shin Poong Pharm | Producer | South Korea | South Korea | CoA, JDMF | 11 products |
| Signa | Producer | Mexico | Mexico | CoA, USDMF | 42 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, GMP, ISO9001 | 762 products |
| Sun Pharma | Producer | India | India | CoA, GMP, USDMF, WC | 219 products |
| Suzhou Lixin Pharmaceutic... | Producer | China | China | BSE/TSE, CEP, CoA, EDMF/ASMF, GMP, MSDS | 34 products |
| Tresinde Biotech | Producer | India | India | CoA, GMP | 50 products |
| Unnati Pharmaceuticals Pv... | Distributor | India | India | CoA | 70 products |
| USV | Producer | India | India | CoA, FDA, GMP, USDMF, WC | 35 products |
| Vasudha Pharma Chem Ltd. | Producer | India | India | CEP, CoA, GMP, MSDS, USDMF, WC | 37 products |
| Vitalife Labs | Producer | India | India | CoA, USDMF | 2 products |
| Yung Zip Chemical | Producer | Taiwan | Taiwan | CoA, USDMF | 12 products |
| Zhejiang Apeloa Tospo-Jia... | Producer | China | China | CEP, CoA, FDA, GMP, KDMF, USDMF | 15 products |
| Zhejiang Changming | Producer | China | China | CoA, WC | 19 products |
| Zhejiang Charioteer | Producer | China | China | CEP, CoA, FDA, GMP, KDMF, USDMF, WC | 9 products |
| Zhejiang Hisun Pharma | Producer | China | China | CoA, WC | 69 products |
| Zhejiang Jiangbei | Producer | China | China | CoA | 7 products |
| Zhejiang Liaoyuan | Producer | China | China | CEP, CoA, FDA, GMP | 5 products |
When sending a request, specify which Clopidogrel 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 Clopidogrel 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 Clopidogrel API
Sourcing
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Technical
What is Clopidogrel (CAS 113665-84-2) used for?
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How does Clopidogrel work?
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What are important formulation and handling considerations for Clopidogrel as an API?
Is Clopidogrel a small molecule?
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Regulatory
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Pharmaoffer
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