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Teriflunomide | CAS No: 163451-81-8 | GMP-certified suppliers
A medication that supports management of relapsing multiple sclerosis by helping reduce disease activity for consistent use across major regulated markets.
Therapeutic categories
Primary indications
- Used in the treatment of relapsing forms of multiple sclerosis (MS)
Product Snapshot
- Teriflunomide is an oral small‑molecule API supplied for tablet and film‑coated tablet formulations
- It is used for products targeting relapsing forms of multiple sclerosis
- It is approved in the US, EU, and Canada
Clinical Overview
The compound inhibits the mitochondrial enzyme dihydroorotate dehydrogenase, a key catalyst in de novo pyrimidine synthesis. Although the complete mechanism in multiple sclerosis is not fully defined, reduced availability of pyrimidines limits proliferation of activated T and B lymphocytes. This activity contributes to a decrease in CNS infiltrating immune cells and supports its disease-modifying effect in relapsing multiple sclerosis.
Teriflunomide demonstrates prolonged persistence in the body due to extensive enterohepatic recirculation, and elimination can take several months unless an accelerated elimination procedure is used. The molecule is highly protein bound and shows slow clearance, characteristics that influence dosing considerations and management of adverse effects. It is a substrate and inhibitor of several transporters, including BCRP and OAT3, and may interact with CYP1A2 and CYP2C8 pathways.
Safety considerations include established risks of hepatotoxicity and teratogenicity, highlighted in regulatory labeling. Baseline and periodic liver function monitoring is standard practice. Use in pregnancy is contraindicated, and validated drug elimination procedures are required if pregnancy is desired. Additional concerns include potential hematologic effects, infection risk due to immunomodulation, and caution in patients receiving concomitant hepatotoxic or enzyme-inducing therapies.
Teriflunomide’s chemistry is characterized by a trifluoromethyl-substituted benzene structure, classified within organofluorine trifluoromethylbenzenes. This influences its metabolic stability and physicochemical behavior in formulation development.
For API procurement, sourcing should prioritize manufacturers with validated control of fluorinated intermediates, robust impurity profiling, and demonstrated capacity to manage long elimination half-life–related safety requirements. Consistent adherence to global GMP and regulatory documentation remains essential.
Identification & chemistry
| Generic name | Teriflunomide |
|---|---|
| Molecule type | Small molecule |
| CAS | 163451-81-8 |
| UNII | 1C058IKG3B |
| DrugBank ID | DB08880 |
Pharmacology
| Summary | Teriflunomide inhibits the mitochondrial enzyme dihydroorotate dehydrogenase, blocking de novo pyrimidine synthesis and limiting proliferation of activated lymphocytes. This action produces immunomodulatory effects, including reduced activated CNS lymphocytes and downstream anti‑inflammatory activity. It is used in relapsing forms of multiple sclerosis, though its precise mechanism in MS is not fully defined. |
|---|---|
| Mechanism of action | The exact mechanism by which teriflunomide acts in MS is not known. What is known is that teriflunomide prevents pyrimidine synthesis by inhibiting the mitochondrial enzyme dihydroorotate dehydrogenase, and this may be involved in its immunomodulatory effect in MS. |
| Pharmacodynamics | Teriflunomide is an immunomodulatory agent that decreases the amount of activated CNS lymphocytes, which results in anti-inflammatory and antiproliferative effects. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Dihydroorotate dehydrogenase (quinone), mitochondrial | Humans | inhibitor |
ADME / PK
| Absorption | After oral administration of teriflunomide, maximum plasma concentrations are reached, on average, in 1-4 hours. |
|---|---|
| Half-life | The median half-life is 18 to 19 days. |
| Protein binding | Teriflunomide is extensively plasma protein bound(>99%). |
| Metabolism | Teriflunomide mainly undergoes hydrolyis to minor metabolites. Other minor metabolic pathways include oxidation, N-acetylation and sulfate conjugation. Teriflunomide is not metabolized by CYP450 or flavin monoamine oxidase. |
| Route of elimination | Teriflunomide is eliminated unchanged and mainly through bile. Specifically 37.5% is eliminated in the feces and 22.6% in urine. |
| Volume of distribution | After a single intravenous dose, the volume of distribution is 11 L. |
| Clearance | After a single IV dose, teriflunomide has a total body clearance of 30.5 mL/h. |
Formulation & handling
- Teriflunomide is a small‑molecule, orally administered API with low aqueous solubility, requiring solid‑dose formulations that support dissolution.
- Its moderate lipophilicity (LogP ~2) supports oral absorption, and food has minimal impact on exposure, allowing flexible administration.
- Solid‑state stability is generally good; standard handling to control moisture and particulate exposure is suitable for tablet manufacturing.
Regulatory status
| Lifecycle | Patent protection for the API in the US spans from 2027 through 2034, indicating a mix of near‑term and longer‑term exclusivity. With commercialization in Canada, the US, and the EU, the product is in established markets but will face increasing maturity as early patents expire. |
|---|
| Markets | Canada, US, EU |
|---|
Supply Chain
| Supply chain summary | Teriflunomide is supplied primarily by a single originator developing the branded product, with multiple branded presentations marketed across the US, EU, and Canada. The product has broad global distribution in these regions, while non‑originator versions mainly appear as authorized or branded generics. Patent protections extending into 2031–2034 in the United States limit widespread generic competition, despite an earlier expiring patent in 2027. |
|---|
Safety
| Toxicity | Teriflunomide is contraindicated in pregnant women or women of childbearing age due to the risk of teratogenicity. Teriflunomide is also contraindicated in severe hepatic impairment due to reports of hepatotoxicity, hepatic failure, and death. |
|---|
- Classified teratogenic
- Handling protocols should minimize exposure, particularly in environments involving reproductive‑risk controls
- Associated with hepatotoxicity and rare hepatic failure
Teriflunomide is a type of Immunosuppressants
Immunosuppressants are a vital subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a crucial role in medical treatments. These substances are designed to suppress or weaken the immune system's response, making them invaluable in various therapeutic applications.
Immunosuppressants find extensive use in the management of autoimmune diseases, organ transplantation, and the prevention of rejection reactions. By modulating the immune system's activity, these APIs help control excessive immune responses that can lead to tissue damage and chronic inflammation.
There are different classes of immunosuppressants, including corticosteroids, calcineurin inhibitors, antimetabolites, and biologics. Each class targets specific immune pathways to achieve the desired therapeutic effect. Corticosteroids, for instance, are known for their potent anti-inflammatory properties, making them effective in managing conditions such as rheumatoid arthritis and asthma.
Calcineurin inhibitors like cyclosporine and tacrolimus act by inhibiting the activity of calcineurin, a protein involved in immune cell activation. These drugs are commonly used in organ transplantation to prevent the immune system from attacking the transplanted organ.
Antimetabolites interfere with DNA synthesis and cell proliferation, thereby dampening immune responses. They are often prescribed for conditions like psoriasis and rheumatoid arthritis.
Biologic immunosuppressants, such as monoclonal antibodies, target specific immune cells or molecules involved in the disease process. They have revolutionized the treatment of autoimmune diseases like rheumatoid arthritis, Crohn's disease, and psoriasis.
Immunosuppressants require careful administration and monitoring due to their potential side effects and interactions with other medications. Close collaboration between healthcare professionals, pharmacists, and patients is essential to ensure the safe and effective use of these APIs in various therapeutic settings.
Overall, immunosuppressants represent a critical category of pharmaceutical APIs that significantly contribute to improving patients' quality of life by controlling the immune system's activity and managing various autoimmune conditions and transplantation outcomes.
Teriflunomide (Immunosuppressants), classified under Immunomodulators
Immunomodulators, a category of pharmaceutical active pharmaceutical ingredients (APIs), are substances that help regulate and modify the immune response of an individual. These compounds play a crucial role in treating various immune-related disorders and diseases. Immunomodulators work by either enhancing or suppressing the immune system, depending on the specific condition being treated.
Immunomodulators are used in the treatment of autoimmune disorders, such as rheumatoid arthritis, multiple sclerosis, and psoriasis. By suppressing the immune system, these APIs help reduce the overactive immune response associated with these conditions, thereby alleviating symptoms and preventing further damage to the body's tissues.
On the other hand, immunomodulators are also employed to boost the immune system in cases of immunodeficiency disorders. These APIs stimulate the immune response, enabling the body to better fight off infections and diseases. Additionally, immunomodulators are utilized in the prevention and treatment of organ transplant rejection, where they help modulate the immune system to accept the transplanted organ.
The development and production of immunomodulators require rigorous testing and quality control to ensure their safety and efficacy. Pharmaceutical companies carefully formulate these APIs into various dosage forms, including tablets, capsules, injections, and topical preparations, to cater to different patient needs.
In summary, immunomodulators form a vital category of pharmaceutical APIs that regulate and modify the immune system. With their ability to modulate immune responses, these compounds contribute significantly to the management and treatment of various immune-related disorders and diseases, improving the quality of life for many patients.
Teriflunomide API manufacturers & distributors
Compare qualified Teriflunomide API suppliers worldwide. We currently have 19 companies offering Teriflunomide 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 |
|---|---|---|---|---|---|
| ACE Japan | Producer | Japan | Japan | CoA | 76 products |
| AXXO GmbH | Distributor | Germany | World | CoA, GMP, GDP, MSDS, USDMF | 243 products |
| Biocon | Producer | India | India | CoA, USDMF | 36 products |
| Emcure Pharma | Producer | India | India | CoA, USDMF | 80 products |
| Formosa Labs | Producer | Taiwan | Taiwan | CoA, USDMF | 36 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Honour Lab | Producer | India | India | CoA, GMP, USDMF, WC | 30 products |
| Intas Pharma | Producer | United Kingdom | Unknown | CoA, USDMF | 30 products |
| Janssen Pharma | Producer | Belgium | Netherlands | CoA, GMP | 63 products |
| MSN Labs. | Producer | India | India | CoA, GMP, USDMF, WC | 119 products |
| Nanjing Hemu Haohai Biote... | Producer | China | China | BSE/TSE, CoA, EDMF/ASMF, MSDS, USDMF | 23 products |
| Natco Pharma | Producer | India | India | CoA, USDMF | 40 products |
| PharmaZell | Producer | Germany | India | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GDP, GMP, MSDS, USDMF, WC, WHO-GMP | 31 products |
| Raks Pharma | Producer | India | India | CoA, USDMF | 58 products |
| Sanofi | Producer | France | France | CoA, GMP | 93 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Shilpa Medicare Ltd | Producer | India | India | BSE/TSE, CoA, GMP, ISO9001, MSDS, USDMF, WC | 54 products |
| Unichem Labs. | Producer | India | India | CoA, USDMF | 62 products |
| Weijie Pharmaceuticals | Producer | China | China | CoA, USDMF | 15 products |
When sending a request, specify which Teriflunomide 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 Teriflunomide 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 Teriflunomide API
Sourcing
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Technical
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Regulatory
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Pharmaoffer
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