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Mycophenolate mofetil | CAS No: 128794-94-5 | GMP-certified suppliers
A medication that supports prevention of kidney, heart, and liver transplant rejection and provides an option for select refractory autoimmune conditions in specialized clinical settings.
Therapeutic categories
Primary indications
- Mycophenolate mofetil is indicated in combination with other immunosuppressants to prevent the rejection of kidney, heart, or liver transplants in adult and pediatric patients ≥3 months old
- Mycophenolate mofetil may also be used off-label as a second-line treatment for autoimmune hepatitis that has not responded adequately to first-line therapy
- Other off-label uses of this drug include lupus-associated nephritis and dermatitis in children
Product Snapshot
- Mycophenolate mofetil is an oral and intravenous small‑molecule immunosuppressant
- It is used primarily for prevention of kidney, heart, and liver transplant rejection, with secondary use in select autoimmune conditions
- It is approved in the US, EU, and Canada, with some investigational listings in other markets
Clinical Overview
Mycophenolic acid inhibits inosine monophosphate dehydrogenase with selectivity for the IMPDH II isoform expressed predominantly in activated lymphocytes. This blocks the de novo guanosine nucleotide synthesis pathway, limiting DNA, RNA, and protein synthesis essential for T‑ and B‑cell proliferation. Additional immunomodulatory effects include reduced cytotoxic T‑cell generation, impaired antibody production, and modulation of adhesion molecule glycosylation that decreases lymphocyte–endothelium interactions. Depletion of tetrahydrobiopterin further reduces inducible nitric oxide synthase activity and downstream inflammatory mediators.
Following oral administration, mycophenolate mofetil is well absorbed and undergoes rapid presystemic conversion to mycophenolic acid, which is predominantly glucuronidated via UGT isoforms and eliminated largely in the urine. It is a substrate for multiple transporters including P‑glycoprotein and OATP1B1/1B3. Exposure may be altered by interacting drugs that induce or inhibit UGT pathways or affect enterohepatic recirculation.
Common toxicities include gastrointestinal disturbances, leukopenia, and increased susceptibility to infections. Teratogenicity is well documented, and use requires strict pregnancy prevention measures. Hepatic or renal impairment may affect metabolite handling, warranting clinical monitoring.
Notable brands include CellCept and regionally marketed generics. For API procurement, manufacturers require control of ester integrity, impurity profiles associated with oxidative degradation, and confirmation of polymorphic form to ensure consistent bioavailability and regulatory compliance across markets.
Identification & chemistry
| Generic name | Mycophenolate mofetil |
|---|---|
| Molecule type | Small molecule |
| CAS | 128794-94-5 |
| UNII | 9242ECW6R0 |
| DrugBank ID | DB00688 |
Pharmacology
| Summary | Mycophenolate mofetil is a prodrug converted to mycophenolic acid, which suppresses lymphocyte proliferation by inhibiting inosine‑5'-monophosphate dehydrogenase, with preferred activity against the IMPDH II isoform. This blockade reduces de novo guanosine nucleotide synthesis, limiting DNA, RNA, and protein production required for T‑ and B‑cell expansion. Additional effects on adhesion molecule glycosylation and tetrahydrobiopterin pathways further attenuate immune‑cell activation and inflammatory signaling. |
|---|---|
| Mechanism of action | The active metabolite of mycophenolate, mycophenolic acid, prevents T-cell and B-cell proliferation and the production of cytotoxic T-cells and antibodies. Lymphocyte and monocyte adhesion to endothelial cells of blood vessels that normally part of inflammation is prevented via the glycosylation of cell adhesion molecules by MPA.MPA inhibits de novo purine biosynthesis (that promotes immune cell proliferation) by inhibiting inosine 5’-monophosphate dehydrogenase enzyme (IMPDH), with a preferential inhibition of IMPDH II.IMPDH normally transforms inosine monophosphate (IMP) to xanthine monophosphate (XMP), a metabolite contributing to the production of guanosine triphosphate (GTP).GTP is an important molecule for the synthesis of ribonucleic acid (RNA), deoxyribonucleic acid (DNA), and protein. As a result of the above cascade of effects, mycophenolate mofetil reduces de-novo production of guanosine nucleotides, interfering with the synthesis of DNA, RNA, and protein required for immune cell production.Further contributing to the above anti-inflammatory effects, MMF depletes tetrahydrobiopterin, causing the decreased function of inducible nitric oxide synthase enzyme, in turn decreasing the production of peroxynitrite, a molecule that promotes inflammation. |
| Pharmacodynamics | Mycophenolate mofetil is a prodrug of mycophenolic acid (MPA). The active form of mycophenolate, MPA, prevents the proliferation of immune cells and the formation of antibodies that cause transplant rejection.The above effects lead to higher rates of successful transplantation, avoiding the devastating effects of graft rejection. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Inosine-5'-monophosphate dehydrogenase 1 | Humans | inhibitor, inducer |
| Inosine-5'-monophosphate dehydrogenase 2 | Humans | inhibitor |
| 6-pyruvoyl tetrahydrobiopterin synthase | Humans | inhibitor |
ADME / PK
| Absorption | Mycophenolate mofetil is rapidly absorbed in the small intestine.The maximum concentration of its active metabolite, MPA, is attained 60 to 90 minutes following an oral dose.The average bioavailability of orally administered mycophenolate mofetil in a pharmacokinetic study of 12 healthy patients was 94%. In healthy volunteers, the Cmax of mycophenolate mofetil was 24.5 (±9.5)μg/mL.In renal transplant patients 5 days post-transplant, Cmax was 12.0 (±3.82) μg/mL, increasing to 24.1 (±12.1)μg/mL 3 months after transplantation. AUC values were 63.9 (±16.2) μg•h/mL in healthy volunteers after one dose, and 40.8 (±11.4) μg•h/mL, and 65.3 (±35.4)μg•h/mL 5 days and 3 months after a renal transplant, respectively.The absorption of mycophenolate mofetil is not affected by food. |
|---|---|
| Half-life | The average apparent half-life of mycophenolate mofetil is 17.9 (±6.5) hours after oral administration and 16.6 (±5.8) hours after intravenous administration. |
| Protein binding | The protein binding of mycophenolic acid, the metabolite of mycophenolate mofetil, is 97%and it is mainly bound to albumin.MPAG, the inactive metabolite, is 82% bound to plasma albumin at normal therapeutic concentrations. At elevated MPAG concentrations due to various reasons, including renal impairment, the binding of MPA may be decreased due to competition for binding. |
| Metabolism | After both oral and intravenous administration mycophenolate mofetil is entirely metabolized by liver carboxylesterases 1 and 2 to mycophenolic acid (MPA), the active parent drug. It is then metabolized by the enzyme glucuronyl transferase, producing the inactive phenolic glucuronide of MPA (MPAG).The glucuronide metabolite is important, as it is then converted to MPA through enterohepatic recirculation. Mycophenolate mofetil that escapes metabolism in the intestine enters the liver via the portal vein and is transformed to pharmacologically active MPA in the liver cells.N-(2-carboxymethyl)-morpholine, N-(2-hydroxyethyl)-morpholine, and the N-oxide portion of N-(2-hydroxyethyl)-morpholine are additional metabolites of MMF occurring in the intestine as a result of liver carboxylesterase 2 activity.UGT1A9 and UGT2B7 in the liver are the major enzymes contributing to the metabolism of MPA in addition to other UGT enzymes, which also play a role in MPA metabolism. The four major metabolites of MPA are 7-O-MPA-β-glucuronide (MPAG, inactive), MPA acyl-glucuronide (AcMPAG), produced by uridine 5ʹ-diphosphate glucuronosyltransferases (UGT) activities, 7-O-MPA glucoside produced via UGT, and small amounts 6-O-des-methyl-MPA (DM-MPA) via CYP3A4/5 and CYP2C8 enzymes. |
| Route of elimination | A small amount of drug is excreted as MPA in the urine (less than 1%). When mycophenolate mofetil was given orally in a pharmacokinetic study, it was found to be 93% excreted in urine and 6% excreted in feces. Approximately 87% of the entire administered dose is found to be excreted in the urine as MPAG, an inactive metabolite. |
| Volume of distribution | The volume of distribution of mycophenolate mofetil is 3.6 (±1.5) to 4.0 (±1.2) L/kg. |
| Clearance | Plasma clearance of mycophenolate mofetil is 193 mL/min after an oral dose and 177 (±31) mL/min after an intravenous dose. |
Formulation & handling
- Low aqueous solubility and moderate lipophilicity favor oral solid formulations, with delayed‑release tablets used to mitigate gastric degradation and food effects.
- Oral products should account for reduced absorption in the presence of multivalent cations and food, suggesting protective coatings or formulation to minimize ion complexation.
- IV use requires reconstitution of lyophilized powder or use of prepared solution, with attention to stability of the ester prodrug under aqueous conditions.
Regulatory status
| Lifecycle | Key patents in the US and Canada expired between 2011 and 2014, indicating the API is in a late‑lifecycle stage. With availability across Canada, the US, and the EU, the product is consistent with a mature market environment where generic competition is likely established. |
|---|
| Markets | Canada, US, EU |
|---|
Supply Chain
| Supply chain summary | The originator product was developed by a single innovator company, but the supply landscape now includes numerous generic manufacturers and packagers with broad participation across North America, Europe, and additional global markets. Branded and authorized products have been present in the US, EU, and Canada, but multiple listed patents have expired between 2011 and 2014. These expiries have enabled wide generic entry, reflected in the large number of active manufacturers and distributors. |
|---|
Safety
| Toxicity | LD50 The LD50 of oral mycophenolate mofetil in rats is 250 mg/kg and >4000 mg/kg in mice. **Overdose information** Possible signs and symptoms of acute overdose may consist of hematological abnormalities including leukopenia and neutropenia, and gastrointestinal symptoms. |
|---|
- Oral LD50 values indicate moderate acute toxicity in rats (≈250 mg/kg) and low acute toxicity in mice (›4000 mg/kg), supporting standard laboratory handling controls
- Acute exposure at high levels has been associated with hematologic disturbances such as leukopenia and neutropenia
- Gastrointestinal irritation has been reported in overdose contexts and may be relevant for hazard assessment and spill-response planning
Certificate of Suitability
CEP (also known as COS) is a certificate that proves that qualifies to the relevant monograph of the European Pharmacopoeia. It links the monograph in the Ph.Eur. to the API itself. A CEP is submitted by the manufacturer as part of the market authorization process, and they will become the CEP holder of the document. Being a European certificate, the CEP is granted by the EDQM but is recognized by other countries or institutes such as the FDA in the US. Furthermore, just like the DMF, the data as submitted in the CEP is handled strictly confidential and provides a centralized system recognized by many countries.
Mycophenolate mofetil 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.
Mycophenolate mofetil (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.
Mycophenolate mofetil API manufacturers & distributors
Compare qualified Mycophenolate mofetil API suppliers worldwide. We currently have 22 companies offering Mycophenolate mofetil API, with manufacturing taking place in 5 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 |
|---|---|---|---|---|---|
| Apino Pharma Co., Ltd. | Producer | China | China | CoA, GMP, MSDS, USDMF | 229 products |
| Apotex Pharmachem | Producer | India | India | CEP, CoA, FDA | 10 products |
| Arevipharma | Producer | Germany | Unknown | CEP, CoA, FDA | 25 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
| AXXO GmbH | Distributor | Germany | World | CoA, GMP, GDP, MSDS, USDMF | 243 products |
| Biocon | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 36 products |
| CCSB-Chunghwa Chemical Sy... | Producer | Taiwan | Taiwan | BSE/TSE, CoA, FDA, GMP, MSDS, USDMF | 27 products |
| Chr. Olesen Group | Distributor | Denmark | China | CEP, CoA, GMP, MSDS, USDMF | 252 products |
| Emcure Pharma | Producer | India | India | CoA, USDMF | 80 products |
| Formosa Labs | Producer | Taiwan | Taiwan | CoA, USDMF | 36 products |
| Humble Healthcaare | Producer | India | India | CoA | 30 products |
| Kleem Pharmaceuticals | Producer | India | India | CoA | 22 products |
| Lee Pharma | Producer | India | India | CEP, CoA, GMP | 21 products |
| Lek Pharma | Producer | Slovenia | Unknown | CEP, CoA, GMP, USDMF | 32 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Rpg Life Sciences | Producer | India | India | CEP, CoA, WC | 13 products |
| Sandoz | Producer | Austria | India | CoA, GMP, WC | 58 products |
| Shandong N.T. Pharma | Producer | China | China | CoA, USDMF | 12 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, ISO9001, MSDS | 762 products |
| Unnati Pharmaceuticals Pv... | Distributor | India | India | CoA | 70 products |
| Zhejiang Hisun Pharma | Producer | China | China | CEP, CoA, GMP, USDMF | 69 products |
When sending a request, specify which Mycophenolate mofetil 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 Mycophenolate mofetil 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.
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