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Also known as: 37415-62-6, Sodium mycophenolate, Mycophenolic acid sodium salt, Mycophenolic acid monosodium salt, Erl 080, Mycophenolate sodium [usan]
Molecular Formula
C17H19NaO6
Molecular Weight
342.3  g/mol
InChI Key
DOZYTHNHLLSNIK-JOKMOOFLSA-M
FDA UNII
WX877SQI1G

Mycophenolate Sodium
Compound derived from Penicillium stoloniferum and related species. It blocks de novo biosynthesis of purine nucleotides by inhibition of the enzyme inosine monophosphate dehydrogenase (IMP DEHYDROGENASE). Mycophenolic acid exerts selective effects on the immune system in which it prevents the proliferation of T-CELLS, LYMPHOCYTES, and the formation of antibodies from B-CELLS. It may also inhibit recruitment of LEUKOCYTES to sites of INFLAMMATION.
1 2D Structure

Mycophenolate Sodium

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
sodium;(E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1H-2-benzofuran-5-yl)-4-methylhex-4-enoate
2.1.2 InChI
InChI=1S/C17H20O6.Na/c1-9(5-7-13(18)19)4-6-11-15(20)14-12(8-23-17(14)21)10(2)16(11)22-3;/h4,20H,5-8H2,1-3H3,(H,18,19);/q;+1/p-1/b9-4+;
2.1.3 InChI Key
DOZYTHNHLLSNIK-JOKMOOFLSA-M
2.1.4 Canonical SMILES
CC1=C2COC(=O)C2=C(C(=C1OC)CC=C(C)CCC(=O)[O-])O.[Na+]
2.1.5 Isomeric SMILES
CC1=C2COC(=O)C2=C(C(=C1OC)C/C=C(\C)/CCC(=O)[O-])O.[Na+]
2.2 Other Identifiers
2.2.1 UNII
WX877SQI1G
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Cellcept

2. Mofetil Hydrochloride, Mycophenolate

3. Mofetil, Mycophenolate

4. Mycophenolate Mofetil

5. Mycophenolate Mofetil Hydrochloride

6. Mycophenolate, Sodium

7. Mycophenolic Acid

8. Mycophenolic Acid Morpholinoethyl Ester

9. Myfortic

10. Rs 61443

11. Rs-61443

12. Rs61443

13. Sodium Mycophenolate

2.3.2 Depositor-Supplied Synonyms

1. 37415-62-6

2. Sodium Mycophenolate

3. Mycophenolic Acid Sodium Salt

4. Mycophenolic Acid Monosodium Salt

5. Erl 080

6. Mycophenolate Sodium [usan]

7. Sodium Mycophenalate

8. Erl-080

9. Mycophenolic Acid, Sodium Salt

10. Wx877sqi1g

11. Chebi:67155

12. Sodium;(e)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1h-2-benzofuran-5-yl)-4-methylhex-4-enoate

13. Nsc-116072

14. 4-hexenoic Acid, 6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-, Sodium Salt(1:1) , (4e)-

15. Mycophenolic Acid (sodium)

16. 4-hexenoic Acid, 6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-, Monosodium Salt, (4e)-

17. Sodium 4(e)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoate

18. Sodium (e)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoate

19. Unii-wx877sqi1g

20. Nsc 116072

21. Femulan

22. Erl 080a

23. Mycophenolic Sod

24. Myfortic (tn)

25. Ec-mps

26. Starbld0043375

27. Mycophenolatesodium

28. Mycophenolate Sodium (usp)

29. 4-hexenoic Acid, 6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-, Monosodium Salt, (e)-

30. Erl-080a

31. Schembl1649229

32. Chembl2106643

33. Hy-b0421a

34. Mycophenolate Sodium [vandf]

35. Mycophenolate Sodium [mart.]

36. Mycophenolate Sodium [usp-rs]

37. Mycophenolate Sodium [who-dd]

38. Akos015969286

39. 4-hexenoic Acid, 6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-5-phthalanyl)-4-methyl-, Sodium Salt

40. As-17786

41. Mycophenolate Sodium [ep Monograph]

42. Mycophenolic Acid Sodium Salt [mi]

43. Mycophenolate Sodium [usp Monograph]

44. Cs-0103129

45. D05095

46. D93087

47. Q27135653

48. Sodium (4e)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydro-2-benzofuran-5-yl)-4-methylhex-4-enoate

49. Sodium;(e)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1h-2-benzofuran-5-yl)-4-methylhex-4-enoic Acid

2.4 Create Date
2008-02-05
3 Chemical and Physical Properties
Molecular Weight 342.3 g/mol
Molecular Formula C17H19NaO6
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count6
Rotatable Bond Count6
Exact Mass342.10793260 g/mol
Monoisotopic Mass342.10793260 g/mol
Topological Polar Surface Area95.9 Ų
Heavy Atom Count24
Formal Charge0
Complexity492
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

Antibiotics, Antineoplastic

Chemical substances, produced by microorganisms, inhibiting or preventing the proliferation of neoplasms. (See all compounds classified as Antibiotics, Antineoplastic.)


Antibiotics, Antitubercular

Substances obtained from various species of microorganisms that are, alone or in combination with other agents, of use in treating various forms of tuberculosis; most of these agents are merely bacteriostatic, induce resistance in the organisms, and may be toxic. (See all compounds classified as Antibiotics, Antitubercular.)


Enzyme Inhibitors

Compounds or agents that combine with an enzyme in such a manner as to prevent the normal substrate-enzyme combination and the catalytic reaction. (See all compounds classified as Enzyme Inhibitors.)


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C","city":"BANGALORE,KARNATAKA","supplier":"BIOCON","supplierCountry":"INDIA","foreign_port":"MOSCOW DOMODEDOVO","customer":"M\/S....","customerCountry":"RUSSIA","quantity":"28.56","actualQuantity":"28.56","unit":"KGS","unitRateFc":"183.8","totalValueFC":"5205.2","currency":"USD","unitRateINR":15486.157212885155,"date":"20-Dec-2024","totalValueINR":"442284.65","totalValueInUsd":"5205.2","indian_port":"Bangalore Air","hs_no":"29163990","bill_no":"6639373","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bangalore Air","supplierAddress":"20TH K M, HOSUR ROAD,,ELECTRONIC C, BANGALORE,KARNATAKA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734892200,"product":"MYCOPHENOLATE SODIUM USP","address":"425\/3 RT D NO 7-1-621\/328,","city":"HYDERABAD.AP","supplier":"RAKSHIT PHARMACEUTICALS LIMITED","supplierCountry":"INDIA","foreign_port":"ISLAMABAD - ISLAMABA","customer":"GENOME PHARMACEUTICALS PVT ","customerCountry":"PAKISTAN","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"220","totalValueFC":"1031.8","currency":"USD","unitRateINR":17535,"date":"23-Dec-2024","totalValueINR":"87675","totalValueInUsd":"1031.8","indian_port":"Hyderabad Air","hs_no":"29163990","bill_no":"6676931","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"PAKISTAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"425\/3 RT D NO 7-1-621\/328,, HYDERABAD.AP","customerAddress":""},{"dataSource":"API Import","activeIngredients":"MYCOPHENOLATE SODIUM","year":"2021","qtr":"Q1","strtotime":1609698600,"product":"MYCOPHENOLIC ACID (FOR MANUFACTURE OF MYCOPHENOLATE SODIUM )LIST 3 SLNO.62","address":"425\/3 RT D NO 7-1-621\/328,S.R.NAGAR","city":"HYDERABAD.AP","supplier":"LUNAN 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","supplierCountry":"CHINA","foreign_port":"NA","customer":"RAKSHIT PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"2000.00","actualQuantity":"2000","unit":"KGS","unitRateFc":"84","totalValueFC":"166851.8","currency":"USD","unitRateINR":"6249.6","date":"07-Oct-2021","totalValueINR":"12499200","totalValueInUsd":"166851.8","indian_port":"MADRAS SEA","hs_no":"29329990","bill_no":"5743287","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"425\/3 RT D NO 7-1-621\/328, S.R.NAGAR Contact No: 919177739734"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1636741800,"product":"MYCOPHENOLIC ACID (FOR MANUFACTURE OF MYCOPHENOLATE SODIUM )LIST 3 SLNO.62","address":"425\/3 RT D NO 7-1-621\/328, S.R.NAGAR Contact No: 919177739734","city":"HYDERABAD","supplier":"LIVZON GROUP NINGXIA ","supplierCountry":"CHINA","foreign_port":"NA","customer":"RAKSHIT PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"84","totalValueFC":"85216.8","currency":"USD","unitRateINR":"6346.2","date":"13-Nov-2021","totalValueINR":"6346200","totalValueInUsd":"85216.8","indian_port":"MADRAS SEA","hs_no":"29329990","bill_no":"6242269","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"425\/3 RT D NO 7-1-621\/328, S.R.NAGAR Contact No: 919177739734"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1648405800,"product":"MYCOPHENOLATE SODIUM MFG BATCH NO.(07S62099-104) S\/B.3313970DTD.20\/06\/2020 PORT:INAMD4 (RE-IMPORT)","address":"1482 1486 TRASAD ROAD,DHOLKA","city":"AHMEDABAD,GUJARAT","supplier":"AUROBINDO PHARMA LIMITED","supplierCountry":"INDIA","foreign_port":"NA","customer":"CONCORD BIOTECH","customerCountry":"INDIA","quantity":"355.02","actualQuantity":"355.016","unit":"KGS","unitRateFc":"252.1","totalValueFC":"109379.6","currency":"USD","unitRateINR":"23483.1","date":"28-Mar-2022","totalValueINR":"8336861.24","totalValueInUsd":"109379.6","indian_port":"AHMEDABAD AIR","hs_no":"29420090","bill_no":"8037899","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"1482 1486 TRASAD ROAD,DHOLKA"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1670783400,"product":"MYCOPHENOLATE SODIUM (FOR R & D PURPOSE ONLY)","address":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ","city":"AHMEDABAD,GUJARAT","supplier":"CHUNGHWA CHEMICAL SYNTHESIS & BIOTECH","supplierCountry":"TAIWAN","foreign_port":"NA","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"210","totalValueFC":"625.7","currency":"USD","unitRateINR":"51562.7","date":"12-Dec-2022","totalValueINR":"51562.71","totalValueInUsd":"625.7","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"3707020","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ"}]
04-Jan-2021
23-Dec-2024
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DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 18...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 180MG BASE

USFDA APPLICATION NUMBER - 50791

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DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 36...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 360MG BASE

USFDA APPLICATION NUMBER - 50791

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ABOUT THIS PAGE

Mycophenolate Sodium Manufacturers

A Mycophenolate Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mycophenolate Sodium, including repackagers and relabelers. The FDA regulates Mycophenolate Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mycophenolate Sodium API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Mycophenolate Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Mycophenolate Sodium Suppliers

A Mycophenolate Sodium supplier is an individual or a company that provides Mycophenolate Sodium active pharmaceutical ingredient (API) or Mycophenolate Sodium finished formulations upon request. The Mycophenolate Sodium suppliers may include Mycophenolate Sodium API manufacturers, exporters, distributors and traders.

click here to find a list of Mycophenolate Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Mycophenolate Sodium USDMF

A Mycophenolate Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Mycophenolate Sodium active pharmaceutical ingredient (API) in detail. Different forms of Mycophenolate Sodium DMFs exist exist since differing nations have different regulations, such as Mycophenolate Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Mycophenolate Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Mycophenolate Sodium USDMF includes data on Mycophenolate Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mycophenolate Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Mycophenolate Sodium suppliers with USDMF on PharmaCompass.

Mycophenolate Sodium KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Mycophenolate Sodium Drug Master File in Korea (Mycophenolate Sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Mycophenolate Sodium. The MFDS reviews the Mycophenolate Sodium KDMF as part of the drug registration process and uses the information provided in the Mycophenolate Sodium KDMF to evaluate the safety and efficacy of the drug.

After submitting a Mycophenolate Sodium KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Mycophenolate Sodium API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Mycophenolate Sodium suppliers with KDMF on PharmaCompass.

Mycophenolate Sodium CEP

A Mycophenolate Sodium CEP of the European Pharmacopoeia monograph is often referred to as a Mycophenolate Sodium Certificate of Suitability (COS). The purpose of a Mycophenolate Sodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Mycophenolate Sodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Mycophenolate Sodium to their clients by showing that a Mycophenolate Sodium CEP has been issued for it. The manufacturer submits a Mycophenolate Sodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Mycophenolate Sodium CEP holder for the record. Additionally, the data presented in the Mycophenolate Sodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Mycophenolate Sodium DMF.

A Mycophenolate Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Mycophenolate Sodium CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Mycophenolate Sodium suppliers with CEP (COS) on PharmaCompass.

Mycophenolate Sodium WC

A Mycophenolate Sodium written confirmation (Mycophenolate Sodium WC) is an official document issued by a regulatory agency to a Mycophenolate Sodium manufacturer, verifying that the manufacturing facility of a Mycophenolate Sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Mycophenolate Sodium APIs or Mycophenolate Sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a Mycophenolate Sodium WC (written confirmation) as part of the regulatory process.

click here to find a list of Mycophenolate Sodium suppliers with Written Confirmation (WC) on PharmaCompass.

Mycophenolate Sodium NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Mycophenolate Sodium as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Mycophenolate Sodium API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Mycophenolate Sodium as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Mycophenolate Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Mycophenolate Sodium NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Mycophenolate Sodium suppliers with NDC on PharmaCompass.

Mycophenolate Sodium GMP

Mycophenolate Sodium Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Mycophenolate Sodium GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Mycophenolate Sodium GMP manufacturer or Mycophenolate Sodium GMP API supplier for your needs.

Mycophenolate Sodium CoA

A Mycophenolate Sodium CoA (Certificate of Analysis) is a formal document that attests to Mycophenolate Sodium's compliance with Mycophenolate Sodium specifications and serves as a tool for batch-level quality control.

Mycophenolate Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Mycophenolate Sodium CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Mycophenolate Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Mycophenolate Sodium EP), Mycophenolate Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mycophenolate Sodium USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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