Find Mycophenolate Mofetil Hydrochloride manufacturers, exporters & distributors on PharmaCompass

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Also known as: 116680-01-4, Mycophenolate mofetil hcl, Mycophenolate mofetil (hydrochloride), Mycophenolate mofetil hydrochloride [usan], Uxh81s8zvb, Rs-61443-190
Molecular Formula
C23H32ClNO7
Molecular Weight
470.0  g/mol
InChI Key
OWLCGJBUTJXNOF-HDNKIUSMSA-N
FDA UNII
UXH81S8ZVB

Mycophenolate Mofetil Hydrochloride
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 Mofetil Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-morpholin-4-ylethyl (E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1H-2-benzofuran-5-yl)-4-methylhex-4-enoate;hydrochloride
2.1.2 InChI
InChI=1S/C23H31NO7.ClH/c1-15(5-7-19(25)30-13-10-24-8-11-29-12-9-24)4-6-17-21(26)20-18(14-31-23(20)27)16(2)22(17)28-3;/h4,26H,5-14H2,1-3H3;1H/b15-4+;
2.1.3 InChI Key
OWLCGJBUTJXNOF-HDNKIUSMSA-N
2.1.4 Canonical SMILES
CC1=C2COC(=O)C2=C(C(=C1OC)CC=C(C)CCC(=O)OCCN3CCOCC3)O.Cl
2.1.5 Isomeric SMILES
CC1=C2COC(=O)C2=C(C(=C1OC)C/C=C(\C)/CCC(=O)OCCN3CCOCC3)O.Cl
2.2 Other Identifiers
2.2.1 UNII
UXH81S8ZVB
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Cellcept

2. Mofetil Hydrochloride, Mycophenolate

3. Mofetil, Mycophenolate

4. Mycophenolate Mofetil

5. Mycophenolate Sodium

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. 116680-01-4

2. Mycophenolate Mofetil Hcl

3. Mycophenolate Mofetil (hydrochloride)

4. Mycophenolate Mofetil Hydrochloride [usan]

5. Uxh81s8zvb

6. Rs-61443-190

7. Cellcept (tn)

8. 2-(4-morpholinyl)ethyl Ester (e)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoic Acid, Hydrochloride

9. 2-morpholin-4-ylethyl (e)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1h-2-benzofuran-5-yl)-4-methylhex-4-enoate;hydrochloride

10. 2-morpholinoethyl (e)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-5-phthalanyl)-4-methyl-4-hexenoate Hydrochloride

11. 2-morpholin-4-ylethyl (e)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1h-isobenzofuran-5-yl)-4-methyl-hex-4-enoate Hydrochloride

12. Mycophenolate Mofetil Hydrochloride (usan)

13. Unii-uxh81s8zvb

14. Rs 61443-190

15. Mycophenolatemofetilhydrochloride

16. Schembl1235420

17. Chembl1200955

18. Hy-b0199a

19. Dtxsid101027191

20. Akos000280984

21. 4-hexenoic Acid, 6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-, 2-(4-morpholinyl)ethyl Ester, Hydrochloride, (4e)-

22. 4-hexenoic Acid, 6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-, 2-(4-morpholinyl)ethyl Ester, Hydrochloride, (e)-

23. D05094

24. Mycophenolate Mofetil Hydrochloride [mart.]

25. Mycophenolate Mofetil Hydrochloride [vandf]

26. Mycophenolate Mofetil Hydrochloride [who-dd]

27. Q27291325

28. Mycophenolate Mofetil Hydrochloride [orange Book]

29. 2-morpholin-4-ylethyl (e)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1h-isobenzofuran-5-yl)-4-methyl-hex-

2.4 Create Date
2006-04-28
3 Chemical and Physical Properties
Molecular Weight 470.0 g/mol
Molecular Formula C23H32ClNO7
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count8
Rotatable Bond Count10
Exact Mass469.1867301 g/mol
Monoisotopic Mass469.1867301 g/mol
Topological Polar Surface Area94.5 Ų
Heavy Atom Count32
Formal Charge0
Complexity646
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameMycophenolate mofetil hydrochloride
Drug LabelCellCept (mycophenolate mofetil) is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor.The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6...
Active IngredientMycophenolate mofetil hydrochloride
Dosage FormInjectable
Routeinjection
Strength500mg
Market StatusTentative Approval
CompanyBedford Labs

2 of 2  
Drug NameMycophenolate mofetil hydrochloride
Drug LabelCellCept (mycophenolate mofetil) is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor.The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6...
Active IngredientMycophenolate mofetil hydrochloride
Dosage FormInjectable
Routeinjection
Strength500mg
Market StatusTentative Approval
CompanyBedford Labs

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

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.)


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.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Antimetabolite Immunosuppressant [EPC]

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ABOUT THIS PAGE

Mycophenolate Mofetil Hydrochloride Manufacturers

A Mycophenolate Mofetil Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mycophenolate Mofetil Hydrochloride, including repackagers and relabelers. The FDA regulates Mycophenolate Mofetil Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mycophenolate Mofetil Hydrochloride 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 Mofetil Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Mycophenolate Mofetil Hydrochloride Suppliers

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

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

Mycophenolate Mofetil Hydrochloride USDMF

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

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

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

Mycophenolate Mofetil Hydrochloride 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 Mofetil Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Mycophenolate Mofetil Hydrochloride 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 Mofetil Hydrochloride 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 Mofetil Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Mycophenolate Mofetil Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

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

Mycophenolate Mofetil Hydrochloride GMP

Mycophenolate Mofetil Hydrochloride 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 Mofetil Hydrochloride 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 Mofetil Hydrochloride GMP manufacturer or Mycophenolate Mofetil Hydrochloride GMP API supplier for your needs.

Mycophenolate Mofetil Hydrochloride CoA

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

Mycophenolate Mofetil Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Mycophenolate Mofetil Hydrochloride 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 Mofetil Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Mycophenolate Mofetil Hydrochloride EP), Mycophenolate Mofetil Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mycophenolate Mofetil Hydrochloride 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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