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    Chemistry

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    Also known as: 24280-93-1, Mycophenolate, Myfortic, Melbex, Mycophenolsaeure, 483-60-3
    Molecular Formula
    C17H20O6
    Molecular Weight
    320.3  g/mol
    InChI Key
    HPNSFSBZBAHARI-RUDMXATFSA-N
    FDA UNII
    HU9DX48N0T
    Mycophenolic Acid
    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.
    Mycophenolic acid is an Antimetabolite Immunosuppressant.
    1 2D Structure

    Mycophenolic Acid

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1H-2-benzofuran-5-yl)-4-methylhex-4-enoic acid
    2.1.2 InChI
    InChI=1S/C17H20O6/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)/b9-4+
    2.1.3 InChI Key
    HPNSFSBZBAHARI-RUDMXATFSA-N
    2.1.4 Canonical SMILES
    CC1=C2COC(=O)C2=C(C(=C1OC)CC=C(C)CCC(=O)O)O
    2.1.5 Isomeric SMILES
    CC1=C2COC(=O)C2=C(C(=C1OC)C/C=C(\C)/CCC(=O)O)O
    2.2 Other Identifiers
    2.2.1 UNII
    HU9DX48N0T
    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. Mycophenolate, Sodium

    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. 24280-93-1

    2. Mycophenolate

    3. Myfortic

    4. Melbex

    5. Mycophenolsaeure

    6. 483-60-3

    7. Lilly-68618

    8. 6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-5-phthalanyl)-4-methyl-4-hexenoic Acid

    9. Nsc-129185

    10. Acido Micofenolico

    11. Micofenolico Acido

    12. Acide Mycophenolique

    13. Acidum Mycophenolicum

    14. (4e)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydro-2-benzofuran-5-yl)-4-methylhex-4-enoic Acid

    15. Ccris 5565

    16. Nsc 129185

    17. Ly 68618

    18. (e)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-5-phthalanyl)-4-methyl-4-hexenoic Acid

    19. (e)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoic Acid

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

    21. Mfcd00036814

    22. Lilly 68618

    23. 4-hexenoic Acid, 6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-, (e)-

    24. Chembl866

    25. Hu9dx48n0t

    26. 6-(1,3-dihydro-7-hydroxy-5-methoxy-4-methyl-1-oxoisobenzofuran-6-yl)-4-methyl-4-hexanoic Acid

    27. Chebi:168396

    28. Tnp00198

    29. Rs-61443 [as Mofetil]

    30. Nsc129185

    31. 4-hexenoic Acid, 6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-5-phthalanyl)-4-methyl-, (e)-

    32. 4-methyl-5-methoxy-7-hydroxy-6-(5-carboxy-3-methylpent-2-en-1-yl)-phthalide (e)-

    33. 6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methylhex-4-enoic Acid

    34. 6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-5-phthalanyl)-4-methyl-4-hexenoic Acid (e)-

    35. 4-hexenoic Acid, 6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-, (4e)-

    36. Ncgc00016786-01

    37. Cas-24280-93-1

    38. Mycophenolic Acid 100 Microg/ml In Acetonitrile

    39. Dsstox_cid_21070

    40. Dsstox_rid_79619

    41. Dsstox_gsid_41070

    42. Mycophenolic Acid-d3 Solution

    43. Mycophenoic Acid

    44. 6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1h-isobenzofuran-5-yl)-4-methyl-4-hexenoic Acid

    45. Micofenolico Acido [spanish]

    46. (4e)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoic Acid (mycophenolic Acid)

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

    48. 4-hexenoic Acid,6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-, (4e)-

    49. 6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoic Acid

    50. 6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoic Acid

    51. Moa

    52. Smr000471887

    53. Acido Micofenolico [inn-spanish]

    54. Acide Mycophenolique [inn-french]

    55. Acidum Mycophenolicum [inn-latin]

    56. Sr-01000597602

    57. Einecs 246-119-3

    58. Unii-hu9dx48n0t

    59. Mycophenolic-acid

    60. Prestwick_817

    61. Einecs 207-595-8

    62. Mycophenolic Acid [usan:inn:ban]

    63. Tocris-1505

    64. (z)-mycophenolic Acid

    65. 1jr1

    66. Starbld0040186

    67. Mycophenolic Acid (tn)

    68. Prestwick2_000556

    69. Prestwick3_000556

    70. Spectrum5_001654

    71. Mycophenolic Acid (mpa)

    72. Mycophenolic Acid Solution

    73. Upcmld-dp028

    74. 4-hexenoic Acid, (e)-

    75. Ec 246-119-3

    76. Mycophenolate;rs-61443

    77. Schembl4549

    78. Mycophenolic (mycophenolate)

    79. Mycophenolic Acid, >=98%

    80. Bspbio_000631

    81. Bspbio_002534

    82. Mycophenolate [vandf]

    83. Mls001074701

    84. Mls002222265

    85. Mls002695945

    86. Bidd:gt0456

    87. Spectrum1500674

    88. Mycophenolic Acid [mi]

    89. Bpbio1_000695

    90. Gtpl6832

    91. Megxm0_000120

    92. Mycophenolic Acid (usan/inn)

    93. Myfortic (mycophenolate Sodium)

    94. Schembl2514376

    95. Zinc1758

    96. Mycophenolic Acid [inn]

    97. Dtxsid4041070

    98. Mycophenolic Acid [usan]

    99. Upcmld-dp028:001

    100. Acon0_000960

    101. Acon1_000496

    102. Bdbm19264

    103. Chebi:92545

    104. Hms500h08

    105. Ex-a975

    106. Mycophenolic Acid [vandf]

    107. Mycophenolic Acid [mart.]

    108. Hms1569p13

    109. Hms1921a18

    110. Hms2089a17

    111. Hms2092g22

    112. Hms2096p13

    113. Hms2268h22

    114. Hms3403p09

    115. Hms3412f09

    116. Hms3676f09

    117. Pharmakon1600-01500674

    118. Mycophenolic Acid [who-dd]

    119. Act02623

    120. Amy40494

    121. Bcp05321

    122. Hy-b0421

    123. Tox21_110610

    124. Bbl034696

    125. Ccg-39914

    126. Nsc757424

    127. S2487

    128. Stl419986

    129. Mycophenolic Acid, Analytical Standard

    130. Akos015888214

    131. Tox21_110610_1

    132. Ac-4491

    133. Bcp9000970

    134. Db01024

    135. Ds-1638

    136. Mycophenolic Acid [orange Book]

    137. Nsc-757424

    138. Sdccgmls-0066618.p001

    139. (e)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1h-isobenzofuran-5-yl)-4-methyl-hex-4-enoic Acid

    140. Idi1_000146

    141. Ncgc00016786-02

    142. Ncgc00016786-03

    143. Ncgc00016786-04

    144. Ncgc00016786-05

    145. Ncgc00016786-06

    146. Ncgc00016786-07

    147. Ncgc00016786-08

    148. Ncgc00016786-09

    149. Ncgc00016786-10

    150. Ncgc00016786-11

    151. Ncgc00016786-12

    152. Ncgc00016786-15

    153. Ncgc00025190-01

    154. Ncgc00025190-02

    155. Ncgc00025190-03

    156. Ncgc00025190-04

    157. Ncgc00025190-05

    158. Ncgc00025190-07

    159. Ncgc00025190-08

    160. Ncgc00025190-09

    161. Ncgc00025190-10

    162. (4e)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxohydroisobenzofuran-5-yl)-4-methylhex -4-enoic Acid

    163. Bm164624

    164. Mycophenolic Acid - Cas 24280-93-1

    165. Sbi-0051945.p003

    166. A-249

    167. M2216

    168. Sw196951-2

    169. C20380

    170. D05096

    171. M 5255

    172. M02087

    173. Ab00052466-13

    174. Ab00052466-14

    175. Ab00052466_15

    176. Ab00052466_16

    177. 280m931

    178. A817192

    179. Mycophenolate Mofetil Impurity, Mycophenolic Acid-

    180. Q420553

    181. Sr-01000597602-1

    182. Sr-01000597602-3

    183. Sr-01000597602-4

    184. Brd-k63750851-001-06-6

    185. Brd-k63750851-001-13-2

    186. Mycophenolate Mofetil Impurity F [ep Impurity]

    187. Mycophenolate Mofetil Impurity, Mycophenolic Acid- [usp Impurity]

    188. Mycophenolic Acid, Powder, Bioreagent, Suitable For Cell Culture, >=98%

    189. 6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-5-phthalanyl)-4-methyl-4-hexenoic Acid;nsc 129185

    190. 6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-5-phthanlanyl)-4-methyl-4-hexanoic Acid

    191. (e)-6-(1,3-dihydro-4-hydroxy-6- Methoxy-7-methyl-3-oxoisobenzofuran-5-yl)-4-methyl-4-hexenoic Acid

    192. (e)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxoisobenzofuran-5-yl)-4-methyl-4-hexenoic Acid

    193. 1162256-90-7

    194. 4-hexenoic Acid, 6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-, (4e)- (9ci)

    195. 4-hexenoic Acid, 6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-5-phthalanyl)-4-methyl-, (e)- (8ci)

    196. 4-hexenoic Acid,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5- Isobenzofuranyl)-4-methyl-, (e)-

    197. 4-methyl-6-[3-oxo-7-methyl-4-hydroxy-6-methoxy-1,3-dihydroisobenzofuran-5-yl]-4-hexenoic Acid

    198. E-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoic Acid

    199. Mycophenolic Acid Solution, 1.0 Mg/ml In Acetonitrile, Ampule Of 1 Ml, Certified Reference Material

    2.4 Create Date
    2005-03-26
    3 Chemical and Physical Properties
    Molecular Weight 320.3 g/mol
    Molecular Formula C17H20O6
    XLogP33.2
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count6
    Rotatable Bond Count6
    Exact Mass320.12598835 g/mol
    Monoisotopic Mass320.12598835 g/mol
    Topological Polar Surface Area93.1 Ų
    Heavy Atom Count23
    Formal Charge0
    Complexity486
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count1
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameMycophenolic acid
    PubMed HealthMycophenolate
    Drug ClassesImmune Suppressant
    Drug LabelMycophenolic acid delayed-release tablets are an enteric formulation of mycophenolate sodium that delivers the active moiety mycophenolic acid (MPA). Mycophenolic acid is an immunosuppressive agent. As the sodium salt, MPA is chemically designated as...
    Active IngredientMycophenolic acid
    Dosage FormTablet, delayed release
    RouteOral
    Strength180mg; 360mg
    Market StatusPrescription
    CompanyMylan Pharms; Apotex

    2 of 4  
    Drug NameMyfortic
    Active IngredientMycophenolic acid
    Dosage FormTablet, delayed release
    RouteOral
    Strength180mg; 360mg
    Market StatusPrescription
    CompanyNovartis

    3 of 4  
    Drug NameMycophenolic acid
    PubMed HealthMycophenolate
    Drug ClassesImmune Suppressant
    Drug LabelMycophenolic acid delayed-release tablets are an enteric formulation of mycophenolate sodium that delivers the active moiety mycophenolic acid (MPA). Mycophenolic acid is an immunosuppressive agent. As the sodium salt, MPA is chemically designated as...
    Active IngredientMycophenolic acid
    Dosage FormTablet, delayed release
    RouteOral
    Strength180mg; 360mg
    Market StatusPrescription
    CompanyMylan Pharms; Apotex

    4 of 4  
    Drug NameMyfortic
    Active IngredientMycophenolic acid
    Dosage FormTablet, delayed release
    RouteOral
    Strength180mg; 360mg
    Market StatusPrescription
    CompanyNovartis

    4.2 Drug Indication

    For the prophylaxis of organ rejection in patients receiving allogeneic renal transplants, administered in combination with cyclosporine and corticosteroids.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Mycophenolic acid is an antibiotic substance derived from Penicillium stoloniferum. It blocks de novo biosynthesis of purine nucleotides by inhibition of the enzyme inosine monophosphate dehydrogenase. Mycophenolic acid is important because of its selective effects on the immune system. It prevents the proliferation of T-cells, lymphocytes, and the formation of antibodies from B-cells. It also may inhibit recruitment of leukocytes to inflammatory sites.

    5.2 MeSH Pharmacological Classification

    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.)

    Antibiotics, Antineoplastic

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

    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.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    MYCOPHENOLIC ACID
    5.3.2 FDA UNII
    HU9DX48N0T
    5.3.3 Pharmacological Classes
    Antimetabolite Immunosuppressant [EPC]
    5.4 ATC Code

    L - Antineoplastic and immunomodulating agents

    L04 - Immunosuppressants

    L04A - Immunosuppressants

    L04AA - Selective immunosuppressants

    L04AA06 - Mycophenolic acid

    5.5 Absorption, Distribution and Excretion

    Absorption

    Bioavailability following oral administration of Myfortic delayed-release tablet ranges from 70-95%

    Volume of Distribution

    54 25 L

    Clearance

    140 +/- 30 mL/min [Stable renal transplant patients]

    5.6 Metabolism/Metabolites

    Mycophenolic acid is metabolized mainly by glucuronyl transferase to glucuronidated metabolites, predominantly the phenolic glucuronide, mycophenolic acid glucuronide (MPAG). MPAG does not manifest pharmacological activity. The acyl glucuronide minor metabolite has pharmacological activity similar to mycophenolic acid. The AUC ratio of Mycophenolic acid:MPAG:acyl glucuronide is approximately 1:24:0.28 at steady state.

    Mycophenolic acid has known human metabolites that include 6-O-desmethyl-MPA (DM-MPA) and Mycophenolic acid glucuronide.

    S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560

    5.7 Biological Half-Life

    The mean elimination half-life for mycophenolic acid ranges from 8-16 hours, while that of the MPAG metabolite ranges from 13-17 hours.

    5.8 Mechanism of Action

    Mycophenolic acid is a potent, selective, uncompetitive, and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), and therefore inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation into DNA. Because T- and B-lymphocytes are critically dependent for their proliferation on de novo synthesis of purines, whereas other cell types can utilize salvage pathways, mycophenolic acid has potent cytostatic effects on lymphocytes. Mycophenolic acid inhibits proliferative responses of T- and B-lymphocytes to both mitogenic and allospecific stimulation. Addition of guanosine or deoxyguanosine reverses the cytostatic effects of mycophenolic acid on lymphocytes. Mycophenolic acid also suppresses antibody formation by B-lymphocytes. Mycophenolic acid prevents the glycosylation of lymphocyte and monocyte glycoproteins that are involved in intercellular adhesion to endothelial cells and may inhibit recruitment of leukocytes into sites of inflammation and graft rejection.

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    ABOUT THIS PAGE

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    API | Excipient name

    Mycophenolic Acid

    Synonyms

    24280-93-1, Mycophenolate, Myfortic, Melbex, Mycophenolsaeure, 483-60-3

    Cas Number

    24280-93-1

    Unique Ingredient Identifier (UNII)

    HU9DX48N0T

    About Mycophenolic Acid

    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.

    Mycophenolic Acid Manufacturers

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

    Mycophenolic Acid Suppliers

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

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

    Mycophenolic Acid USDMF

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

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

    click here to find a list of Mycophenolic Acid suppliers with USDMF on PharmaCompass.

    Mycophenolic Acid CEP

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

    A Mycophenolic Acid CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Mycophenolic Acid 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 Mycophenolic Acid suppliers with CEP (COS) on PharmaCompass.

    Mycophenolic Acid 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 Mycophenolic Acid as an active pharmaceutical ingredient (API).

    Finished drug products

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

    click here to find a list of Mycophenolic Acid suppliers with NDC on PharmaCompass.

    Mycophenolic Acid GMP

    Mycophenolic Acid 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 Mycophenolic Acid 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 Mycophenolic Acid GMP manufacturer or Mycophenolic Acid GMP API supplier for your needs.

    Mycophenolic Acid CoA

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

    Mycophenolic Acid CoA mostly includes findings from lab analyses of a specific batch. For each Mycophenolic Acid 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.

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