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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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Mycophenolic Acid

About the Company : Zhejiang Hisun Chemical Co., Ltd (hereafter called as ”Hisun Chemical), founded in 1998, is a state-holding enterprise invested by State Development & Investment Corporation(SDIC...

Zhejiang Hisun Chemical Co., Ltd (hereafter called as ”Hisun Chemical), founded in 1998, is a state-holding enterprise invested by State Development & Investment Corporation(SDIC), Zhejiang Hisun Group and ZMC Co., Ltd. The company now covers an area of 312,000 square meters and 35% of its staff members are technicians. With its total assets of nearly USD 60 million, Hisun Chemical has created a niche in agrochemical field through its sustainable researching, marketing efforts and strong distribution network. The company, with its headquarter located in Taizhou, Zhejiang, now has two wholly-owned subsidiary companies , two Sino-foreign joint ventures and one Provincial Hi-tech R&D Centre. Since it was established, Hisun Chemical has already passed ISO9000 & ISO14000 and gained lots of honors like “First AA-level Credit Enterprise of China Pesticide Industry” and “National Hi-tech Enterprise”, etc. Its product, Abamectin has also gained such awards as ”First Prize of S&T Advance Award of China Chemical Industry”, “Major Achievements in National Technologies R&D Program of the 8th Five-year plan of China” and “ Outstanding Project Award in National Technology Innovation Program of the 8th Five-year of China”. Meanwhile, Hisun Chemical has also undertaken the project of Emamectin Benzoate in National Key Technologies R&D program of the 9th Five-year plan of China. And Ascomycin, a kind of its biofungicides, has been listed in “National S&T Pillar Program of Technical Material Development in the 11th Five-year plan of China.” Based on full implement of EHS system and high quality product, Hisun Chemical has been one of the suppliers to many multinational companies, like Bayer, Syngenta, Boehringer Ingelheim and Cheminova, establishing long term business relationship with them. Hisun Chemical exports 85% of its products, ranging from Insecticides, Herbicides to Fungicides, directly to more than 50 countries over the world. Among those products, its patented products such as Oxine copper 33.5% SC & Flazasulfuron have obtained exclusive registration in China. Hisun Chemical adheres to “For Shareholders, For Staff, For Community” as its management purpose, “Honesty, Innovation, Collaboration& Diligence” as its core values, and “Broad Mind& Integrity” as its spirit. With advanced technology, and R&D, Hisun Chemical will strive to become a representative of Agrochemical, Pharmaceutical &Animal Health Field in the 21st century. Our Group-ZHEJIANG HISUN GROUP The original name of Hisun is HaiMen Pharmaceutical Company founded in 1956 and changed her name at 1997 to Zhejiang Hisun Group. Hisun is located in Taizhou, which is a scenic and coastal city at East Sea in China and is part of the southern tip of Shanghai Economic Zone. It contains 100 hectare area and there are more than 3000 employees. Hisun is ranked in the top 520 key enterprises in China, total asset of Hisun has reached RMB 1.6 billion, there is a national R&D center in Hisun and more than 30% of its staff are technician. Hisun has developed into the largest antibiotic and antineoplastic manufacturer and become a reputed one of main chemical production bases in China. There are three main subsidiary companies under Hisun Group which are Hisun pharmaceutical has been listed in SSE, Hisun Chemical and Hisun thermoelectricity. T products of Hisun have been approved and certified by FDA of U.S.A. meanwhile Hisun have got the approvals of ISO9001, ISO9002 and ISO14000. Hisun exports 80% of its products to approximately 100 countries all over the world, the products performance has been approved by domestic and international consumers.
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01-Jan-2022
16-Apr-2025
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ABOUT THIS PAGE

Looking for 24280-93-1 / Mycophenolic Acid API manufacturers, exporters & distributors?

Mycophenolic Acid manufacturers, exporters & distributors 1

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

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Mycophenolic Acid manufacturer or Mycophenolic Acid supplier.

PharmaCompass also assists you with knowing the Mycophenolic Acid API Price utilized in the formulation of products. Mycophenolic Acid API Price is not always fixed or binding as the Mycophenolic Acid Price is obtained through a variety of data sources. The Mycophenolic Acid Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

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.

MOA Manufacturers

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

MOA Suppliers

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

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

MOA USDMF

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

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

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

MOA CEP

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

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

MOA 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 MOA as an active pharmaceutical ingredient (API).

Finished drug products

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

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

MOA GMP

MOA 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 MOA 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 MOA GMP manufacturer or MOA GMP API supplier for your needs.

MOA CoA

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

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

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