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    Chemistry

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    Also known as: Mitomycin, 50-07-7, Ametycine, Mutamycin, Mitomycin-c, Mitocin-c
    Molecular Formula
    C15H18N4O5
    Molecular Weight
    334.33  g/mol
    InChI Key
    NWIBSHFKIJFRCO-WUDYKRTCSA-N
    FDA UNII
    50SG953SK6
    Mitomycin
    An antineoplastic antibiotic produced by Streptomyces caespitosus. It is one of the bi- or tri-functional ALKYLATING AGENTS causing cross-linking of DNA and inhibition of DNA synthesis.
    Mitomycin is an Alkylating Drug. The mechanism of action of mitomycin is as an Alkylating Activity.
    1 2D Structure

    Mitomycin

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    [(4S,6S,7R,8S)-11-amino-7-methoxy-12-methyl-10,13-dioxo-2,5-diazatetracyclo[7.4.0.02,7.04,6]trideca-1(9),11-dien-8-yl]methyl carbamate
    2.1.2 InChI
    InChI=1S/C15H18N4O5/c1-5-9(16)12(21)8-6(4-24-14(17)22)15(23-2)13-7(18-13)3-19(15)10(8)11(5)20/h6-7,13,18H,3-4,16H2,1-2H3,(H2,17,22)/t6-,7+,13+,15-/m1/s1
    2.1.3 InChI Key
    NWIBSHFKIJFRCO-WUDYKRTCSA-N
    2.1.4 Canonical SMILES
    CC1=C(C(=O)C2=C(C1=O)N3CC4C(C3(C2COC(=O)N)OC)N4)N
    2.1.5 Isomeric SMILES
    CC1=C(C(=O)C2=C(C1=O)N3C[C@H]4[C@@H]([C@@]3([C@@H]2COC(=O)N)OC)N4)N
    2.2 Other Identifiers
    2.2.1 UNII
    50SG953SK6
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Ametycine

    2. Mitocin C

    3. Mitocin-c

    4. Mitocinc

    5. Mitomycin

    6. Mitomycin-c

    7. Mutamycin

    8. Nsc 26980

    9. Nsc-26980

    10. Nsc26980

    2.3.2 Depositor-Supplied Synonyms

    1. Mitomycin

    2. 50-07-7

    3. Ametycine

    4. Mutamycin

    5. Mitomycin-c

    6. Mitocin-c

    7. Mytozytrex

    8. Ametycin

    9. Mitomycinum

    10. Mytomycin

    11. Mitozytrex

    12. Mitamycin

    13. Mitosol

    14. Mmc

    15. Nsc-26980

    16. Muamycin

    17. 7-amino-9alpha-methoxymitosane

    18. C15h18n4o5

    19. Nsc 26980

    20. Mitomycyna C

    21. Nci-c04706

    22. Mito-c

    23. Nsc26980

    24. Mit-c

    25. Mitomycinum C

    26. Mitocin C

    27. Chebi:27504

    28. Rcra Waste Number U010

    29. Ugn-101

    30. Ugn-102

    31. 50sg953sk6

    32. Mitomycyna C [polish]

    33. 6-amino-1,1a,2,8,8a,8b-hexahydro-8-(hydroxymethyl)-8a-methoxy-5-methylazirino(2',3':3,4)pyrrolo(1,2-a)indole-4,7-dione Carbamate (ester)

    34. Dsstox_cid_898

    35. Dsstox_rid_75853

    36. Dsstox_gsid_20898

    37. Mitomycin (tn)

    38. [(1as,8s,8ar,8bs)-6-amino-8a-methoxy-5-methyl-4,7-dioxo-1,1a,2,4,7,8,8a,8b-octahydroazireno[2',3':3,4]pyrrolo[1,2-a]indol-8-yl]methyl Carbamate

    39. [(4s,6s,7r,8s)-11-amino-7-methoxy-12-methyl-10,13-dioxo-2,5-diazatetracyclo[7.4.0.0^{2,7}.0^{4,6}]trideca-1(9),11-dien-8-yl]methyl Carbamate

    40. Azirino[2',3':3,4]pyrrolo[1,2-a]indole-4,7-dione, 6-amino-8-[[(aminocarbonyl)oxy]methyl]-1,1a,2,8,8a,8b-hexahydro-8a-methoxy-5-methyl-, (1as,8s,8ar,8bs)-

    41. Cas-50-07-7

    42. Muamycin (tn)

    43. ((1as,8s,8ar,8bs)-6-amino-8a-methoxy-5-methyl-4,7-dioxo-1,1a,2,4,7,8,8a,8b-octahydroazirino[2',3':3,4]pyrrolo[1,2-a]indol-8-yl)methyl Carbamate

    44. [1as-(1a?,8?,8a?,8b?)]-6-amino-8-[[(aminocarbonyl)oxy]methyl]-1,1a,2,8,8a,8b-hexahydro-8a-methoxy-5-methylazirino[2',3':3,4]pyrrolo[1,2-a]indole-4,7-dione

    45. Azirino(2',3':3,4)pyrrolo(1,2-a)indole-4,7-dione, 6-amino-8-(((aminocarbonyl)oxy)methyl)-1,1a,2,8,8a,8b-hexahydro-8a-methoxy-5-methyl-, (1as,8s,8ar,8bs)-

    46. Ccris 414

    47. Hsdb 3239

    48. Mitomycin (usp/inn)

    49. Mls002702984

    50. (amino-methoxy-methyl-dioxo-[?]yl)methyl Carbamate

    51. Einecs 200-008-6

    52. Rcra Waste No. U010

    53. 7-amino-9.alpha.-methoxymitosane

    54. Mitonco

    55. Mitoplus

    56. Mitoextra

    57. Unii-50sg953sk6

    58. Ai3-26199

    59. Mitomycin [usan:usp:inn:ban]

    60. Ncgc00095258-01

    61. [(1as,8s,8ar,8bs)-6-amino-8a-methoxy-5-methyl-4,7-dioxo-1,1a,2,4,7,8,8a,8b-octahydroazirino[2'',3'':3,4]pyrrolo[1,2-a]indol-8-yl]methyl Carbamate

    62. [(1as,8s,8ar,8bs)-6-amino-8a-methoxy-5-methyl-4,7-dioxo-1,1a,2,4,7,8,8a,8b-octahydroazirino[2',3':3,4]pyrrolo[1,2-a]indol-8-yl]methyl Carbamate

    63. Azirino(2',3':3,4)pyrrolo(1,2-a)indole-4,7-dione, 6-amino-1,1a,2,8,8a,8b-hexahydro-8-(hydroxymethyl)-8a-methoxy-5-methyl-, Carbamate (ester)

    64. Jelmyto (tn)

    65. Mfcd00078109

    66. Jelmyto

    67. Mitomycin C- Bio-x

    68. Azirino(2',3':3,4)pyrrolo(1,2-a)indole-4,7-dione, 6-amino-8-(((aminocarbonyl)oxy)methyl)-1,1a,2,8,8a,8b-hexahydro-8a-methoxy-5-methyl-, (1as-(1aalpha,8beta,8aalpha,8balpha))-

    69. Mitomycin C From Streptomyces Caespitosus

    70. Mitomycin [inn]

    71. Mitomycin C (jp17)

    72. Mitomycin [hsdb]

    73. Mitomycin [usan]

    74. Mitomycin [vandf]

    75. Mitomycin C [mi]

    76. Chembl105

    77. Mitomycin [mart.]

    78. Mitomycin C [jan]

    79. Mitomycin [usp-rs]

    80. Mitomycin [who-dd]

    81. Mitomycin C [iarc]

    82. Schembl3760

    83. Cbiol_001927

    84. Bspbio_001267

    85. Kbiogr_000607

    86. Kbioss_000607

    87. Mitomycin C (4% In Nacl)

    88. Mls001332654

    89. Mitozytrex (tn) (supergene)

    90. 50-07-7 (non-salt)

    91. Ametycin Pound Notmitomycin C

    92. Gtpl7089

    93. Mitomycin [orange Book]

    94. Dtxsid2020898

    95. Mitomycin [ep Monograph]

    96. Kbio2_000607

    97. Kbio2_003175

    98. Kbio2_005743

    99. Kbio3_001073

    100. Kbio3_001074

    101. Ex-a501

    102. Mitomycin [usp Monograph]

    103. Bcpp000410

    104. Bio1_000213

    105. Bio1_000702

    106. Bio1_001191

    107. Bio2_000464

    108. Bio2_000944

    109. Hms1362o09

    110. Hms1792o09

    111. Hms1990o09

    112. Hms2089f16

    113. Hms3403o09

    114. Amy10316

    115. Azirino(2',3':3,4)pyrrolo(1,2-a)indole-4,7-dione, 6-amino-8-(((aminocarbonyl)oxy)methyl)-1,1a,2,8,8a,8b-hexahydro-8a-methoxy-5-methyl-, (1as-(1a.alpha.,8.beta.,8a.alpha.,8b.alpha.))-

    116. Tox21_111493

    117. Ac-918

    118. Bdbm50428658

    119. Gr-311

    120. S8146

    121. Zinc30726187

    122. Akos015895703

    123. Tox21_111493_1

    124. Bcp9000285

    125. Ccg-208564

    126. Cs-0564

    127. Db00305

    128. Ks-5148

    129. Idi1_002219

    130. Smp1_000307

    131. Mitomycin 100 Microg/ml In Acetonitrile

    132. Ncgc00163468-02

    133. Ncgc00163468-03

    134. Ncgc00163468-05

    135. Ncgc00163468-06

    136. 1404-00-8

    137. Bm164668

    138. Hy-13316

    139. Smr000058401

    140. Bcp0726000181

    141. M2320

    142. C06681

    143. D00208

    144. D91590

    145. Ab00918689-03

    146. Ab00918689-04

    147. 078m109

    148. Mitomycin C, Antibiotic For Culture Media Use Only

    149. Q-201410

    150. Brd-k59670716-001-02-6

    151. Brd-k59670716-001-06-7

    152. Q19856779

    153. Wln: T D3 B556 Bn Em Jv Mvttt&j Go1 H1ovz Kz L1

    154. Mitomycin C From Streptomyces Caespitosus, >=970 Mug/mg (usp Xxiv)

    155. Mitomycin C From Streptomyces Caespitosus, Powder, Bioreagent, Suitable For Cell Culture

    156. Mitomycin C From Streptomyces Caespitosus, Powder, Contains Nacl As Solubilizer

    157. Azirino[2',4]pyrrolo[1,2-a]indole-4,7-dione, 6-amino-1,1a,2,8,8a,8b-hexahydro-8-(hydroxymethyl)-8a- Methoxy-5-methyl-, Carbamate (ester)

    158. Azirino[2',4]pyrrolo[1,2-a]indole-4,7-dione, 6-amino-8-[[(aminocarbonyl)oxy]methyl]-1,1a,2,8,8a,8b- Hexahydro-8a-methoxy-5-methyl-, [1ar-(1a.alpha.,8.beta.,8a.alpha.,8b.alpha.)]-

    159. Mitomycin C From Streptomyces Caespitosus, >=98% (hplc), Potency: >=970 Mug Per Mg (usp Xxiv), Gamma-irradiated, Suitable For Cell Culture

    2.4 Create Date
    2004-09-16
    3 Chemical and Physical Properties
    Molecular Weight 334.33 g/mol
    Molecular Formula C15H18N4O5
    XLogP3-0.4
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count4
    Exact Mass334.12771969 g/mol
    Monoisotopic Mass334.12771969 g/mol
    Topological Polar Surface Area147 Ų
    Heavy Atom Count24
    Formal Charge0
    Complexity757
    Isotope Atom Count0
    Defined Atom Stereocenter Count4
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameMitomycin
    PubMed HealthMitomycin
    Drug ClassesAntibiotic, Antineoplastic Agent
    Drug LabelMitomycin (also known as mitomycin and/or mitomycin-C) is an antibiotic isolated from the broth of Streptomyces caespitosus which has been shown to have antitumor activity. The compound is heat stable, has a high melting point, and is freely soluble...
    Active IngredientMitomycin
    Dosage FormInjectable
    RouteInjection
    Strength5mg/vial; 20mg/vial; 40mg/vial
    Market StatusPrescription
    CompanyBedford; Accord Hlthcare; Hikma Maple

    2 of 4  
    Drug NameMitosol
    Active IngredientMitomycin
    Dosage FormFor solution
    RouteTopical
    Strength0.2mg/vial
    Market StatusPrescription
    CompanyMobius Therap

    3 of 4  
    Drug NameMitomycin
    PubMed HealthMitomycin
    Drug ClassesAntibiotic, Antineoplastic Agent
    Drug LabelMitomycin (also known as mitomycin and/or mitomycin-C) is an antibiotic isolated from the broth of Streptomyces caespitosus which has been shown to have antitumor activity. The compound is heat stable, has a high melting point, and is freely soluble...
    Active IngredientMitomycin
    Dosage FormInjectable
    RouteInjection
    Strength5mg/vial; 20mg/vial; 40mg/vial
    Market StatusPrescription
    CompanyBedford; Accord Hlthcare; Hikma Maple

    4 of 4  
    Drug NameMitosol
    Active IngredientMitomycin
    Dosage FormFor solution
    RouteTopical
    Strength0.2mg/vial
    Market StatusPrescription
    CompanyMobius Therap

    4.2 Therapeutic Uses

    Antibiotics, Antineoplastic; Nucleic Acid Synthesis Inhibitors

    National Library of Medicine's Medical Subject Headings online file (MeSH, 1999)

    Mitomycin is useful for the palliative treatment of gastric adenocarcinoma, in conjunction with fluorouracil and doxorubicin. It has produced temporary beneficial effects in carcinomas of the cervix, colon, rectum, pancreas, breast, bladder, head and neck, and lung, and in melanoma. It has also shown activity against lymphomas and leukemia, particularly chronic granulocytic leukemia, but not in myeloma.

    Gilman, A.G., T.W. Rall, A.S. Nies and P. Taylor (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 8th ed. New York, NY. Pergamon Press, 1990., p. 1247

    Thirty patients with advanced colorectal adenocarcinoma were treated by chemotherapy with an alternating regimen consisting of 5-fluorouracil mitomycin C and 5-fluorouracil dacarbazine at 3 wk intervals. ... The toxicity of this regimen was essentially digestive with 30% of grade 3 or 4 nausea and vomiting. In spite of the reported active and synergistic action of drug association in colorectal carcinoma, this treatment schedule is not better than 5-fluorouracil alone. Gastrointestinal toxicity was incr.

    PMID:2496369 Herait P et al; Oncology 46 (2): 88-90 (1989)

    Forty-two patients with metastatic breast cancer refractory to first line therapies were treated with combination chemotherapy with mitomycin-C and vinblastine. ... The toxicity was acceptable with 20 episodes of moderate myelosuppression (58.8%) and 2 cases with congestive heart failure that responded to medical treatment.

    PMID:2497417 Navarro M et al; Oncology 46 (3): 137-42 (1989)

    For more Therapeutic Uses (Complete) data for MITOMYCIN C (19 total), please visit the HSDB record page.

    4.3 Drug Warning

    Mitomycin is contraindicated in patients with pre-existing myelosupression & anemia.

    Knoben, J.E. and P.O. Anderson (eds.) Handbook of Clinical Drug Data. 6th ed. Bethesda, MD: Drug Intelligence Publications, Inc. 1988., p. 417

    Because normal defense mechanisms may be suppressed by mitomycin therapy, the patient's antibody response to the vaccine may be decreased. The interval between discontinuation of medications that cause immunosuppression and restoration of the patient's ability to respond to the vaccine depends on the intensity and type of immunosuppression-causing medication used, the underlying disease, and other factors; estimates vary from 3 months to 1 year.

    USP Convention. USPDI - Drug Information for the Health Care Professional. 16th ed. Volume I. Rockville, MD: U.S. Pharmaceutical Convention, Inc. 1996 (Plus updates)., p. 2088

    cBecause normal defense mechanisms may be suppressed by mitomycin therapy, concurrent use with a live virus vaccine may potentiate the replication of the vaccine virus, may increase the side/adverse effects of the vaccine virus, and/or may decrease the patient's antibody response to the vaccine; immunization of these patients should be undertaken only with extreme caution after careful review of the patient's hematologic status and only with the knowledge and consent of the physician managing the cytarabine therapy. The interval between discontinuation of medication that cause immunosuppression and restoration of the patient's ability to respond to the vaccine depends on the intensity and type of immunosuppression-causing medications used, the underlying disease, and other factors; estimates vary from 3 months to 1 year. Patients with leukemia in remission should not receive live virus vaccine until at least 3 months after their last chemotherapy. In addition, immunization with oral polio-virus vaccine should be postponed in persons in close contact with the patient, especially family members.

    USP Convention. USPDI - Drug Information for the Health Care Professional. 16th ed. Volume I. Rockville, MD: U.S. Pharmaceutical Convention, Inc. 1996 (Plus updates)., p. 2088

    Gonadal suppression, resulting in amenorrhea or azoospermia, may occur in patients taking antineoplastic therapy, especially with the alkylating agents. In general, these effects appear to be related to dose and length of therapy and may be irreversible. Prediction of the degree of testicular or ovarian function impairment is complicated by the common use of combinations of several antineoplastics, which makes it difficult to assess the effects of individual agents.

    USP Convention. USPDI - Drug Information for the Health Care Professional. 16th ed. Volume I. Rockville, MD: U.S. Pharmaceutical Convention, Inc. 1996 (Plus updates)., p. 2087

    For more Drug Warnings (Complete) data for MITOMYCIN C (6 total), please visit the HSDB record page.

    4.4 Drug Indication

    For treatment of malignant neoplasm of lip, oral cavity, pharynx, digestive organs, peritoneum, female breast, and urinary bladder. Also used as an adjunct to ab externo glaucoma surgery. Mitomycin is also indicated as a pyelocalyceal solution for the treatment of adults with low-grade upper tract urothelial cancer (LG-UTUC).

    FDA Label

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Mitomycin is one of the older chemotherapy drugs, which has been around and in use for decades. It is an antibiotic which has been shown to have antitumor activity. Mitomycin selectively inhibits the synthesis of deoxyribonucleic acid (DNA). The guanine and cytosine content correlates with the degree of mitomycin-induced cross-linking. At high concentrations of the drug, cellular RNA and protein synthesis are also suppressed. Mitomycin has been shown in vitro to inhibit B cell, T cell, and macrophage proliferation and impair antigen presentation, as well as the secretion of interferon gamma, TNFa, and IL-2.

    5.2 MeSH Pharmacological Classification

    Alkylating Agents

    Highly reactive chemicals that introduce alkyl radicals into biologically active molecules and thereby prevent their proper functioning. Many are used as antineoplastic agents, but most are very toxic, with carcinogenic, mutagenic, teratogenic, and immunosuppressant actions. They have also been used as components in poison gases. (See all compounds classified as Alkylating Agents.)

    Antibiotics, Antineoplastic

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

    Nucleic Acid Synthesis Inhibitors

    Compounds that inhibit cell production of DNA or RNA. (See all compounds classified as Nucleic Acid Synthesis Inhibitors.)

    Cross-Linking Reagents

    Reagents with two reactive groups, usually at opposite ends of the molecule, that are capable of reacting with and thereby forming bridges between side chains of amino acids in proteins; the locations of naturally reactive areas within proteins can thereby be identified; may also be used for other macromolecules, like glycoproteins, nucleic acids, or other. (See all compounds classified as Cross-Linking Reagents.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    MITOMYCIN
    5.3.2 FDA UNII
    50SG953SK6
    5.3.3 Pharmacological Classes
    Alkylating Drug [EPC]; Alkylating Activity [MoA]
    5.4 ATC Code

    L - Antineoplastic and immunomodulating agents

    L01 - Antineoplastic agents

    L01D - Cytotoxic antibiotics and related substances

    L01DC - Other cytotoxic antibiotics

    L01DC03 - Mitomycin

    5.5 Absorption, Distribution and Excretion

    Absorption

    Erratic.

    Route of Elimination

    Approximately 10% of a dose of mitomycin is excreted unchanged in the urine.

    FOLLOWING IV INJECTION OF 2 MG/KG BODY WT ... WISTAR RATS, 18% WAS RECOVERED UNCHANGED IN URINE WITHIN 24 HR AT ... 8 MG/KG ... 35% WAS RECOVERED IN URINE, BUT NONE IN FECES OR TISSUES.

    IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work). Available at: https://monographs.iarc.fr/ENG/Classification/index.php, p. V10 174 (1976)

    THIRTY MIN AFTER IV INJECTION OF 8 MG/KG BODY WT TO MICE TRACES REMAINED IN BLOOD. IN GUINEA PIGS DRUG WAS CONCN IN KIDNEYS & NOT IN LIVER, SPLEEN OR BRAIN & WAS EXCRETED IN URINE.

    IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work). Available at: https://monographs.iarc.fr/ENG/Classification/index.php, p. V10 174 (1976)

    Mitomycin is absorbed inconsistently from the gastrointestinal tract, and it is therefore administered intravenously. It disappears rapidly from the blood after injection. Peak concentrations in plasma are 0.4 ug/ml after doses of 20 mg/m sq ... The drug is widely distributed throughout the body but is not detected in the brain.

    Gilman, A.G., T.W. Rall, A.S. Nies and P. Taylor (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 8th ed. New York, NY. Pergamon Press, 1990., p. 1247

    In animals, highest mitomycin concentrations are found in the kidneys, followed by muscles, eyes, lung, intestines, and stomach. The drug is not detectable in the liver, spleen, or brain which rapidly inactivate mitomycin. Higher concentrations of the drug are generally present in cancer tissues than in normal tissues.

    McEvoy, G.K. (ed.). AHFS Drug Information 90. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1990 (Plus Supplements 1990)., p. 537

    For more Absorption, Distribution and Excretion (Complete) data for MITOMYCIN C (9 total), please visit the HSDB record page.

    5.6 Metabolism/Metabolites

    Primarily hepatic, some in various other tissues.

    SUGGESTED ALKYLATING METABOLITES OF CARCINOGENS: MITOMYCIN C: REDUCTION PRODUCTS. /FROM TABLE/

    Searle, C. E. (ed.). Chemical Carcinogens. ACS Monograph 173. Washington, DC: American Chemical Society, 1976., p. 95

    Inactivation occurs by metabolism, but the products have not been identified. It is metabolized primarily in the liver, and less than 10% of the active drug is excreted in the urine or the bile.

    Gilman, A.G., T.W. Rall, A.S. Nies and P. Taylor (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 8th ed. New York, NY. Pergamon Press, 1990., p. 1247

    The drug is eliminated primarily by hepatic metabolism with about 20% hepatic extraction and 10-30% recovery of intact drug in the urine. Clearance is 0.3-0.4 l/hr/kg.

    IATA. Dangerous Goods Regulations. 30th ed. Montreal, Canada: International Air Transport Association. Dangerous Goods Board, January 1, 1989., p. 416

    Mitomycin disappears rapidly from the blood after intravenous injection. It is widely distributed but does not appear to cross the blood-brain barrier. Mitomycin is metabolized mainly in the liver; up to 10% of a dose is excreted unchanged in the urine.

    Reynolds, J.E.F., Prasad, A.B. (eds.) Martindale-The Extra Pharmacopoeia. 28th ed. London: The Pharmaceutical Press, 1982., p. 221

    MITOMYCIN C WAS PREFERENTIALLY ACTIVATED & METABOLIZED BY SONICATED CELL PREPARATIONS. BIOACTIVATION OF MITOMYCIN TO ALKYLATING AGENT BY EMT6 & SARCOMA 180 CELL SONICATES REQUIRED HYPOXIC CONDITIONS & NADPH-GENERATING SYSTEM.

    PMID:7388797 KENNEDY KA ET AL; CANCER RES 40 (7): 2356 (1980)

    5.7 Biological Half-Life

    8-48 min

    After doses of 20 mg/m sq ... Mitomycin is cleared from plasma with a half-time of approximately 1 hour.

    Gilman, A.G., T.W. Rall, A.S. Nies and P. Taylor (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 8th ed. New York, NY. Pergamon Press, 1990., p. 1247

    /Mitomycin/ has an alpha half-life of 5-10 min after IV injection and beta half-life of 46 min.

    Knoben, J.E. and P.O. Anderson (eds.) Handbook of Clinical Drug Data. 6th ed. Bethesda, MD: Drug Intelligence Publications, Inc. 1988., p. 416

    5.8 Mechanism of Action

    Mitomycin is activated in vivo to a bifunctional and trifunctional alkylating agent. Binding to DNA leads to cross-linking and inhibition of DNA synthesis and function. Mitomycin is cell cycle phase-nonspecific.

    ... REACTS WITH BACTERIAL DNA BUT NOT WITH ISOLATED DNA, UNLESS ... REDUCING SYSTEM IS ADDED. CROSS LINKING EFFICIENCY ... INCR IN ISOLATED BACTERIAL DNA CONTAINING INCR AMT OF CYTOSINE & GUANOSINE.

    IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work). Available at: https://monographs.iarc.fr/ENG/Classification/index.php, p. V10 175 (1976)

    ITS REDUCED FORM CONTAINS INDOLE GROUP EMBODYING ALLYLIC CARBAMATE RESIDUE. ANTIBIOTIC IS CYTOTOXIC & CARCINOGENIC BUT IS INACTIVE AS CYTOTOXIC AGENT UNLESS REDUCED ... IT ACTS AS DIFUNCTIONAL AGENT IN CROSS LINKING DNA.

    Searle, C. E. (ed.). Chemical Carcinogens. ACS Monograph 173. Washington, DC: American Chemical Society, 1976., p. 96

    The drug inhibits DNA synthesis and cross-links DNA at the N6 position of adenine and at the O6 and N2 positions of guanine. In addition, single-strand breakage of DNA is caused by reduced mitomycin; this can be prevented by free radical scavengers. Its action is most prominent during the late G1 and early S phases of the cell cycle.

    Gilman, A.G., T.W. Rall, A.S. Nies and P. Taylor (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 8th ed. New York, NY. Pergamon Press, 1990., p. 1247

    In high concentrations ... /mitomycin/ may ... inhibit RNA and protein synthesis.

    McEvoy, G.K. (ed.). AHFS Drug Information 90. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1990 (Plus Supplements 1990)., p. 537

    For more Mechanism of Action (Complete) data for MITOMYCIN C (11 total), please visit the HSDB record page.

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SOLA BRIDGE,,","city":"AHMEDABAD,GUJARAT","supplier":"TEVA API","supplierCountry":"ITALY","foreign_port":"N\/A","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.15","actualQuantity":"150","unit":"GMS","unitRateFc":"1000","totalValueFC":"151925.1","currency":"USD","unitRateINR":"83650","date":"24-Feb-2023","totalValueINR":"12547500","totalValueInUsd":"151925.1","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29419090","bill_no":"1000814","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Non-sterile","supplierPort":"N\/A","supplierAddress":"PIET HEIN BUILDING, PIET HEINKADE 1 07 1019 GM AMSTERDAM THE NEATHERLAN NETHERLANDS","customerAddress":"CORPORATE HOUSE, NR. SOLA BRIDGE,,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1678645800,"product":"MITOMYCIN","address":"6-3-865\/1\/2, FLAT NO.201,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"ZHEJIANG HISUN PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"GLAND PHARMA LIMITED","customerCountry":"INDIA","quantity":"0.60","actualQuantity":"600","unit":"GMS","unitRateFc":"255","totalValueFC":"155324.5","currency":"USD","unitRateINR":"21292.5","date":"13-Mar-2023","totalValueINR":"12775500","totalValueInUsd":"155324.5","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29419090","bill_no":"1000482","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"N\/A","customerAddress":"6-3-865\/1\/2, FLAT NO.201,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1690914600,"product":"MITOMYCIN IP","address":"304,TOWN CENTRE, ANDHERI KURLA ROAD,ANDHERI (E)","city":"MUMBAI","supplier":"APC PHARMACEUTICALS CHEMICALS LIMITED","supplierCountry":"CHINA","foreign_port":"NA","customer":"NAPROD LIFE SCIENCES","customerCountry":"INDIA","quantity":"0.04","actualQuantity":"0.04","unit":"KGS","unitRateFc":"240000","totalValueFC":"9185.7","currency":"USD","unitRateINR":"18832451.6","date":"02-Aug-2023","totalValueINR":"760907.136","totalValueInUsd":"9185.7","indian_port":"SAHAR AIR","hs_no":"29419090","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"304,TOWN CENTRE, ANDHERI KURLA ROAD,ANDHERI (E)"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1690914600,"product":"MITOMYCIN","address":"6-3-865\/1\/2, FLAT NO.201,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"ZHEJIANG HISUN PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"GLAND PHARMA LIMITED","customerCountry":"INDIA","quantity":"0.85","actualQuantity":"850","unit":"GMS","unitRateFc":"255","totalValueFC":"217047.5","currency":"USD","unitRateINR":"21152.3","date":"02-Aug-2023","totalValueINR":"17979413","totalValueInUsd":"217047.5","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29419090","bill_no":"1001453","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO.46,WAISHA ROAD,JIAOJIANG,TAIZHOU,ZHEJIANG,P.R.CHINASDNF China","customerAddress":"6-3-865\/1\/2, FLAT NO.201,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1691519400,"product":"MITOMYCIN IP","address":"304,TOWN CENTRE, ANDHERI KURLA ROAD,ANDHERI (E)","city":"MUMBAI","supplier":"APC PHARMACEUTICALS CHEMICALS LIMITED","supplierCountry":"CHINA","foreign_port":"NA","customer":"NAPROD LIFE SCIENCES","customerCountry":"INDIA","quantity":"0.06","actualQuantity":"61","unit":"GMS","unitRateFc":"225","totalValueFC":"13823.8","currency":"USD","unitRateINR":"18584.7","date":"09-Aug-2023","totalValueINR":"1145115.18","totalValueInUsd":"13823.8","indian_port":"SAHAR AIR","hs_no":"29419090","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"304,TOWN CENTRE, ANDHERI KURLA ROAD,ANDHERI (E)"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1691519400,"product":"MITOMYCIN IP","address":"304,TOWN CENTRE, ANDHERI KURLA ROAD,ANDHERI (E)","city":"MUMBAI","supplier":"APC PHARMACEUTICALS CHEMICALS LIMITED","supplierCountry":"CHINA","foreign_port":"NA","customer":"NAPROD LIFE SCIENCES","customerCountry":"INDIA","quantity":"0.10","actualQuantity":"99","unit":"GMS","unitRateFc":"225","totalValueFC":"22435.4","currency":"USD","unitRateINR":"18584.7","date":"09-Aug-2023","totalValueINR":"1858465.62","totalValueInUsd":"22435.4","indian_port":"SAHAR AIR","hs_no":"29419090","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"304,TOWN CENTRE, ANDHERI KURLA ROAD,ANDHERI (E)"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1691519400,"product":"MITOMYCIN IP","address":"304,TOWN CENTRE, ANDHERI KURLA ROAD,ANDHERI (E)","city":"MUMBAI","supplier":"APC PHARMACEUTICALS CHEMICALS LIMITED","supplierCountry":"CHINA","foreign_port":"NA","customer":"NAPROD LIFE SCIENCES","customerCountry":"INDIA","quantity":"0.37","actualQuantity":"365","unit":"GMS","unitRateFc":"225","totalValueFC":"82716.4","currency":"USD","unitRateINR":"18584.7","date":"09-Aug-2023","totalValueINR":"6851918.7","totalValueInUsd":"82716.4","indian_port":"SAHAR AIR","hs_no":"29419090","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"304,TOWN CENTRE, ANDHERI KURLA ROAD,ANDHERI (E)"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1693765800,"product":"MITOMYCIN IP","address":"304,TOWN CENTRE,","city":"MUMBAI \/ MAHARASHTRA","supplier":"APC PHARMACEUTICALS & CHEMICALS LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"NAPROD LIFE SCIENCES","customerCountry":"INDIA","quantity":"0.50","actualQuantity":"0.5","unit":"KGS","unitRateFc":"225000","totalValueFC":"113708.6","currency":"USD","unitRateINR":"18877500","date":"04-Sep-2023","totalValueINR":"9438750","totalValueInUsd":"113708.6","indian_port":"Bombay Air","hs_no":"29419090","bill_no":"7666319","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"UNIT 1003, BANK OF EAST ASIA HARBOUR, VIEW CENTRE NO 56, GLOUCESTER ROAD, WAN CHAI, HONG KONG","customerAddress":"304,TOWN CENTRE,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1696444200,"product":"(77010AO) MITOMYCIN NON STERILE","address":"CORPORATE HOUSE, NR. SOLA BRIDGE,,","city":"AHMEDABAD,GUJARAT","supplier":"TEVA API","supplierCountry":"ITALY","foreign_port":"N\/A","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.93","actualQuantity":"927","unit":"GMS","unitRateFc":"700","totalValueFC":"655298.6","currency":"USD","unitRateINR":"58835","date":"05-Oct-2023","totalValueINR":"54540045","totalValueInUsd":"655298.6","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29419090","bill_no":"1004108","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Non-sterile","supplierPort":"N\/A","supplierAddress":"PIET HEIN BUILDING, PIET HEINKADE 1 07 1019 GM AMSTERDAM THE NEATHERLAN D NETHERLANDS","customerAddress":"CORPORATE HOUSE, NR. SOLA BRIDGE,,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1701109800,"product":"MITOMYCIN NON STERILE - 77010AO - 7010AO00223 (QTY 250 GRM)","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"TEVA API","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"VIATRIS","customerCountry":"INDIA","quantity":"0.25","actualQuantity":"0.25","unit":"KGS","unitRateFc":"894200","totalValueFC":"225775.9","currency":"USD","unitRateINR":"75202220","date":"28-Nov-2023","totalValueINR":"18800555","totalValueInUsd":"225775.9","indian_port":"Bangalore Air","hs_no":"29419090","bill_no":"8976085","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Non-sterile","supplierPort":"MILAN - MALPENSA","supplierAddress":"Piet Hein Building, Piet Heinkade 107 1019 GM Amsterdam The Netherlands Netherlands","customerAddress":"564\/A\/22, ROAD NO.92"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1711650600,"product":"MITOMYCIN USP","address":"CORPORATE HOUSE, NR. SOLA BRIDGE,,","city":"AHMEDABAD,GUJARAT","supplier":"ZHEJIANG HISUN PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1000","unit":"GMS","unitRateFc":"250","totalValueFC":"252903","currency":"USD","unitRateINR":"21000","date":"29-Mar-2024","totalValueINR":"21000000","totalValueInUsd":"252903","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29419090","bill_no":"1001201","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO.46 WAISHA ROAD, JIAOJIANG, TAIZHOU, ZHEJIANG, , CHINA","customerAddress":"CORPORATE HOUSE, NR. SOLA BRIDGE,,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1713897000,"product":"MITOMYCIN IP","address":"304,TOWN CENTRE,","city":"MUMBAI \/ MAHARASHTRA","supplier":"APC PHARMACEUTICALS & CHEMICALS LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"NAPROD LIFE SCIENCES","customerCountry":"INDIA","quantity":"0.23","actualQuantity":"0.226","unit":"KGS","unitRateFc":"225000","totalValueFC":"51393.6","currency":"USD","unitRateINR":"18990000","date":"24-Apr-2024","totalValueINR":"4291740","totalValueInUsd":"51393.6","indian_port":"Bombay Air","hs_no":"29419090","bill_no":"3175471","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"UNIT 1003, BANK OF EAST ASIA HARBOUR VIEW CENTRE, NO. 56, GLOUCESTER ROAD, WAN CHAI HONG KONG","customerAddress":"304,TOWN CENTRE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1713897000,"product":"MITOMYCIN IP","address":"304,TOWN CENTRE,","city":"MUMBAI \/ MAHARASHTRA","supplier":"APC PHARMACEUTICALS & CHEMICALS LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"NAPROD LIFE SCIENCES","customerCountry":"INDIA","quantity":"0.25","actualQuantity":"0.249","unit":"KGS","unitRateFc":"225000","totalValueFC":"56623.9","currency":"USD","unitRateINR":"18990000","date":"24-Apr-2024","totalValueINR":"4728510","totalValueInUsd":"56623.9","indian_port":"Bombay Air","hs_no":"29419090","bill_no":"3175471","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"UNIT 1003, BANK OF EAST ASIA HARBOUR VIEW CENTRE, NO. 56, GLOUCESTER ROAD, WAN CHAI HONG KONG","customerAddress":"304,TOWN CENTRE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1715884200,"product":"MITOMYCIN USP","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"APC PHARMACEUTICALS &CHEMICAL LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"CIPLA","customerCountry":"INDIA","quantity":"0.05","actualQuantity":"50","unit":"GMS","unitRateFc":"345","totalValueFC":"17456.1","currency":"USD","unitRateINR":"29100.8","date":"17-May-2024","totalValueINR":"1455037.5","totalValueInUsd":"17456.1","indian_port":"Bombay Air","hs_no":"29419090","bill_no":"3529788","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"UNIT 1003, BANK OF EAST ASIAHARBOUR VIEW CENTRE, NO.56GLOUCESTER ROAD WAN CHAI HONG KONG","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717957800,"product":"MITOMYCIN","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"APC PHARMACEUTICALS &CHEMICAL LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"CIPLA","customerCountry":"INDIA","quantity":"0.05","actualQuantity":"50","unit":"GMS","unitRateFc":"345","totalValueFC":"17419.6","currency":"USD","unitRateINR":"29083.5","date":"10-Jun-2024","totalValueINR":"1454175","totalValueInUsd":"17419.6","indian_port":"Bombay Air","hs_no":"29419090","bill_no":"3921122","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"UNIT 1003, BANK OF EAST ASIAHARBOUR VIEW CENTRE, NO.56GLOUCESTER ROAD WAN CHAI HONG KONG","customerAddress":"MUMBAI CENTRAL,"}]
    18-Jan-2021
    10-Jun-2024
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    ABOUT THIS PAGE

    Mitomycin Manufacturers

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

    Mitomycin Suppliers

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

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

    Mitomycin USDMF

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

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

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

    Mitomycin JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Mitomycin Drug Master File in Japan (Mitomycin JDMF) empowers Mitomycin API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Mitomycin JDMF during the approval evaluation for pharmaceutical products. At the time of Mitomycin JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Mitomycin suppliers with JDMF on PharmaCompass.

    Mitomycin CEP

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

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

    Mitomycin WC

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

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

    Mitomycin 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 Mitomycin as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Mitomycin GMP

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

    Mitomycin CoA

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

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

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