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    Chemistry

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    Also known as: 2-chloro-2'-deoxyadenosine, 4291-63-8, Leustatin, 2-chlorodeoxyadenosine, 2-cda, Chlorodeoxyadenosine
    Molecular Formula
    C10H12ClN5O3
    Molecular Weight
    285.69  g/mol
    InChI Key
    PTOAARAWEBMLNO-KVQBGUIXSA-N
    FDA UNII
    47M74X9YT5
    Cladribine
    An antineoplastic agent used in the treatment of lymphoproliferative diseases including hairy-cell leukemia.
    Cladribine is a Purine Antimetabolite.
    1 2D Structure

    Cladribine

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (2R,3S,5R)-5-(6-amino-2-chloropurin-9-yl)-2-(hydroxymethyl)oxolan-3-ol
    2.1.2 InChI
    InChI=1S/C10H12ClN5O3/c11-10-14-8(12)7-9(15-10)16(3-13-7)6-1-4(18)5(2-17)19-6/h3-6,17-18H,1-2H2,(H2,12,14,15)/t4-,5+,6+/m0/s1
    2.1.3 InChI Key
    PTOAARAWEBMLNO-KVQBGUIXSA-N
    2.1.4 Canonical SMILES
    C1C(C(OC1N2C=NC3=C(N=C(N=C32)Cl)N)CO)O
    2.1.5 Isomeric SMILES
    C1[C@@H]([C@H](O[C@H]1N2C=NC3=C(N=C(N=C32)Cl)N)CO)O
    2.2 Other Identifiers
    2.2.1 UNII
    47M74X9YT5
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 2'-deoxy-2-chloroadenosine

    2. 2-chloro-2'-deoxyadenosine

    3. 2-chlorodeoxyadenosine

    4. Leustatin

    2.3.2 Depositor-Supplied Synonyms

    1. 2-chloro-2'-deoxyadenosine

    2. 4291-63-8

    3. Leustatin

    4. 2-chlorodeoxyadenosine

    5. 2-cda

    6. Chlorodeoxyadenosine

    7. Litak

    8. Adenosine, 2-chloro-2'-deoxy-

    9. Cldado

    10. 2-chloro-2'-deoxy-beta-adenosine

    11. Mavenclad

    12. Cladaribine

    13. 2cda

    14. Rwj 26251

    15. 2-chloro-deoxyadenosine

    16. 2clado

    17. Rwj-26251

    18. Mls000028377

    19. Cladarabine

    20. Nsc-105014

    21. (2r,3s,5r)-5-(6-amino-2-chloropurin-9-yl)-2-(hydroxymethyl)oxolan-3-ol

    22. Leustat

    23. Smr000058553

    24. (2r,3s,5r)-5-(6-amino-2-chloro-9h-purin-9-yl)-2-(hydroxymethyl)oxolan-3-ol

    25. (2r,3s,5r)-5-(6-amino-2-chloro-9h-purin-9-yl)-2-(hydroxymethyl)tetrahydrofuran-3-ol

    26. 2-chloro-6-amino-9-(2-deoxy-beta-d-erythro-pentofuranosyl)purine

    27. Chebi:567361

    28. 47m74x9yt5

    29. Movectro

    30. Mylinax

    31. Dsstox_cid_2828

    32. Dsstox_rid_76747

    33. Dsstox_gsid_22828

    34. Cladribina

    35. Cladribinum

    36. Leustatin (tn)

    37. Cl9

    38. Cas-4291-63-8

    39. 2 Chlorodeoxyadenosine

    40. Sr-01000003063

    41. Nsc 105014

    42. Brn 0624220

    43. Cladiribine

    44. Unii-47m74x9yt5

    45. Ccris 9374

    46. Adenosine, 2-chloro-2'-deoxy

    47. Hsdb 7564

    48. 2-chloro-6-amino-9-(2-deoxy-beta-d-erythropentofuranosyl)purine

    49. Cladribine [usan:usp:inn:ban]

    50. Mavenclad (tn)

    51. Ncgc00018167-03

    52. Cladribine- Bio-x

    53. Mfcd00153939

    54. S1199

    55. Cladribine [mi]

    56. Rwj-26251-000

    57. Cladribine [inn]

    58. Cladribine [jan]

    59. Opera_id_1191

    60. Cladribine [hsdb]

    61. Cladribine [usan]

    62. Cladribine [vandf]

    63. Cladribine [mart.]

    64. Schembl3775

    65. Chembl1619

    66. Cladribine [usp-rs]

    67. Cladribine [who-dd]

    68. Cladribine (jan/usp/inn)

    69. 2-chloro-2'-deoxy-adenosine

    70. Cid_20279

    71. Mls000028484

    72. Mls000759397

    73. Mls001077345

    74. Mls001424194

    75. Cladribine [ema Epar]

    76. Gtpl4799

    77. Cladribine [orange Book]

    78. Dtxsid8022828

    79. Bdbm38920

    80. Cladribine [ep Monograph]

    81. Cladribine [usp Impurity]

    82. Cladribine For Peak Identification

    83. Cladribine [usp Monograph]

    84. Hms2052k13

    85. Hms2232c23

    86. Hms3715f17

    87. 5542-92-7

    88. Act02615

    89. Amy22140

    90. Bcp02868

    91. Zinc3798064

    92. Tox21_110834

    93. Tox21_300596

    94. Nsc-05014

    95. Nsc-105014-f

    96. Akos015854898

    97. Akos015892544

    98. Ac-7591

    99. Bcp9000538

    100. Ccg-101116

    101. Cs-2057

    102. Db00242

    103. Nc00366

    104. Ncgc00022567-05

    105. Ncgc00022567-06

    106. Ncgc00022567-07

    107. Ncgc00022567-08

    108. Ncgc00164384-01

    109. Ncgc00254518-01

    110. 2-chloro-2'-deoxyadenosine, Antileukemic

    111. As-12366

    112. Bc164318

    113. Bp-25407

    114. Hy-13599

    115. Sw197746-4

    116. D01370

    117. Ab00382963-17

    118. Ab00382963_19

    119. 291c638

    120. A826062

    121. Q414030

    122. 2-chloro-2 Inverted Exclamation Marka-deoxyadenosine

    123. Sr-01000003063-7

    124. Sr-01000003063-10

    125. Cladribine, European Pharmacopoeia (ep) Reference Standard

    126. 6-amino-2-chloro-9-(2-deoxy-beta-erythropentofuranosyl)purine

    127. Cladribine, United States Pharmacopeia (usp) Reference Standard

    128. 6-amino-2-chloro-9-(2-deoxy-beta-d-erythro-pentofuranosyl)purine

    129. (2r,3s,5r)-5-(6-amino-2-chloropurin-9-yl)-2-(hydroxymethyl)oxalan-3-ol

    130. (2r,3s,5r)-5-(6-amino-2-chloro-purin-9-yl)-2-(hydroxymethyl)tetrahydrofuran-3-ol

    131. Cladribine For Peak Identification, European Pharmacopoeia (ep) Reference Standard

    132. 2-chloro-2'-deoxyadenosine;(2r,3s,5r)-5-(6-amino-2-chloro-purin-9-yl)-2-(hydroxymethyl)tetrahydrofuran-3-ol

    133. 24757-90-2

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 285.69 g/mol
    Molecular Formula C10H12ClN5O3
    XLogP30.8
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count7
    Rotatable Bond Count2
    Exact Mass285.0628670 g/mol
    Monoisotopic Mass285.0628670 g/mol
    Topological Polar Surface Area119 Ų
    Heavy Atom Count19
    Formal Charge0
    Complexity338
    Isotope Atom Count0
    Defined Atom Stereocenter Count3
    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 2  
    Drug NameCladribine
    PubMed HealthCladribine (Injection)
    Drug ClassesAntineoplastic Agent
    Drug LabelCladribine Injection (also commonly known as 2-chloro-2-deoxy--D-adenosine) is a synthetic antineoplastic agent for continuous intravenous infusion. It is a clear, colorless, sterile, preservative-free, isotonic solution. Cladribine injectio...
    Active IngredientCladribine
    Dosage FormInjectable
    RouteInjection
    Strength1mg/ml
    Market StatusPrescription
    CompanyFresenius Kabi Usa; Onco Therapies; Eurohlth Intl

    2 of 2  
    Drug NameCladribine
    PubMed HealthCladribine (Injection)
    Drug ClassesAntineoplastic Agent
    Drug LabelCladribine Injection (also commonly known as 2-chloro-2-deoxy--D-adenosine) is a synthetic antineoplastic agent for continuous intravenous infusion. It is a clear, colorless, sterile, preservative-free, isotonic solution. Cladribine injectio...
    Active IngredientCladribine
    Dosage FormInjectable
    RouteInjection
    Strength1mg/ml
    Market StatusPrescription
    CompanyFresenius Kabi Usa; Onco Therapies; Eurohlth Intl

    4.2 Therapeutic Uses

    Antineoplastic

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

    Cladribine is indicated for active treatment of hairy cell leukemia as defined by clinically significant anemia, neutropenia, thrombocytopenia, or disease-related symptoms. /Included in US product label/

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007.

    Cladribine is accepted for treatment of B-cell chronic lymphocytic leukemia (CLL) in both previously untreated patients and patients refractory to previous treatment, based upon reports of objective tumor responses, most of which were partial, in noncomparative studies. /Not included in US product label/

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007.

    Cladribine is accepted for treatment of low-grade non-Hodgkin's lymphomas in patients refractory to previous treatment, based upon reports of objective tumor responses, most of which were partial, in two noncomparative studies. /Not included in US product label/

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007.

    Cladribine is accepted for treatment of Waldenstrom macroglobulinemia, based upon reports of objective tumor responses in one noncomparative study. /Not included in US product label/

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007.

    4.3 Drug Warning

    The most common adverse effects of cladribine in patients with hairy cell leukemia during the first month after initiation of therapy in clinical trials were severe neutropenia, fever (often culture negative), and documented infection. Myelosuppression, which may be severe, usually is reversible, and appears to be dose dependent, should be anticipated with use of the drug. At recommended doses, cladribine appears to be rarely associated with many adverse effects that frequently occur with antineoplastic therapy (e.g., nausea, vomiting, hair loss, abnormal renal or hepatic function). The most frequent adverse nonhematologic effects of the drug that occur during the first 2 weeks after initiation of therapy are fatigue, nausea, rash, headache, and reactions at the injection site. Most adverse nonhematologic effects are mild to moderate in severity.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 979

    Severe bone marrow suppression resulting in neutropenia, anemia, and thrombocytopenia occurs frequently in patients with hairy cell leukemia receiving cladribine, especially at high doses or in patients with preexisting pancytopenia. Most patients with hairy cell leukemia receiving cladribine in clinical trials had hematologic impairment as a manifestation of the disease. Following cladribine treatment, further hematologic impairment occurred before recovery of peripheral blood counts began. Prolonged pancytopenia including aplastic anemia and hemolytic anemia (reported in patients with lymphoid malignancies within the first few weeks following cladribine therapy) has been reported in postmarketing surveillance of patients usually receiving multiple courses of the drug.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 979

    Myelosuppression occurred frequently during the first month after initiation of cladribine therapy in patients with hairy cell leukemia in clinical trials; 44% of patients received red blood cell transfusions and 14% received platelet transfusions. During the first 2 weeks after treatment was initiated, mean platelet count, absolute neutrophil count (ANC), and hemoglobin concentration declined and subsequently increased with normalization of mean counts by day 12, week 5, and week 8, respectively. Platelet recovery may be delayed in patients with severe baseline thrombocytopenia.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 979

    Multiple cycles of cladribine therapy may be associated with cumulative myelotoxicity and prolonged thrombocytopenia. Thrombocytopenia was the limiting toxicity in 20-30% of patients with chronic lymphocytic leukemia or lymphomas after repeated courses of cladribine therapy.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 979

    For more Drug Warnings (Complete) data for CLADRIBINE (32 total), please visit the HSDB record page.

    4.4 Drug Indication

    For the treatment of active hairy cell leukemia (leukemic reticuloendotheliosis) as defined by clinically significant anemia, neutropenia, thrombocytopenia, or disease-related symptoms. Also used as an alternative agent for the treatment of chronic lymphocytic leukemia (CLL), low-grade non-Hodgkin's lymphoma, and cutaneous T-cell lymphoma.

    Treatment of adult patients with highly active relapsing multiple sclerosis (MS) as defined by clinical or imaging features.

    Litak is indicated for the treatment of hairy-cell leukaemia.

    Multiple Sclerosis

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Cladribine is a synthetic purine nucleoside that acts as an antineoplastic agent with immunosuppressive effects. Cladribine differs structurally from deoxyadenosine only by the presence of a chlorine atom at position 2 of the purine ring, which results in resistance to enzymatic degradation by adenosine deaminase. Due to this resistance, cladribine exhibits a more prolonged cytotoxic effect than deoxyadenosine against resting and proliferating lymphocytes. Cladribine is one of a group of chemotherapy drugs known as the anti-metabolites. Anti-metabolites stop cells from making and repairing DNA, which are processes that are necessary for cancer cells to grow and multiply.

    5.2 MeSH Pharmacological Classification

    Antineoplastic Agents

    Substances that inhibit or prevent the proliferation of NEOPLASMS. (See all compounds classified as Antineoplastic Agents.)

    Immunosuppressive Agents

    Agents that suppress immune function by one of several mechanisms of action. Classical cytotoxic immunosuppressants act by inhibiting DNA synthesis. Others may act through activation of T-CELLS or by inhibiting the activation of HELPER CELLS. While immunosuppression has been brought about in the past primarily to prevent rejection of transplanted organs, new applications involving mediation of the effects of INTERLEUKINS and other CYTOKINES are emerging. (See all compounds classified as Immunosuppressive Agents.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    CLADRIBINE
    5.3.2 FDA UNII
    47M74X9YT5
    5.3.3 Pharmacological Classes
    Purine Antimetabolite [EPC]
    5.4 ATC Code

    L04AA40

    L01BB04

    L01BB04

    S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

    L - Antineoplastic and immunomodulating agents

    L01 - Antineoplastic agents

    L01B - Antimetabolites

    L01BB - Purine analogues

    L01BB04 - Cladribine

    L - Antineoplastic and immunomodulating agents

    L04 - Immunosuppressants

    L04A - Immunosuppressants

    L04AA - Selective immunosuppressants

    L04AA40 - Cladribine

    5.5 Absorption, Distribution and Excretion

    Absorption

    Oral bioavailability is 34 to 48%.

    Volume of Distribution

    4.5 2.8 L/kg [patients with hematologic malignancies]

    9 L/kg

    Clearance

    978 +/- 422 mL/h/kg

    Cladribine is bound approximately 20% to plasma proteins.

    Physicians Desk Reference 61st ed, Thomson PDR, Montvale, NJ 2007., p. 2357

    It is not known whether cladribine is distributed into breast milk.

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007.

    It is not known whether cladribine is removed from circulation by dialysis or hemofiltration.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 979

    Cladribine penetrates into cerebrospinal fluid. One report indicates that concentrations are approximately 25% of those in plasma.

    Physicians Desk Reference 61st ed, Thomson PDR, Montvale, NJ 2007., p. 2357

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

    5.6 Metabolism/Metabolites

    Metabolized in all cells with deoxycytidine kinase activity to 2-chloro-2'-deoxyadenosine-5'-triphosphate

    Metabolized in all cells with deoxycytidine kinase activity to 2-chloro-2'-deoxyadenosine-5'-triphosphate.

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007.

    5.7 Biological Half-Life

    5.4 hours

    Cladribine plasma concentration after intravenous administration declines multi-exponentially with an average half-life of 6.7 +/-2.5 hours.

    Physicians Desk Reference 61st ed, Thomson PDR, Montvale, NJ 2007., p. 2357

    ... The terminal half-life varies from 5.7 to 19.7 hours ...

    PMID:9068927 Liliemark J; Clin Pharmacokinet 32 (2): 120-31 (1997)

    ... The terminal phase half-life in 22 patients ranged from 14.3-25.8 hr, with a mean (SD) of 19.7 (3.4) hr. ...

    PMID:7906999 Kearns C, Blakley R et al; Cancer Res 54 (5): 1235-9 (1994)

    5.8 Mechanism of Action

    Cladribine is structurally related to fludarabine and pentostatin but has a different mechanism of action. Although the exact mechanism of action has not been fully determined, evidence shows that cladribine is phosphorylated by deoxycytidine kinase to the nucleotidecladribine triphosphate (CdATP; 2-chloro-2-deoxyadenosine 5-triphosphate), which accumulates and is incorporated into DNA in cells such as lymphocytes that contain high levels of deoxycytidine kinase and low levels of deoxynucleotidase, resulting in DNA strand breakage and inhibition of DNA synthesis and repair. High levels of CdATP also appear to inhibit ribonucleotide reductase, which leads to an imbalance in triphosphorylated deoxynucleotide (dNTP) pools and subsequent DNA strand breaks, inhibition of DNA synthesis and repair, nicotinamide adenine dinucleotide (NAD) and ATP depletion, and cell death. Unlike other antimetabolite drugs, cladribine has cytotoxic effects on resting as well as proliferating lymphocytes. However, it does cause cells to accumulate at the G1/S phase junction, suggesting that cytotoxicity is associated with events critical to cell entry into S phase. It also binds purine nucleoside phosphorylase (PNP), however no relationship between this binding and a mechanism of action has been established.

    Cladribine is an antimetabolite. The exact mechanism of action in hairy cell leukemia is unknown. Cladribine is resistant to the action of adenosine deaminase (ADA), which deaminates deoxyadenosine to deoxyinosine. The phosphorylated metabolites of cladribine accumulate in cells with a high ratio of deoxycytidine kinase activity to 5' nucleotidase activity (lymphocytes, monocytes ) and are converted to the active triphosphate deoxynucleotide. Intracellular accumulation of toxic deoxynucleotides selectively kills these cells, which become unable to properly repair single-strand DNA breaks, leading to disruption of cell metabolism. In addition, there is some evidence that deoxynucleotides are incorporated into the DNA of dividing cells and impair DNA synthesis. Cladribine also induces apoptosis (a form of programmed cell death in sensitive cells). Cladribine's action is cell cycle-phase nonspecific; cladribine equally affects dividing and resting lymphocytes.

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007.

    Cladribine has immunosuppressant activity ; restoration of lymphocyte subsets after treatment takes at least 6 to 12 months, although clinical immunocompetence is usually restored after about a month. Significant reductions in T and B lymphocytes occur during treatment (both CD4 and CD8 are affected) and CD4 counts recover more slowly after treatment.

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007.

    /Investigators/ have studied the role of caspases and mitochondria in apoptosis induced by 2-chloro-2'-deoxyadenosine (cladribine) in several human leukemic cell lines. Cladribine treatment induced mitochondrial transmembrane potential (DeltaPsi(m)) loss, phosphatidylserine exposure, caspase activation and development of typical apoptotic morphology in JM1 (pre-B), Jurkat (T) and U937 (promonocytic) cells. Western-blot analysis of cell extracts revealed the activation of at least caspases 3, 6, 8 and 9. Co-treatment with Z-VAD-fmk (benzyloxy-carbonyl-Val-Ala-Asp-fluoromethylketone), a general caspase inhibitor, significantly prevented cladribine-induced death in JM1 and Jurkat cells for the first approximately 40 h, but not for longer times. Z-VAD-fmk also partly prevented some morphological and biochemical features of apoptosis in U937 cells, but not cell death. Co-incubation with selective caspase inhibitors Ac-DEVD-CHO (N-acetyl-Asp-Glu-Val-Asp-aldehyde), Ac-LEHD-CHO (N-acetyl-Leu-Glu-His-Asp-aldehyde) or Z-IETD-fmk (benzyloxycarbonyl-Ile-Glu-Thr-Asp-fluoromethylketone), inhibition of protein synthesis with cycloheximide or cell-cycle arrest with aphidicolin did not prevent cell death. Overexpression of Bcl-2, but not CrmA, efficiently prevented death in Jurkat cells. In all cell lines, death was always preceded by Delta Psi(m) loss and accompanied by the translocation of the protein apoptosis-inducing factor (AIF) from mitochondria to the nucleus. These results suggest that caspases are differentially involved in induction and execution of apoptosis depending on the leukemic cell lineage. In any case, Delta Psi(m) loss marked the point of no return in apoptosis and may be caused by two different pathways, one caspase-dependent and the other caspase-independent. Execution of apoptosis was always performed after Delta Psi(m) loss by a caspase-9-triggered caspase cascade and the action of AIF.

    PMID:11672427 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1222174 Marzo I, Perez-Galan P et al; Biochem J 359 (Pt 3): 537-46 (2001)

    Cladribine (chlorodeoxyadenosine, 2-CdA), a synthetic purine nucleoside, is an antineoplastic agent. ... The precise mechanism(s) of antileukemic action of cladribine has not been fully elucidated. Cladribine is phosphorylated by deoxycytidine kinase to the nucleotide cladribine triphosphate (CdATP; 2-chloro-2'-deoxyadenosine 5'-triphosphate), which accumulates and is incorporated into DNA in cells such as lymphocytes that have high levels of deoxycytidine kinase and low levels of deoxynucleotidase. High intracellular concentrations of cladribine triphosphate appear to inhibit ribonucleotide reductase, causing an imbalance in triphosphorylated deoxynucleotide (dNTP) pools and subsequent DNA strand breaks, inhibition of DNA synthesis and repair, nicotinamide adenine dinucleotide (NAD) and ATP depletion, and cell death. Incorporation of accumulated cladribine triphosphate into DNA also may contribute to DNA strand breakage and inhibition of DNA synthesis and repair. Unlike other commonly used antineoplastic drugs that affect purine and pyrimidine metabolism, cladribine has cytotoxic effects on resting as well as proliferating lymphocytes and monocytes.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 979

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    Virtual BoothTransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.

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    About the Company : Transo-Pharm is a licensed distributor of pharmaceutical components for human and veterinary markets. The company supports the full API life cycle, from development to sales, and a...

    Transo-Pharm is a licensed distributor of pharmaceutical components for human and veterinary markets. The company supports the full API life cycle, from development to sales, and acts as a sourcing and regulatory marketing agent for API manufacturers. Transo-Pharm assists with DMF setup, GMP consulting, and regulatory activities, supported by a regulatory team, warehouse facilities, proprietary API process IPs, and laboratory partnerships, with offices in Shanghai, Hong Kong, Singapore, and the US. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    02

    Biophore India Pharmaceuticals Pvt ...

    India
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    • fda
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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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    Cladribine

    About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&...

    Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance record with major regulatory agencies. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.
    Biophore

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    03

    Aspen Bio

    India
    PEGS Boston Summit
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    Aspen Bio

    India
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    Cladribine

    About the Company : Aspen Bio is a multifaceted company that was established in 2014. Aspen Bio defines development and novelty as a challenge for competitive markets to provide improved health servic...

    Aspen Bio is a multifaceted company that was established in 2014. Aspen Bio defines development and novelty as a challenge for competitive markets to provide improved health services to people, through pioneering Research & Development in agreement with the latest principles to ensure safe and secured wellness. The Company is established in bringing the benefit of high quality APIs & Finished Formulations, yet reasonably priced, to patients in India and other emerging markets.
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    04

    Mac-Chem Products (India) Pvt.Ltd

    India
    PEGS Boston Summit
    Not Confirmed
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    Mac-Chem Products (India) Pvt.Ltd

    India
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    PEGS Boston Summit
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    Cladribine

    About the Company : Established in 2010, Mac-Chem is a NMM Group company. Mac-Chem is focused on oncology and other niche specialty APIs. It supplies quality APIs to the top 15 oncology players in Ind...

    Established in 2010, Mac-Chem is a NMM Group company. Mac-Chem is focused on oncology and other niche specialty APIs. It supplies quality APIs to the top 15 oncology players in India. It is also the sole manufacturer of some of the molecules in the oncology segment and general segment. The company’s investments are mostly geared toward exports, especially to regulated markets. Mac-Chem has a cGMP-compliant manufacturing facility near Mumbai in India. The company’s facility is USFDA, EDQM, COFEPRIS, ANVISA, MFDS-Korea, WHO-GMP-approved and ISO-certified. Mac-Chem enjoys a global reach, serving more than 40 countries.
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    05

    Morepen Laboratories

    India
    PEGS Boston Summit
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    Morepen Laboratories

    India
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    Cladribine

    About the Company : Morepen Laboratories Ltd.’ is 31 years old company. Went to public in 1993. Manufacturer and Exporter of complex and high margins molecules (APIs/Intermediates) for regulated mar...

    Morepen Laboratories Ltd.’ is 31 years old company. Went to public in 1993. Manufacturer and Exporter of complex and high margins molecules (APIs/Intermediates) for regulated markets of USA, Europe, Russia, Canada and also for non-regulated markets. The first Morepen manufacturing plant was set up on the foothills of the Himalayas in the idyllic surroundings of Parwanoo. The large and spread-out facility is USDFA approved for manufacture of Loratadine, an anti-allergy drug- internationally known as Claritin.
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    06

    ScinoPharm Taiwan Ltd

    Taiwan
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    Not Confirmed
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    ScinoPharm Taiwan Ltd

    Taiwan
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    PEGS Boston Summit
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    Cladribine

    About the Company : ScinoPharm Taiwan Ltd. is a leading process R&D and API manufacturing service provider to the global pharmaceutical industry. With cGMP production facilities, ScinoPharm offers a w...

    ScinoPharm Taiwan Ltd. is a leading process R&D and API manufacturing service provider to the global pharmaceutical industry. With cGMP production facilities, ScinoPharm offers a wide portfolio of services ranging from custom synthesis for early phase pharmaceutical activities to brand companies as well as APIs for the generic industry.Combining cost-effective resources and productivity of Asia along with unmatched regulatory know-how, ScinoPharm is uniquely positioned to serve global pharmaceutical R&D and manufacturing needs at any level and for any company in this sector.
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    07

    Sichuan Huiyu Pharmaceutical

    China
    PEGS Boston Summit
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    Sichuan Huiyu Pharmaceutical

    China
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    Cladribine

    About the Company : Huiyu Pharma, established in Oct. 2010, is a specialized pharmaceutical company focusing on developing and manufacturing high-quality oncology products. At present, products in our...

    Huiyu Pharma, established in Oct. 2010, is a specialized pharmaceutical company focusing on developing and manufacturing high-quality oncology products. At present, products in our list include the following:Azacitidine, Bendamustine HCl, Bortezomib, Camptothecin, Carboplatin, Decitabine, Docetaxel, Doxorubicin HCl, Epirubicin HCl, Gemcitabine Hydrochloride, Irinotecan Hydrochloride, Methotrexate, Oxaliplatin, Paclitaxel, Pemetrexed disodium...We welcome those traders, distributors, and wholesalers who are interested in our products.
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    08

    Synbias Pharma AG

    Switzerland
    PEGS Boston Summit
    Not Confirmed
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    Synbias Pharma AG

    Switzerland
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    Cladribine

    About the Company : Synbias Pharma is a globally recognized leader in the supply of anthracycline antibiotic APIs, commanding a 30-50% share of the international market. With an annual distribution of...

    Synbias Pharma is a globally recognized leader in the supply of anthracycline antibiotic APIs, commanding a 30-50% share of the international market. With an annual distribution of approximately 200 kg, we serve clients across 21 countries and five continents. Our robust Quality System is meticulously designed to comply with cGMP standards and is rigorously inspected by regulatory authorities, including German authorities, Swissmedic, the FDA, and ANVISA. Committed to excellence, we deliver high-quality, compliant, and reliable pharmaceutical ingredients worldwide.
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    09

    Zhejiang Hisun Chemical Co., Ltd.

    China
    PEGS Boston Summit
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    Zhejiang Hisun Chemical Co., Ltd.

    China
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    Cladribine

    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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    ABOUT THIS PAGE

    Looking for 4291-63-8 / Cladribine API manufacturers, exporters & distributors?

    Cladribine manufacturers, exporters & distributors 1

    22

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

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

    API | Excipient name

    Cladribine

    Synonyms

    2-chloro-2'-deoxyadenosine, 4291-63-8, Leustatin, 2-chlorodeoxyadenosine, 2-cda, Chlorodeoxyadenosine

    Cas Number

    4291-63-8

    Unique Ingredient Identifier (UNII)

    47M74X9YT5

    About Cladribine

    An antineoplastic agent used in the treatment of lymphoproliferative diseases including hairy-cell leukemia.

    C10H12ClN5O3.C3H8 Manufacturers

    A C10H12ClN5O3.C3H8 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of C10H12ClN5O3.C3H8, including repackagers and relabelers. The FDA regulates C10H12ClN5O3.C3H8 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. C10H12ClN5O3.C3H8 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 C10H12ClN5O3.C3H8 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.

    C10H12ClN5O3.C3H8 Suppliers

    A C10H12ClN5O3.C3H8 supplier is an individual or a company that provides C10H12ClN5O3.C3H8 active pharmaceutical ingredient (API) or C10H12ClN5O3.C3H8 finished formulations upon request. The C10H12ClN5O3.C3H8 suppliers may include C10H12ClN5O3.C3H8 API manufacturers, exporters, distributors and traders.

    click here to find a list of C10H12ClN5O3.C3H8 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.

    C10H12ClN5O3.C3H8 USDMF

    A C10H12ClN5O3.C3H8 DMF (Drug Master File) is a document detailing the whole manufacturing process of C10H12ClN5O3.C3H8 active pharmaceutical ingredient (API) in detail. Different forms of C10H12ClN5O3.C3H8 DMFs exist exist since differing nations have different regulations, such as C10H12ClN5O3.C3H8 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A C10H12ClN5O3.C3H8 DMF submitted to regulatory agencies in the US is known as a USDMF. C10H12ClN5O3.C3H8 USDMF includes data on C10H12ClN5O3.C3H8's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The C10H12ClN5O3.C3H8 USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of C10H12ClN5O3.C3H8 suppliers with USDMF on PharmaCompass.

    C10H12ClN5O3.C3H8 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 C10H12ClN5O3.C3H8 Drug Master File in Japan (C10H12ClN5O3.C3H8 JDMF) empowers C10H12ClN5O3.C3H8 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 C10H12ClN5O3.C3H8 JDMF during the approval evaluation for pharmaceutical products. At the time of C10H12ClN5O3.C3H8 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 C10H12ClN5O3.C3H8 suppliers with JDMF on PharmaCompass.

    C10H12ClN5O3.C3H8 CEP

    A C10H12ClN5O3.C3H8 CEP of the European Pharmacopoeia monograph is often referred to as a C10H12ClN5O3.C3H8 Certificate of Suitability (COS). The purpose of a C10H12ClN5O3.C3H8 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of C10H12ClN5O3.C3H8 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of C10H12ClN5O3.C3H8 to their clients by showing that a C10H12ClN5O3.C3H8 CEP has been issued for it. The manufacturer submits a C10H12ClN5O3.C3H8 CEP (COS) as part of the market authorization procedure, and it takes on the role of a C10H12ClN5O3.C3H8 CEP holder for the record. Additionally, the data presented in the C10H12ClN5O3.C3H8 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the C10H12ClN5O3.C3H8 DMF.

    A C10H12ClN5O3.C3H8 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. C10H12ClN5O3.C3H8 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 C10H12ClN5O3.C3H8 suppliers with CEP (COS) on PharmaCompass.

    C10H12ClN5O3.C3H8 WC

    A C10H12ClN5O3.C3H8 written confirmation (C10H12ClN5O3.C3H8 WC) is an official document issued by a regulatory agency to a C10H12ClN5O3.C3H8 manufacturer, verifying that the manufacturing facility of a C10H12ClN5O3.C3H8 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting C10H12ClN5O3.C3H8 APIs or C10H12ClN5O3.C3H8 finished pharmaceutical products to another nation, regulatory agencies frequently require a C10H12ClN5O3.C3H8 WC (written confirmation) as part of the regulatory process.

    click here to find a list of C10H12ClN5O3.C3H8 suppliers with Written Confirmation (WC) on PharmaCompass.

    C10H12ClN5O3.C3H8 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 C10H12ClN5O3.C3H8 as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for C10H12ClN5O3.C3H8 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 C10H12ClN5O3.C3H8 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 C10H12ClN5O3.C3H8 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a C10H12ClN5O3.C3H8 NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of C10H12ClN5O3.C3H8 suppliers with NDC on PharmaCompass.

    C10H12ClN5O3.C3H8 GMP

    C10H12ClN5O3.C3H8 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 C10H12ClN5O3.C3H8 GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right C10H12ClN5O3.C3H8 GMP manufacturer or C10H12ClN5O3.C3H8 GMP API supplier for your needs.

    C10H12ClN5O3.C3H8 CoA

    A C10H12ClN5O3.C3H8 CoA (Certificate of Analysis) is a formal document that attests to C10H12ClN5O3.C3H8's compliance with C10H12ClN5O3.C3H8 specifications and serves as a tool for batch-level quality control.

    C10H12ClN5O3.C3H8 CoA mostly includes findings from lab analyses of a specific batch. For each C10H12ClN5O3.C3H8 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.

    C10H12ClN5O3.C3H8 may be tested according to a variety of international standards, such as European Pharmacopoeia (C10H12ClN5O3.C3H8 EP), C10H12ClN5O3.C3H8 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (C10H12ClN5O3.C3H8 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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