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    Chemistry

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    Also known as: 119413-54-6, Topotecan hcl, Hycamtin, Nogitecan hydrochloride, Topotecan (hydrochloride), Topotecan monohydrochloride
    Molecular Formula
    C23H24ClN3O5
    Molecular Weight
    457.9  g/mol
    InChI Key
    DGHHQBMTXTWTJV-BQAIUKQQSA-N
    FDA UNII
    956S425ZCY
    Topotecan Hydrochloride
    An antineoplastic agent used to treat ovarian cancer. It works by inhibiting DNA TOPOISOMERASES, TYPE I.
    1 2D Structure

    Topotecan Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (19S)-8-[(dimethylamino)methyl]-19-ethyl-7,19-dihydroxy-17-oxa-3,13-diazapentacyclo[11.8.0.02,11.04,9.015,20]henicosa-1(21),2,4(9),5,7,10,15(20)-heptaene-14,18-dione;hydrochloride
    2.1.2 InChI
    InChI=1S/C23H23N3O5.ClH/c1-4-23(30)16-8-18-20-12(9-26(18)21(28)15(16)11-31-22(23)29)7-13-14(10-25(2)3)19(27)6-5-17(13)24-20;/h5-8,27,30H,4,9-11H2,1-3H3;1H/t23-;/m0./s1
    2.1.3 InChI Key
    DGHHQBMTXTWTJV-BQAIUKQQSA-N
    2.1.4 Canonical SMILES
    CCC1(C2=C(COC1=O)C(=O)N3CC4=CC5=C(C=CC(=C5CN(C)C)O)N=C4C3=C2)O.Cl
    2.1.5 Isomeric SMILES
    CC[C@@]1(C2=C(COC1=O)C(=O)N3CC4=CC5=C(C=CC(=C5CN(C)C)O)N=C4C3=C2)O.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    956S425ZCY
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 9 Dimethylaminomethyl 10 Hydroxycamptothecin

    2. 9-dimethylaminomethyl-10-hydroxycamptothecin

    3. Hycamtamine

    4. Hycamtin

    5. Hydrochloride, Nogitecan

    6. Hydrochloride, Topotecan

    7. Nogitecan Hydrochloride

    8. Nsc 609699

    9. Nsc-609699

    10. Nsc609699

    11. Sk And F 104864 A

    12. Sk And F-104864-a

    13. Sk And F104864a

    14. Skf 104864 A

    15. Skf-104864-a

    16. Skf104864a

    17. Topotecan

    18. Topotecan Monohydrochloride, (s)-isomer

    2.3.2 Depositor-Supplied Synonyms

    1. 119413-54-6

    2. Topotecan Hcl

    3. Hycamtin

    4. Nogitecan Hydrochloride

    5. Topotecan (hydrochloride)

    6. Topotecan Monohydrochloride

    7. Sk&f S-104864-a

    8. Evotopin

    9. Topotecan Hydrochloride [usan]

    10. Nsc 609699

    11. Topotecan Teva

    12. Topotecan Actavis

    13. Topotecan Hospira

    14. Nsc609699

    15. Skf 104864a

    16. Nsc-609699

    17. Nsc-759263

    18. Topotecan (as Hydrochloride)

    19. (s)-10-((dimethylamino)methyl)-4-ethyl-4,9-dihydroxy-1h-pyrano(3',4':6,7)indolizino(1,2-b)quinoline-3,14(4h,12h)-dione Monohydrochloride

    20. 956s425zcy

    21. Sk&f-s-104864-a

    22. Ncgc00095189-01

    23. Hycamtin (tn)

    24. Skf 104864a; Nsc 609669

    25. Dsstox_cid_25952

    26. Dsstox_rid_81248

    27. Dsstox_gsid_45952

    28. 1h-pyrano(3',4':6,7)indolizino(1,2-b)quinoline-3,14(4h,12h)-dione, 10-((dimethylamino)methyl)-4-ethyl-4,9-dihydroxy-, Monohydrochloride, (s)-

    29. Nogitecan Hydrochloride (jan)

    30. Topotecan Hydrochloride (usan)

    31. Skf 104864a (hydrochloride);nsc 609669 (hydrochloride)

    32. Topotecanhydrochloride

    33. Chembl1607

    34. Hycamptamine Hydrochloride

    35. Nogitecan Hydrochloride [jan]

    36. (s)-10-((dimethylamino)methyl)-4-ethyl-4,9-dihydroxy-1h-pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4h,12h)-dione Hydrochloride

    37. Smr000466344

    38. Cas-119413-54-6

    39. Sk&f-s-104864a

    40. Nsc 609669

    41. Drg-0288

    42. 9-dimethylaminomethyl-10-hydroxycamptothecin.

    43. Potactasol

    44. Evotropin

    45. Unii-956s425zcy

    46. Nogitecan Hcl

    47. Potactasol (tn)

    48. (s)-10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1h-pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4h,12h)-dione Hydrochloride

    49. Topotecan Hydrocholoride

    50. Topotecan Hcl - Hycamtin

    51. Schembl7247

    52. Hycamtin (tn) (glaxosmith)

    53. Mls000759456

    54. Mls001401447

    55. Spectrum1505820

    56. Dtxsid1045952

    57. Skfs 104864a

    58. Hms1922h22

    59. Pharmakon1600-01505820

    60. 10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1h-pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4h,12h)-dione Hydrochloride

    61. Amy24931

    62. Bcp00930

    63. Skf-104864a

    64. Skf-s 104864-a

    65. Topotecan Hydrochloride [mi]

    66. Tox21_111478

    67. Ccg-37460

    68. Hy-13768a

    69. Mfcd00866235

    70. Ncgc00014925

    71. Nci609699

    72. Nk-211

    73. Nsc759263

    74. S1231

    75. Akos015900415

    76. Sk&f 104864-a

    77. Tox21_111478_1

    78. Ac-1551

    79. Cs-1498

    80. Ks-1410

    81. Nc00177

    82. Nsc 759263

    83. Topotecan Hydrochloride [mart.]

    84. Topotecan Hydrochloride [vandf]

    85. Topotecan Hydrochloride [usp-rs]

    86. Topotecan Hydrochloride [who-dd]

    87. Ncgc00014925-06

    88. Ncgc00095189-02

    89. Ncgc00095189-03

    90. Sw197557-5

    91. T-160

    92. T2795

    93. Topotecan Hydrochloride [orange Book]

    94. D02168

    95. 413t546

    96. E-89/001

    97. 9-dimethylaminomethyl-10-hydroxycamptothecin, Hcl Salt

    98. Q27271753

    99. 9-[(dimethylamino)methyl]-10-hydroxy-(20s)-camptothecin, Hcl

    100. (4s)-10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1h-pyrano[3',4',6-7]indolizino[1,2-b]quinoline-3,14(4h,12h)-dione

    101. (4s)-10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1h-pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4h,12h)-dionehydrochloride (1:1)

    102. (s)-10-((dimethylamino)methyl)-4-ethyl-4,9-dihydroxy-1h-pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4h,12h)-dionehydrochloride

    103. (s)-10-((dimethylamino)methyl)-4-ethyl-4,9-dihydroxy-1h-pyrano[3,4:6,7]indolizino[1,2-b]quinoline-3,14(4h,12h)-dione Hydrochloride

    104. (s)-10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1h-pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4h,12h)-dionemonohydrochloride

    105. (s)-10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1h-pyrano[3',4':6,7]indolizino[l,2-b]quinoline-3,14(4h,12h)-dione Monohydrochloride

    106. 1h-pyrano[3',7]indolizino[1,2-b]quinoline- 3,14(4h,12h)-dione, 10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-, Monohydrochloride, (4s)-

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 457.9 g/mol
    Molecular Formula C23H24ClN3O5
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count7
    Rotatable Bond Count3
    Exact Mass457.1404486 g/mol
    Monoisotopic Mass457.1404486 g/mol
    Topological Polar Surface Area103 Ų
    Heavy Atom Count32
    Formal Charge0
    Complexity867
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameTopotecan hydrochloride
    Drug LabelTopotecan hydrochloride is a semi-synthetic derivative of camptothecin and is an anti-tumor drug with topoisomerase I-inhibitory activity.The chemical name for topotecan hydrochloride is (S)-10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1H-pyrano[...
    Active IngredientTopotecan hydrochloride
    Dosage FormInjectable; Solution
    RouteInjection; Intravenous
    Strengtheq 4mg base/4ml (eq 1mg base/ml); eq 4mg base/vial
    Market StatusPrescription
    CompanyHospira; Fresenius Kabi Oncol; Accord Hlthcare; Sun Pharm Inds; Innopharma Licensing; Teva Pharms Usa; Actavis Elizabeth; Fresenius Kabi Usa; Onco Therapies; Sagent Pharms; Dr Reddys Labs; Three Rivers Pharms

    2 of 2  
    Drug NameTopotecan hydrochloride
    Drug LabelTopotecan hydrochloride is a semi-synthetic derivative of camptothecin and is an anti-tumor drug with topoisomerase I-inhibitory activity.The chemical name for topotecan hydrochloride is (S)-10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1H-pyrano[...
    Active IngredientTopotecan hydrochloride
    Dosage FormInjectable; Solution
    RouteInjection; Intravenous
    Strengtheq 4mg base/4ml (eq 1mg base/ml); eq 4mg base/vial
    Market StatusPrescription
    CompanyHospira; Fresenius Kabi Oncol; Accord Hlthcare; Sun Pharm Inds; Innopharma Licensing; Teva Pharms Usa; Actavis Elizabeth; Fresenius Kabi Usa; Onco Therapies; Sagent Pharms; Dr Reddys Labs; Three Rivers Pharms

    4.2 Drug Indication

    Hycamtin capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate.

    Topotecan is indicated for the treatment of patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy.

    Hycamtin capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate.

    Topotecan monotherapy is indicated for the treatment of patients with relapsed small-cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate.

    Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment-free interval to justify treatment with the combination.

    Topotecan monotherapy is indicated for the treatment of patients with relapsed small cell lung cancer [SCLC] for whom re-treatment with the first-line regimen is not considered appropriate.

    Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination.

    Topotecan monotherapy is indicated for the treatment of:

    - patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy

    - patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with thefirst-line regimen is not considered appropriate.

    Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination.

    Topotecan monotherapy is indicated for the treatment of:

    - patients with metastatic carcinoma of the ovary after failure of first line or subsequent therapy;

    - patients with relapsed small cell lung cancer [SCLC] for whom re-treatment with the first-line regimen is not considered appropriate.

    Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination.

    Topotecan monotherapy is indicated for the treatment of patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate.

    Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination.

    Topotecan is indicated for the treatment of patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy.

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Topoisomerase I Inhibitors

    Compounds that inhibit the activity of DNA TOPOISOMERASE I. (See all compounds classified as Topoisomerase I Inhibitors.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Topoisomerase Inhibitors [MoA]; Topoisomerase Inhibitor [EPC]
    5.3 ATC Code

    L01CE01

    L01XX17

    L01XX17

    L01XX17

    L01XX17

    L01XX17

    L01XX17

    API Reference Price

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HIGHWAY, THALTEJ","city":"AHMEDABAD,GUJARAT","supplier":"SCINOPHARM TAIWAN, LTD","supplierCountry":"TAIWAN","foreign_port":"NA","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.05","actualQuantity":"48","unit":"GMS","unitRateFc":"800","totalValueFC":"38616.9","currency":"USD","unitRateINR":"61320","date":"17-Mar-2022","totalValueINR":"2943360","totalValueInUsd":"38616.9","indian_port":"AHMEDABAD AIR","hs_no":"29420090","bill_no":"7902286","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1654626600,"product":"CHEMICAL : TOPOTECAN HYDROCHLORIDE PH.EUR.","address":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ","city":"AHMEDABAD,GUJARAT","supplier":"SCINO PHARMA TAIWAN,LTD.","supplierCountry":"TAIWAN","foreign_port":"NA","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.10","actualQuantity":"0.1","unit":"KGS","unitRateFc":"800000","totalValueFC":"80497","currency":"USD","unitRateINR":"62800000","date":"08-Jun-2022","totalValueINR":"6280000","totalValueInUsd":"80497","indian_port":"AHMEDABAD AIR","hs_no":"29420090","bill_no":"9021996","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1663093800,"product":"CHEMICAL : TOPOTECAN HYDROCHLORIDE PH.EUR","address":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. 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HIGHWAY, THALTEJ"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1677609000,"product":"TOPOTECAN HYDROCHLORIDE","address":"S.C.O.857, CABIN NO. 10, 2ND FLOOR ,,NAC, MANIMAJRA,","city":"CHANDIGARH,CHANDIGARH","supplier":"CHEMISTRY & HEALTH FZ LLC","supplierCountry":"TAIWAN","foreign_port":"NA","customer":"VENUS REMEDIES","customerCountry":"INDIA","quantity":"0.02","actualQuantity":"15","unit":"GMS","unitRateFc":"1100","totalValueFC":"16780.8","currency":"USD","unitRateINR":"92015","date":"01-Mar-2023","totalValueINR":"1380225","totalValueInUsd":"16780.8","indian_port":"DELHI AIR","hs_no":"29419090","bill_no":"4855497","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"S.C.O.857, CABIN NO. 10, 2ND FLOOR ,,NAC, MANIMAJRA,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1680028200,"product":"TOPOTECAN HYDROCHLORIDE","address":"S.C.O.857, CABIN NO. 10, 2ND FLOOR ,,NAC, MANIMAJRA,","city":"CHANDIGARH,CHANDIGARH","supplier":"CHEMISTRY & HEALTH FZ LLC","supplierCountry":"TAIWAN","foreign_port":"NA","customer":"VENUS REMEDIES","customerCountry":"INDIA","quantity":"0.02","actualQuantity":"15","unit":"GMS","unitRateFc":"1100","totalValueFC":"16790.8","currency":"USD","unitRateINR":"92070","date":"29-Mar-2023","totalValueINR":"1381050","totalValueInUsd":"16790.8","indian_port":"DELHI AIR","hs_no":"29419090","bill_no":"5282368","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"S.C.O.857, CABIN NO. 10, 2ND FLOOR ,,NAC, MANIMAJRA,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1680201000,"product":"TOPOTECAN HYDROCHLORIDE (TOPOTECAN HYDROCHLORIDE PH.EUR)","address":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ","city":"AHMEDABAD,GUJARAT","supplier":"SCINOPHARM TAIWAN, LTD","supplierCountry":"TAIWAN","foreign_port":"NA","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.10","actualQuantity":"100","unit":"GMS","unitRateFc":"800","totalValueFC":"81410","currency":"USD","unitRateINR":"66960","date":"31-Mar-2023","totalValueINR":"6696000","totalValueInUsd":"81410","indian_port":"AHMEDABAD AIR","hs_no":"29420090","bill_no":"5313758","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. 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    24-Aug-2021
    08-Nov-2024
    KGS
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    Average Price (USD/KGS)

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    Total Quantity (KGS)

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    Quantity (KGS) & Unit rate (USD/KGS) over time

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    DOSAGE - SOLUTION;INTRAVENOUS - EQ 1MG BASE/M...DOSAGE - SOLUTION;INTRAVENOUS - EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 200199

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    DOSAGE - SOLUTION;INTRAVENOUS - EQ 3MG BASE/3...DOSAGE - SOLUTION;INTRAVENOUS - EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 200199

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    DOSAGE - SOLUTION;INTRAVENOUS - EQ 4MG BASE/4...DOSAGE - SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 200199

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    DOSAGE - SOLUTION;INTRAVENOUS - EQ 4MG BASE/4...DOSAGE - SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

    USFDA APPLICATION NUMBER - 200582

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    DOSAGE - INJECTABLE;INJECTION - EQ 4MG BASE/V...DOSAGE - INJECTABLE;INJECTION - EQ 4MG BASE/VIAL

    USFDA APPLICATION NUMBER - 20671

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    DOSAGE - CAPSULE;ORAL - EQ 0.25MG BASE

    USFDA APPLICATION NUMBER - 20981

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    DOSAGE - CAPSULE;ORAL - EQ 1MG BASE

    USFDA APPLICATION NUMBER - 20981

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    ABOUT THIS PAGE

    Looking for 119413-54-6 / Topotecan Hydrochloride API manufacturers, exporters & distributors?

    Topotecan Hydrochloride manufacturers, exporters & distributors 1

    22

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

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

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

    API | Excipient name

    Topotecan Hydrochloride

    Synonyms

    119413-54-6, Topotecan hcl, Hycamtin, Nogitecan hydrochloride, Topotecan (hydrochloride), Topotecan monohydrochloride

    Cas Number

    119413-54-6

    Unique Ingredient Identifier (UNII)

    956S425ZCY

    About Topotecan Hydrochloride

    An antineoplastic agent used to treat ovarian cancer. It works by inhibiting DNA TOPOISOMERASES, TYPE I.

    Topotecan Hydrochloride Manufacturers

    A Topotecan Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Topotecan Hydrochloride, including repackagers and relabelers. The FDA regulates Topotecan Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Topotecan Hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of Topotecan Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Topotecan Hydrochloride Suppliers

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

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

    Topotecan Hydrochloride USDMF

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

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

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

    Topotecan Hydrochloride KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Topotecan Hydrochloride Drug Master File in Korea (Topotecan Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Topotecan Hydrochloride. The MFDS reviews the Topotecan Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Topotecan Hydrochloride KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Topotecan Hydrochloride KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Topotecan Hydrochloride API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Topotecan Hydrochloride suppliers with KDMF on PharmaCompass.

    Topotecan Hydrochloride WC

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

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

    Topotecan Hydrochloride NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Topotecan Hydrochloride as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Topotecan Hydrochloride API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Topotecan Hydrochloride as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Topotecan Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Topotecan Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

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

    Topotecan Hydrochloride GMP

    Topotecan Hydrochloride Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

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

    Topotecan Hydrochloride CoA

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

    Topotecan Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Topotecan Hydrochloride CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

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

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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