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    Chemistry

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    Also known as: 100286-90-6, Irinotecan hcl, Topotecin, Campto, Camptothecin 11 hydrochloride, Camptosar
    Molecular Formula
    C33H39ClN4O6
    Molecular Weight
    623.1  g/mol
    InChI Key
    GURKHSYORGJETM-WAQYZQTGSA-N
    FDA UNII
    06X131E4OE
    Irinotecan Hydrochloride
    A semisynthetic camptothecin derivative that inhibits DNA TOPOISOMERASE I to prevent nucleic acid synthesis during S PHASE. It is used as an antineoplastic agent for the treatment of COLORECTAL NEOPLASMS and PANCREATIC NEOPLASMS.
    1 2D Structure

    Irinotecan Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    [(19S)-10,19-diethyl-19-hydroxy-14,18-dioxo-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)-heptaen-7-yl] 4-piperidin-1-ylpiperidine-1-carboxylate;hydrochloride
    2.1.2 InChI
    InChI=1S/C33H38N4O6.ClH/c1-3-22-23-16-21(43-32(40)36-14-10-20(11-15-36)35-12-6-5-7-13-35)8-9-27(23)34-29-24(22)18-37-28(29)17-26-25(30(37)38)19-42-31(39)33(26,41)4-2;/h8-9,16-17,20,41H,3-7,10-15,18-19H2,1-2H3;1H/t33-;/m0./s1
    2.1.3 InChI Key
    GURKHSYORGJETM-WAQYZQTGSA-N
    2.1.4 Canonical SMILES
    CCC1=C2CN3C(=CC4=C(C3=O)COC(=O)C4(CC)O)C2=NC5=C1C=C(C=C5)OC(=O)N6CCC(CC6)N7CCCCC7.Cl
    2.1.5 Isomeric SMILES
    CCC1=C2CN3C(=CC4=C(C3=O)COC(=O)[C@@]4(CC)O)C2=NC5=C1C=C(C=C5)OC(=O)N6CCC(CC6)N7CCCCC7.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    06X131E4OE
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 7 Ethyl 10 Hydroxycamptothecin

    2. 7-ethyl-10-hydroxycamptothecin

    3. Camptosar

    4. Camptothecin 11

    5. Camptothecin-11

    6. Cpt 11

    7. Cpt-11

    8. Cpt11

    9. Irinotecan

    10. Irrinotecan

    11. Nk012 Compound

    12. Sn 38

    13. Sn 38 11

    14. Sn-38

    15. Sn-38-11

    16. Sn3811

    2.3.2 Depositor-Supplied Synonyms

    1. 100286-90-6

    2. Irinotecan Hcl

    3. Topotecin

    4. Campto

    5. Camptothecin 11 Hydrochloride

    6. Camptosar

    7. Cpt 11

    8. Cpt-11

    9. Irinotecan (hydrochloride)

    10. Camptothecin 11

    11. U 101440e

    12. Chebi:5971

    13. (s)-4,11-diethyl-4-hydroxy-3,14-dioxo-3,4,12,14-tetrahydro-1h-pyrano[3',4':6,7]indolizino[1,2-b]quinolin-9-yl [1,4'-bipiperidine]-1'-carboxylate Hydrochloride

    14. Camptothecin Analog

    15. 06x131e4oe

    16. 7-ethyl-10-(4-(1-piperidino)-1-piperidino)carbonyloxy Camptothecin Hydrochloride

    17. Nsc616348

    18. Nsc-616348

    19. Ncgc00095190-01

    20. Dsstox_cid_25953

    21. Dsstox_rid_81249

    22. Dsstox_gsid_45953

    23. [(19s)-10,19-diethyl-19-hydroxy-14,18-dioxo-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)-heptaen-7-yl] 4-piperidin-1-ylpiperidine-1-carboxylate;hydrochloride

    24. Irinotecan Hydrochloride Anhydrous

    25. Cas-100286-90-6

    26. U-101440e

    27. Unii-06x131e4oe

    28. Irinotecan Hydrochloride [usan:jan]

    29. Mfcd01862255

    30. Irinotecanhydrochloride

    31. Cpt-11 Hydrochloride

    32. Irinotecan Monohydrochloride

    33. Schembl4033

    34. Camptosar (tn) (pharmacia)

    35. (s)-[1,4'-bipiperidine]-1'-carboxylic Acid, 4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo-1h-pyrano[3',4':6,7]indolizino[1,2-b]quinolin-9-yl Ester Hydrochloride

    36. Spectrum1505821

    37. Chembl541887

    38. Dtxsid6045953

    39. Hms1922j04

    40. Pharmakon1600-01505821

    41. Amy24895

    42. Bcp17234

    43. Irinotecan Hydrochloride (anhydrous)

    44. Tox21_111479

    45. Hy-16562a

    46. Nsc759878

    47. S5026

    48. Akos015901921

    49. Tox21_111479_1

    50. Ccg-213561

    51. Irinotecan Hydrochloride [who-dd]

    52. Ncgc00095190-02

    53. Ncgc00178697-04

    54. (1,4'-bipiperidine)-1'-carboxylic Acid, (4s)-4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo-1h-pyrano(3',4':6,7)indolizino(1,2-b)quinolin-9-yl Ester, Monohydrochloride

    55. (1,4'-bipiperidine)-1'-carboxylic Acid, 3,4,12,14-tetrahydro-4,11-diethyl-4-hydroxy-3,4-dioxo-1h-pyrano(3',4':6,7)indolizino(1,2-b)quinolin-9-yl Ester, Monohydrochloride, (s)-

    56. Ac-28335

    57. As-13304

    58. I0714

    59. Irinotecan Hydrochloride Anhydrous [mi]

    60. Irinotecan Hydrochloride, Topoisomerase Inhibitor

    61. 286i906

    62. A897508

    63. Sr-01000763864

    64. Q-100016

    65. Sr-01000763864-3

    66. Q27106952

    67. Z1550648758

    68. (+)-7-ethyl-10-hydroxycamptothecine 10-(1,4'-bipiperidine)-1'-carboxylate, Monohydrochloride

    69. (1,4'-bipiperidine)-1'-carboxylic Acid, (4s)-4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo-1h-pyrano(3',4':6,7)indolizino(1,2-b)quinolin-9-yl Ester, Hydrochloride (1:1)

    70. (19s)-10,19-diethyl-19-hydroxy-14,18-dioxo-17-oxa-3,13-diazapentacyclo[11.8.0.0^{2,11}.0^{4,9}.0^{15,20}]henicosa-1(21),2(11),3,5,7,9,15(20)-heptaen-7-yl [1,4'-bipiperidine]-1'-carboxylate Hydrochloride

    71. (4s)-4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo-1h-pyrano[3',4':6,7]indolizino[1,2-b]quinolin-9-yl [1,4'-bipiperidine]-1'-carboxylic Acid Ester Hydrochloride

    72. (4s)-4,11-diethyl-4-hydroxy-3,14-dioxo-3,4,12,14-tetrahydro-1h-pyrano[3',4':6,7]indolizino[1,2-b]quinolin-9-yl [1,4'-bipiperidine]-1'-carboxylate Hydrochloride

    73. (s)-4,11-diethyl-4-hydroxy-3,14-dioxo-3,4,12,14-tetrahydro-1h-pyrano[3',4':6,7]indolizino[1,2-b]quinolin-9-yl[1,4'-bipiperidine]-1'-carboxylatehydrochloride

    74. [(19s)-10,19-diethyl-19-hydroxy-14,18-dioxo-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)-heptaen-7-yl] 4-piperidin-1-ylpiperidine-1-carboxylate Hydrochloride

    75. [1, 4,11-diethyl-3,4,12, 14-tetrahydro-4-hydroxy-3,14-dioxo-1h-pyrano[3',4':6,7] Indolizino[1,2-b]quinolin-9-yl Ester, Monohydrochloride (s)-

    76. [1,4'-bipiperidine]-1'-carboxylic Acid,(4s)-4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo-1h-pyrano[3',4':6,7]indolizino[1,2-b]quinolin-9-yl Ester, Monohydrochloride

    77. 1-[1-({[(4s)-4,11-diethyl-4-hydroxy-3,14-dioxo-3,4,12,14-tetrahydro-1h-pyrano[3',4':6,7]indolizino[1,2-b]quinolin-9-yl]oxy}carbonyl)piperidin-4-yl]piperidin-1-ium Chloride

    2.3.3 Other Synonyms

    1. Camptosar

    2. Campto

    3. Irinotecan

    4. Hy-16562

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 623.1 g/mol
    Molecular Formula C33H39ClN4O6
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count5
    Exact Mass622.2558127 g/mol
    Monoisotopic Mass622.2558127 g/mol
    Topological Polar Surface Area113 Ų
    Heavy Atom Count44
    Formal Charge0
    Complexity1200
    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 NameIrinotecan hydrochloride
    Drug LabelIrinotecan hydrochloride injection is an antineoplastic agent of the topoisomerase I inhibitor class. Irinotecan hydrochloride was clinically investigated as CPT-11. Irinotecan hydrochloride injection is supplied as a sterile, pale yellow, clear, aqu...
    Active IngredientIrinotecan hydrochloride
    Dosage FormInjectable
    Routeinjection; Injection
    Strength20mg/ml; 100mg/5ml (20mg/ml); 500mg/25ml (20mg/ml); 100mg/5ml; 40mg/2ml (20mg/ml)
    Market StatusPrescription
    CompanyPliva Lachema; Hospira; Teva Parenteral; Fresenius Kabi Oncol; Accord Hlthcare; Jiangsu Hengrui Med; Hikma Farmaceutica; Teva Pharms Usa; Cipla; Hisun Pharm Hangzhou; Sun Pharma Global; Actavis Elizabeth; Emcure Pharms; Mustafa Nevzat Ilac; Fresenius Kabi

    2 of 2  
    Drug NameIrinotecan hydrochloride
    Drug LabelIrinotecan hydrochloride injection is an antineoplastic agent of the topoisomerase I inhibitor class. Irinotecan hydrochloride was clinically investigated as CPT-11. Irinotecan hydrochloride injection is supplied as a sterile, pale yellow, clear, aqu...
    Active IngredientIrinotecan hydrochloride
    Dosage FormInjectable
    Routeinjection; Injection
    Strength20mg/ml; 100mg/5ml (20mg/ml); 500mg/25ml (20mg/ml); 100mg/5ml; 40mg/2ml (20mg/ml)
    Market StatusPrescription
    CompanyPliva Lachema; Hospira; Teva Parenteral; Fresenius Kabi Oncol; Accord Hlthcare; Jiangsu Hengrui Med; Hikma Farmaceutica; Teva Pharms Usa; Cipla; Hisun Pharm Hangzhou; Sun Pharma Global; Actavis Elizabeth; Emcure Pharms; Mustafa Nevzat Ilac; Fresenius Kabi

    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]

    API Reference Price

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HIGHWAY, THALTEJ"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1680114600,"product":"IRINOTECAN HYDROCHLORIDE TRIHYDRATE BATCH NO-71134AA113","address":"PLOT NO. 3, PHARMEZ, SEZ, SARKEHJ","city":"TAL- SANAND, DIST- AHMEDABAD","supplier":"SCION PHARMA TAIWAN LTD","supplierCountry":"TAIWAN","foreign_port":"TAIPEI","customer":"ZYDUS LIFESCIENCES","customerCountry":"INDIA","quantity":"17.00","actualQuantity":"17","unit":"KGS","unitRateFc":"40437.5","totalValueFC":"699552.8","currency":"USD","unitRateINR":"3384616.4","date":"30-Mar-2023","totalValueINR":"57538479","totalValueInUsd":"699552.8","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29349990","bill_no":"1001328","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIPEI","supplierAddress":"N\/A","customerAddress":"PLOT NO. 3, PHARMEZ, SEZ, SARKEHJ"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1688322600,"product":"IRINOTECAN HYDROCHLORIDE TRIHYDRATE BATCH NO.-71134AA128","address":"PLOT NO. 3, PHARMEZ, SEZ, SARKEHJ","city":"TAL- SANAND, DIST- AHMEDABAD","supplier":"SCINOPHARM TAIWAN LTD","supplierCountry":"TAIWAN","foreign_port":"TAIPEI","customer":"ZYDUS LIFESCIENCES","customerCountry":"INDIA","quantity":"9.00","actualQuantity":"9","unit":"KGS","unitRateFc":"40616.8","totalValueFC":"369378.5","currency":"USD","unitRateINR":"3373226.8","date":"03-Jul-2023","totalValueINR":"30359041","totalValueInUsd":"369378.5","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29333990","bill_no":"1002813","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIPEI","supplierAddress":"NO. 1, NAN-KE 8TH ROAD, SOUTHERN TAIWN SCIENCE PARK,","customerAddress":"PLOT NO. 3, PHARMEZ, SEZ, SARKEHJ"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723401000,"product":"IRINOTECAN HCL (OLON 4-PIPECLOCLO BC) BATCH:23011FR12B","address":"PLOT NO. 3, PHARMEZ, SEZ, SARKEHJ","city":"TAL- SANAND, DIST- AHMEDABAD","supplier":"ESSERS LSP NORMAL","supplierCountry":"ITALY","foreign_port":"BRUSSEL (BRUXELLES)","customer":"ZYDUS LIFESCIENCES","customerCountry":"INDIA","quantity":"3.01","actualQuantity":"3.006","unit":"KGS","unitRateFc":"43520","totalValueFC":"131946.3","currency":"USD","unitRateINR":"3681792","date":"12-Aug-2024","totalValueINR":"11067466.75","totalValueInUsd":"131946.3","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29397900","bill_no":"5006801","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"BRUSSEL (BRUXELLES)","supplierAddress":"TRANSPORTLAAN 4 3600 GENK SDNF Belgium","customerAddress":"PLOT NO. 3, PHARMEZ, SEZ, SARKEHJ"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725906600,"product":"IRINOTECAN HCL (OLON 4-PIPECLOCLO BC) BATCH:0023711342","address":"PLOT NO. 3, PHARMEZ, SEZ, SARKEHJ","city":"TAL- SANAND, DIST- AHMEDABAD","supplier":"ESSERS LSP NORMAL","supplierCountry":"ITALY","foreign_port":"BRUSSEL (BRUXELLES)","customer":"ZYDUS LIFESCIENCES","customerCountry":"INDIA","quantity":"3.04","actualQuantity":"3.04","unit":"KGS","unitRateFc":"43520","totalValueFC":"134035.5","currency":"USD","unitRateINR":"3694848","date":"10-Sep-2024","totalValueINR":"11232337.92","totalValueInUsd":"134035.5","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29397900","bill_no":"5522185","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"BRUSSEL (BRUXELLES)","supplierAddress":"Transportlaan 4 3600 GENK SDNF Belgium","customerAddress":"PLOT NO. 3, PHARMEZ, SEZ, SARKEHJ"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731954600,"product":"IRINOTECAN HYDROCHLORIDE TRIHYDRATE BATCH NO.71781AA001","address":"PLOT NO. 3, PHARMEZ, SEZ, SARKEHJ","city":"TAL- SANAND, DIST- AHMEDABAD","supplier":"SCINOPHARM TAIWAN LTD","supplierCountry":"TAIWAN","foreign_port":"TAIPEI","customer":"ZYDUS LIFESCIENCES","customerCountry":"INDIA","quantity":"4.21","actualQuantity":"4.206","unit":"KGS","unitRateFc":"40686.6","totalValueFC":"172976.8","currency":"USD","unitRateINR":"3470565.5","date":"19-Nov-2024","totalValueINR":"14597198.7","totalValueInUsd":"172976.8","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29398000","bill_no":"6751604","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIPEI","supplierAddress":"NO.1, Nan-Ke 8th Road, Shan-Hua SDNF Taiwan","customerAddress":"PLOT NO. 3, PHARMEZ, SEZ, SARKEHJ"}]
    11-Jan-2021
    28-Mar-2025
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    DOSAGE - INJECTABLE;INJECTION - 100MG/5ML (20...DOSAGE - INJECTABLE;INJECTION - 100MG/5ML (20MG/ML)

    USFDA APPLICATION NUMBER - 20571

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    DOSAGE - INJECTABLE;INJECTION - 300MG/15ML (2...DOSAGE - INJECTABLE;INJECTION - 300MG/15ML (20MG/ML)

    USFDA APPLICATION NUMBER - 20571

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    DOSAGE - INJECTABLE;INJECTION - 40MG/2ML (20M...DOSAGE - INJECTABLE;INJECTION - 40MG/2ML (20MG/ML)

    USFDA APPLICATION NUMBER - 20571

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    DOSAGE - INJECTABLE, LIPOSOMAL;INTRAVENOUS - ...DOSAGE - INJECTABLE, LIPOSOMAL;INTRAVENOUS - EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)

    USFDA APPLICATION NUMBER - 207793

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    ABOUT THIS PAGE

    Looking for 100286-90-6 / Irinotecan Hydrochloride API manufacturers, exporters & distributors?

    Irinotecan Hydrochloride manufacturers, exporters & distributors 1

    58

    PharmaCompass offers a list of Irinotecan 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 Irinotecan Hydrochloride manufacturer or Irinotecan Hydrochloride supplier for your needs.

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

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

    API | Excipient name

    Irinotecan Hydrochloride

    Synonyms

    100286-90-6, Irinotecan hcl, Topotecin, Campto, Camptothecin 11 hydrochloride, Camptosar

    Cas Number

    100286-90-6

    Unique Ingredient Identifier (UNII)

    06X131E4OE

    About Irinotecan Hydrochloride

    A semisynthetic camptothecin derivative that inhibits DNA TOPOISOMERASE I to prevent nucleic acid synthesis during S PHASE. It is used as an antineoplastic agent for the treatment of COLORECTAL NEOPLASMS and PANCREATIC NEOPLASMS.

    Irinotecan Hydrochloride Trihydrate Manufacturers

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

    Irinotecan Hydrochloride Trihydrate Suppliers

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

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

    Irinotecan Hydrochloride Trihydrate USDMF

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

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

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

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

    Irinotecan Hydrochloride Trihydrate KDMF

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

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

    After submitting a Irinotecan Hydrochloride Trihydrate 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 Irinotecan Hydrochloride Trihydrate API can apply through the Korea Drug Master File (KDMF).

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

    Irinotecan Hydrochloride Trihydrate CEP

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

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

    Irinotecan Hydrochloride Trihydrate WC

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

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

    Irinotecan Hydrochloride Trihydrate 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 Irinotecan Hydrochloride Trihydrate as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Irinotecan Hydrochloride Trihydrate GMP

    Irinotecan Hydrochloride Trihydrate 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 Irinotecan Hydrochloride Trihydrate 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 Irinotecan Hydrochloride Trihydrate GMP manufacturer or Irinotecan Hydrochloride Trihydrate GMP API supplier for your needs.

    Irinotecan Hydrochloride Trihydrate CoA

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

    Irinotecan Hydrochloride Trihydrate CoA mostly includes findings from lab analyses of a specific batch. For each Irinotecan Hydrochloride Trihydrate 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.

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