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    Chemistry

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    Also known as: 183319-69-9, Erlotinib hcl, Tarceva, Osi-774, N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine hydrochloride, Osi 774
    Molecular Formula
    C22H24ClN3O4
    Molecular Weight
    429.9  g/mol
    InChI Key
    GTTBEUCJPZQMDZ-UHFFFAOYSA-N
    FDA UNII
    DA87705X9K
    Erlotinib Hydrochloride
    A quinazoline derivative and ANTINEOPLASTIC AGENT that functions as a PROTEIN KINASE INHIBITOR for EGFR associated tyrosine kinase. It is used in the treatment of NON-SMALL CELL LUNG CANCER.
    1 2D Structure

    Erlotinib Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine;hydrochloride
    2.1.2 InChI
    InChI=1S/C22H23N3O4.ClH/c1-4-16-6-5-7-17(12-16)25-22-18-13-20(28-10-8-26-2)21(29-11-9-27-3)14-19(18)23-15-24-22;/h1,5-7,12-15H,8-11H2,2-3H3,(H,23,24,25);1H
    2.1.3 InChI Key
    GTTBEUCJPZQMDZ-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    COCCOC1=C(C=C2C(=C1)C(=NC=N2)NC3=CC=CC(=C3)C#C)OCCOC.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    DA87705X9K
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 11c Erlotinib

    2. 11c-erlotinib

    3. 358,774, Cp

    4. 358774, Cp

    5. Cp 358,774

    6. Cp 358774

    7. Cp-358,774

    8. Cp-358774

    9. Cp358,774

    10. Cp358774

    11. Erlotinib

    12. Erlotinib Hcl

    13. Hcl, Erlotinib

    14. Hydrochloride, Erlotinib

    15. N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine

    16. Osi 774

    17. Osi-774

    18. Osi774

    19. Tarceva

    2.3.2 Depositor-Supplied Synonyms

    1. 183319-69-9

    2. Erlotinib Hcl

    3. Tarceva

    4. Osi-774

    5. N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine Hydrochloride

    6. Osi 774

    7. Erlotinib (hydrochloride)

    8. Cp-358774

    9. Cp 358774

    10. Erlotinib, Hydrochloride Salt

    11. Tarceva (erlotinib Hydrochloride)

    12. Nsc 718781

    13. Cp-358,774-01

    14. Da87705x9k

    15. 6,7-bis(2-methoxyethoxy)-4-(3-ethynylanilino)quinazoline Hydrochloride

    16. N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine;hydrochloride

    17. Cp-358

    18. 4-quinazolinamine, N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-, Hydrochloride (1:1)

    19. Nsc-718781

    20. 6,7-bis(2-methoxyethoxy)-4-(3-ethynylanilino)quinazoline Hcl

    21. 183319-69-9 (hcl)

    22. 4-(m-ethynylanilino)-6,7-bis(2-methoxyethoxy)quinazoline Monohydrochloride

    23. Cp-358774-01

    24. 4-quinazolinamine, N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-, Monohydrochloride

    25. [6,7-bis-(2-methoxy-ethoxy)-quinazolin-4-yl]-(3-ethynyl-phenyl)-amine Hydrochloride

    26. N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine Monohydrochloride.

    27. Chebi:53509

    28. Osi-744

    29. Smr002529980

    30. Erlotinib Hydrochloride [usan]

    31. Nsc718781

    32. 183319-69-9 Pound Not183321-74-6

    33. Erlotinib Hcl (osi-744)

    34. Unii-da87705x9k

    35. Erlotinib, Hcl

    36. Erlotinib Hcl Salt

    37. Erlotinib Hydrochloride [usan:inn]

    38. Tarceva (osi)

    39. Tarceva Hydrochloride

    40. Mfcd07781272

    41. Erlotonib Hydrochloride

    42. Erlotinib Hydrochlroide

    43. Erlotinib(osi-744)

    44. Mls003899192

    45. Mls004774139

    46. Chembl1079742

    47. Nsc 718781) Hcl

    48. Dtxsid10171412

    49. Ex-a064

    50. Erlotinib Hydrochloride (tarceva)

    51. Bcpp000238

    52. Bcp02600

    53. Erlotinib Hydrochloride [mi]

    54. Ac-400

    55. Erlotinib Hydrochloride [jan]

    56. S1023

    57. Akos015849087

    58. Bcp9000658

    59. Ccg-269002

    60. Cs-0123

    61. Erlotinib Hydrochloride [mart.]

    62. Ks-1202

    63. Pb30965

    64. Sb16917

    65. Erlotinib Hydrochloride [usp-rs]

    66. Erlotinib Hydrochloride [who-dd]

    67. Ro-50-8231

    68. Be164421

    69. Bp-30224

    70. Hy-12008

    71. (cp358774

    72. Db-011534

    73. Am20090622

    74. Erlotinib Hydrochloride [orange Book]

    75. Ft-0651479

    76. Ec-000.2313

    77. E-4007

    78. 319e699

    79. Q27124083

    80. F0001-2385

    81. Erlotinib Hydrochloride Is Known As A Egfr Kinase Inhibitor.

    82. Erlotinib Hydrochloride,cp-358774, Osi-774, Nsc 718781

    83. 6,7-bis-(2-methoxyethoxy)-4-(3-ethynylanilino)quinazoline Hydrochloride

    84. [6,7-bis(2-methoxy-ethoxy)-quinazolin-4-yl]-(3-ethynyl- Phenyl)amine Hydrochloride

    85. N-(3-ethenylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine Hydrochloride

    86. N-(3-ethynylphenyl)-6,7-bis(1-methoxyethoxy)-4-quinazolinamine Hydrochloride

    87. N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine, Monohydrochloride

    88. N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-quinazolin-4-amine Hydrochloride

    2.4 Create Date
    2005-03-26
    3 Chemical and Physical Properties
    Molecular Weight 429.9 g/mol
    Molecular Formula C22H24ClN3O4
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count7
    Rotatable Bond Count11
    Exact Mass429.1455339 g/mol
    Monoisotopic Mass429.1455339 g/mol
    Topological Polar Surface Area74.7 Ų
    Heavy Atom Count30
    Formal Charge0
    Complexity525
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    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 4  
    Drug NameErlotinib hydrochloride
    Drug LabelTARCEVA (erlotinib), a kinase inhibitor, is a quinazolinamine with the chemical name N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine. TARCEVA contains erlotinib as the hydrochloride salt that has the following structural formula:Erloti...
    Active IngredientErlotinib hydrochloride
    Dosage FormTablet
    RouteOral
    Strengtheq 100mg base; eq 150mg base; eq 25mg base
    Market StatusPrescription
    CompanyMylan Pharms

    2 of 4  
    Drug NameTarceva
    PubMed HealthErlotinib (By mouth)
    Drug ClassesAntineoplastic Agent, Immunological Agent
    Drug LabelTARCEVA (erlotinib), a kinase inhibitor, is a quinazolinamine with the chemical name N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine. TARCEVA contains erlotinib as the hydrochloride salt that has the following structural formula:Erloti...
    Active IngredientErlotinib hydrochloride
    Dosage FormTablet
    RouteOral
    Strengtheq 100mg base; eq 150mg base; eq 25mg base
    Market StatusPrescription
    CompanyOsi Pharms

    3 of 4  
    Drug NameErlotinib hydrochloride
    Drug LabelTARCEVA (erlotinib), a kinase inhibitor, is a quinazolinamine with the chemical name N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine. TARCEVA contains erlotinib as the hydrochloride salt that has the following structural formula:Erloti...
    Active IngredientErlotinib hydrochloride
    Dosage FormTablet
    RouteOral
    Strengtheq 100mg base; eq 150mg base; eq 25mg base
    Market StatusPrescription
    CompanyMylan Pharms

    4 of 4  
    Drug NameTarceva
    PubMed HealthErlotinib (By mouth)
    Drug ClassesAntineoplastic Agent, Immunological Agent
    Drug LabelTARCEVA (erlotinib), a kinase inhibitor, is a quinazolinamine with the chemical name N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine. TARCEVA contains erlotinib as the hydrochloride salt that has the following structural formula:Erloti...
    Active IngredientErlotinib hydrochloride
    Dosage FormTablet
    RouteOral
    Strengtheq 100mg base; eq 150mg base; eq 25mg base
    Market StatusPrescription
    CompanyOsi Pharms

    4.2 Drug Indication

    * Non-small cell lung cancer (NSCLC):

    Tarceva is also indicated for switch maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer with EGFR activating mutations and stable disease after first-line chemotherapy.

    Tarceva is also indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.

    In patients with tumours without EGFR activating mutations, Tarceva is indicated when other treatment options are not considered suitable.

    When prescribing Tarceva, factors associated with prolonged survival should be taken into account.

    No survival benefit or other clinically relevant effects of the treatment have been demonstrated in patients with Epidermal Growth Factor Receptor (EGFR)-IHC - negative tumours.

    * Pancreatic cancer :

    Tarceva in combination with gemcitabine is indicated for the treatment of patients with metastatic pancreatic cancer .

    When prescribing Tarceva, factors associated with prolonged survival should be taken into account.

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Antineoplastic Agents

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

    Protein Kinase Inhibitors

    Agents that inhibit PROTEIN KINASES. (See all compounds classified as Protein Kinase Inhibitors.)

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

    L01EB02

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KALAWAT, WARASIYA RING ROAD CO, VADODARA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1679941800,"product":"ERLOTINIB HYDROCHLORIDE (FORM-P) (OTHER","address":"NATCO HOUSE, ROAD NO.2,,BANJARA H ILLS,","city":"HYDERABAD,TELANGANA","supplier":"NATCO PHARMA","supplierCountry":"INDIA","foreign_port":"ZAGREB","customer":"PLIVA HRVATSKA","customerCountry":"CROATIA","quantity":"3.00","actualQuantity":"3","unit":"KGS","unitRateFc":"4200","totalValueFC":"12401.2","currency":"USD","unitRateINR":340000,"date":"28-Mar-2023","totalValueINR":"1020000","totalValueInUsd":"12401.2","indian_port":"HYDERABAD AIR","hs_no":"29214290","bill_no":"8878683","productDescription":"API","marketType":"REGULATED MARKET","country":"CROATIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"NATCO HOUSE, ROAD NO.2,,BANJARA H ILLS,, HYDERABAD,TELANGANA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1690655400,"product":"BULK DRUG(ERLOTINIB HYDROCHLORIDE)","address":"","city":"","supplier":"SHILPA PHARMA LIFESCIENCES LIMITED","supplierCountry":"INDIA","foreign_port":"HO CHI MINH C","customer":"RELIV PHARMACEUTICAL JOINT STOCK CO","customerCountry":"VIETNAM","quantity":"10.50","actualQuantity":"10.5","unit":"KGS","unitRateFc":"4405","totalValueFC":"45662.8","currency":"USD","unitRateINR":357428.60399999999,"date":"30-Jul-2023","totalValueINR":"3753000.342","totalValueInUsd":"45662.8","indian_port":"MADRAS AIR","hs_no":"29349990","bill_no":"0","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"VIETNAM, DEMOCRATIC REP. OF","selfForZScoreResived":"Pharma Grade","supplierPort":"MADRAS AIR","supplierAddress":"","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1692556200,"product":"ERLOTINIB HYDROCHLORIDE BATCH NO;ERLC001","address":"N0 116\/117 KIADB INDUSTRIAL AREA JIGANI 2ND PHASE","city":"BANGALORE","supplier":"ACEBRIGHT INDIA PHARMA PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"BUENOS AIRES","customer":"LABORATORIO ECZANE PHARMA","customerCountry":"ARGENTINA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"2500","totalValueFC":"2096.3","currency":"USD","unitRateINR":173652.432,"date":"21-Aug-2023","totalValueINR":"173652.432","totalValueInUsd":"2096.3","indian_port":"BANGALORE AIR","hs_no":"29335990","bill_no":"0","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ARGENTINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BANGALORE AIR","supplierAddress":"N0 116\/117 KIADB INDUSTRIAL AREA JIGANI 2ND PHASE, BANGALORE","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1692901800,"product":"ERLOTINIB HYDROCHLORIDE BATCH NO;ERLD230","address":"N0 116\/117 KIADB INDUSTRIAL AREA JIGANI 2ND PHASE","city":"BANGALORE","supplier":"ACEBRIGHT INDIA PHARMA PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"LARNACA","customer":"REMEDICA LIMITED","customerCountry":"CYPRUS","quantity":"74.64","actualQuantity":"74.64","unit":"KGS","unitRateFc":"2000","totalValueFC":"147200.7","currency":"USD","unitRateINR":163364.96717577707,"date":"25-Aug-2023","totalValueINR":"12193561.15","totalValueInUsd":"147200.7","indian_port":"BANGALORE AIR","hs_no":"29335990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CYPRUS","selfForZScoreResived":"Pharma Grade","supplierPort":"BANGALORE AIR","supplierAddress":"N0 116\/117 KIADB INDUSTRIAL AREA JIGANI 2ND PHASE, BANGALORE","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1699209000,"product":"ERLOTINIB HYDROCHLORIDE BATCH NO;ERLC0017004","address":"N0 116\/117, KIADB INDUSTRIAL AREA,","city":"BANGALORE","supplier":"CDYMAX (INDIA) PHARMA PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"MOSCOW DOMODEDOVO","customer":"LLC BRATSKCHEMSYNTEZ","customerCountry":"RUSSIA","quantity":"6.00","actualQuantity":"6","unit":"KGS","unitRateFc":"127296","totalValueFC":"8838.6","currency":"INR","unitRateINR":122666.66666666667,"date":"06-Nov-2023","totalValueINR":"736000","totalValueInUsd":"8838.6","indian_port":"Bangalore Air","hs_no":"29335990","bill_no":"5173300","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bangalore Air","supplierAddress":"N0 116\/117, KIADB INDUSTRIAL AREA,, BANGALORE","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1702405800,"product":"ERLOTINIB HYDROCHLORIDE BATCH NO;ERLD23007P2","address":"N0 116\/117, KIADB INDUSTRIAL AREA,","city":"BANGALORE","supplier":"CDYMAX (INDIA) PHARMA PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"MOSCOW DOMODEDOVO","customer":"M\/S,OZON LLC","customerCountry":"RUSSIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"232400","totalValueFC":"2450.7","currency":"INR","unitRateINR":204000,"date":"13-Dec-2023","totalValueINR":"204000","totalValueInUsd":"2450.7","indian_port":"Bangalore Air","hs_no":"29335990","bill_no":"6010657","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bangalore Air","supplierAddress":"N0 116\/117, KIADB INDUSTRIAL AREA,, BANGALORE","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1703269800,"product":"ERLOTINIB HYDROCHLORIDE BATCH NO;ERLD23009P1,ERLD23010P1,ERLD23011P1,ERLD23012P1,& ERLD23013P1","address":"N0 116\/117, KIADB INDUSTRIAL AREA,","city":"BANGALORE","supplier":"CDYMAX (INDIA) PHARMA PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"LARNACA","customer":"REMEDICA LTD.","customerCountry":"CYPRUS","quantity":"201.14","actualQuantity":"201.135","unit":"KGS","unitRateFc":"1900","totalValueFC":"377784.8","currency":"USD","unitRateINR":156352.69843637358,"date":"23-Dec-2023","totalValueINR":"31448000","totalValueInUsd":"377784.8","indian_port":"Bangalore Air","hs_no":"29335990","bill_no":"6249797","productDescription":"API","marketType":"REGULATED MARKET","country":"CYPRUS","selfForZScoreResived":"Pharma Grade","supplierPort":"Bangalore Air","supplierAddress":"N0 116\/117, KIADB INDUSTRIAL AREA,, BANGALORE","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729017000,"product":"PHARMA INGREDIENTS - ERLOTINIB HYDROCHLORIDE IN-HOUSE","address":"30, AROHI VILLA, S.P. RING ROAD, BOPAL,","city":"AHMEDABAD","supplier":"GREENCROSS EXPORT PRIVATE ","supplierCountry":"INDIA","foreign_port":"MOSCOW DOMODEDOVO","customer":"TO THE ORDER","customerCountry":"RUSSIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"5000","totalValueFC":"24417.7","currency":"USD","unitRateINR":410347.79999999999,"date":"16-Oct-2024","totalValueINR":"2051739","totalValueInUsd":"24417.7","indian_port":"Ahmedabad Air","hs_no":"29339990","bill_no":"4846026","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Ahmedabad Air","supplierAddress":"30, AROHI VILLA, S.P. RING ROAD, BOPAL,, AHMEDABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731436200,"product":"ERLOTINIB HYDROCHLORIDE BATCH NO;ERLE22002P1","address":"N0 116\/117, KIADB INDUSTRIAL AREA,","city":"BANGALORE","supplier":"CDYMAX (INDIA) PHARMA PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"KUALA LUMPUR - INT\\'L","customer":"M\/S,NOVUGEN ONCOLOGY SDN BHD","customerCountry":"MALAYSIA","quantity":"2.50","actualQuantity":"2.5","unit":"KGS","unitRateFc":"1600","totalValueFC":"3621.8","currency":"USD","unitRateINR":122253.23999999999,"date":"13-Nov-2024","totalValueINR":"305633.1","totalValueInUsd":"3621.8","indian_port":"Bangalore Air","hs_no":"29335990","bill_no":"5568031","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MALAYSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bangalore Air","supplierAddress":"N0 116\/117, KIADB INDUSTRIAL AREA,, BANGALORE","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731436200,"product":"ERLOTINIB HYDROCHLORIDE BATCH NO;ERLE22002P1","address":"N0 116\/117, KIADB INDUSTRIAL AREA,","city":"BANGALORE","supplier":"CDYMAX (INDIA) PHARMA PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"KUALA LUMPUR - INT\\'L","customer":"M\/S,NOVUGEN ONCOLOGY SDN BHD","customerCountry":"MALAYSIA","quantity":"2.50","actualQuantity":"2.5","unit":"KGS","unitRateFc":"1600","totalValueFC":"3621.8","currency":"USD","unitRateINR":122253.23999999999,"date":"13-Nov-2024","totalValueINR":"305633.1","totalValueInUsd":"3621.8","indian_port":"Bangalore Air","hs_no":"29335990","bill_no":"5568032","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MALAYSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bangalore Air","supplierAddress":"N0 116\/117, KIADB INDUSTRIAL AREA,, BANGALORE","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1648060200,"product":"(RE-IMPORT- REJECTED CARGO)ERLOTINIB HYDROCHLORIDE(BATCH NO#ERLD21008P1)","address":"N0 116\/117, KIADB INDUSTRIAL AREA, ,JIGANI 2ND PHASE","city":"BANGALORE,KARNATAKA","supplier":"REMEDICA LTD","supplierCountry":"CYPRUS","foreign_port":"NA","customer":"CDYMAX (INDIA) PHARMA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"36.92","actualQuantity":"36.917","unit":"KGS","unitRateFc":"2000","totalValueFC":"76115.1","currency":"USD","unitRateINR":"157148.7","date":"24-Mar-2022","totalValueINR":"5801456.65","totalValueInUsd":"76115.1","indian_port":"BANGALORE AIR","hs_no":"29420090","bill_no":"7992787","productDescription":"API","marketType":"REGULATED MARKET","country":"CYPRUS","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"N0 116\/117, KIADB INDUSTRIAL AREA, ,JIGANI 2ND PHASE"}]
    11-Jan-2021
    13-Nov-2024
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - EQ 100MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21743

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    DOSAGE - TABLET;ORAL - EQ 150MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21743

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    DOSAGE - TABLET;ORAL - EQ 25MG BASE **Federal...DOSAGE - TABLET;ORAL - EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21743

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    ABOUT THIS PAGE

    Erlotinib Hydrochloride Manufacturers

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

    Erlotinib Hydrochloride Suppliers

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

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

    Erlotinib Hydrochloride USDMF

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

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

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

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

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

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

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

    Erlotinib Hydrochloride WC

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

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

    Erlotinib 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 Erlotinib Hydrochloride as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Erlotinib Hydrochloride GMP

    Erlotinib 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 Erlotinib 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 Erlotinib Hydrochloride GMP manufacturer or Erlotinib Hydrochloride GMP API supplier for your needs.

    Erlotinib Hydrochloride CoA

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

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

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