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    Chemistry

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    Also known as: 388082-77-7, Tykerb, Tykerb ditosylate, Lapatinib (gw-572016) ditosylate, Tyverb, Lapatinib (ditosylate)
    Molecular Formula
    C43H42ClFN4O10S3
    Molecular Weight
    925.5  g/mol
    InChI Key
    UWYXLGUQQFPJRI-UHFFFAOYSA-N
    FDA UNII
    4WK72K94MC
    Lapatinib Ditosylate
    A quinazoline derivative that inhibits EPIDERMAL GROWTH FACTOR RECEPTOR and HER2 (RECEPTOR, ERBB-2) tyrosine kinases. It is used for the treatment of advanced or metastatic breast cancer, where tumors overexpress HER2.
    1 2D Structure

    Lapatinib Ditosylate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    N-[3-chloro-4-[(3-fluorophenyl)methoxy]phenyl]-6-[5-[(2-methylsulfonylethylamino)methyl]furan-2-yl]quinazolin-4-amine;4-methylbenzenesulfonic acid
    2.1.2 InChI
    InChI=1S/C29H26ClFN4O4S.2C7H8O3S/c1-40(36,37)12-11-32-16-23-7-10-27(39-23)20-5-8-26-24(14-20)29(34-18-33-26)35-22-6-9-28(25(30)15-22)38-17-19-3-2-4-21(31)13-19;2*1-6-2-4-7(5-3-6)11(8,9)10/h2-10,13-15,18,32H,11-12,16-17H2,1H3,(H,33,34,35);2*2-5H,1H3,(H,8,9,10)
    2.1.3 InChI Key
    UWYXLGUQQFPJRI-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC1=CC=C(C=C1)S(=O)(=O)O.CC1=CC=C(C=C1)S(=O)(=O)O.CS(=O)(=O)CCNCC1=CC=C(O1)C2=CC3=C(C=C2)N=CN=C3NC4=CC(=C(C=C4)OCC5=CC(=CC=C5)F)Cl
    2.2 Other Identifiers
    2.2.1 UNII
    4WK72K94MC
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Gw 282974x

    2. Gw 572016

    3. Gw-282974x

    4. Gw-572016

    5. Gw282974x

    6. Gw572016

    7. Lapatinib

    8. N-(3-chloro-4-(((3-fluorobenzyl)oxy)phenyl)-6-(5-(((2-methylsulfonyl)ethyl)amino)methyl) -2-furyl)-4-quinazolinamine

    9. Tykerb

    2.3.2 Depositor-Supplied Synonyms

    1. 388082-77-7

    2. Tykerb

    3. Tykerb Ditosylate

    4. Lapatinib (gw-572016) Ditosylate

    5. Tyverb

    6. Lapatinib (ditosylate)

    7. N-(3-chloro-4-((3-fluorobenzyl)oxy)phenyl)-6-(5-(((2-(methylsulfonyl)ethyl)amino)methyl)furan-2-yl)quinazolin-4-amine Bis(4-methylbenzenesulfonate)

    8. 388082-78-8

    9. Lapatinib Ditosylate Anhydrous

    10. 4wk72k94mc

    11. 388082-77-7 (ditosylate)

    12. Bis(4-methylbenzene-1-sulfonic Acid); N-{3-chloro-4-[(3-fluorophenyl)methoxy]phenyl}-6-(5-{[(2-methanesulfonylethyl)amino]methyl}furan-2-yl)quinazolin-4-amine

    13. Gw-572016

    14. 4-quinazolinamine, N-(3-chloro-4-((3-fluorophenyl)methoxy)phenyl)-6-(5-(((2-(methylsulfonyl)ethyl)amino)methyl)-2-furanyl)-, Bis(4-methylbenzenesulfonate)

    15. N-(3-chloro-4-((3-fluorobenzyl)oxy)phenyl)-6-(5-(((2-(methylsulfonyl)ethyl)amino)methyl)furan-2-yl)quinazolin-4-amine Ditosylate

    16. Sr-05000001472

    17. N-[3-chloro-4-[(3-fluorophenyl)methoxy]phenyl]-6-[5-[(2-methylsulfonylethylamino)methyl]furan-2-yl]quinazolin-4-amine;4-methylbenzenesulfonic Acid

    18. S1028

    19. Unii-4wk72k94mc

    20. Gw 572016f

    21. Gw-572016 Ditosylate

    22. Lapatinib Ditosylate,tykerb

    23. Schembl93590

    24. Quinazolin-4-amine Ditosylate

    25. Chembl1201183

    26. Dtxsid60959606

    27. Hms3265i13

    28. Hms3265i14

    29. Hms3265j13

    30. Hms3265j14

    31. Hms3654e07

    32. Hy-50898a

    33. Mfcd09264195

    34. Akos015888607

    35. Ac-5247

    36. Ccg-264661

    37. Cs-0831

    38. Gs-3661

    39. Db-119273

    40. Ft-0670728

    41. Lapatinib Ditoluenesulfonate Anhydrous

    42. Sw199101-4

    43. Ec-000.2339

    44. Lapatinib Ditosylate Anhydrous [who-dd]

    45. Gw 572016 Ditosylate;gw-572016 Ditosylate

    46. Lapatinib Ditoluenesulfonate Anhydrous [mi]

    47. Sr-05000001472-2

    48. Sr-05000001472-5

    49. Q27260601

    50. Z1692482592

    51. 4-methylbenzene-1-sulfonic Acid--n-{3-chloro-4-[(3-fluorophenyl)methoxy]phenyl}-6-[5-({[2-(methanesulfonyl)ethyl]amino}methyl)furan-2-yl]quinazolin-4-amine (2/1)

    52. 4-quinazolinamine, N-(3-chloro-4-((3-fluorophenyl)methoxy)phenyl)-6-(5-(((2-(methylsulfonyl)ethyl)amino)methyl)-2-furanyl)-, 4-methylbenzenesulfonate (1:2)

    53. N-(3-chloro-4-((3-fluorobenzyl)oxy)phenyl)-6-(5-(((2-(methylsulfonyl)ethyl)amino)methyl)furan-2-yl)quinazolin-4-amine Bis(4-methylbenzenesulfona

    54. N-(3-chloro-4-(3-fluorobenzyloxy)phenyl)-6-(5-((2-(methylsulfonyl) Ethylamino)methyl)furan-2-yl)quinazolin-4-amine Ditosylate

    55. N-(3-chloro-4-(3-fluorobenzyloxy)phenyl)-6-(5-((2-(methylsulfonyl)ethylamino)methyl)furan-2-yl)quinazolin-4-amine Ditosylate

    56. N-[3-chloro-4-[(3-fluorophenyl)methoxy]phenyl]-6-[5-[(2-methylsulfonylethylamino)methyl]-2-furyl]

    2.4 Create Date
    2006-10-25
    3 Chemical and Physical Properties
    Molecular Weight 925.5 g/mol
    Molecular Formula C43H42ClFN4O10S3
    Hydrogen Bond Donor Count4
    Hydrogen Bond Acceptor Count15
    Rotatable Bond Count13
    Exact Mass924.1735629 g/mol
    Monoisotopic Mass924.1735629 g/mol
    Topological Polar Surface Area240 Ų
    Heavy Atom Count62
    Formal Charge0
    Complexity1100
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count3
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameTykerb
    PubMed HealthLapatinib (By mouth)
    Drug ClassesAntineoplastic Agent
    Drug LabelLapatinib is a small molecule and a member of the 4-anilinoquinazoline class of kinase inhibitors. It is present as the monohydrate of the ditosylate salt, with chemical name N-(3-chloro-4-{[(3-fluorophenyl)methyl]oxy}phenyl)-6-[5-({[2-(methylsulfony...
    Active IngredientLapatinib ditosylate
    Dosage FormTablet
    RouteOral
    Strengtheq 250mg base
    Market StatusPrescription
    CompanySmithkline Beecham

    2 of 2  
    Drug NameTykerb
    PubMed HealthLapatinib (By mouth)
    Drug ClassesAntineoplastic Agent
    Drug LabelLapatinib is a small molecule and a member of the 4-anilinoquinazoline class of kinase inhibitors. It is present as the monohydrate of the ditosylate salt, with chemical name N-(3-chloro-4-{[(3-fluorophenyl)methyl]oxy}phenyl)-6-[5-({[2-(methylsulfony...
    Active IngredientLapatinib ditosylate
    Dosage FormTablet
    RouteOral
    Strengtheq 250mg base
    Market StatusPrescription
    CompanySmithkline Beecham

    4.2 Drug Indication

    Tyverb is indicated for the treatment of patients with breast cancer , whose tumours overexpress HER2 (ErbB2):

    - in combination with capecitabine for patients with advanced or metastatic disease with progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting;

    - in combination with trastuzumab for patients with hormone-receptor-negative metastatic disease that has progressed on prior trastuzumab therapy or therapies in combination with chemotherapy;

    - in combination with an aromatase inhibitor for post-menopausal women with hormone-receptor-positive metastatic disease, not currently intended for chemotherapy. The patients in the registration study had not previously been treated with trastuzumab or an aromatase inhibitor. No data are available on the efficacy of this combination relative to trastuzumab in combination with an aromatase inhibitor in this patient population.

    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 ATC Code

    L01EH01

    API Reference Price

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","customerCountry":"CROATIA","quantity":"118.74","actualQuantity":"118.74","unit":"KGS","unitRateFc":"4750","totalValueFC":"556159","currency":"USD","unitRateINR":392511.39885464043,"date":"27-Sep-2024","totalValueINR":"46606803.5","totalValueInUsd":"556159","indian_port":"Hyderabad Air","hs_no":"29214290","bill_no":"4405289","productDescription":"API","marketType":"REGULATED MARKET","country":"CROATIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"NATCO HOUSE, ROAD NO.2,, HYDERABAD, A.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727375400,"product":"LAPATINIB DITOSYLATE MONOHYDRATE IH","address":"Lakshmi Nilayam, Flat No.24, Plot No.29 B, Road No.8, FilmNagar","city":"Hyderabad","supplier":"RYPTUS LIFE SCIENCES LLP","supplierCountry":"INDIA","foreign_port":"BUENOS AIRES","customer":"LABORATORIO ECZANE PHARMA","customerCountry":"ARGENTINA","quantity":"0.30","actualQuantity":"300","unit":"GMS","unitRateFc":"8.5","totalValueFC":"2225.8","currency":"USD","unitRateINR":621.75,"date":"27-Sep-2024","totalValueINR":"186525","totalValueInUsd":"2225.8","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"4395805","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ARGENTINA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"Lakshmi Nilayam, Flat No.24, Plot No.29 B, Road No.8, FilmNagar, Hyderabad","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728844200,"product":"LAPATINIB DITOSYLATE MONOHYDRATE IH, DRUM NO 18952\/24, BATCH NO.- LK24070005, MFG.- JUL 2024, EXP\/RETEST- JUL 2026, BATC","address":"HETERO HOUSE,H.NO.8-3-166\/7\/1ERRAGADDA","city":"HYDERABAD","supplier":"HETERO DRUGS","supplierCountry":"INDIA","foreign_port":"TEL AVIV YAFO","customer":"TEVA PHARMACEUTICAL INDUSTRIES","customerCountry":"ISRAEL","quantity":"90.00","actualQuantity":"90","unit":"KGS","unitRateFc":"2650","totalValueFC":"227066.4","currency":"USD","unitRateINR":211995.62222222221,"date":"14-Oct-2024","totalValueINR":"19079606","totalValueInUsd":"227066.4","indian_port":"Bombay Air","hs_no":"29333990","bill_no":"4807639","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ISRAEL","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"HETERO HOUSE,H.NO.8-3-166\/7\/1ERRAGADDA, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728844200,"product":"LAPATINIB DITOSYLATE MONOHYDRATE IH, DRUM NO 18953\/24-18961\/24, BATCH NO. LK24070005, MFG. JUL 2024, EXP\/RETEST JUL 2026","address":"HETERO HOUSE,H.NO.8-3-166\/7\/1ERRAGADDA","city":"HYDERABAD","supplier":"HETERO DRUGS","supplierCountry":"INDIA","foreign_port":"TEL AVIV YAFO","customer":"TEVA PHARMACEUTICAL INDUSTRIES","customerCountry":"ISRAEL","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"2650","totalValueFC":"12005.9","currency":"USD","unitRateINR":201762.20000000001,"date":"14-Oct-2024","totalValueINR":"1008811","totalValueInUsd":"12005.9","indian_port":"Bombay Air","hs_no":"29333990","bill_no":"4807639","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ISRAEL","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"HETERO HOUSE,H.NO.8-3-166\/7\/1ERRAGADDA, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729017000,"product":"LAPATINIB DITOSYLATE MONOHYDRATE IH","address":"HETERO HOUSE,H.NO.8-3-166\/7\/1ERRAGADDA","city":"HYDERABAD","supplier":"HETERO DRUGS","supplierCountry":"INDIA","foreign_port":"BUENOS AIRES, BA","customer":"LABORATORIO ECZANE PHARMA","customerCountry":"ARGENTINA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"2600","totalValueFC":"25069.2","currency":"USD","unitRateINR":210647.5,"date":"16-Oct-2024","totalValueINR":"2106475","totalValueInUsd":"25069.2","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"4869625","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ARGENTINA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"HETERO HOUSE,H.NO.8-3-166\/7\/1ERRAGADDA, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730140200,"product":"LAPATINIB DITOSYLATE IH BATCH NO: SBL\/LPT\/24\/010 AS PER INV","address":"BLOCK-A,SHOP-114,GANESH MERIDIAN,O","city":"AHMEDABAD,GUJARAT","supplier":"SUMAR BIOTECH","supplierCountry":"INDIA","foreign_port":"SHEREMETYEVO","customer":"BIOKHIMIK JSC","customerCountry":"RUSSIA","quantity":"40.00","actualQuantity":"40","unit":"KGS","unitRateFc":"163500","totalValueFC":"80163.8","currency":"RUB","unitRateINR":168397.27499999999,"date":"29-Oct-2024","totalValueINR":"6735891","totalValueInUsd":"80163.8","indian_port":"Ahmedabad Air","hs_no":"29349990","bill_no":"5242271","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Ahmedabad Air","supplierAddress":"BLOCK-A,SHOP-114,GANESH MERIDIAN,O, AHMEDABAD,GUJARAT","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729017000,"product":"(RE-IMPORT GOODS) LAPATINIB DITOSYLATE MONOHYDRATE IHS","address":"HETERO CORPORATE, NO. 7-2-A2,","city":"HYDERABAD","supplier":"TEVA PHARMACEUTICAL INDUSTRIES","supplierCountry":"INDIA","foreign_port":"TEL AVIV YAFO","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"35.07","actualQuantity":"35.073","unit":"KGS","unitRateFc":"2650","totalValueFC":"94622.4","currency":"USD","unitRateINR":"226692.7","date":"16-Oct-2024","totalValueINR":"7950794.51","totalValueInUsd":"94622.4","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"6158473","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"TEL AVIV YAFO","supplierAddress":"18, ELI HURVITZ STREET 44102 KFAR S ABA SDNF Israel","customerAddress":"HETERO CORPORATE, NO. 7-2-A2,"}]
    28-Jan-2021
    29-Oct-2024
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    Drugs in Development

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    Ambrx Announces Closing of $75 Million Market Priced Registered Offering

    Details:

    The Company intends to use the net proceeds to fund the research and development of its product candidates, including ARX788, a next-generation, site-specific anti-HER2 ADC, being developed for the treatment of HER2-positive metastatic breast cancer.


    Lead Product(s): ARX788,Capecitabine,Lapatinib Ditosylate

    Therapeutic Area: Oncology Brand Name: ARX788

    Study Phase: Phase IIProduct Type: Large molecule

    Sponsor: Undisclosed

    Deal Size: $75.0 million Upfront Cash: Undisclosed

    Deal Type: Public Offering June 28, 2023

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    Lead Product(s) : ARX788,Capecitabine,Lapatinib Ditosylate

    Therapeutic Area : Oncology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : $75.0 million

    Deal Type : Public Offering

    DEALS_DEV arrow-down

    Ambrx Announces Closing of $75 Million Market Priced Registered Offering

    Details : The Company intends to use the net proceeds to fund the research and development of its product candidates, including ARX788, a next-generation, site-specific anti-HER2 ADC, being developed for the treatment of HER2-positive metastatic breast cancer.

    Brand Name : ARX788

    Molecule Type : Large molecule

    Upfront Cash : Undisclosed

    June 28, 2023

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    ACE-Breast-02 Pivotal Phase 3 Study of Ambrx’s ARX788 for the Treatment of HER2 Positive Metastatic Breast Cancer Achieves Positive Results

    Details:

    ARX788, an anti-HER2 antibody drug conjugate currently being studied broadly in breast cancer, gastric/GEJ cancer and other solid tumor clinical trials.


    Lead Product(s): ARX788,Capecitabine,Lapatinib Ditosylate

    Therapeutic Area: Oncology Brand Name: ARX788

    Study Phase: Phase IIProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable March 01, 2023

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    Lead Product(s) : ARX788,Capecitabine,Lapatinib Ditosylate

    Therapeutic Area : Oncology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    ACE-Breast-02 Pivotal Phase 3 Study of Ambrx’s ARX788 for the Treatment of HER2 Positive Metasta...

    Details : ARX788, an anti-HER2 antibody drug conjugate currently being studied broadly in breast cancer, gastric/GEJ cancer and other solid tumor clinical trials.

    Brand Name : ARX788

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    March 01, 2023

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    ABOUT THIS PAGE

    Lapatinib Ditosylate Manufacturers

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

    Lapatinib Ditosylate Suppliers

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

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

    Lapatinib Ditosylate USDMF

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

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

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

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

    Lapatinib Ditosylate KDMF

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

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

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

    click here to find a list of Lapatinib Ditosylate suppliers with KDMF on PharmaCompass.

    Lapatinib Ditosylate WC

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

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

    Lapatinib Ditosylate 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 Lapatinib Ditosylate as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Lapatinib Ditosylate GMP

    Lapatinib Ditosylate 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 Lapatinib Ditosylate 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 Lapatinib Ditosylate GMP manufacturer or Lapatinib Ditosylate GMP API supplier for your needs.

    Lapatinib Ditosylate CoA

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

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

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