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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

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STATES","quantity":"9.98","actualQuantity":"9.975","unit":"KGS","unitRateFc":"4000","totalValueFC":"39402.3","currency":"USD","unitRateINR":328000,"date":"21-Mar-2024","totalValueINR":"3271800","totalValueInUsd":"39402.3","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"8527043","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"SECOND FLOOR, BLOCK-III,MY HOME HUB, HYDERABAD, AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1711823400,"product":"(REWARD ITEM) LAPATINIB DITOSYLATE MONOHYDRATE(TAX INVOICE NO-VLS\/EXP\/039\/23-24DT-28-03-2024)","address":"01-076\/3\/1A\/F1\/NR,1ST FLOOR, GANGA","city":"","supplier":"VANNSH LIFE SCIENCES","supplierCountry":"INDIA","foreign_port":"BUENOS AIRES","customer":"LABORATORIOS ASPEN 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","customerCountry":"CROATIA","quantity":"73.26","actualQuantity":"73.26","unit":"KGS","unitRateFc":"4750","totalValueFC":"343441.4","currency":"USD","unitRateINR":391873.21184821182,"date":"16-Jul-2024","totalValueINR":"28708631.5","totalValueInUsd":"343441.4","indian_port":"Hyderabad Air","hs_no":"29214290","bill_no":"2466407","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":1722191400,"product":"(REWARD ITEM)(PHARMACEUTICAL GRADE ALLOPATHIC RAW MATERIAL)LAPATINIB DITOSYLATEMONOHYDRATE(LC NO.0043LC79641-2024-)","address":"01-076\/3\/1A\/F1\/NR,1ST FLOOR, GANGA","city":"N\/A","supplier":"VANNSH LIFE SCIENCES","supplierCountry":"INDIA","foreign_port":"LAHORE","customer":"M\/S PHARMASOL (PVT) 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STATES","quantity":"22.04","actualQuantity":"22.04","unit":"KGS","unitRateFc":"4032.8","totalValueFC":"87739.6","currency":"USD","unitRateINR":333914.32985480945,"date":"01-Aug-2024","totalValueINR":"7359471.83","totalValueInUsd":"87739.6","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"2889646","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"SECOND FLOOR, BLOCK-III,MY HOME HUB, HYDERABAD, AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722537000,"product":"LAPATINIB DITOSYLATE API","address":"SECOND FLOOR, BLOCK-III,MY HOME HUB","city":"HYDERABAD, AP","supplier":"GRANULES INDIA LIMITED","supplierCountry":"INDIA","foreign_port":"NEW YORK","customer":"GRANULES INDIA LIMITED","customerCountry":"UNITED 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INDUSTRIES","customerCountry":"ISRAEL","quantity":"70.00","actualQuantity":"70","unit":"KGS","unitRateFc":"2650","totalValueFC":"173306.3","currency":"USD","unitRateINR":207666.89814285713,"date":"14-Aug-2024","totalValueINR":"14536682.87","totalValueInUsd":"173306.3","indian_port":"Bombay Air","hs_no":"29333990","bill_no":"3214171","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ISRAEL","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"HETERO CORPORATE, NO. 7-2-A2,, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724869800,"product":"LAPATINIB DITOSYLATE MONOHYDRATE IH","address":"HETERO CORPORATE, NO. 7-2-A2,","city":"HYDERABAD","supplier":"HETERO DRUGS","supplierCountry":"INDIA","foreign_port":"BUENOS AIRES, BA","customer":"LABORATORIO ECZANE PHARMA","customerCountry":"ARGENTINA","quantity":"0.15","actualQuantity":"0.15","unit":"KGS","unitRateFc":"3400","totalValueFC":"345.4","currency":"USD","unitRateINR":193168.46666666667,"date":"29-Aug-2024","totalValueINR":"28975.27","totalValueInUsd":"345.4","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"3587621","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ARGENTINA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"HETERO CORPORATE, NO. 7-2-A2,, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727375400,"product":"LAPATINIB DITOSYLATE ANHYDROUS (APPENDIX4R,RODTEP ENTRY NO:9559)(OUR REF(S)CI NO:524070)","address":"NATCO HOUSE, ROAD NO.2,","city":"HYDERABAD, A.P.","supplier":"NATCO PHARMA","supplierCountry":"INDIA","foreign_port":"ZAGREB","customer":"A2B EXPRESS LIGISTIKA ","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":"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 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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":"16.89","actualQuantity":"16.889","unit":"KGS","unitRateFc":"2650","totalValueFC":"45564.3","currency":"USD","unitRateINR":"226692.7","date":"16-Oct-2024","totalValueINR":"3828613.71","totalValueInUsd":"45564.3","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,"},{"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":"32.12","actualQuantity":"32.118","unit":"KGS","unitRateFc":"2650","totalValueFC":"86650.2","currency":"USD","unitRateINR":"226692.7","date":"16-Oct-2024","totalValueINR":"7280917.46","totalValueInUsd":"86650.2","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,"}]
    26-Apr-2021
    29-Oct-2024
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    ABOUT THIS PAGE

    Looking for 388082-77-7 / Lapatinib Ditosylate API manufacturers, exporters & distributors?

    Lapatinib Ditosylate manufacturers, exporters & distributors 1

    51

    PharmaCompass offers a list of Lapatinib Ditosylate 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 Lapatinib Ditosylate manufacturer or Lapatinib Ditosylate supplier for your needs.

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

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

    API | Excipient name

    Lapatinib Ditosylate

    Synonyms

    388082-77-7, Tykerb, Tykerb ditosylate, Lapatinib (gw-572016) ditosylate, Tyverb, Lapatinib (ditosylate)

    Cas Number

    388082-77-7

    Unique Ingredient Identifier (UNII)

    4WK72K94MC

    About 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.

    GW282974X Manufacturers

    A GW282974X manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of GW282974X, including repackagers and relabelers. The FDA regulates GW282974X manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. GW282974X 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 GW282974X manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    GW282974X Suppliers

    A GW282974X supplier is an individual or a company that provides GW282974X active pharmaceutical ingredient (API) or GW282974X finished formulations upon request. The GW282974X suppliers may include GW282974X API manufacturers, exporters, distributors and traders.

    click here to find a list of GW282974X suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    GW282974X USDMF

    A GW282974X DMF (Drug Master File) is a document detailing the whole manufacturing process of GW282974X active pharmaceutical ingredient (API) in detail. Different forms of GW282974X DMFs exist exist since differing nations have different regulations, such as GW282974X USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A GW282974X DMF submitted to regulatory agencies in the US is known as a USDMF. GW282974X USDMF includes data on GW282974X's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The GW282974X USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of GW282974X suppliers with USDMF on PharmaCompass.

    GW282974X 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 GW282974X Drug Master File in Japan (GW282974X JDMF) empowers GW282974X 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 GW282974X JDMF during the approval evaluation for pharmaceutical products. At the time of GW282974X 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 GW282974X suppliers with JDMF on PharmaCompass.

    GW282974X KDMF

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

    Pharmaceutical companies submit a GW282974X Drug Master File in Korea (GW282974X KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of GW282974X. The MFDS reviews the GW282974X KDMF as part of the drug registration process and uses the information provided in the GW282974X KDMF to evaluate the safety and efficacy of the drug.

    After submitting a GW282974X 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 GW282974X API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of GW282974X suppliers with KDMF on PharmaCompass.

    GW282974X WC

    A GW282974X written confirmation (GW282974X WC) is an official document issued by a regulatory agency to a GW282974X manufacturer, verifying that the manufacturing facility of a GW282974X active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting GW282974X APIs or GW282974X finished pharmaceutical products to another nation, regulatory agencies frequently require a GW282974X WC (written confirmation) as part of the regulatory process.

    click here to find a list of GW282974X suppliers with Written Confirmation (WC) on PharmaCompass.

    GW282974X 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 GW282974X as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for GW282974X 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 GW282974X 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 GW282974X and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a GW282974X NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of GW282974X suppliers with NDC on PharmaCompass.

    GW282974X GMP

    GW282974X 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 GW282974X 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 GW282974X GMP manufacturer or GW282974X GMP API supplier for your needs.

    GW282974X CoA

    A GW282974X CoA (Certificate of Analysis) is a formal document that attests to GW282974X's compliance with GW282974X specifications and serves as a tool for batch-level quality control.

    GW282974X CoA mostly includes findings from lab analyses of a specific batch. For each GW282974X 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.

    GW282974X may be tested according to a variety of international standards, such as European Pharmacopoeia (GW282974X EP), GW282974X JP (Japanese Pharmacopeia) and the US Pharmacopoeia (GW282974X 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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