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    Chemistry

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    Also known as: 540737-29-9, Tasocitinib citrate, Xeljanz, Cp-690550 citrate, Tofacitinib (citrate), Tofacitinib (cp-690550) citrate
    Molecular Formula
    C22H28N6O8
    Molecular Weight
    504.5  g/mol
    InChI Key
    SYIKUFDOYJFGBQ-YLAFAASESA-N
    FDA UNII
    O1FF4DIV0D
    Tofacitinib Citrate
    1 2D Structure

    Tofacitinib Citrate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-hydroxypropane-1,2,3-tricarboxylic acid;3-[(3R,4R)-4-methyl-3-[methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino]piperidin-1-yl]-3-oxopropanenitrile
    2.1.2 InChI
    InChI=1S/C16H20N6O.C6H8O7/c1-11-5-8-22(14(23)3-6-17)9-13(11)21(2)16-12-4-7-18-15(12)19-10-20-16;7-3(8)1-6(13,5(11)12)2-4(9)10/h4,7,10-11,13H,3,5,8-9H2,1-2H3,(H,18,19,20);13H,1-2H2,(H,7,8)(H,9,10)(H,11,12)/t11-,13+;/m1./s1
    2.1.3 InChI Key
    SYIKUFDOYJFGBQ-YLAFAASESA-N
    2.1.4 Canonical SMILES
    CC1CCN(CC1N(C)C2=NC=NC3=C2C=CN3)C(=O)CC#N.C(C(=O)O)C(CC(=O)O)(C(=O)O)O
    2.1.5 Isomeric SMILES
    C[C@@H]1CCN(C[C@@H]1N(C)C2=NC=NC3=C2C=CN3)C(=O)CC#N.C(C(=O)O)C(CC(=O)O)(C(=O)O)O
    2.2 Other Identifiers
    2.2.1 UNII
    O1FF4DIV0D
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Cp 690,550

    2. Cp 690550

    3. Cp-690,550

    4. Cp-690550

    5. Cp690550

    6. Tasocitinib

    7. Tofacitinib

    8. Xeljanz

    2.3.2 Depositor-Supplied Synonyms

    1. 540737-29-9

    2. Tasocitinib Citrate

    3. Xeljanz

    4. Cp-690550 Citrate

    5. Tofacitinib (citrate)

    6. Tofacitinib (cp-690550) Citrate

    7. Xeljanz Xr

    8. Tofacitinib Citrate [usan]

    9. Cp-690,550-10

    10. Tasocitinib Monocitrate

    11. 540737-29-9 (citrate)

    12. Cp-690550-10

    13. Cp 690550 Citrate

    14. O1ff4div0d

    15. 3-((3r,4r)-4-methyl-3-(methyl(7h-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxopropanenitrile 2-hydroxypropane-1,2,3-tricarboxylate

    16. Chebi:71197

    17. 1-piperidinepropanenitrile, 4-methyl-3-(methyl-7h-pyrrolo(2,3-d)pyrimidin-4-ylamino)- Beta-oxo-, (3r,4r)-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1)

    18. 2-hydroxypropane-1,2,3-tricarboxylic Acid; 3-[(3r,4r)-4-methyl-3-[methyl({7h-pyrrolo[2,3-d]pyrimidin-4-yl})amino]piperidin-1-yl]-3-oxopropanenitrile

    19. 2-hydroxypropane-1,2,3-tricarboxylic Acid;3-[(3r,4r)-4-methyl-3-[methyl(7h-pyrrolo[2,3-d]pyrimidin-4-yl)amino]piperidin-1-yl]-3-oxopropanenitrile

    20. Unii-o1ff4div0d

    21. Mfcd11616529

    22. 3-{(3r,4r)-4-methyl-3-[methyl(7h-pyrrolo[2,3-d]pyrimidin-4-yl)amino]piperidin-1-yl}-3-oxopropanenitrile 2-hydroxypropane-1,2,3-tricarboxylate

    23. 3-{(3r,4r)-4-methyl-3-[methyl-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1-yl}-3-oxo-propionitrile Citrate Salt

    24. 3-{(3r,4r)-4-methyl-3-[methyl-(7h-pyrrolo[2,3-d]pyrimidin-4-yl}-amino]-piperidin-1-yl)-3-oxo-propionitrile Citrate Salt

    25. Xeljanz (tn)

    26. Tofacitinib Monocitrate

    27. Tasocitinib Citric Acid Salt

    28. Cep-18770(delanzomib)

    29. Mls006010058

    30. Schembl1374185

    31. Chembl2103743

    32. Tofacitinib Citrate (jan/usan)

    33. Amy4175

    34. Dtxsid80202404

    35. Ex-a204

    36. Tofacitinib Citrate [jan]

    37. C16h20n6o.c6h8o7

    38. Tofacitinib Monocitrate [mi]

    39. Hy-40354a

    40. S5001

    41. Tofacitinib Citrate [who-dd]

    42. Akos022178222

    43. Cp-690550 - Tofacitinib Citrate

    44. Tofacitinib Citrate, >=98% (hplc)

    45. Ccg-269730

    46. Cs-0928

    47. Tofacitinib Citrate [orange Book]

    48. Ac-25004

    49. As-19392

    50. Bt163661

    51. Smr004701220

    52. Cp-690550 Citrate (tofacitinib Citrate)

    53. Tofacitinib Citrate (cp-690550 Citrate)

    54. Cp 690550-10

    55. D09783

    56. Q27139435

    57. (3r,4r)-4-methyl-3-(methyl-7h-pyrro Lo[2,3-d]pyrimidin-4-ylamino)-beta-oxo-1-piperidinepro Panenitrile Citrate

    58. (3r,4r)-4-methyl-3-(methyl-7h-pyrrolo[2,3-d]pyrimidin-4-ylamino)-?-oxo-1-piperidinepropanenitrile Citrate

    59. (3r,4r)-4-methyl-3-(methyl-7h-pyrrolo[2,3-d]pyrimidin-4-ylamino)-beta-oxo-1-piperidine Propanenitrile 2-hydroxy-1,2,3-propanetricarboxylate

    60. (3r,4r)-4-methyl-3-(methyl-7h-pyrrolo[2,3-d]pyrimidin-4-ylamino)-ss-oxo-1-piperidinepropanenitrile Citrate Salt

    61. 1-piperidinepropanenitrile, 4-methyl-3-(methyl-7h-pyrrolo(2,3-d)pyrimidin-4-ylamino)-.beta.-oxo-, (3r,4r)-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1)

    62. 1-piperidinepropanenitrile,4-methyl-3-(methyl-7h-pyrrolo[2,3-d]pyrimidin-4-ylamino)-beta-oxo-,(3r,4r)-,2-hydroxy-1,2,3-propanetricarboxylate(1:1)

    63. 3-((3r,4r)-4-methyl-3-(methyl(7h-pyrrolo(2,3-d)pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxo-propanenitrile2-hydroxypropane-1,2,3-tricarboxylate (1:1)

    64. 3-((3r,4r)-4-methyl-3-(methyl(7h-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxopropanenitrile Mono Citrate Salt

    65. 3-{(3r,4r)-4-methyl-3-[methyl-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1-yl}-3-oxo-propionitrile Mono Citrate Salt

    2.4 Create Date
    2006-10-25
    3 Chemical and Physical Properties
    Molecular Weight 504.5 g/mol
    Molecular Formula C22H28N6O8
    Hydrogen Bond Donor Count5
    Hydrogen Bond Acceptor Count12
    Rotatable Bond Count8
    Exact Mass504.19686187 g/mol
    Monoisotopic Mass504.19686187 g/mol
    Topological Polar Surface Area221 Ų
    Heavy Atom Count36
    Formal Charge0
    Complexity716
    Isotope Atom Count0
    Defined Atom Stereocenter Count2
    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 NameXeljanz
    PubMed HealthTofacitinib (By mouth)
    Drug ClassesAntirheumatic, Musculoskeletal Agent
    Drug LabelXELJANZ is the citrate salt of tofacitinib, a JAK inhibitor.Tofacitinib citrate is a white to off-white powder with the following chemical name: (3R,4R)-4-methyl-3-(methyl-7H-pyrrolo [2,3-d]pyrimidin-4-ylamino)--oxo-1-piperidinepropanenitrile, 2-hy...
    Active IngredientTofacitinib citrate
    Dosage FormTablet
    RouteOral
    Strengtheq 5mg base
    Market StatusPrescription
    CompanyPf Prism Cv

    2 of 2  
    Drug NameXeljanz
    PubMed HealthTofacitinib (By mouth)
    Drug ClassesAntirheumatic, Musculoskeletal Agent
    Drug LabelXELJANZ is the citrate salt of tofacitinib, a JAK inhibitor.Tofacitinib citrate is a white to off-white powder with the following chemical name: (3R,4R)-4-methyl-3-(methyl-7H-pyrrolo [2,3-d]pyrimidin-4-ylamino)--oxo-1-piperidinepropanenitrile, 2-hy...
    Active IngredientTofacitinib citrate
    Dosage FormTablet
    RouteOral
    Strengtheq 5mg base
    Market StatusPrescription
    CompanyPf Prism Cv

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Janus Kinase Inhibitors

    Agents that inhibit JANUS KINASES. (See all compounds classified as Janus Kinase Inhibitors.)

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    TOFACITINIB CITRATE

    NDC Package Code : 11712-895

    Start Marketing Date : 2021-02-19

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

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    TOFACITINIB CITRATE

    NDC Package Code : 42765-036

    Start Marketing Date : 2021-05-29

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (10kg/10kg)

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    TOFACITINIB CITRATE

    NDC Package Code : 42765-061

    Start Marketing Date : 2023-01-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (4kg/4kg)

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    TOFACITINIB CITRATE

    NDC Package Code : 71796-050

    Start Marketing Date : 2022-07-29

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    NDC Package Code : 52076-6267

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    NDC Package Code : 42571-289

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    TOFACITINIB CITRATE

    NDC Package Code : 68724-1000

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    TOFACITINIB CITRATE

    NDC Package Code : 60715-1000

    Start Marketing Date : 2012-11-06

    End Marketing Date : 2025-12-31

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    TOFACITINIB CITRATE

    NDC Package Code : 84206-0094

    Start Marketing Date : 2024-08-22

    End Marketing Date : 2025-12-31

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AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1713119400,"product":"TOFACITINIB CITRATE IHS, METROCHEM BATCHNO.PAI-P\/24003","address":"FLAT NO.302, BHANU ENCLAVE","city":"HYDERABAD.AP","supplier":"METROCHEM API PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"BARCELONA","customer":"TOWA PHARMACEUTICAL","customerCountry":"SPAIN","quantity":"3.69","actualQuantity":"3.69","unit":"KGS","unitRateFc":"10000","totalValueFC":"36382.6","currency":"USD","unitRateINR":823363.95663956646,"date":"15-Apr-2024","totalValueINR":"3038213","totalValueInUsd":"36382.6","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"9124805","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"FLAT NO.302, BHANU ENCLAVE, HYDERABAD.AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1715193000,"product":"ACTIVE PHARMACEUTICALS INGREDIENTS (API)EXPORT INVOICE NUMBER : F32518000357 DT. 30.04.2024 TOFACITINIB CITRATE","address":"PLOT 170-172, CHANDRAMOULI,INDUSTR","city":"SOLAPUR,MAHARASHTRA","supplier":"GLENMARK PHARMACEUTICALS","supplierCountry":"INDIA","foreign_port":"BUENOS AIRES, BA","customer":"TO THE ORDER","customerCountry":"ARGENTINA","quantity":"0.60","actualQuantity":"0.6","unit":"KGS","unitRateFc":"18000","totalValueFC":"10558.8","currency":"USD","unitRateINR":1466870.7333333334,"date":"09-May-2024","totalValueINR":"880122.44","totalValueInUsd":"10558.8","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"9748327","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ARGENTINA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"PLOT 170-172, CHANDRAMOULI,INDUSTR, SOLAPUR,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727116200,"product":"HSN CODE : 29339900 SAP CODE : 2021430 HARMLESS PHARMACEUTICAL BULK DRUG -TOFACITINIB CITRATE,PACK : KG","address":"ACME PLAZA, ANDHERI KURLA ROAD,","city":"MUMBAI, MAHARASHTRA.","supplier":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","supplierCountry":"INDIA","foreign_port":"LISBON","customer":"M\/S","customerCountry":"PORTUGAL","quantity":"7.00","actualQuantity":"7","unit":"KGS","unitRateFc":"21000","totalValueFC":"145252.8","currency":"USD","unitRateINR":1738909.0442857144,"date":"24-Sep-2024","totalValueINR":"12172363.31","totalValueInUsd":"145252.8","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"4306080","productDescription":"API","marketType":"REGULATED MARKET","country":"PORTUGAL","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"ACME PLAZA, ANDHERI KURLA ROAD,, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728585000,"product":"TOFACITINIB CITRATE API (TAX INVOICE NO:KPLEXP\/111\/24-25 DT:30-SEP-24)","address":"A-4, MADHURANAGAR COLONY","city":"HYDERABAD, ANDHRA PRADESH","supplier":"KEKULE PHARMA","supplierCountry":"INDIA","foreign_port":"MOSCOW DOMODEDOVO","customer":"CHEMICAL DIVERSITY RESEARCH ","customerCountry":"RUSSIA","quantity":"11.00","actualQuantity":"11","unit":"KGS","unitRateFc":"751432.5","totalValueFC":"97976.9","currency":"INR","unitRateINR":748423.40909090906,"date":"11-Oct-2024","totalValueINR":"8232657.5","totalValueInUsd":"97976.9","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"4765416","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"A-4, MADHURANAGAR COLONY, HYDERABAD, ANDHRA PRADESH","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730399400,"product":"TOFACITINIB CITRATE API (TAX INVOICE NO:KPLEXP\/119\/24-25 DT:25-OCT-24)","address":"A-4, MADHURANAGAR COLONY","city":"HYDERABAD, ANDHRA PRADESH","supplier":"KEKULE PHARMA","supplierCountry":"INDIA","foreign_port":"MOSCOW DOMODEDOVO","customer":"CHEMICAL DIVERSITY RESEARCH ","customerCountry":"RUSSIA","quantity":"11.00","actualQuantity":"11","unit":"KGS","unitRateFc":"751432.5","totalValueFC":"97574.2","currency":"INR","unitRateINR":748555.40909090906,"date":"01-Nov-2024","totalValueINR":"8234109.5","totalValueInUsd":"97574.2","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"5321755","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"A-4, MADHURANAGAR COLONY, HYDERABAD, ANDHRA PRADESH","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733423400,"product":"ACTIVE PHARMACEUTICALS INGREDIENTS (API) EXPORT INVOICE NUMBER : F32518003336 DT. 26.11.2024 TOFACITINIB CITRATE","address":"PLOT 170-172, CHANDRAMOULI,INDUSTR","city":"SOLAPUR,MAHARASHTRA","supplier":"GLENMARK PHARMACEUTICALS","supplierCountry":"INDIA","foreign_port":"BUENOS AIRES, BA","customer":"TO THE ORDER","customerCountry":"ARGENTINA","quantity":"0.60","actualQuantity":"0.6","unit":"KGS","unitRateFc":"18000","totalValueFC":"10519.1","currency":"USD","unitRateINR":1489664.3333333333,"date":"06-Dec-2024","totalValueINR":"893798.6","totalValueInUsd":"10519.1","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"6223284","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ARGENTINA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"PLOT 170-172, CHANDRAMOULI,INDUSTR, SOLAPUR,MAHARASHTRA","customerAddress":""},{"dataSource":"API 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    06-Jan-2021
    17-Dec-2024
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    ABOUT THIS PAGE

    Tofacitinib Citrate Manufacturers

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

    Tofacitinib Citrate Suppliers

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

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

    Tofacitinib Citrate USDMF

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

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

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

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

    Tofacitinib Citrate KDMF

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

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

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

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

    Tofacitinib Citrate WC

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

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

    Tofacitinib Citrate 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 Tofacitinib Citrate as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Tofacitinib Citrate GMP

    Tofacitinib Citrate 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 Tofacitinib Citrate 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 Tofacitinib Citrate GMP manufacturer or Tofacitinib Citrate GMP API supplier for your needs.

    Tofacitinib Citrate CoA

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

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

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