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    Synopsis

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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.)

    API Reference Price

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AP","customerAddress":""},{"dataSource":"API Import","activeIngredients":"TOFACITINIB CITRATE","year":"2021","qtr":"Q2","strtotime":1618511400,"product":"TOFACITINIB CITRATE[DRUG LICENCE NO:TL\/HZ\/21\/001631 DT:01.04.2021]","address":"SANDOZ BAUG, KOLSHETTHANE","city":"THANE,MAHARASHTRA","supplier":"SANDOZ B2B","supplierCountry":"SLOVENIA","foreign_port":"LJUBLJANA - BRNIK","customer":"NOVARTIS PHARMACEUTICALS CORPORATION","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"5","unit":"GMS","unitRateFc":"300","totalValueFC":"1848.6","currency":"EUR","unitRateINR":"27525","date":"16-Apr-2021","totalValueINR":"137625","totalValueInUsd":"1848.6","indian_port":"HYDERABAD AIR","hs_no":"29335990","bill_no":"3592699","productDescription":"API","marketType":"REGULATED MARKET","country":"SLOVENIA","selfForZScoreResived":"Pharma Grade","supplierPort":"LJUBLJANA - BRNIK","supplierAddress":"","customerAddress":"SANDOZ BAUG, KOLSHETTHANE"},{"dataSource":"API Import","activeIngredients":"TOFACITINIB CITRATE","year":"2021","qtr":"Q2","strtotime":1620585000,"product":"TOFACITINIB CITRATE","address":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"N\/A","customer":"APL HEALTHCARE","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"17000","totalValueFC":"173482.8","currency":"USD","unitRateINR":"1270750","date":"10-May-2021","totalValueINR":"12707500","totalValueInUsd":"173482.8","indian_port":"APIIC MULTI PRODUCT SEZ NAIDUPET AP","hs_no":"29335990","bill_no":"1000679","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"STRADA RIVOLTANA KM 6\/7 RODANO MI ITALY","customerAddress":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q3","strtotime":1627324200,"product":"TOFACITINIB CITRATE","address":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"N\/A","customer":"APL HEALTHCARE","customerCountry":"INDIA","quantity":"3.00","actualQuantity":"3","unit":"KGS","unitRateFc":"17000","totalValueFC":"51597.6","currency":"USD","unitRateINR":"1281800","date":"27-Jul-2021","totalValueINR":"3845400","totalValueInUsd":"51597.6","indian_port":"APIIC MULTI PRODUCT SEZ NAIDUPET AP","hs_no":"29335990","bill_no":"1001047","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"STRADA RIVOLTANA 6\/7 RODANO MI 20090 005 IT","customerAddress":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1641321000,"product":"TOFACITINIB CITRATE","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"N\/A","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"17464","totalValueFC":"35212.5","currency":"USD","unitRateINR":"1311550","date":"05-Jan-2022","totalValueINR":"2623100","totalValueInUsd":"35212.5","indian_port":"SEZ\/Mahaboobnagar","hs_no":"29339990","bill_no":"1000020","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"SEDE LEGALE STRADE RIVOLTANA KM6\/7 RODANO (MI) ITALY","customerAddress":"PLOT NO.2, MAITRIVIHAR,"}]
    06-Jan-2021
    17-Dec-2024
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    ABOUT THIS PAGE

    Tofacitinib Manufacturers

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

    Tofacitinib Suppliers

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

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

    Tofacitinib USDMF

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

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

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

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

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

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

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

    Tofacitinib WC

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

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

    Tofacitinib 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 as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Tofacitinib GMP

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

    Tofacitinib CoA

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

    Tofacitinib CoA mostly includes findings from lab analyses of a specific batch. For each Tofacitinib 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Tofacitinib EP), Tofacitinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tofacitinib 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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