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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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RIVOLTANA KM 6\/7 20090 RODANO ( MI) ITALY","customerAddress":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1654713000,"product":"TOFACITINIB CITRATE API - FOC ITEM","address":"HOTEL DREAMZ PARK OFFICE COMPLEX\\r\\nUNIT G, 571\/2, ANNA SALAI,\\r\\nTEYNAMPET, CHENNAI, TAMIL NADU.","city":"CHENNAI,","supplier":"PFIZER MANUFACTURING DEUTSCHLA","supplierCountry":"GERMANY","foreign_port":"NA","customer":"PFIZER HEALTHCARE INDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"0.10","actualQuantity":"100","unit":"GMS","unitRateFc":"5.4","totalValueFC":"545.1","currency":"USD","unitRateINR":"425.2","date":"09-Jun-2022","totalValueINR":"42523.16","totalValueInUsd":"545.1","indian_port":"MADRAS AIR","hs_no":"29337990","bill_no":"9034175","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"HOTEL DREAMZ PARK OFFICE COMPLEX\\r\\nUNIT G, 571\/2, ANNA SALAI,\\r\\nTEYNAMPET, CHENNAI, TAMIL NADU."},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1654799400,"product":"FOC - TOFACITINIB CITRATE API TUAS (METERIAL CODE:H000010795) (BATCH:DW2034)","address":"HOTEL DREAMZ PARK OFFICE COMPLEX\\r\\nUNIT G, 571\/2, ANNA SALAI,\\r\\nTEYNAMPET, CHENNAI, TAMIL NADU.","city":"CHENNAI,","supplier":"PFIZER ASIA MANUFACTURING PTE LTD","supplierCountry":"SINGAPORE","foreign_port":"NA","customer":"PFIZER HEALTHCARE INDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"0.05","actualQuantity":"0.05","unit":"KGS","unitRateFc":"5992.8","totalValueFC":"301.5","currency":"USD","unitRateINR":"470434.8","date":"10-Jun-2022","totalValueINR":"23521.74","totalValueInUsd":"301.5","indian_port":"MADRAS AIR","hs_no":"29335990","bill_no":"9062681","productDescription":"API","marketType":"","country":"SINGAPORE","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"HOTEL DREAMZ PARK OFFICE COMPLEX\\r\\nUNIT G, 571\/2, ANNA SALAI,\\r\\nTEYNAMPET, CHENNAI, TAMIL NADU."},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1659637800,"product":"PHARMACEUTICAL RAW MATERIALS - TOFACITINIB CITRATE ( FOR RESEARCH PURPOSE )","address":"A\/242, TTC INDUSTRIAL AREA,,MAHAPE MIDC, MAHAPE,","city":"NAVIMUMBAI,MAHARASHTRA","supplier":"BEIJING SJAR TECHNOLOGY DEVELOPMENT","supplierCountry":"CHINA","foreign_port":"NA","customer":"RAPTIM RESEARCH PRIVATE LTD","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"4725","totalValueFC":"4819.2","currency":"USD","unitRateINR":"383447","date":"05-Aug-2022","totalValueINR":"383447.04","totalValueInUsd":"4819.2","indian_port":"BOMBAY AIR","hs_no":"29339990","bill_no":"9877215","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"A\/242, TTC INDUSTRIAL AREA,,MAHAPE MIDC, MAHAPE,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1699468200,"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":"MS APL HEALTHCARE LTD","customerCountry":"INDIA","quantity":"12.00","actualQuantity":"12","unit":"KGS","unitRateFc":"17000","totalValueFC":"206153.7","currency":"USD","unitRateINR":"1430550","date":"09-Nov-2023","totalValueINR":"17166600","totalValueInUsd":"206153.7","indian_port":"APIIC MULTI PRODUCT SEZ NAIDUPET AP","hs_no":"29335990","bill_no":"1001779","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"VIA XX SETTEMBRE 43 20090 GARBAGNAT E MILANESE (MI) ITALY ITALY","customerAddress":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,"}]
    05-Jan-2022
    23-Oct-2025
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    Drugs in Development

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    Immunosuppressant Management in Rheumatology Patients Undergoing Shoulder Arthroplasty

    Details:

    Methotrexate is a Other Small Molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Rheumatic Diseases.


    Lead Product(s): Methotrexate,Sulfasalazine,Hydroxychloroquine Sulphate,Leflunomide,Azathioprine,Mycophenolic Acid,Cyclosporine,Tacrolimus,

    Therapeutic Area: Rheumatology Brand Name: Undisclosed

    Study Phase: Phase IIProduct Type: Cytotoxic Drug

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 24, 2025

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    01

    NYU Langone Health

    U.S.A
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    BIO Partnering at JPM
    Not Confirmed

    NYU Langone Health

    U.S.A
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    Lead Product(s) : Methotrexate,Sulfasalazine,Hydroxychloroquine Sulphate,Leflunomide,Azathioprine,Mycophenolic Acid,Cyclosporine,Tacrolimus,

    Therapeutic Area : Rheumatology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Immunosuppressant Management in Rheumatology Patients Undergoing Shoulder Arthroplasty

    Details : Methotrexate is a Other Small Molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Rheumatic Diseases.

    Product Name : Undisclosed

    Product Type : Cytotoxic Drug

    Upfront Cash : Inapplicable

    August 24, 2025

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    A Study to Assess Efficacy and Safety of CGB-500, 1% Tofacitinib Versus an Active Comparator for Atopic Dermatitis

    Details:

    Tofacitinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Dermatitis, Atopic.


    Lead Product(s): Tofacitinib Citrate,CGB-500

    Therapeutic Area: Dermatology Brand Name: Undisclosed

    Study Phase: Phase IIProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable April 11, 2025

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    02

    CAGE Bio

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    CAGE Bio

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    Lead Product(s) : Tofacitinib Citrate,CGB-500

    Therapeutic Area : Dermatology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    A Study to Assess Efficacy and Safety of CGB-500, 1% Tofacitinib Versus an Active Comparator for A...

    Details : Tofacitinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Dermatitis, Atopic.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    April 11, 2025

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    Phase 2b Safety and Efficacy Study of CGB-500 Topical Ointment with 0.5% and 1% Tofacitnib for Treatment of Atopic Dermatitis

    Details:

    Tofacitinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Dermatitis, Atopic.


    Lead Product(s): Tofacitinib Citrate,CGB-500

    Therapeutic Area: Dermatology Brand Name: Undisclosed

    Study Phase: Phase IIProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable February 05, 2025

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    CAGE Bio

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    Lead Product(s) : Tofacitinib Citrate,CGB-500

    Therapeutic Area : Dermatology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Phase 2b Safety and Efficacy Study of CGB-500 Topical Ointment with 0.5% and 1% Tofacitnib for Tre...

    Details : Tofacitinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Dermatitis, Atopic.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    February 05, 2025

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    Biora Therapeutics Prices $3M Direct Offering Under Nasdaq Rules

    Details:

    The net proceeds will be used to fund the clinical development of its oral biotherapeutics platform, BT-600 (tofacitinib) for the treatment of Ulcerative Colitis.


    Lead Product(s): Tofacitinib Citrate,Inapplicable

    Therapeutic Area: Immunology Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: H.C. Wainwright & Co

    Deal Size: $3.0 million Upfront Cash: Undisclosed

    Deal Type: Public Offering October 29, 2024

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    Biora Therapeutics

    U.S.A
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    Not Confirmed

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    Lead Product(s) : Tofacitinib Citrate,Inapplicable

    Therapeutic Area : Immunology

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : H.C. Wainwright & Co

    Deal Size : $3.0 million

    Deal Type : Public Offering

    DEALS_DEV arrow-down

    Biora Therapeutics Prices $3M Direct Offering Under Nasdaq Rules

    Details : The net proceeds will be used to fund the clinical development of its oral biotherapeutics platform, BT-600 (tofacitinib) for the treatment of Ulcerative Colitis.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Undisclosed

    October 29, 2024

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    Biora Announces Supplemental Data from Phase 1 Trial of BT-600

    Details:

    BT-600 (tofacitinib) is a drug-device combination program consisting of the orally administered NaviCap™ device which delivers tofacitinib to the colon for treatment of ulcerative colitis.


    Lead Product(s): Tofacitinib Citrate,Inapplicable

    Therapeutic Area: Immunology Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable July 18, 2024

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    Biora Therapeutics

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    BIO Partnering at JPM
    Not Confirmed

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    Lead Product(s) : Tofacitinib Citrate,Inapplicable

    Therapeutic Area : Immunology

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Biora Announces Supplemental Data from Phase 1 Trial of BT-600

    Details : BT-600 (tofacitinib) is a drug-device combination program consisting of the orally administered NaviCap™ device which delivers tofacitinib to the colon for treatment of ulcerative colitis.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    July 18, 2024

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    Biora Therapeutics Announces Positive Clinical Trial Results for BT-600

    Details:

    BT-600 (tofacitinib) is a drug-device combination program consisting of the orally administered NaviCap™ device which delivers tofacitinib to the colon for treatment of ulcerative colitis.


    Lead Product(s): Tofacitinib Citrate,Inapplicable

    Therapeutic Area: Immunology Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable July 01, 2024

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    Biora Therapeutics

    U.S.A
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    BIO Partnering at JPM
    Not Confirmed

    Biora Therapeutics

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    Lead Product(s) : Tofacitinib Citrate,Inapplicable

    Therapeutic Area : Immunology

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Biora Therapeutics Announces Positive Clinical Trial Results for BT-600

    Details : BT-600 (tofacitinib) is a drug-device combination program consisting of the orally administered NaviCap™ device which delivers tofacitinib to the colon for treatment of ulcerative colitis.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    July 01, 2024

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    Biora Completes Multiple-Ascending Dose Cohorts for BT-600 Clinical Trial

    Details:

    BT-600 (tofacitinib) is a drug-device combination using the NaviCap™ device to deliver a liquid formulation of tofacitinib to the colon, aimed at treating moderate to severe ulcerative colitis.


    Lead Product(s): Tofacitinib Citrate,Inapplicable

    Therapeutic Area: Immunology Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable April 30, 2024

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    Biora Therapeutics

    U.S.A
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    BIO Partnering at JPM
    Not Confirmed

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    Not Confirmed
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    Lead Product(s) : Tofacitinib Citrate,Inapplicable

    Therapeutic Area : Immunology

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Biora Completes Multiple-Ascending Dose Cohorts for BT-600 Clinical Trial

    Details : BT-600 (tofacitinib) is a drug-device combination using the NaviCap™ device to deliver a liquid formulation of tofacitinib to the colon, aimed at treating moderate to severe ulcerative colitis.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    April 30, 2024

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    Biora Therapeutics Achieves Positive Interim Results for BT-600 in NaviCa Platform Trial

    Details:

    BT-600 is a drug device combination containing liquid formulation of tofacitinib (JAK inhibitor). It is being evaluated for the treatment of ulcerative colitis


    Lead Product(s): Tofacitinib Citrate,Inapplicable

    Therapeutic Area: Immunology Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable April 04, 2024

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    08

    Biora Therapeutics

    U.S.A
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    BIO Partnering at JPM
    Not Confirmed

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    Lead Product(s) : Tofacitinib Citrate,Inapplicable

    Therapeutic Area : Immunology

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Biora Therapeutics Achieves Positive Interim Results for BT-600 in NaviCa Platform Trial

    Details : BT-600 is a drug device combination containing liquid formulation of tofacitinib (JAK inhibitor). It is being evaluated for the treatment of ulcerative colitis

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    April 04, 2024

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    Biora Therapeutics Closes $6 Million Registered Direct Offering Priced At-the-Market

    Details:

    Biora intends to use the net proceeds from this offering to support its operations, complete its ongoing BT-600 (tofacitinib) clinical trial for the treatment of moderate to severe ulcerative colitis.


    Lead Product(s): Tofacitinib Citrate,Inapplicable

    Therapeutic Area: Immunology Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: H.C. Wainwright & Co

    Deal Size: $6.0 million Upfront Cash: Undisclosed

    Deal Type: Private Placement April 03, 2024

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    Biora Therapeutics

    U.S.A
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    BIO Partnering at JPM
    Not Confirmed

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    Lead Product(s) : Tofacitinib Citrate,Inapplicable

    Therapeutic Area : Immunology

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : H.C. Wainwright & Co

    Deal Size : $6.0 million

    Deal Type : Private Placement

    DEALS_DEV arrow-down

    Biora Therapeutics Closes $6 Million Registered Direct Offering Priced At-the-Market

    Details : Biora intends to use the net proceeds from this offering to support its operations, complete its ongoing BT-600 (tofacitinib) clinical trial for the treatment of moderate to severe ulcerative colitis.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Undisclosed

    April 03, 2024

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    Biora Announces $6 Million Direct Offering Priced At-the-Market

    Details:

    Biora intends to complete its clinical trial of BT-600, a drug-device combination delivering tofacitinib to the colon for treating moderate to severe ulcerative colitis.


    Lead Product(s): Tofacitinib Citrate,Inapplicable

    Therapeutic Area: Immunology Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: H.C. Wainwright & Co

    Deal Size: $6.0 million Upfront Cash: Undisclosed

    Deal Type: Public Offering April 01, 2024

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    10

    Biora Therapeutics

    U.S.A
    arrow
    BIO Partnering at JPM
    Not Confirmed

    Biora Therapeutics

    U.S.A
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    BIO Partnering at JPM
    Not Confirmed
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    Lead Product(s) : Tofacitinib Citrate,Inapplicable

    Therapeutic Area : Immunology

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : H.C. Wainwright & Co

    Deal Size : $6.0 million

    Deal Type : Public Offering

    DEALS_DEV arrow-down

    Biora Announces $6 Million Direct Offering Priced At-the-Market

    Details : Biora intends to complete its clinical trial of BT-600, a drug-device combination delivering tofacitinib to the colon for treating moderate to severe ulcerative colitis.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Undisclosed

    April 01, 2024

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    Stock Recap
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    INTERMEDIATE SUPPLIERS

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    01

    Zhejiang Hengkang Pharmaceutical

    China
    BIO Partnering at JPM
    Not Confirmed
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    • fda
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    Virtual BoothZhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.

    4-Chloro-7H-pyrrolo[2,3-d]pyrimidine

    CAS Number : 3680-69-1

    End Use API : Tofacitinib Citrate

    About The Company : Established in 2004 and headquartered in Hangzhou, Hengkang established multiple factories, research and sales centers in Zhejiang, Shandong, and Henan. With fa...

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    Zhejiang Hengkang Pharmaceutical

    China
    BIO Partnering at JPM
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    Virtual BoothZhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.

    (3R,4R)-N,4-Dimethyl-1-(phenylmethyl)-3-piperidina...

    CAS Number : 1062580-52-2

    End Use API : Tofacitinib Citrate

    About The Company : Established in 2004 and headquartered in Hangzhou, Hengkang established multiple factories, research and sales centers in Zhejiang, Shandong, and Henan. With fa...

    Zhejiang Hengkang Pharmaceutical

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    03

    Aarti Pharmalabs

    India
    CPhI North America
    Booth #1636
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    Virtual BoothAarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.

    4-Chloropyrrolo[2,3-d]pyrimidine

    CAS Number : 3680-69-1

    End Use API : Tofacitinib Citrate

    About The Company : Aarti Pharmalabs is generic APIs & Intermediates manufacturing company & small molecule drug substance CDMO and the largest Indian manufacturer of Xanthine Deri...

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    04

    Shanghai Minbiotech

    China
    BIO Partnering at JPM
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    Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

    (3R,4R)-N,4-Dimethyl-1 (phenylmethyl)-3-piperidina...

    CAS Number : 1062580-52-2

    End Use API : Tofacitinib Citrate

    About The Company : Shanghai Minbiotech is specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square mete...

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    05

    Shanghai Minbiotech

    China
    BIO Partnering at JPM
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    Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

    4-Chloro-7-[(4- methylphenyl)sulfonyl]-7H- pyrrolo...

    CAS Number : 479633-63-1

    End Use API : Tofacitinib Citrate

    About The Company : Shanghai Minbiotech is specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square mete...

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    06

    Tagoor Laboratories

    India
    BIO Partnering at JPM
    Not Confirmed
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    Virtual BoothTagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.

    (3R,4R)-N,4-Dimethyl-1-(phenylmethyl)-3-piperidina...

    CAS Number : 1062580-52-2

    End Use API : Tofacitinib Citrate

    About The Company : Tagoor Laboratories, established in 2018 and part of the Tagoor Group, provides APIs, advanced intermediates, and key starting materials for critical and high-g...

    Tagoor Laboratories

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    07

    Indian Drugs And Chemicals

    India
    BIO Partnering at JPM
    Not Confirmed
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    • fda
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    Virtual BoothIndian Drugs & Chemicals – delivering trusted APIs, intermediates & fine chemicals worldwide with 40+ years of quality expertise.

    4-Chloro-5h-pyrrolo[3,2-d] Pyrimidine

    CAS Number : 84905-80-6

    End Use API : Tofacitinib Citrate

    About The Company : Indian Drugs And Chemicals supplies quality products using modern technologies, supported by strong industry expertise. The company serves global markets with a...

    Company Banner

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    08

    Hangzhou Allsino Chemicals

    China
    BIO Partnering at JPM
    Not Confirmed
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    Hangzhou Allsino Chemicals

    China
    BIO Partnering at JPM
    Not Confirmed
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    4-Chloro-7H-pyrrolo-[2,3-d]pyrimidine

    CAS Number : 3680-69-1

    End Use API : Tofacitinib Citrate

    About The Company : Allsino Pharmaceutical, established in May 2004, spans 97,350m² and specializes in the R&D and manufacturing of RSMs, GMP intermediates, and APIs. Our products...

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    09

    Almelo

    India
    BIO Partnering at JPM
    Not Confirmed
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    Almelo

    India
    BIO Partnering at JPM
    Not Confirmed
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    5(N-methyl-N-((3S,4R)-4- methylpiperidin-3-yl)-7Hp...

    CAS Number : CAS-477600-74-1

    End Use API : Tofacitinib Citrate

    About The Company : Almelo are the industry leaders in manufacturing advanced intermediates, Active Pharmaceutical Ingredients (APIs) and specialty fine chemicals. With a diverse p...

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    10

    Almelo

    India
    BIO Partnering at JPM
    Not Confirmed
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    Almelo

    India
    BIO Partnering at JPM
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    (3R,4R)-1-Benzyl-N,4- Dimethylpiperidin-3-Amine

    CAS Number : CAS-477600-70-7

    End Use API : Tofacitinib Citrate

    About The Company : Almelo are the industry leaders in manufacturing advanced intermediates, Active Pharmaceutical Ingredients (APIs) and specialty fine chemicals. With a diverse p...

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    FDF Dossiers

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    01

    Dr. Reddy's Laboratories

    India
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    CPhI Milan
    Booth #5D18
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : Lead Market Dossiers- Under Development

    Registration Country : India

    Tofacitinib Citrate

    Brand Name :

    Dosage Form : Oral Solid Dosage Form

    Dosage Strength : 22MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Lead Market Dossiers- Under Development

    Registration Country : India

    Dr Reddy Company Banner

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    02

    Breckenridge Pharmaceutical

    U.S.A
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    BIO Partnering at JPM
    Not Confirmed
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    • WHO-GMP
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    Digital Content Digital Content

    Regulatory Info :

    Registration Country : USA

    TOFACITINIB

    Brand Name : TOFACITINIB

    Dosage Form : TABLET;ORAL

    Dosage Strength : 5MG

    Packaging :

    Approval Date :

    Application Number : 209633

    Regulatory Info :

    Registration Country : USA

    Breckenridge Pharmaceutical

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    03

    NanoAlvand

    Iran
    arrow
    BIO Partnering at JPM
    Not Confirmed
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    Virtual BoothNanoAlvand is the entrance to Global Markets as a trusted Highly Potent Products manufacturer.

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    Regulatory Info :

    Registration Country : Iran

    Tofacitinib Citrate

    Brand Name : Rhofanib

    Dosage Form : Film Coated Tablet

    Dosage Strength : 5MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Iran

    NanoAlvand

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    04

    NanoAlvand

    Iran
    arrow
    BIO Partnering at JPM
    Not Confirmed
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    • WHO-GMP

    Virtual BoothNanoAlvand is the entrance to Global Markets as a trusted Highly Potent Products manufacturer.

    Contact Supplier Contact Supplier
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    Digital Content Digital Content

    Regulatory Info :

    Registration Country : Iran

    Tofacitinib Citrate

    Brand Name : Rhofanib

    Dosage Form : Film Coated Tablet

    Dosage Strength : 10MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Iran

    NanoAlvand

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    05

    Micro Labs Limited

    India
    BIO Partnering at JPM
    Not Confirmed
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    Micro Labs Limited

    India
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    BIO Partnering at JPM
    Not Confirmed
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    Regulatory Info : DISCN

    Registration Country : USA

    TOFACITINIB CITRATE

    Brand Name : TOFACITINIB CITRATE

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 5MG BASE

    Packaging :

    Approval Date : 2023-03-13

    Application Number : 209738

    Regulatory Info : DISCN

    Registration Country : USA

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    06

    Pfizer Inc

    U.S.A
    BIO Partnering at JPM
    Not Confirmed
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    Pfizer Inc

    U.S.A
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    BIO Partnering at JPM
    Not Confirmed
    • fda
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    Regulatory Info : RX

    Registration Country : USA

    TOFACITINIB CITRATE

    Brand Name : XELJANZ

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 5MG BASE

    Packaging :

    Approval Date : 2012-11-06

    Application Number : 203214

    Regulatory Info : RX

    Registration Country : USA

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    07

    Pfizer Inc

    U.S.A
    BIO Partnering at JPM
    Not Confirmed
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    Pfizer Inc

    U.S.A
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    BIO Partnering at JPM
    Not Confirmed
    • fda
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    Regulatory Info : RX

    Registration Country : USA

    TOFACITINIB CITRATE

    Brand Name : XELJANZ

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 10MG BASE

    Packaging :

    Approval Date : 2018-05-30

    Application Number : 203214

    Regulatory Info : RX

    Registration Country : USA

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    Pfizer Inc

    U.S.A
    BIO Partnering at JPM
    Not Confirmed
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    Pfizer Inc

    U.S.A
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    BIO Partnering at JPM
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    Regulatory Info : RX

    Registration Country : USA

    TOFACITINIB CITRATE

    Brand Name : XELJANZ XR

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 11MG BASE

    Packaging :

    Approval Date : 2016-02-23

    Application Number : 208246

    Regulatory Info : RX

    Registration Country : USA

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    Pfizer Inc

    U.S.A
    BIO Partnering at JPM
    Not Confirmed
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    Pfizer Inc

    U.S.A
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    BIO Partnering at JPM
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    Regulatory Info : RX

    Registration Country : USA

    TOFACITINIB CITRATE

    Brand Name : XELJANZ XR

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 22MG BASE

    Packaging :

    Approval Date : 2019-12-12

    Application Number : 208246

    Regulatory Info : RX

    Registration Country : USA

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    10

    Prinston

    U.S.A
    BIO Partnering at JPM
    Not Confirmed
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    Prinston

    U.S.A
    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
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    Regulatory Info :

    Registration Country : USA

    TOFACITINIB

    Brand Name : TOFACITINIB

    Dosage Form : TABLET;ORAL

    Dosage Strength : 5MG

    Packaging :

    Approval Date :

    Application Number : 209923

    Regulatory Info :

    Registration Country : USA

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    FDA Orange Book

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    01

    BRECKENRIDGE PHARMS

    U.S.A
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    BIO Partnering at JPM
    Not Confirmed
    • fda
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    RLD :

    TE Code :

    TOFACITINIB

    Brand Name : TOFACITINIB

    Dosage Form : TABLET;ORAL

    Dosage Strength : 5MG

    Approval Date :

    Application Number : 209633

    RX/OTC/DISCN :

    RLD :

    TE Code :

    Breckenridge Pharmaceutical

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    02

    AJANTA PHARMA LTD

    India
    BIO Partnering at JPM
    Not Confirmed
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    AJANTA PHARMA LTD

    India
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    BIO Partnering at JPM
    Not Confirmed
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    RLD : No

    TE Code : AB

    TOFACITINIB CITRATE

    Brand Name : TOFACITINIB CITRATE

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 11MG BASE

    Approval Date : 2025-08-19

    Application Number : 219542

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    AUROBINDO PHARMA LIMITED

    India
    BIO Partnering at JPM
    Not Confirmed
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    AUROBINDO PHARMA LIMITED

    India
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    BIO Partnering at JPM
    Not Confirmed
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    RLD :

    TE Code :

    TOFACITINIB

    Brand Name : TOFACITINIB

    Dosage Form : TABLET

    Dosage Strength : 5MG

    Approval Date :

    Application Number : 215356

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    04

    BIOCON PHARMA

    India
    BIO Partnering at JPM
    Not Confirmed
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    BIOCON PHARMA

    India
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    BIO Partnering at JPM
    Not Confirmed
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    RLD :

    TE Code :

    TOFACITINIB CITRATE

    Brand Name : TOFACITINIB CITRATE

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 11MG BASE

    Approval Date :

    Application Number : 219442

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    BIOCON PHARMA

    India
    BIO Partnering at JPM
    Not Confirmed
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    BIOCON PHARMA

    India
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    BIO Partnering at JPM
    Not Confirmed
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    RLD :

    TE Code :

    TOFACITINIB CITRATE

    Brand Name : TOFACITINIB CITRATE

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 22MG BASE

    Approval Date :

    Application Number : 219442

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    06

    PF PRISM CV

    U.S.A
    BIO Partnering at JPM
    Not Confirmed
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    PF PRISM CV

    U.S.A
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    BIO Partnering at JPM
    Not Confirmed
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    RLD : Yes

    TE Code :

    TOFACITINIB CITRATE

    Brand Name : XELJANZ

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 5MG BASE

    Approval Date : 2012-11-06

    Application Number : 203214

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    PF PRISM CV

    U.S.A
    BIO Partnering at JPM
    Not Confirmed
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    PF PRISM CV

    U.S.A
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    BIO Partnering at JPM
    Not Confirmed
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    RLD : Yes

    TE Code :

    TOFACITINIB CITRATE

    Brand Name : XELJANZ

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 10MG BASE

    Approval Date : 2018-05-30

    Application Number : 203214

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    PFIZER

    U.S.A
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    RLD : Yes

    TE Code : AB

    TOFACITINIB CITRATE

    Brand Name : XELJANZ XR

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 11MG BASE

    Approval Date : 2016-02-23

    Application Number : 208246

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    PFIZER

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    Not Confirmed
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    RLD : Yes

    TE Code :

    TOFACITINIB CITRATE

    Brand Name : XELJANZ XR

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 22MG BASE

    Approval Date : 2019-12-12

    Application Number : 208246

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    YAOPHARMA CO LTD

    China
    BIO Partnering at JPM
    Not Confirmed
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    YAOPHARMA CO LTD

    China
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    RLD :

    TE Code :

    Tofacitinib

    Brand Name : Tofacitinib

    Dosage Form : TABLET;ORAL

    Dosage Strength : 5MG

    Approval Date :

    Application Number : 215552

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    ABOUT THIS PAGE

    Looking for 540737-29-9 / Tofacitinib Citrate API manufacturers, exporters & distributors?

    Tofacitinib Citrate manufacturers, exporters & distributors 1

    81

    PharmaCompass offers a list of Tofacitinib Citrate 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 Tofacitinib Citrate manufacturer or Tofacitinib Citrate supplier for your needs.

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

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

    API | Excipient name

    Tofacitinib Citrate

    Synonyms

    540737-29-9, Tasocitinib citrate, Xeljanz, Cp-690550 citrate, Tofacitinib (citrate), Tofacitinib (cp-690550) citrate

    Cas Number

    540737-29-9

    Unique Ingredient Identifier (UNII)

    O1FF4DIV0D

    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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