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    Chemistry

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    Also known as: 1310726-60-3, Abt-494, Rinvoq, Upadacitinib anhydrous, 4ra0kn46e0, (3s,4r)-3-ethyl-4-(1,5,7,10-tetrazatricyclo[7.3.0.02,6]dodeca-2(6),3,7,9,11-pentaen-12-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide
    Molecular Formula
    C17H19F3N6O
    Molecular Weight
    380.4  g/mol
    InChI Key
    WYQFJHHDOKWSHR-MNOVXSKESA-N
    FDA UNII
    4RA0KN46E0
    Upadacitinib
    Upadacitinib is an oral Janus kinase (JAK)1-selective inhibitor and a disease-modifying antirheumatic drug (DMARD) used in the treatment of rheumatoid arthritis to slow down disease progression. Rheumatoid arthritis is a chronic autoimmune inflammatory disease affecting the peripheral joints. It is characterized by synovial inflammation and hyperplasia, autoantibody production, cartilage damage and bone destruction, leading to co-morbidities. Despite a variety of therapeutic agents available for treatment, up to 40% of the patients do not respond to current therapies, including biological therapies. The etiology of the disease is mostly unknown; however, the role of JAK as a driver of immune-mediated conditions was discovered, leading to the use of JAK as therapeutic targets for rheumatoid arthritis. To reduce dose-related toxicity (as seen with some pan-JAK inhibitors) without significantly affecting efficacy, more selective JAK1 inhibitors, upadacitinib and [filgotinib], were developed. The FDA approved Upadacitinib in August 2019 for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. In December 2019, it was additionally approved by the European Commission for the same indication in patients with inadequate response or intolerance to one or more DMARDs and can be used as monotherapy or in combination with methotrexate. Upadacitinib is marketed under the brand name RINVOQ for oral administration. It is currently being investigated in several clinical trials assessing its therapeutic effectiveness in other inflammatory diseases, such as psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and atopic dermatitis.
    1 2D Structure

    Upadacitinib

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (3S,4R)-3-ethyl-4-(1,5,7,10-tetrazatricyclo[7.3.0.02,6]dodeca-2(6),3,7,9,11-pentaen-12-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide
    2.1.2 InChI
    InChI=1S/C17H19F3N6O/c1-2-10-7-25(16(27)24-9-17(18,19)20)8-11(10)13-5-22-14-6-23-15-12(26(13)14)3-4-21-15/h3-6,10-11,21H,2,7-9H2,1H3,(H,24,27)/t10-,11+/m1/s1
    2.1.3 InChI Key
    WYQFJHHDOKWSHR-MNOVXSKESA-N
    2.1.4 Canonical SMILES
    CCC1CN(CC1C2=CN=C3N2C4=C(NC=C4)N=C3)C(=O)NCC(F)(F)F
    2.1.5 Isomeric SMILES
    CC[C@@H]1CN(C[C@@H]1C2=CN=C3N2C4=C(NC=C4)N=C3)C(=O)NCC(F)(F)F
    2.2 Other Identifiers
    2.2.1 UNII
    4RA0KN46E0
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. (3s,4r)-3-ethyl-4-(3h-imidazo(1,2-a)pyrrolo(2,3-e)pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)-1-pyrrolidinecarboxamide

    2. Abt-494

    3. Rinvoq

    2.3.2 Depositor-Supplied Synonyms

    1. 1310726-60-3

    2. Abt-494

    3. Rinvoq

    4. Upadacitinib Anhydrous

    5. 4ra0kn46e0

    6. (3s,4r)-3-ethyl-4-(1,5,7,10-tetrazatricyclo[7.3.0.02,6]dodeca-2(6),3,7,9,11-pentaen-12-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide

    7. (3s,4r)-3-ethyl-4-(3h-imidazo(1,2-a)pyrrolo(2,3-e)pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)-1-pyrrolidinecarboxamide

    8. (3s,4r)-3-ethyl-4-(3h-imidazo[1,2-a]pyrrolo[2,3-e]pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide

    9. 1-pyrrolidinecarboxamide, 3-ethyl-4-(3h-imidazo(1,2-a)pyrrolo(2,3-e)pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)-, (3s,4r)-

    10. Mfcd30502663

    11. Upadacitinib [usan]

    12. Upadacitinib [mi]

    13. Upadacitinib, Abt-494

    14. Upadacitinib (usan/inn)

    15. Upadacitinib [inn]

    16. Upadacitinib [usan:inn]

    17. Upadacitinib (abt-494)

    18. Unii-4ra0kn46e0

    19. Upadacitinib [who-dd]

    20. Gtpl9246

    21. Schembl9991056

    22. Chembl3622821

    23. Abt 494

    24. Dtxsid901027919

    25. Upadacitinib [orange Book]

    26. Amy16528

    27. Bcp19011

    28. Ex-a1628

    29. Bdbm50503287

    30. S8162

    31. Cs-6150

    32. Db15091

    33. Abbv-599 Component Upadacitinib

    34. Abt494;abt-494;abt 494

    35. Ncgc00588874-01

    36. Ac-30326

    37. As-56379

    38. Hy-19569

    39. Upadacitinib Component Of Abbv-599

    40. J3.590.729g

    41. C72237

    42. D10994

    43. Q27074125

    44. (3s,4r)-3-ethyl-4-(3h-imidazo(1,2-a)pyrrolo(2,3-e)pyrazin- 8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide Tyrosine Kinase Inhibitor

    45. (3s,4r)-3-ethyl-4-(3h-imidazo(1,2-a)pyrrolo(2,3-e)pyrazin-8-yl)-n-(2,2,2- Trifluoroethyl)pyrrolidine-1-carboxamide

    46. Rel-(-)-(3s,4r)-3-ethyl-4-(3h-imidazo(1,2-a)pyrrolo(2,3-e)pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide

    2.4 Create Date
    2012-08-19
    3 Chemical and Physical Properties
    Molecular Weight 380.4 g/mol
    Molecular Formula C17H19F3N6O
    XLogP32.7
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count6
    Rotatable Bond Count3
    Exact Mass380.15724374 g/mol
    Monoisotopic Mass380.15724374 g/mol
    Topological Polar Surface Area78.3 Ų
    Heavy Atom Count27
    Formal Charge0
    Complexity561
    Isotope Atom Count0
    Defined Atom Stereocenter Count2
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Indication

    Upadacitinib is indicated for the treatment of moderately to severely active rheumatoid arthritis or active psoriatic arthritis in adult patients who have had an inadequate response or intolerance to one or more disease-modifying anti-rheumatic drugs (DMARDs), such as methotrexate or TNF blockers. For these indications, upadacitinib may be used as monotherapy or in combination with methotrexate. Upadacitinib is also indicated for the treatment of active ankylosing spondylitis in adult patients who have an inadequate response to conventional therapy and for the treatment of moderate to severe atopic dermatitis in patients aged 12 years and older who are candidates for systemic therapy. Combining upadacitinib with other JAK inhibitors, biologic DMARDs, or other potent immunosuppressive agents is not recommended.

    FDA Label

    Rheumatoid arthritis

    RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate.

    Psoriatic arthritis

    RINVOQ is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate.

    Axial spondyloarthritis

    Non-radiographic axial spondyloarthritis (nr-axSpA)

    RINVOQ is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).

    Ankylosing spondylitis (AS, radiographic axial spondyloarthritis )

    RINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.

    Atopic dermatitis

    RINVOQ is indicated for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.

    Ulcerative colitis

    RINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

    Treatment of ulcerative colitis

    Treatment of Crohn's disease

    Treatment of vasculitides

    Treatment of vasculitides

    Treatment of atopic dermatitis

    Treatment of chronic idiopathic arthritis (including rheumatoid arthritis , psoriatic arthritis , spondyloarthritis and juvenile idiopathic arthritis )

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Upadacitinib is a DMARD that works by inhibiting the Janus Kinases (JAKs), which are essential downstream cell signalling mediators of pro-inflammatory cytokines. It is believed that these pro-inflammatory cytokines play a role in many autoimmune inflammatory conditions, such as rheumatoid arthritis. In clinical trials, upadacitinib decreased the activity of pro-inflammatory interleukins, transiently increased the levels of lymphocytes, and insignificantly decreased the levels of immunoglobulins from the baseline.

    5.2 MeSH Pharmacological Classification

    Antirheumatic Agents

    Drugs that are used to treat RHEUMATOID ARTHRITIS. (See all compounds classified as Antirheumatic Agents.)

    Janus Kinase Inhibitors

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

    5.3 ATC Code

    L04AA

    L - Antineoplastic and immunomodulating agents

    L04 - Immunosuppressants

    L04A - Immunosuppressants

    L04AA - Selective immunosuppressants

    L04AA44 - Upadacitinib

    5.4 Absorption, Distribution and Excretion

    Absorption

    Upadacitinib displays a dose-proportional pharmacokinetic profile over the therapeutic dose range. Following oral administration, the median time to reach Cmax (Tmax) ranges from 2 to 4 hours. The steady-state plasma concentrations of upadacitinib are reached within 4 days following multiple once-daily administrations, with minimal accumulation. Food intake has no clinically relevant effect on the AUC, Cmax, and Cmin of upadacitinib from the extended-release formulation.

    Route of Elimination

    Following administration of a single radio-labelled dose from the immediate-release formulation, approximately 53% of the total dose was excreted in the feces where 38% of the excreted dose was an unchanged parent drug. About 43% of the total dose was excreted in the urine, where 24% of that dose was in the unchanged parent drug form. Approximately 34% of the total dose of upadacitinib dose was excreted as metabolites.

    Volume of Distribution

    The volume of distribution of upadacitinib in a patient with rheumatoid arthritis and a body weight of 74 kg is estimated to be 224 L following oral administration of an extended-release formula. In a pharmacokinetic study consisting of healthy volunteers receiving the extended-release formulation, the steady-state volume of distribution was 294 L. Upadacitinib partitions similarly between plasma and blood cellular components with a blood to plasma ratio of 1.0.

    Clearance

    The apparent oral clearance of upadacitinib in healthy volunteers receiving the extended-release formulation was 53.7 L/h.

    5.5 Metabolism/Metabolites

    Upadacitinib predominantly undergoes CYP3A4-mediated metabolism; however, upadacitinib is a nonsensitive substrate of CYP3A4. It is also metabolized by CYP2D6 to a lesser extent. In a human radio-labelled study, about 79% of the total plasma radioactivity accounted for the parent drug, and about 13% of the total plasma radioactivity accounted for the main metabolite produced from mono-oxidation, followed by glucuronidation. There are no known active metabolites of upadacitinib.

    5.6 Biological Half-Life

    The mean terminal elimination half-life of upadacitinib ranged from 8 to 14 hours following administration of the extended-release formulation. In clinical trials, approximately 90% of upadacitinib in the systemic circulation was eliminated within 24 hours of dosing.

    5.7 Mechanism of Action

    Rheumatoid arthritis (RA) is a chronic autoimmune inflammatory disease that involves the interplay of several mediators, including the immune cells (mainly T- and B-lymphocytes) and pro-inflammatory cytokines, such as the tumour necrosis factor (TNF), transforming growth factor (TGF), and interleukin 6 (IL-6). The Janus Kinase (JAK) family plays an essential role in the normal physiological functions (such as erythropoiesis), but also the signalling of pro-inflammatory cytokines that are implicated in many immune-mediated diseases. The JAK family consists of four isoforms (JAK1, JAK2, JAK3, and Tyrosine Kinase 2) that each interacts with different cytokine receptors and uniquely associates with the intracellular domains of Type I/II cytokine receptors. JAK1 is primarily involved in the signalling transduction pathways of IL-6, IFN and the common -chain cytokines, including IL-2 and IL-15. IL-6 has been closely studied in particular, as it is a major cytokine involved in B- and T-cell differentiation and the acute phase response in inflammation. Upon interaction of cytokines with their cytokine receptors, the JAKs mediate the JAK-STAT signal transduction pathway in response to receptor activation. JAKs are tyrosine kinases that cause phosphorylation of several proteins, including cytokine receptors and JAKs themselves. Phosphorylation of JAKs promotes the phosphorylation and activation of the signalling molecules called STATs, leading to their nuclear translocation, binding to DNA promoters, and target gene transcription. JAK1-mediated signalling pathways ultimately promote pro-inflammatory events, such as increased proliferation and survival of immune cells, T cell differentiation, and macrophage activation. Upadacitinib is a selective JAK1 inhibitor that has a negligible effect on JAK3, leading to an improved drug safety profile. Upadacitinib blocks the cellular processes that contribute to the inflammatory conditions in rheumatoid arthritis. In human leukocytes cellular assays, upadacitinib inhibited JAK1/3-induced phosphorylation of STAT3/5 mediated by IL-6/7.

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    U.S.A
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    Not Confirmed

    GDUFA

    DMF Review : Complete

    Rev. Date : 2022-08-16

    Pay. Date : 2022-06-15

    DMF Number : 37149

    Submission : 2022-06-01

    Status : Active

    Type : II

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    05

    Lee Pharma Ltd

    India

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    Not Confirmed

    05

    Lee Pharma Ltd

    India
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    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39581

    Submission : 2024-03-12

    Status : Active

    Type : II

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    06

    Biotech Showcase
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    06

    Msn Laboratories Private Ltd

    India
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    Biotech Showcase
    Not Confirmed

    GDUFA

    DMF Review : Complete

    Rev. Date : 2023-07-17

    Pay. Date : 2023-04-25

    DMF Number : 38153

    Submission : 2023-03-26

    Status : Active

    Type : II

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    07

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    07

    Optimus Drugs Private Ltd

    India
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    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 38051

    Submission : 2023-02-09

    Status : Active

    Type : II

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    08

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    08

    Sichuan Gowell Pharmaceutical Co Ltd

    China
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    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 40344

    Submission : 2024-08-19

    Status : Active

    Type : II

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    09

    Hoster Labs Private Ltd

    Country

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    09

    Hoster Labs Private Ltd

    Country
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    GDUFA

    DMF Review : Complete

    Rev. Date : 2023-07-05

    Pay. Date : 2023-05-15

    DMF Number : 38344

    Submission : 2023-05-20

    Status : Active

    Type : II

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    NDC API

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    01

    AbbVie Ireland NL B.V.

    U.S.A
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    Not Confirmed
    • fda
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    UPADACITINIB

    NDC Package Code : 68513-2320

    Start Marketing Date : 2024-06-27

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    Abbvie Company Banner

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    02

    Aurobindo Pharma Limited

    India
    Biotech Showcase
    Not Confirmed
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    Aurobindo Pharma Limited

    India
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    Biotech Showcase
    Not Confirmed
    • fda
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    UPADACITINIB

    NDC Package Code : 59651-788

    Start Marketing Date : 2023-12-25

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (50kg/50kg)

    Marketing Category : BULK INGREDIENT

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    03

    Curia Spain S.A.U.

    U.S.A
    Biotech Showcase
    Not Confirmed
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    Curia Spain S.A.U.

    U.S.A
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    Not Confirmed
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    UPADACITINIB

    NDC Package Code : 65089-0067

    Start Marketing Date : 2024-03-22

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    04

    MSN Laboratories Private Limited

    India
    Biotech Showcase
    Not Confirmed
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    MSN Laboratories Private Limited

    India
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    Biotech Showcase
    Not Confirmed
    • fda
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    Post an Enquiry Post an Enquiry
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    UPADACITINIB

    NDC Package Code : 14501-0111

    Start Marketing Date : 2023-03-26

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    05

    HOSTER LABS PRIVATE LIMITED

    Country
    Biotech Showcase
    Not Confirmed
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    HOSTER LABS PRIVATE LIMITED

    Country
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    UPADACITINIB

    NDC Package Code : 82708-0001

    Start Marketing Date : 2019-08-16

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    Listed Suppliers

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    01

    Zhejiang Hengkang Pharmaceutical

    China
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    CPhI China
    Attending
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    • EDQM
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    Virtual BoothZhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.

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    Upadacitinib

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

    Established in 2004 and headquartered in Hangzhou, Hengkang established multiple factories, research and sales centers in Zhejiang, Shandong, and Henan. With facilities conforming to global API standards, along with professional R&D and marketing teams, Hengkang’s operations span major pharmaceutical markets such as China, Europe, the CIS region, Japan, and South Korea. Hengkang has established long-term and stable relationships with nearly 70 countries overseas and hundreds of domestic enterprises.
    Zhejiang Hengkang Pharmaceutical

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    02

    Transo-Pharm USA LLC

    U.S.A
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    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
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    Virtual BoothTransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.

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    Upadacitinib

    About the Company : Transo-Pharm, a fully licensed and certified distributor, specializes in pharmaceutical components for the health and veterinary industries. It offers support to clients throughout...

    Transo-Pharm, a fully licensed and certified distributor, specializes in pharmaceutical components for the health and veterinary industries. It offers support to clients throughout the entire API life cycle, from product development through sales. Transo-Pharm serves as a sourcing and regulatory marketing agent for API manufacturers. It aids clients in establishing DMFs and provides GMP consulting. With a dedicated regulatory department, a warehouse, proprietary IPs for API processes, and partnerships with laboratories, Transo-Pharm offers a wide range of services. It operates from its offices in Shanghai, Hong Kong, Singapore, and the US.
    Transo Pharm USA Company Banner

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    03

    Metrochem API Private Limited

    India
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    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
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    Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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    Upadacitinib

    About the Company :

    Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product ...

    Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
    Metrochem

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    04

    Egis Pharmaceuticals PLC

    Hungary
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    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
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    Virtual BoothEgis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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    Upadacitinib

    About the Company : Egis is a member of the Servier Group. Egis’ products are manufactured at 3 production sites in Hungary, which are certified by EMA,FDA, ANVISA, PMDA ,KFDA. Egis sells its produc...

    Egis is a member of the Servier Group. Egis’ products are manufactured at 3 production sites in Hungary, which are certified by EMA,FDA, ANVISA, PMDA ,KFDA. Egis sells its products under Egis’ brand names in 18 countries. In total, the company’s APIs & finished products reach 100 countries. Egis’ focus lies on treating diseases of cardiovascular & central nervous systems; however, it also provides modern treatment solutions in the fields of diabetology, dermatology & wound care. Our research and development activities focus on high-quality, value-added branded generic products. From 2023, Egis offers its CDMO & CMO services as well.
    Egis Pharmaceuticals

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    05

    Shandong Chenghui Shuangda Pharmace...

    China
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    CPhI China
    Attending
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    Virtual BoothChina's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.

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    Upadacitinib

    About the Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experience,the company has ...

    Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experience,the company has 6 workshops and 9 production lines which has 100t/month production capacity.The company is committed to maintain the standards with continuous improvements to the current standards throughout the product lifecycle.The main products include local anesthetic drugs, antiviral drugs, cardiovascular and cerebrovascular drugs, antitumor drugs, gastrointestinal drugs, diabetic drugs, veterinary drugs, and CDMO products.
    Shandong Chenghui Shuangda Pharmaceutical

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    06

    Jinan Tantu Chemicals

    China
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    CPhI China
    Exhibiting
    • fda
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    Virtual BoothJinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.

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    Upadacitinib

    About the Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our core services include c...

    Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our core services include customized R&D as well as the production of small molecule pharmaceutical intermediates and Active Pharmaceutical Ingredients (APIs) for both international and domestic pharmaceutical firms. Our capabilities span from laboratory-scale kilograms to commercial ton-scale production. Additionally, we are committed to independent research and development, as well as the production and sales of high-end pharmaceutical intermediates and API products.
    Jinan Tantu Chemicals

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    07

    Shandong Loncom Pharmaceutical

    China
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    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothShandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.

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    Upadacitinib

    About the Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe Economic Development...

    Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe Economic Development Zone, Shandong Province, Shandong Loncom has operational API pilot tests and production bases adhering to international standards. With 13 production lines dedicated to oral solid preparations, oral liquid preparations and API, it is actively expanding its preparation workshops for small-volume injections, soft capsules, eye drops, topical medicines and innovative drug R&D centres.
    Shandong Loncom Pharmaceutical company banner

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    08

    TAPI Technology & API Services

    Israel
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    CPhI WW Frankfurt
    Booth #6.1A32
    • fda
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    Virtual BoothTAPI offers customized CDMO Solutions for API development and manufacturing services.

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    Upadacitinib

    About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...

    Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, driving progress in the pharmaceutical industry. Leveraging our extensive experience and world-class expertise, we deliver one of the most comprehensive API portfolios in the industry. Additionally, we provide tailored CDMO services, harnessing our proficiency in diverse technologies to meet our partners' unique needs, ensuring flexibility and excellence in every project.
    TAPI Company Banner

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    09

    Changzhou Pharmaceutical Factory

    China
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Changzhou Pharmaceutical Factory

    China
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    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Upadacitinib

    About the Company : Changzhou Pharmaceutical Factory (CPF) is a subsidiary company of Shanghai Pharma Holdings Co., Ltd., It is headquartered in Changzhou, Jiangsu Province, China. The company was fou...

    Changzhou Pharmaceutical Factory (CPF) is a subsidiary company of Shanghai Pharma Holdings Co., Ltd., It is headquartered in Changzhou, Jiangsu Province, China. The company was founded in 1949 by (Tan Ruiting) with a registered capital of 108 million yuan and the company was restructured as a Changzhou pharmaceutical Factory under the aegis of the Shanghai Pharma Group. The company mainly involves leading pharmaceutical manufacturers a wide range of key Intermediates, Active pharmaceutical ingredients, and Finished Formulations that meet with global standards.
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    10

    Lee Pharma

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Lee Pharma

    India
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    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Upadacitinib

    About the Company : Lee helps you focus on the business results that matter to your company. Over the years, we have leveraged our position in the global market with an enviable list of clients and a ...

    Lee helps you focus on the business results that matter to your company. Over the years, we have leveraged our position in the global market with an enviable list of clients and a phenomenal growth rate achieved through product innovation, dedicated teams and timely implementation of solutions. Our success is based on providing a value-added service by adopting a customer-orientated approach. Our corporate independence allows us to respond as fast as possible, gives us a greater flexibility, and enables us to invest in plant and processes.
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    API Reference Price

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    [{"dataSource":"API Export","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1635791400,"product":"UPADACITINIB API, B\/N: B626573\/V2994\/021","address":"SANDOZ HOUSEDR. A.B. ROAD, WORLI,","city":"MUMBAI ,MAHARASHTRA","supplier":"SANDOZ B2B","supplierCountry":"INDIA","foreign_port":"MADRID","customer":"CURIA","customerCountry":"SPAIN","quantity":"0.04","actualQuantity":"0.04","unit":"KGS","unitRateFc":"122459.5","totalValueFC":"4646.1","currency":"USD","unitRateINR":8650000,"date":"02-Nov-2021","totalValueINR":"346000","totalValueInUsd":"4646.1","indian_port":"BOMBAY AIR","hs_no":"29339990","bill_no":"5762444","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"SANDOZ HOUSEDR. A.B. 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    29-Jul-2021
    12-Nov-2024
    KGS
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    Average Price (USD/KGS)

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    Quantity (KGS) & Unit rate (USD/KGS) over time

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    Drugs in Development

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    AbbVie’s Phase 3 SELECT-GCA Study of Upadacitinib Shows Positive Results in GCA

    Details:

    Rinvoq (upadacitinib) is a FDA approved selective JAK inhibitor that is being investigated in adult patients with giant cell arteritis as a Phase 3 clinical trial.


    Lead Product(s): Upadacitinib

    Therapeutic Area: Immunology Brand Name: Rinvoq

    Study Phase: Phase IIIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable April 23, 2024

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    Lead Product(s) : Upadacitinib

    Therapeutic Area : Immunology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

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    AbbVie’s Phase 3 SELECT-GCA Study of Upadacitinib Shows Positive Results in GCA

    Details : Rinvoq (upadacitinib) is a FDA approved selective JAK inhibitor that is being investigated in adult patients with giant cell arteritis as a Phase 3 clinical trial.

    Brand Name : Rinvoq

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    April 23, 2024

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    • Development Update
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    Phase 3 SELECT-GCA Study of Upadacitinib Shows Positive Results for Giant Cell Arteritis

    Details:

    Rinvoq (upadacitinib) is a janus kinase inhibitor, small molecule drug candidate which is being evaluated for the treatment of giant cell arteritis.


    Lead Product(s): Upadacitinib,Corticosteroid

    Therapeutic Area: Immunology Brand Name: Rinvoq

    Study Phase: Phase IIIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable April 18, 2024

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    AbbVie Inc

    U.S.A
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    Lead Product(s) : Upadacitinib,Corticosteroid

    Therapeutic Area : Immunology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Phase 3 SELECT-GCA Study of Upadacitinib Shows Positive Results for Giant Cell Arteritis

    Details : Rinvoq (upadacitinib) is a janus kinase inhibitor, small molecule drug candidate which is being evaluated for the treatment of giant cell arteritis.

    Brand Name : Rinvoq

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    April 18, 2024

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    AbbVie Announces Upadacitinib (RINVOQ®) Met the Primary Endpoint in Phase 2 Clinical Trial of Vitiligo as Program Advances to Phase 3

    Details:

    Rinvoq (upadacitinib), a Janus kinase (JAK) inhibitor that interferes with the JAK-STAT signaling pathway, being developed for the treatment in adults with non-segmental vitiligo.


    Lead Product(s): Upadacitinib

    Therapeutic Area: Dermatology Brand Name: Rinvoq

    Study Phase: Phase IIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable October 12, 2023

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    AbbVie Inc

    U.S.A
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    Lead Product(s) : Upadacitinib

    Therapeutic Area : Dermatology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    AbbVie Announces Upadacitinib (RINVOQ®) Met the Primary Endpoint in Phase 2 Clinical Trial of Vit...

    Details : Rinvoq (upadacitinib), a Janus kinase (JAK) inhibitor that interferes with the JAK-STAT signaling pathway, being developed for the treatment in adults with non-segmental vitiligo.

    Brand Name : Rinvoq

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    October 12, 2023

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    Health Canada Approves AbbVie's RINVOQ® (upadacitinib) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis Français

    Details:

    Rinvoq (upadacitinib), a Janus kinase (JAK) inhibitor that interferes with the JAK-STAT signaling pathway, indicated for the treatment of adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis and atopic dermatitis.


    Lead Product(s): Upadacitinib

    Therapeutic Area: Gastroenterology Brand Name: Rinvoq

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 25, 2023

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    AbbVie Inc

    U.S.A
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    Lead Product(s) : Upadacitinib

    Therapeutic Area : Gastroenterology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Health Canada Approves AbbVie's RINVOQ® (upadacitinib) for the Treatment of Adults with Moderatel...

    Details : Rinvoq (upadacitinib), a Janus kinase (JAK) inhibitor that interferes with the JAK-STAT signaling pathway, indicated for the treatment of adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis and atopic dermatitis.

    Brand Name : Rinvoq

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    July 25, 2023

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    AbbVie Advances Immunology Pipeline with First Patient Dosed in Global Phase 3 Trial of Upadacitinib (RINVOQ®) in Hidradenitis Suppurativa

    Details:

    Rinvoq (upadacitinib) is a selective JAK inhibitor that is being studied in several immune-mediated inflammatory diseases including, hidradenitis suppurativa in the Phase 3 clinical trial.


    Lead Product(s): Upadacitinib

    Therapeutic Area: Dermatology Brand Name: Rinvoq

    Study Phase: Phase IIIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 24, 2023

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    AbbVie Inc

    U.S.A
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    Lead Product(s) : Upadacitinib

    Therapeutic Area : Dermatology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    AbbVie Advances Immunology Pipeline with First Patient Dosed in Global Phase 3 Trial of Upadacitin...

    Details : Rinvoq (upadacitinib) is a selective JAK inhibitor that is being studied in several immune-mediated inflammatory diseases including, hidradenitis suppurativa in the Phase 3 clinical trial.

    Brand Name : Rinvoq

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    July 24, 2023

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    Phase 2 Study of Upadacitinib (RINVOQ®) Alone or as a Combination Therapy Meets Primary and Key Secondary Endpoints in Patients with Systemic Lupus Ery...

    Details:

    ABBV-599 is a novel fixed-dose combination of the Bruton's tyrosine kinase (BTK) inhibitor elsubrutinib and the Janus kinase (JAK) inhibitor upadacitinib under investigation for the treatment of systemic lupus erythematosus.


    Lead Product(s): Elsubrutinib,Upadacitinib

    Therapeutic Area: Immunology Brand Name: ABBV-599

    Study Phase: Phase IIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable May 31, 2023

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    AbbVie Inc

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    Lead Product(s) : Elsubrutinib,Upadacitinib

    Therapeutic Area : Immunology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Phase 2 Study of Upadacitinib (RINVOQ®) Alone or as a Combination Therapy Meets Primary and Key S...

    Details : ABBV-599 is a novel fixed-dose combination of the Bruton's tyrosine kinase (BTK) inhibitor elsubrutinib and the Janus kinase (JAK) inhibitor upadacitinib under investigation for the treatment of systemic lupus erythematosus.

    Brand Name : ABBV-599

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    May 31, 2023

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    U.S. FDA Approves RINVOQ® (upadacitinib) as a Once-Daily Pill for Moderately to Severely Active Crohn's Disease in Adults

    Details:

    Rinvoq (upadacitinib) is a JAK inhibitor, involved in the process of immune-mediated inflammatory diseases. It has been approved by USFDA for the treatment of moderately to severely active crohn's disease.


    Lead Product(s): Upadacitinib

    Therapeutic Area: Gastroenterology Brand Name: Rinvoq

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable May 18, 2023

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    AbbVie Inc

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    Lead Product(s) : Upadacitinib

    Therapeutic Area : Gastroenterology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    U.S. FDA Approves RINVOQ® (upadacitinib) as a Once-Daily Pill for Moderately to Severely Active C...

    Details : Rinvoq (upadacitinib) is a JAK inhibitor, involved in the process of immune-mediated inflammatory diseases. It has been approved by USFDA for the treatment of moderately to severely active crohn's disease.

    Brand Name : Rinvoq

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    May 18, 2023

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    AbbVie Announces European Commission Approval of RINVOQ® (upadacitinib) for the Treatment of Moderately to Severely Active Crohn's Disease

    Details:

    Rinvoq (upadacitinib) is a JAK inhibitor, involved in the process of immune-mediated inflammatory diseases. It has been approved in EU for the treatment of moderately to severely active crohn's disease.


    Lead Product(s): Upadacitinib

    Therapeutic Area: Gastroenterology Brand Name: Rinvoq

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable April 17, 2023

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    AbbVie Inc

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    Lead Product(s) : Upadacitinib

    Therapeutic Area : Gastroenterology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    AbbVie Announces European Commission Approval of RINVOQ® (upadacitinib) for the Treatment of Mode...

    Details : Rinvoq (upadacitinib) is a JAK inhibitor, involved in the process of immune-mediated inflammatory diseases. It has been approved in EU for the treatment of moderately to severely active crohn's disease.

    Brand Name : Rinvoq

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    April 17, 2023

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    AbbVie Advances Upadacitinib (RINVOQ®) to Phase 3 Clinical Trials in Systemic Lupus Erythematosus

    Details:

    ABBV-599 is a combination of upadacitinib, a JAK inhibitor and elsubrutinib a bruton tyrosine kinase inhibitor which is being investigated for the treatment of systemic lupus erythematosus.


    Lead Product(s): Upadacitinib,Elsubrutinib

    Therapeutic Area: Immunology Brand Name: ABBV-599

    Study Phase: Phase IIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable March 23, 2023

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    AbbVie Inc

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    Lead Product(s) : Upadacitinib,Elsubrutinib

    Therapeutic Area : Immunology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    AbbVie Advances Upadacitinib (RINVOQ®) to Phase 3 Clinical Trials in Systemic Lupus Erythematosus

    Details : ABBV-599 is a combination of upadacitinib, a JAK inhibitor and elsubrutinib a bruton tyrosine kinase inhibitor which is being investigated for the treatment of systemic lupus erythematosus.

    Brand Name : ABBV-599

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    March 23, 2023

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    AbbVie Receives Positive CHMP Opinion for Upadacitinib (RINVOQ®) for the Treatment of Adults with Moderate to Severe Crohn's Disease

    Details:

    Rinvoq (upadacitinib) is a JAK inhibitor which are intracellular enzymes which transmit signals arising from cytokine or growth factor-receptor interactions on the cellular membrane to influence cellular processes of hematopoiesis and immune cell function.


    Lead Product(s): Upadacitinib

    Therapeutic Area: Gastroenterology Brand Name: Rinvoq

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable February 27, 2023

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    AbbVie Inc

    U.S.A
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    Lead Product(s) : Upadacitinib

    Therapeutic Area : Gastroenterology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    AbbVie Receives Positive CHMP Opinion for Upadacitinib (RINVOQ®) for the Treatment of Adults with...

    Details : Rinvoq (upadacitinib) is a JAK inhibitor which are intracellular enzymes which transmit signals arising from cytokine or growth factor-receptor interactions on the cellular membrane to influence cellular processes of hematopoiesis and immune cell functio...

    Brand Name : Rinvoq

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    February 27, 2023

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    INTERMEDIATES SUPPLIERS

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    01

    Cohance Lifesciences

    India
    Pharma, Lab & Chemical Expo
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    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

    Trimethylsulfoxonium chloride

    CAS Number : 5034-06-0

    End Use API : Upadacitinib

    About The Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commer...

    Cohance

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    Shandong Chenghui Shuangda Pharmace...

    China
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    Virtual BoothChina's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.

    (3R,4S)-3-(2-Bromoacetyl)-4- ethyl-1-pyrrolidineca...

    CAS Number : 1428243-26-8

    End Use API : Upadacitinib

    About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experie...

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    Shandong Chenghui Shuangda Pharmace...

    China
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    Virtual BoothChina's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.

    tert-butyl 5-tosyl-5H-pyrrolo[2,3- b]pyrazin-2-yl...

    CAS Number : 1201187-44-1

    End Use API : Upadacitinib

    About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experie...

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    Shandong Chenghui Shuangda Pharmace...

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    Virtual BoothChina's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.

    8-((3R,4S)-4-ethylpyrrolidin-3-yl)- 3-tosyl-3H-imi...

    CAS Number : 1428243-28-0

    End Use API : Upadacitinib

    About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experie...

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    ASolution Pharmaceuticals

    India
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    Virtual BoothASolution Pharmaceuticals: Your Partner for cGMP Development & Manufacturing Services – Supplying APIs, FDFs, and Specialty Molecules.

    Trimethylsulfoxonium Chloride

    CAS Number : 5034-06-0

    End Use API : Upadacitinib

    About The Company : Since 2010, our dedication to our clientele has been unwavering in addressing pharmaceutical hurdles, regardless of scale. We prioritize integrity, responsivene...

    ASolution Pharmaceuticals

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    Aarti Pharmalabs

    India
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    Virtual BoothAarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

    2-bromo-5-(p-tolylsulfonyl) pyrrolo[2,3-b] pyrazin...

    CAS Number : 1201186-54-0

    End Use API : Upadacitinib

    About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...

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    Aarti Pharmalabs

    India
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    Virtual BoothAarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

    N-[5-[(4-methylphenyl)sulfonyl]-5H-pyrrolo[2,3- b]...

    CAS Number : 1201187-44-1

    End Use API : Upadacitinib

    About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...

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    Jinan Tantu Chemicals

    China
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    Virtual BoothJinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.

    (3R,4S)-3-(2-Bromoacetyl)-4-ethyl-1-pyrrolidinecar...

    CAS Number : 1428243-26-8

    End Use API : Upadacitinib

    About The Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our cor...

    Jinan Tantu Chemicals

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    Jinan Tantu Chemicals

    China
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    Virtual BoothJinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.

    N-[5-[(4-Methylphenyl)sulfonyl]-5H-pyrrolo[2,3-b]p...

    CAS Number : 1201187-44-1

    End Use API : Upadacitinib

    About The Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our cor...

    Jinan Tantu Chemicals

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    Almelo

    India
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    Almelo

    India
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    3,7-Dihydro-4H-Pyrrolo[2,3-d] Pyrimidin-4-One

    CAS Number : CAS-3680-71-5

    End Use API : Upadacitinib

    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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    ABBVIE

    U.S.A
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    RLD : Yes

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    UPADACITINIB

    Brand Name : RINVOQ

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 15MG

    Approval Date : 2019-08-16

    Application Number : 211675

    RX/OTC/DISCN : RX

    RLD : Yes

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    RLD : Yes

    TE Code :

    UPADACITINIB

    Brand Name : RINVOQ

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 30MG

    Approval Date : 2022-01-14

    Application Number : 211675

    RX/OTC/DISCN : RX

    RLD : Yes

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    RLD : Yes

    TE Code :

    UPADACITINIB

    Brand Name : RINVOQ

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 45MG

    Approval Date : 2022-03-16

    Application Number : 211675

    RX/OTC/DISCN : RX

    RLD : Yes

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    RLD : Yes

    TE Code :

    UPADACITINIB

    Brand Name : RINVOQ LQ

    Dosage Form : SOLUTION;ORAL

    Dosage Strength : 1MG/ML

    Approval Date : 2024-04-26

    Application Number : 218347

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    Upadacitinib (60 g) API needed in India [ENA21176]
    A CRO that provides formulation and analytical development services for OSDs, parenteral and liquid orals is looking for suppliers of Upadacitinib (60 g) API for development purposes. The suppliers must support this enquiry with USDMF & CoA.
    20 Nov 2024

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    20 Nov 2024

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    Upadacitinib (100 kg) API needed in China [ENA19530]
    A company that focuses on manufacturing and development of various intermediates is looking for suppliers of Upadacitinib (100 kg) API for commercial purposes. The suppliers must support this enquiry with CoA.
    18 May 2024

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    18 May 2024

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    Upadacitinib (5 g - 10 g) API needed in India [ENA16837]
    A CRO that focuses on the development of impurities and intermediates is looking for suppliers of Upadacitinib (5 g - 10 g) API for development purposes. The suppliers must support this enquiry with CoA.
    07 Apr 2023

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    07 Apr 2023

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    07 Apr 2023

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    Upadacitinib (50 g) API needed in Egypt [ENA15718]
    A company that focuses on the development and manufacturing of OSDs, semi-solids & oral liquids is looking for suppliers of Upadacitinib (50 g) API for development purposes. The suppliers must support this enquiry with GMP & CoA.
    02 Dec 2022

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    02 Dec 2022

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    Upadacitinib API needed in the United States [ENA11566]
    A company that deals in the research & development of special pharmaceutical products with various advanced drug delivery systems in areas of immunology, cardiology, CNS, blood system, metabolism, digestive system, anti-infective, and anti-tumor therapeutic fields is looking for suppliers of Upadacitinib API for development purpose.
    05 Oct 2021

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    05 Oct 2021

    PharmaCompass
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    Patents & EXCLUSIVITIES

    Check the patents & exclusivity for this product

    US Patents

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    Patent Expiration Date : 2036-10-17

    UPADACITINIB

    US Patent Number : 10519164

    Drug Substance Claim :

    Drug Product Claim : Y

    Application Number : 211675

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2036-10-17

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    Patent Expiration Date : 2031-01-15

    UPADACITINIB

    US Patent Number : 8962629

    Drug Substance Claim : Y

    Drug Product Claim :

    Application Number : 211675

    Patent Use Code : U-3624

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2031-01-15

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    Patent Expiration Date : 2036-10-17

    UPADACITINIB

    US Patent Number : 10202393

    Drug Substance Claim :

    Drug Product Claim : Y

    Application Number : 211675

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2036-10-17

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    Patent Expiration Date : 2036-10-17

    UPADACITINIB

    US Patent Number : 11535626

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 211675

    Patent Use Code : U-3298

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    Patent Use Description :

    Patent Expiration Date : 2036-10-17

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    US Patent Number : 11198697

    Drug Substance Claim :

    Drug Product Claim : Y

    Application Number : 211675

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    Patent Expiration Date : 2036-10-17

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    Patent Expiration Date : 2036-10-17

    UPADACITINIB

    US Patent Number : 12110298

    Drug Substance Claim : Y

    Drug Product Claim :

    Application Number : 218347

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2036-10-17

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    Patent Expiration Date : 2036-10-17

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    US Patent Number : 12077545

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    Drug Product Claim : Y

    Application Number : 211675

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    Patent Expiration Date : 2036-10-17

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    Patent Expiration Date : 2036-10-17

    UPADACITINIB

    US Patent Number : 9951080

    Drug Substance Claim : Y

    Drug Product Claim :

    Application Number : 218347

    Patent Use Code :

    Delist Requested :

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    Patent Expiration Date : 2036-10-17

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    Patent Expiration Date : 2033-08-16

    UPADACITINIB

    US Patent Number : RE47221

    Drug Substance Claim : Y

    Drug Product Claim :

    Application Number : 211675

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2033-08-16

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    10

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    Patent Expiration Date : 2036-10-17

    UPADACITINIB

    US Patent Number : 11365198

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 211675

    Patent Use Code : U-3275

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2036-10-17

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    ABOUT THIS PAGE

    Upadacitinib Manufacturers

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

    Upadacitinib Suppliers

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

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

    Upadacitinib USDMF

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

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

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

    Upadacitinib 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 Upadacitinib as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Upadacitinib GMP

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

    Upadacitinib CoA

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

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

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