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    Chemistry

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    Also known as: 936563-96-1, Pci-32765, Imbruvica, Pci 32765, Ibrutinib (pci-32765), Pci-32765 (ibrutinib)
    Molecular Formula
    C25H24N6O2
    Molecular Weight
    440.5  g/mol
    InChI Key
    XYFPWWZEPKGCCK-GOSISDBHSA-N
    FDA UNII
    1X70OSD4VX
    Ibrutinib
    Ibrutinib is an orally bioavailable, small-molecule inhibitor of Bruton's tyrosine kinase (BTK) with potential antineoplastic activity. Upon oral administration, ibrutinib binds to and irreversibly inhibits BTK activity, thereby preventing both B-cell activation and B-cell-mediated signaling. This leads to an inhibition of the growth of malignant B cells that overexpress BTK. BTK, a member of the src-related BTK/Tec family of cytoplasmic tyrosine kinases, is required for B cell receptor signaling, plays a key role in B-cell maturation, and is overexpressed in a number of B-cell malignancies. The expression of BTK in tumor cells is also associated with increased proliferation and survival.
    Ibrutinib is a Kinase Inhibitor. The mechanism of action of ibrutinib is as a Protein Kinase Inhibitor.
    1 2D Structure

    Ibrutinib

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)pyrazolo[3,4-d]pyrimidin-1-yl]piperidin-1-yl]prop-2-en-1-one
    2.1.2 InChI
    InChI=1S/C25H24N6O2/c1-2-21(32)30-14-6-7-18(15-30)31-25-22(24(26)27-16-28-25)23(29-31)17-10-12-20(13-11-17)33-19-8-4-3-5-9-19/h2-5,8-13,16,18H,1,6-7,14-15H2,(H2,26,27,28)/t18-/m1/s1
    2.1.3 InChI Key
    XYFPWWZEPKGCCK-GOSISDBHSA-N
    2.1.4 Canonical SMILES
    C=CC(=O)N1CCCC(C1)N2C3=NC=NC(=C3C(=N2)C4=CC=C(C=C4)OC5=CC=CC=C5)N
    2.1.5 Isomeric SMILES
    C=CC(=O)N1CCC[C@H](C1)N2C3=NC=NC(=C3C(=N2)C4=CC=C(C=C4)OC5=CC=CC=C5)N
    2.2 Other Identifiers
    2.2.1 UNII
    1X70OSD4VX
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 1-((3r)-3-(4-amino-3-(4-phenoxyphenyl)-1h-pyrazolo(3,4-d)pyrimidin-1-yl)piperidin-1- Yl)prop-2-en-1-one

    2. Imbruvica

    3. Pci 32765

    4. Pci-32765

    5. Pci32765

    2.3.2 Depositor-Supplied Synonyms

    1. 936563-96-1

    2. Pci-32765

    3. Imbruvica

    4. Pci 32765

    5. Ibrutinib (pci-32765)

    6. Pci-32765 (ibrutinib)

    7. Cra-032765

    8. Pc-32765

    9. (r)-1-(3-(4-amino-3-(4-phenoxyphenyl)-1h-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one

    10. 1x70osd4vx

    11. Pci-32765-00

    12. Chebi:76612

    13. Pci32765

    14. 1-[(3r)-3-[4-amino-3-(4-phenoxyphenyl)pyrazolo[3,4-d]pyrimidin-1-yl]piperidin-1-yl]prop-2-en-1-one

    15. 1-((3r)-3-(4-amino-3-(4-phenoxyphenyl)-1h-pyrazolo(3,4-d)pyrimidin-1-yl)piperidin-1- Yl)prop-2-en-1-one

    16. 1-[(3r)-3-[4-amino-3-(4-phenoxyphenyl)-1h-pyrazolo[3,4-d]pyrimidin-1-yl]piperidin-1-yl]prop-2-en-1-one

    17. 1-{(3r)-3-[4-amino-3-(4-phenoxyphenyl)-1h-pyrazolo[3,4-d]pyrimidin-1-yl]piperidin-1-yl}prop-2-en-1-one

    18. 2-propen-1-one, 1-((3r)-3-(4-amino-3-(4-phenoxyphenyl)-1h-pyrazolo(3,4-d)pyrimidin-1-yl)-1-piperidinyl)-

    19. (r)-1-(3-(4-amino-3-(4-phenoxyphenyl)-1h-pyrazolo-[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one

    20. (r)-1-(3-(4-amino-3-(4-phenoxyphenyl)-1h-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one.

    21. Ibrutinib [usan]

    22. Ibrutinib [usan:inn]

    23. Unii-1x70osd4vx

    24. Ibrutinibum

    25. Jnj 02

    26. Imbruvica (tn)

    27. Ibrutinib- Bio-x

    28. Cra 032765

    29. Ibrutinib [inn]

    30. Ibrutinib [jan]

    31. Ibrutinib [mi]

    32. Ibrutinib (jan/usan)

    33. Ibrutinib [vandf]

    34. Ibrutinib [who-dd]

    35. Imbruvica; Pci-32765

    36. 1-[(3r)-3-[4-amino-3-(4-phenoxyphenyl)-1h-pyrazolo[3,4-d]pyrimidin-1-yl]-1-piperidinyl]-2-propen-1-one

    37. Mls006010041

    38. Schembl201859

    39. Gtpl6912

    40. Ibrutinib [orange Book]

    41. Chembl1873475

    42. Hsdb 8260

    43. Dtxsid60893450

    44. Ex-a066

    45. Amy27873

    46. Bdbm50357312

    47. Mfcd20261150

    48. Nsc800769

    49. Zinc35328014

    50. Akos022185476

    51. Db09053

    52. Ex-5960

    53. Nsc-800769

    54. Ncgc00187912-01

    55. Ncgc00187912-02

    56. Ncgc00187912-03

    57. Ncgc00187912-12

    58. Ac-26942

    59. Bi164531

    60. Hy-10997

    61. Smr004701213

    62. Sw218096-2

    63. D10223

    64. A1-01649

    65. J-523872

    66. Q5984881

    67. (r)-3-(4-amino-3-(4-phenoxyphenyl)-1h-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-ylprop-2-en-1-one

    68. 1-((r)-3-(4-amino-3-(4-phenoxyphenyl)-1h-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one

    69. 1-[(3r)-3-[4-amino-3-(4-phenoxyphenyl)-1h-pyrazolo[3,4-d]pyrimidin-1-yl]-1-piperidinyl]-2-propen-1-one1-[(3r)-3-[4-amino-3-(4-phenoxyphenyl)pyrazolo[3, 4-d]pyrimidin-1-yl]

    70. 1-[(3r)-3-[4-amino-3-(4-phenoxyphenyl)pyrazolo[3, 4-d]pyrimidin-1-yl]piperidin-1-yl]prop-2-en-1-one

    71. Ibrutinibci-32765mbruvica(r)-1-(3-(4-amino-3-(4-phenoxyphenyl)-1h-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one

    72. Piperidin-1-yl]prop-2-en-1-one1-{3-[4-amino-3-(4-phenoxy-phenyl)-pyrazolo[3,4-d]pyrimidin-1-yl]-piperidin-1-yl}-propenone

    2.4 Create Date
    2008-06-30
    3 Chemical and Physical Properties
    Molecular Weight 440.5 g/mol
    Molecular Formula C25H24N6O2
    XLogP33.6
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count6
    Rotatable Bond Count5
    Exact Mass440.19607403 g/mol
    Monoisotopic Mass440.19607403 g/mol
    Topological Polar Surface Area99.2 Ų
    Heavy Atom Count33
    Formal Charge0
    Complexity678
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Therapeutic Uses

    Ibrutinib is a novel oral tyrosine kinase inhibitor that irreversibly binds and inhibits tyrosine-protein kinase BTK (Bruton tyrosine kinase). BTK has been found to be important in the function of B-cell receptor signaling and therefore in the maintenance and expansion of various B-cell malignancies including chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). Targeting BTK with ibrutinib has been found to be an effective strategy in treating these malignancies. Phase I clinical testing in non-Hodgkin's lymphomas and CLL showed that the drug was extremely well tolerated with no major dose-limiting toxicities and a 54% overall response rate. Subsequently, two phase Ib/II studies were performed on patients with CLL, one in relapsed/refractory CLL and one in previously untreated elderly patients with CLL. Both of these studies continued to show good tolerability of the drug and an overall response rate of about 71% with extended duration of response. Another phase II study using ibrutinib in relapsed/refractory MCL was conducted and also showed that it was well tolerated with an overall response rate of 68% and extended duration of response. Due to these results, the U.S. Food and Drug Administration granted accelerated approval for ibrutinib in November 2013 for patients with MCL who had received at least one prior therapy and in February 2014 for patients with CLL who had received at least one prior therapy. This review will discuss the preclinical pharmacology, pharmacokinetics and clinical efficacy to date of ibrutinib in the treatment of CLL and MCL.

    PMID:24918646 McDermott J, Jimeno A; Drugs Today (Barc) 50(4):291-300 (2014)

    /CLINICAL TRIALS/ ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. The Web site is maintained by the National Library of Medicine (NLM) and the National Institutes of Health(NIH). Each ClinicalTrials.gov record presents summary information about a study protocol and includes the following: Disease or condition; Intervention (for example, the medical product, behavior, or procedure being studied); Title, description, and design of the study; Requirements for participation (eligibility criteria); Locations where the study is being conducted; Contact information for the study locations; and Links to relevant information on other health Web sites, such as NLM's MedlinePlus for patient health information and PubMed for citations and abstracts for scholarly articles in the field of medicine. Ibrutinib is included in the database.

    NIH/NLM; ClinicalTrials.Gov. Available from, as of July 18, 2015: https://clinicaltrials.gov/search/intervention=%22PCI-32765%22+OR+%22CRA-032765%22+OR+Ibrutinib+OR+%22PCI+32765%22+OR+PCI32765

    Imbruvica is indicated for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials. /Included in US product label/

    NIH; DailyMed. Current Medication Information for Imbruvica (Ibrutinib) Capsule (Updated: February 2015). Available from, as of May 4, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0dfd0279-ff17-4ea9-89be-9803c71bab44

    Imbruvica is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. /Included in US product label/

    NIH; DailyMed. Current Medication Information for Imbruvica (Ibrutinib) Capsule (Updated: February 2015). Available from, as of May 4, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0dfd0279-ff17-4ea9-89be-9803c71bab44

    For more Therapeutic Uses (Complete) data for IBRUTINIB (7 total), please visit the HSDB record page.

    4.2 Drug Warning

    Fatal and non-fatal infections have occurred with IMBRUVICA therapy. Grade 3 or greater infections occurred in 14% to 26% of patients. Cases of progressive multifocal leukoencephalopathy (PML) have occurred in patients treated with IMBRUVICA. Monitor patients for fever and infections and evaluate promptly.

    NIH; DailyMed. Current Medication Information for Imbruvica (Ibrutinib) Capsule (Updated: February 2015). Available from, as of July 22, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0dfd0279-ff17-4ea9-89be-9803c71bab44#S1.4

    Fatal bleeding events have occurred in patients treated with IMBRUVICA. Grade 3 or higher bleeding events (subdural hematoma, gastrointestinal bleeding, hematuria and post procedural hemorrhage) have occurred in up to 6% of patients. Bleeding events of any grade, including bruising and petechiae, occurred in approximately half of patients treated with IMBRUVICA. The mechanism for the bleeding events is not well understood. IMBRUVICA may increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies. Consider the benefit-risk of withholding IMBRUVICA for at least 3 to 7 days pre and post-surgery depending upon the type of surgery and the risk of bleeding.

    NIH; DailyMed. Current Medication Information for Imbruvica (Ibrutinib) Capsule (Updated: February 2015). Available from, as of July 20, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0dfd0279-ff17-4ea9-89be-9803c71bab44#S1.4

    Treatment-emergent Grade 3 or 4 cytopenias including neutropenia (range, 19 to 29%), thrombocytopenia (range, 5 to 17%), and anemia (range, 0 to 9%) occurred in patients treated with IMBRUVICA. Monitor complete blood counts monthly.

    NIH; DailyMed. Current Medication Information for Imbruvica (Ibrutinib) Capsule (Updated: February 2015). Available from, as of July 22, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0dfd0279-ff17-4ea9-89be-9803c71bab44#S1.4

    Atrial fibrillation and atrial flutter (range, 6 to 9%) have occurred in patients treated with IMBRUVICA, particularly in patients with cardiac risk factors, acute infections, and a previous history of atrial fibrillation. Periodically monitor patients clinically for atrial fibrillation. Patients who develop arrhythmic symptoms (e.g., palpitations, lightheadedness) or new onset dyspnea should have an ECG performed. If atrial fibrillation persists, consider the risks and benefits of IMBRUVICA treatment and dose modification.

    NIH; DailyMed. Current Medication Information for Imbruvica (Ibrutinib) Capsule (Updated: February 2015). Available from, as of July 22, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0dfd0279-ff17-4ea9-89be-9803c71bab44#S1.4

    For more Drug Warnings (Complete) data for IBRUTINIB (8 total), please visit the HSDB record page.

    4.3 Drug Indication

    Ibrutinib acquired an accelerated approval for the treatment of mantle cell lymphoma who have received at least one prior therapy. Mantle cell lymphoma (MCL) is a B-cell non-Hodgkin lymphoma that develops in the outer edge of a lymph node. MCL is usually diagnosed at late stages and it is easily spread into bone marrow, spleen, liver and gastrointestinal tract. Ibrutinib is indicated for the treatment of chronic lymphocytic leukemia (CLL) who have at least one prior therapy. CLL is a type of cancer caused by an overproduction of lymphocytes by the bone marrow. Some of the symptoms include swollen lymph nodes and tiredness. Ibrutinib is indicated for the treatment of chronic lymphocytic leukemia (CLL) with 17p deletion. CLL with 17p is a type of leukemia in which a deletion in 17p disrupts the tumor suppressor p53 by deleting one allele of the TP53 gene. The remaining allele is mainly inactivated and thus, this type of leukemia is unresponsive to p53-dependent treatments. Ibrutinib is indicated for the treatment of patients with Waldenstrom's Macroglobulinemia (WM). WM, also called lymphoplasmacytic lymphoma, is a type of non-Hodgkin lymphoma in which the cancer cells make large amounts of macroglobulin. The macroglobulin is a monoclonal protein that corresponds to the type of IgM antibodies and the unrestricted formation of this protein causes typical symptoms such as excessive bleeding and effects in vision and nervous system.

    FDA Label

    IMBRUVICA as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).

    IMBRUVICA as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5. 1).

    IMBRUVICA as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.

    IMBRUVICA as a single agent is indicated for the treatment of adult patients with Waldenstrms macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy. IMBRUVICA in combination with rituximab is indicated for the treatment of adult patients with WM.

    Treatment of chronic Graft versus Host Disease (cGvHD)

    Treatment of lymphoplasmacytic lymphoma

    Treatment of mantle cell lymphoma

    Treatment of lymphoplasmacytic lymphoma

    Treatment of mantle cell lymphoma

    Treatment of mature B-cell neoplasms

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    In vitro studies have shown an induction of CLL cell apoptosis even in presence of prosurvival factors. It has also been reported an inhibition of CLL cell survival and proliferation as well as an impaired in cell migration and a reduction in the secretion of chemokines such as CCL3 and CCL4. The latter effect has been shown to produce regression in xenograft mouse models. Clinical studies for relapsed/refractory CLL in phase I and II showed an approximate 71% of overall response rate.. In the case of relapsed/refractory mantle cell lymphoma, approximately 70% of the tested patients presented a partial or complete response.. In clinical trials for relapsed/refractory diffuse large B-cell lymphoma, a partial response was found in between 15-20% of the patients studied; while for patients with relapsed/refractory Waldenstrom's macroglobulinemia, a partial response was observed in over 75% of the patients tested. Finally, for patients with relapsed/refractory follicular lymphoma, a partial to complete response was obtained in approximately 54% of the patients.

    5.2 FDA Pharmacological Classification
    5.2.1 Active Moiety
    IBRUTINIB
    5.2.2 FDA UNII
    1X70OSD4VX
    5.2.3 Pharmacological Classes
    Protein Kinase Inhibitors [MoA]; Kinase Inhibitor [EPC]
    5.3 ATC Code

    L01EL01

    L01XE27

    S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

    L - Antineoplastic and immunomodulating agents

    L01 - Antineoplastic agents

    L01E - Protein kinase inhibitors

    L01EL - Bruton's tyrosine kinase (btk) inhibitors

    L01EL01 - Ibrutinib

    5.4 Absorption, Distribution and Excretion

    Absorption

    Ibrutinib is rapidly absorbed after oral administration and it presents a Cmax, tmax and AUC of approximately 35 ng/ml, 1-2 hour and 953 mg.h/ml respectively.

    Route of Elimination

    The cumulative excretion of ibrutinib in urine is of about 7.8% of the administered dose and most of this excretion is found during the first 24 hours after administration. In feces, the cumulative excretion accounts for 80% of the administered dose and the excretion occurs within 48 hours of the initial administration. The total excretion of ibrutinib during the first 168 hours after initial administration accounts for 88.5% of the administered dose.

    Volume of Distribution

    The volume of distribution at steady-state of ibrutinib is in approximately 10,000 L.

    Clearance

    In patients with normal renal function, the clearance rate is in the range of 112-159 ml/min.

    5.5 Metabolism/Metabolites

    Three metabolic pathways have been identified according to the possible metabolites. These pathways are the hydroxylation of the phenyl group (M35), the opening of the piperidine with a reduction of the primary alcohol (M34) and the oxidation to a carboxylic acid and epoxidation of the ethylene followed by a hydrolysis to the formation of dihydrodiol (PCI-45227). The latter metabolite presents also 15 times lower inhibitory activity against BTK. The metabolism of ibrutinib is mainly performed by CYP3A5 and CYP3A4. and in a minor extent it is seen to be performed by CYP2D6.

    Since 2014, Ibrutinib has been available as a new drug for the treatment of leukemic diseases. Ibrutinib (Imbruvica) is metabolized in the liver mainly by the isoenzyme CYP3A4 and to a minor extent by CYP2D6. Simultaneous application of Imbruvica and consumption of foods containing secondary metabolites strongly inhibiting the CYP3A4 isoform, could significantly influence the toxicity of this drug. This article references the respective foods.

    PMID:25975016 Kronabel D; Clin Lab 61 (3-4): 443-4 (2015)

    5.6 Biological Half-Life

    The elimination half-life of ibrutinib is of approximately 4-6 hours.

    5.7 Mechanism of Action

    Ibrutinib is an inhibitor of Brutons tyrosine kinase (BTK). It forms a covalent bond with a cysteine residue in the active site of BTK (Cys481), leading to its inhibition. The inhibition of BTK plays a role in the B-cell receptor signaling and thus, the presence of ibrutinib prevents the phosphorylation of downstream substrates such as PLC-.

    Ibrutinib is a novel oral tyrosine kinase inhibitor that irreversibly binds and inhibits tyrosine-protein kinase BTK (Bruton tyrosine kinase). BTK has been found to be important in the function of B-cell receptor signaling and therefore in the maintenance and expansion of various B-cell malignancies including chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). Targeting BTK with ibrutinib has been found to be an effective strategy in treating these malignancies. Phase I clinical testing in non-Hodgkin's lymphomas and CLL showed that the drug was extremely well tolerated with no major dose-limiting toxicities and a 54% overall response rate. Subsequently, two phase Ib/II studies were performed on patients with CLL, one in relapsed/refractory CLL and one in previously untreated elderly patients with CLL. Both of these studies continued to show good tolerability of the drug and an overall response rate of about 71% with extended duration of response. Another phase II study using ibrutinib in relapsed/refractory MCL was conducted and also showed that it was well tolerated with an overall response rate of 68% and extended duration of response. Due to these results, the U.S. Food and Drug Administration granted accelerated approval for ibrutinib in November 2013 for patients with MCL who had received at least one prior therapy and in February 2014 for patients with CLL who had received at least one prior therapy. This review will discuss the preclinical pharmacology, pharmacokinetics and clinical efficacy to date of ibrutinib in the treatment of CLL and MCL.

    PMID:24918646 McDermott J, Jimeno A; Drugs Today (Barc) 50(4):291-300 (2014)

    ... In this study we report for the first time that ibrutinib is cytotoxic to malignant plasma cells from patients with multiple myeloma (MM) and furthermore that treatment with ibrutinib significantly augments the cytotoxic activity of bortezomib and lenalidomide chemotherapies. We describe that the cytotoxicity of ibrutinib in MM is mediated via an inhibitory effect on the nuclear factor-(k)B (NF-(k)B) pathway. Specifically, ibrutinib blocks the phosphorylation of serine-536 of the p65 subunit of NF-(k)B, preventing its nuclear translocation, resulting in down-regulation of anti-apoptotic proteins Bcl-xL, FLIP(L) and survivin and culminating in caspase-mediated apoptosis within the malignant plasma cells....

    PMID:22975686 Rushworth SA et al; Cell Signal 25 (1): 106-12 (2013)

    Mantle cell lymphoma (MCL) is an aggressive B-cell malignancy that characteristically shows overexpression of cyclin-D1 due to an alteration in the t(11;14)(q13;q32) chromosomal region. Although there are some promising treatment modalities, great majority of patients with this disease remain incurable. The B-cell antigen receptor (BCR) signaling plays a crucial role in B-cell biology and lymphomagenesis. Bruton tyrosine kinase (BTK) has been identified as a key component of the BCR signaling pathway. Evidence suggests that the blockade of BTK activity by potent pharmacologic inhibitors attenuates BCR signaling and induces cell death. Notably, the expression levels and the role of BTK in MCL survival are still elusive. Here, we demonstrated a moderate to strong BTK expression in all MCL cases (n=19) compared to benign lymphoid tissues. Treatment of MCL cell lines (Mino or Jeko-1) with a potent BTK pharmacologic inhibitor, Ibrutinib, decreased phospho-BTK-Tyr(223) expression. Consistent with this observation, Ibrutinib inhibited the viability of both Mino and JeKo-1 cells in concentration- and time-dependent manners. Ibrutinib also induced a concentration-dependent apoptosis in both cell lines. Consistently, Ibrutinib treatment decreased the levels of anti-apoptotic Bcl-2, Bcl-xL, and Mcl-1 protein. These findings suggest that BTK signaling plays a critical role in MCL cell survival, and the targeting of BTK could represent a promising therapeutic modality for aggressive lymphoma.

    PMID:23962569 Cinar M et al; Leuk Res 37 (10): 1271-7 (2013)

    Ibrutinib is a small-molecule inhibitor of Bruton's tyrosine kinase (BTK). Ibrutinib forms a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK enzymatic activity. BTK is a signaling molecule of the B-cell antigen receptor (BCR) and cytokine receptor pathways. BTK's role in signaling through the B-cell surface receptors results in activation of pathways necessary for B-cell trafficking, chemotaxis, and adhesion. Nonclinical studies show that ibrutinib inhibits malignant B-cell proliferation and survival in vivo as well as cell migration and substrate adhesion in vitro.

    NIH; DailyMed. Current Medication Information for Imbruvica (Ibrutinib) Capsule (Updated: February 2015). Available from, as of May 20, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0dfd0279-ff17-4ea9-89be-9803c71bab44

    API SUPPLIERS

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    01

    Aarti Pharmalabs

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    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.

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    USDMF CEP/COS JDMF EU-WCarrow-down
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    Date of Issue : 2025-08-22

    Valid Till : 2028-08-21

    Written Confirmation Number : WC-0099

    Address of the Firm :

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    NDC Package Code : 15308-2402

    Start Marketing Date : 2024-01-31

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (200kg/200kg)

    Marketing Category : BULK INGREDIENT

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    02

    Olpha

    Latvia

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Virtual BoothOlpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.

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    Minakem (formerly Delmar Chemicals...

    Canada

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    Virtual BoothMinakem is manufacturing small molecules APIs including corticosteroids

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    LGM Pharma

    U.S.A

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    Booth #730
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    Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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    Rochem International Inc

    U.S.A

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    Virtual BoothRochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

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    Wavelength Pharmaceuticals

    Israel

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    USDMF CEP/COS JDMF EU-WC NDC arrow-down
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    NDC Package Code : 58175-0602

    Start Marketing Date : 2014-12-30

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    Seqens Company Banner

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    Shanghai Minbiotech

    China

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

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    Tagoor Laboratories

    India

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    Booth #4C108
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    Virtual BoothTagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.

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    TAPI Technology & API Services

    Israel

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    FCE Pharma
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    Virtual BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-07-05

    Pay. Date : 2017-04-17

    DMF Number : 31631

    Submission : 2017-06-08

    Status : Active

    Type : II

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    MSN Laboratories

    India

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    MSN Laboratories

    India

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 30759

    Submission : 2016-07-31

    Status : Active

    Type : II

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    NDC Package Code : 54893-0082

    Start Marketing Date : 2018-11-30

    End Marketing Date : 2027-12-31

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    Listed Suppliers

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    Aarti Pharmalabs

    India
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    Virtual BoothAarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.

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    About the Company : Aarti Pharmalabs is generic APIs & Intermediates manufacturing company & small molecule drug substance CDMO and the largest Indian manufacturer of Xanthine Derivatives (Caffeine, e...

    Aarti Pharmalabs is generic APIs & Intermediates manufacturing company & small molecule drug substance CDMO and the largest Indian manufacturer of Xanthine Derivatives (Caffeine, etc.). It has dedicated facilities to manufacture HPAPIs, corticosteroids, cytotoxic & oncology products. It has 3 R&D centers and 3 cGMP plants successfully audited by the USFDA, EUGMP, EDQM, KFDA & COFEPRIS. Note: None of the products will be supplied to countries in which this could be in 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.
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    02

    Olpha

    Latvia
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    Virtual BoothOlpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.

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    Ibrutinib

    About the Company : Olpha, a subsidiary of JSC AB City, is one of the largest companies in the Baltic states with 50 years of experience in producing medicines and chemical pharmaceuticals. Its portfo...

    Olpha, a subsidiary of JSC AB City, is one of the largest companies in the Baltic states with 50 years of experience in producing medicines and chemical pharmaceuticals. Its portfolio includes 60 formulations, 25 APIs, and over 20 intermediates, covering nervous system, cardiovascular, antiviral, antibacterial, and anti-allergic drugs. Olpha’s products enhance access to essential medicines and support its global growth and reputation. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Olpha

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    03

    Minakem (formerly Delmar Chemicals)

    Canada
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    Virtual BoothMinakem is manufacturing small molecules APIs including corticosteroids

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    Ibrutinib

    About the Company : Minakem Montreal is developing and manufacturing small molecules APIs and advanced intermediates, including corticosteroids. Following efficient processes and methodologies, our em...

    Minakem Montreal is developing and manufacturing small molecules APIs and advanced intermediates, including corticosteroids. Following efficient processes and methodologies, our employees operate a regularly inspected cGMP facility equipped with reactors ranging from 40 to 7,600 litres. Located in Montreal, Canada, we have contributed to the success of our North-American and international clients since 1964.
    Minakem Delmar

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    04

    LGM Pharma

    U.S.A
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    Booth #730
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    Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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    Ibrutinib

    About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...

    LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product CDMO, offering formulation, analytical method development and testing, regulatory support, and commercial manufacturing. Supported by a network of over 220 accredited cGMP manufacturing partners and more than 100,000 sq. ft. of FDA-inspected cGMP manufacturing and warehouse space, LGM delivers secure, end-to-end solutions across multiple dosage forms. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    Rochem International Inc

    U.S.A
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    Ibrutinib

    About the Company : Rochem, established in 1994, is a global distributor of pharmaceutical, food, nutritional, and animal health ingredients, sourcing high-quality products from China. Headquartered i...

    Rochem, established in 1994, is a global distributor of pharmaceutical, food, nutritional, and animal health ingredients, sourcing high-quality products from China. Headquartered in Hauppauge, New York, it operates 16 offices worldwide. Rochem’s operations are fully cGMP compliant and have been audited by the USFDA and several multinational organizations. The company also trains and audits its partners to ensure FDA-compliant technologies and systems. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Rochem

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    06

    Shanghai Minbiotech

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

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    Ibrutinib

    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 meters of R&D centers in...

    Shanghai Minbiotech is specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square meters of R&D centers in Nantong, Jiangsu and Jinan, Shandong, with more than 13,000㎡ of production sites. While supplying products to customers, the company also provides services such as technology development, technology transfer and technology exchange, aiming to provide customers with comprehensive supply and solutions in the biomedical industry. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Shanghai Minbiotech CB

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    07

    Tagoor Laboratories

    India
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    Booth #4C108
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    Virtual BoothTagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.

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    Ibrutinib

    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-growth therapeutic ar...

    Tagoor Laboratories, established in 2018 and part of the Tagoor Group, provides APIs, advanced intermediates, and key starting materials for critical and high-growth therapeutic areas. The company emphasizes affordability, quality, and timely delivery, and also offers end-to-end CDMO services. Headquartered in Hyderabad, Tagoor Labs serves branded and generic pharmaceutical companies worldwide, with integrated functions covering R&D, manufacturing, quality, regulatory affairs, supply chain, marketing, and warehousing. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Tagoor Laboratories

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    TAPI Technology & API Services

    Israel
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    Virtual BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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    Ibrutinib

    About the Company : Founded in 1935, TAPI Technology & API Services has a long legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios ...

    Founded in 1935, TAPI Technology & API Services has a long legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios with over 350 products, alongside tailored CDMO services. Leveraging deep expertise and diverse technologies, we deliver flexible, high-quality solutions to meet our partners’ needs. Note: None of the products will be supplied to countries in which this could be in 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.
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    09

    Divis Laboratories

    India
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    Divis Laboratories

    India
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    Ibrutinib

    About the Company : Divis Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for...

    Divis Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big Pharma companies under full cGMP. Customers regularly audit our facilities in areas of quality, EHS, business continuity etc. Unmatched Infrastructure:2 manufacturing sites. Both sites were successfully US-FDA Inspected No of DMFs 373 Pilot Plants30 Production Buildings39 Pharma Suites944 Reactors - 250 L to 30 KLTotal Capacity - 6676 M34 R&D Centers325 Scientists.
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    10

    Hangzhou Longshine Bio-Tech

    China
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    Hangzhou Longshine Bio-Tech

    China
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    IBRUTINIB

    About the Company : Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and chemical products, cat...

    Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and chemical products, catering to both export and import markets. The company consists of two primary business departments: the Professional Sourcing/Product Team and the Quality Team. Backed by experienced partners, Longshine has evolved into a trustworthy supplier of high-quality products and received ISO9001:2008 certification in 2017.
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    INTERMEDIATE SUPPLIERS

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    01

    Aarti Pharmalabs

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

    (S)-BOC-3-hydroxy piperidine

    CAS Number : 143900-44-1

    End Use API : Ibrutinib

    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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    Aarti Pharmalabs

    India
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    Virtual BoothAarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.

    3-(4-Phenoxy Phenyl)-1H-pyrazole [3,4-d] pyrimidin...

    CAS Number : 330786-24-8

    End Use API : Ibrutinib

    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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    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.

    (R)-3-(4-Phenoxy phenyl)-1-(Piperidin-3-yl)-1H-pyr...

    CAS Number : 1022150-12-4

    End Use API : Ibrutinib

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

    (S)-1-Boc-3-hydroxypiperidine

    CAS Number : 143900-44-1

    End Use API : Ibrutinib

    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

    Tagoor Laboratories

    India
    CPhI Milan
    Booth #4C108
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    Virtual BoothTagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.

    3-Hydroxypiperidine

    CAS Number : 6859-99-0

    End Use API : Ibrutinib

    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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    06

    Agno Pharma

    U.S.A
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    Agno Pharma

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    (S)-1-Boc-3-hydroxypiperidine

    CAS Number : 143900-44-1

    End Use API : Ibrutinib

    About The Company : Agno Pharma is a global pharmaceutical contract research and manufacturing organization (CRO & CMO), with a US-FDA approved, ISO 9001, ISO 14001, & OHSAS 18001 ...

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    07

    Ami Organics Private Limited

    India
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    Ami Organics Private Limited

    India
    PEGS Boston Summit
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    3-BROMO-1-[(3R)-PIPERIDIN -3-YL]-1H-PYRAZOLO [3,4...

    CAS Number : 1022150-12-4

    End Use API : Ibrutinib

    About The Company : Founded with a mission to transform strategic capital into specialty chemicals, Ami Group focuses on Agrochemicals, Cosmetics, and Polymers. Ami Organics Ltd. i...

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    08

    Ami Organics Private Limited

    India
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    Ami Organics Private Limited

    India
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    4-AMINO PYRAZOLO [3,4-D] PYRIMIDINE

    CAS Number : 2380-63-4

    End Use API : Ibrutinib

    About The Company : Founded with a mission to transform strategic capital into specialty chemicals, Ami Group focuses on Agrochemicals, Cosmetics, and Polymers. Ami Organics Ltd. i...

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    Anhui HaiKang Pharmaceutical Co. Lt...

    China
    PEGS Boston Summit
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    Anhui HaiKang Pharmaceutical Co. Lt...

    China
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    Ibrutinib N-1

    CAS Number : 1022150-12-4

    End Use API : Ibrutinib

    About The Company : Anhui Haikang Pharmaceutical Co., Ltd. was established in 2009 and located in a High-tech industry park, Anqing City, Anhui Province---a famous historical and c...

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    Anhui HaiKang Pharmaceutical Co. Lt...

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    Anhui HaiKang Pharmaceutical Co. Lt...

    China
    PEGS Boston Summit
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    Ibrutinib N-2

    CAS Number : 330786-24-8

    End Use API : Ibrutinib

    About The Company : Anhui Haikang Pharmaceutical Co., Ltd. was established in 2009 and located in a High-tech industry park, Anqing City, Anhui Province---a famous historical and c...

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    india-flag.png
    Ibrutinib API needed in India [ENA25931]
    A company that focuses on the development and manufacturing of various finished formulations is looking for suppliers of Ibrutinib API for development purposes. The suppliers must support this enquiry with CoA.
    27 Apr 2026

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    27 Apr 2026

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    27 Apr 2026

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    Ibrutinib API needed in India [ENA25004]
    A company that focuses on the development and manufacturing of various finished formulations is looking for suppliers of Ibrutinib API for development purposes. The suppliers must support this enquiry with CoA.
    08 Jan 2026

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    08 Jan 2026

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    08 Jan 2026

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    Ibrutinib API needed in India [ENA24046]
    A globally-renowned pharmaceutical company that focuses on research, development, manufacturing and marketing of high-quality chemical and biologic medicines across diverse therapeutic areas is looking for suppliers of Ibrutinib API for development purposes. The suppliers must support this enquiry with GMP & CoA.
    15 Sep 2025

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    15 Sep 2025

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    15 Sep 2025

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    Ibrutinib API needed in India [ENA22955]
    A company that focuses on the development and manufacturing of OSDs, liquids, semi-solids and injectables is looking for suppliers of Ibrutinib API. The initial required quantity is 50 kg - 70 kg for development & exhibit batches, later 400 kg - 600 kg for commercial purposes. The suppliers must support this enquiry with USDMF & CoA.
    14 May 2025

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    14 May 2025

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    14 May 2025

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    Ibrutinib API needed in Egypt [ENA20629]
    A company that focuses on research, development & manufacturing of generic, specialty and branded pharmaceutical products is looking for suppliers of Ibrutinib API for commercial purposes. The suppliers must support this enquiry with USDMF, GMP & CoA.
    23 Sep 2024

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    23 Sep 2024

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    23 Sep 2024

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    Ibrutinib (600 g) API needed in India [ENA20324]
    A company that focuses on development and manufacturing of various finished formulations majorly in oncology and antiretrovirals areas is looking for suppliers of Ibrutinib (600 g) API for commercial purposes. The suppliers must support this enquiry with CoA.
    22 Aug 2024

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    22 Aug 2024

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    22 Aug 2024

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    Various APIs needed in India [ENA09294]
    An independent consultant based in India is looking for suppliers of Various APIs for commercial purposes. Interested suppliers can contact them via their email: skt.drssklabs@gmail.com. 1. IP Grade Atosiban (35 kg) API. 2. IP Grade Cetilistat (10 kg) API. 3. IP Grade Revaprazan (10 kg) API. 4. IP Grade Ceftaroline Fosamil (10 kg) API. 5. IP Grade Ceftobiprole (10 kg) API. 6. IP Grade Gagaentine (10 kg) API. 7. IP Grade Febuxostat (10 kg) API. 8. IP Grade Bedaquiline (10 kg) API. 9. IP Grade Epalrestat (10 kg) API. 10. IP Grade Acotiamide (10 kg) API. 11. IP Grade Ibrutinib (10 kg) API.
    15 Dec 2020

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    15 Dec 2020

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    15 Dec 2020

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    FDF DOSSIERS

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    Tender// Various Finished Dosage Formulations needed in Bulgaria [ENA14678]
    Universitetska Mnogoprofilna Bolnitsa Za Aktivno Lechenie "Sveti Georgi" Ead is looking for supplies of Various Finished Dosage Formulations for commercial purpose. The deadline is 7-Sep-2022. 1. Ibrutinib (140 mg) Hard Capsules. The required quantity is 9,072,000 units. 2. Abiraterone (500 mg) Tablets. The required quantity is 8,100,000 units.
    13 Aug 2022

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    13 Aug 2022

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    13 Aug 2022

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    Tender// Various Finished Dosage Formulations needed in Bulgaria [ENA14466]
    University Multiprofessional Hospital For Active Treatment "Alexandrovska" Jsc is looking for supplies of Various Finished Dosage Formulations for commercial purpose. The deadline is 19-Aug-2022. 1. Midazolam (5 mg/ ml) Solution for Injections. The required quantity is 25,000 units. 2. Ibrutinib (140 mg) Hard Capsules. The required quantity is 22,500 units.
    26 Jul 2022

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    26 Jul 2022

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    26 Jul 2022

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    Tender// Ibrutinib (140 mg) Capsules needed in Russia [ENA12566]
    State Committee of the Republic of Bashkortostan on Competitive Policy is looking for supplies of Ibrutinib (140 mg) Capsules. The required quantity is 22,680 units. The deadline is 8-Feb-2022.
    31 Jan 2022

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    31 Jan 2022

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    31 Jan 2022

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    Tender// Various Finished Dosage Formulations needed in Bulgaria [ENA11486]
    University Multiprofile Hospital for active Treatment "St. Ivan Rilski" EAD is looking for supplies of Various Finished Dosage Formulations for commercial purpose. The deadline is 18-Oct-2021. 1. Eltrombopag (25 mg) Film-Coated Tablets. The required quantity is 13,932 units. 2. Dexamethasone (4 mg) Tablets. The required quantity is 4,000 units. 3. Dexamethasone (4 mg) Solution for Injection. The required quantity is 50,000 units. 4. Cyclophosphamide (500 mg) Powder for Solution for Injection. The required quantity is 5,000 units. 5. Temozolomide (100 mg) Hard Capsules. The required quantity is 10,000 units. 6. Capecitabine (500 mg) Film-Coated Tablets. The required quantity is 35,000 units. 7. Ibrutinib (140 mg) Hard Capsules. The required quantity is 40,000 units. 8. Sorafenib (200 mg) Film-Coated Tablets. The required quantity is 10,080 units. 9. Nilotinib (150 mg) Hard Capsules. The required quantity is 40,000 units. 10. Pazopanib (200 mg) Film-Coated Tablets. The required quantity is 14,000 units.
    24 Sep 2021

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    24 Sep 2021

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    24 Sep 2021

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    Tender// Various Finished Dosage Formulations needed in Poland [ENA11059]
    Independent Public Clinical Hospital No. 1 PUM is looking for supplies of Various Finished Dosage Formulations for commercial purpose. The deadline is 7-Sep-2021. 1. Azacitidine (0.1 g / 4 ml) Powder for Suspension for Injection. The required quantity is 2,800 units. 2. Ibrutinib (140 mg) Hard Capsules. The required quantity is 240 units. 3. Docetaxel (20 mg / 2 ml) Vials. The required quantity is 150 units. 4. Paclitaxel (300 mg / 50 ml) Vials. The required quantity is 350 units. 5. Gemcitabine (2000 mg / 50 ml) Vials. The required quantity is 450 units. 6. Fluorouracil (5000 mg / 100 ml) Vials. The required quantity is 950 units. 7. Oxaliplatin (100 mg / 20 ml) Vials. The required quantity is 1,400 units. 8. Irinotecan Hydrochloride Trihydrate (100 mg / 5 ml) Vials. The required quantity is 900 units.
    07 Aug 2021

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    07 Aug 2021

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    07 Aug 2021

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    Patents & EXCLUSIVITIES

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    ABOUT THIS PAGE

    Looking for 936563-96-1 / Ibrutinib API manufacturers, exporters & distributors?

    Ibrutinib manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Ibrutinib API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Ibrutinib manufacturer or Ibrutinib supplier for your needs.

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

    API | Excipient name

    Ibrutinib

    Synonyms

    936563-96-1, Pci-32765, Imbruvica, Pci 32765, Ibrutinib (pci-32765), Pci-32765 (ibrutinib)

    Cas Number

    936563-96-1

    Unique Ingredient Identifier (UNII)

    1X70OSD4VX

    About Ibrutinib

    Ibrutinib is an orally bioavailable, small-molecule inhibitor of Bruton's tyrosine kinase (BTK) with potential antineoplastic activity. Upon oral administration, ibrutinib binds to and irreversibly inhibits BTK activity, thereby preventing both B-cell activation and B-cell-mediated signaling. This leads to an inhibition of the growth of malignant B cells that overexpress BTK. BTK, a member of the src-related BTK/Tec family of cytoplasmic tyrosine kinases, is required for B cell receptor signaling, plays a key role in B-cell maturation, and is overexpressed in a number of B-cell malignancies. The expression of BTK in tumor cells is also associated with increased proliferation and survival.

    Ibrutinib Manufacturers

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

    Ibrutinib Suppliers

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

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

    Ibrutinib USDMF

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

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

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

    Ibrutinib KDMF

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

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

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

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

    Ibrutinib WC

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

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

    Ibrutinib 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 Ibrutinib as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Ibrutinib GMP

    Ibrutinib 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 Ibrutinib GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Ibrutinib GMP manufacturer or Ibrutinib GMP API supplier for your needs.

    Ibrutinib CoA

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

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

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