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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

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C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"ALGIERS","customer":"SPA PROFAM ZONE INDUSTRIELLE OUED S","customerCountry":"ALGERIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"5000","totalValueFC":"24619.1","currency":"USD","unitRateINR":415512.59999999998,"date":"11-Nov-2024","totalValueINR":"2077563","totalValueInUsd":"24619.1","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"5518411","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ALGERIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733164200,"product":"IBRUTINIB (FROM-C)","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"ISTANBUL","customer":"ABDI IBRAHIM","customerCountry":"TURKEY","quantity":"60.00","actualQuantity":"60","unit":"KGS","unitRateFc":"4500","totalValueFC":"265247.1","currency":"USD","unitRateINR":375629.61666666664,"date":"03-Dec-2024","totalValueINR":"22537777","totalValueInUsd":"265247.1","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"6139919","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"TURKEY","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1735583400,"product":"IBRUTINIB","address":"12 6 214 A1 SHILPA HOUSE HYDERABAD ROAD","city":"RAICHUR","supplier":"SHILPA PHARMA LIFESCIENCES LIMITED","supplierCountry":"INDIA","foreign_port":"BOGOTA","customer":"RC2 PHARMACEUTICAL S.A.S","customerCountry":"COLOMBIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"2396.8","totalValueFC":"11882.6","currency":"USD","unitRateINR":201930,"date":"31-Dec-2024","totalValueINR":"1009650","totalValueInUsd":"11882.6","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"6926218","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"COLOMBIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"12 6 214 A1 SHILPA HOUSE HYDERABAD ROAD, RAICHUR","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1657218600,"product":"(N.C.V) IBRUTINIB (API) 1-(3R)-3-[4-AMINO-3-(4-PHENOXYPHENYL)-1H-PYRAZOLO[3,4-D]PYRIMIDIN-1-YL]-1-PIPERIDINYL-2-PROPEN-1","address":"L.B.S. MARG,,MULUND-WEST","city":"MUMBAI,MAHARASHTRA","supplier":"CHANGZHOU SYNTHEALL PHARMACEUTICAL CO., LTD.","supplierCountry":"CHINA","foreign_port":"NA","customer":"JOHNSON & JOHNSON","customerCountry":"INDIA","quantity":"0.63","actualQuantity":"0.626","unit":"KGS","unitRateFc":"2685.5","totalValueFC":"2140.5","currency":"USD","unitRateINR":"271892.8","date":"08-Jul-2022","totalValueINR":"170204.89","totalValueInUsd":"2140.5","indian_port":"BOMBAY AIR","hs_no":"29335990","bill_no":"9468074","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"L.B.S. MARG,,MULUND-WEST"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1685730600,"product":"(N.C.V)IBRUTINIB (JNJ-54179060-AAA)POWDER (1BOTTLE=90G)(FORR&D UNIT ONLY)","address":"L.B.S. MARG,,MULUND-WEST","city":"MUMBAI,MAHARASHTRA","supplier":"JOHNSON & JOHNSON","supplierCountry":"BELGIUM","foreign_port":"NA","customer":"JOHNSON & JOHNSON","customerCountry":"INDIA","quantity":"0.09","actualQuantity":"90","unit":"GMS","unitRateFc":"90","totalValueFC":"8854.2","currency":"EUR","unitRateINR":"8086.8","date":"03-Jun-2023","totalValueINR":"727784.603","totalValueInUsd":"8854.2","indian_port":"BOMBAY AIR","hs_no":"29335990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"BELGIUM","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"L.B.S. MARG,,MULUND-WEST"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1687199400,"product":"(N.C.V) INTERMEDIATE OF IBRUTINIB (PCL-7534)(T-3580) POWDER(1BOTTLE X 5GRAM)(FOR TESTING PURPOSE ONLY)","address":"L.B.S. MARG,,MULUND-WEST","city":"MUMBAI,MAHARASHTRA","supplier":"JOHNSON & JOHNSON","supplierCountry":"CHINA","foreign_port":"NA","customer":"JOHNSON & JOHNSON","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"5","unit":"GMS","unitRateFc":"0.5","totalValueFC":"82.2","currency":"EUR","unitRateINR":"1351.1","date":"20-Jun-2023","totalValueINR":"6757.296","totalValueInUsd":"82.2","indian_port":"BOMBAY AIR","hs_no":"29333990","bill_no":"0","productDescription":"Intermediate","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"L.B.S. MARG,,MULUND-WEST"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1687545000,"product":"(N.C.V)JNJ-54179060-AAA,R605030 REF STD OF IBRUTINIB 2-PROPEN-1-ONE,1-[(3R)-3-[4-AMINO-3-(4-PHENOXYPHENYL)-1H-PYRAZOLO[3","address":"L.B.S. MARG,,MULUND-WEST","city":"MUMBAI,MAHARASHTRA","supplier":"JOHNSON & JOHNSON","supplierCountry":"CHINA","foreign_port":"NA","customer":"JOHNSON & JOHNSON","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"9","unit":"GMS","unitRateFc":"286","totalValueFC":"2834","currency":"EUR","unitRateINR":"25883","date":"24-Jun-2023","totalValueINR":"232946.784","totalValueInUsd":"2834","indian_port":"BOMBAY AIR","hs_no":"29335990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"L.B.S. MARG,,MULUND-WEST"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1692124200,"product":"CHEMICAL : IBRUTINIB","address":"10\/13 NR. M.N. DESAI PETROL PUMP,S ARKHEJ BAVLA HIGHWAY CHANGODAR","city":"AHMEDABAD","supplier":"SHANGHAI ACEBRIGHT PHARMACEUTICALS","supplierCountry":"CHINA","foreign_port":"NA","customer":"SAKAR HEALTHCARE LIMITED","customerCountry":"INDIA","quantity":"3.45","actualQuantity":"3.45","unit":"KGS","unitRateFc":"9000","totalValueFC":"31273.6","currency":"USD","unitRateINR":"743386.2","date":"16-Aug-2023","totalValueINR":"2590588.44","totalValueInUsd":"31273.6","indian_port":"AHEMDABAD AIR","hs_no":"29339990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"10\/13 NR. M.N. DESAI PETROL PUMP,S ARKHEJ BAVLA HIGHWAY CHANGODAR"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1695839400,"product":"(N.C.V.)IBRUTINIB\/PCL-32765\/JNJ-54179060-AAA IBRUTINIB API)1-[(3R)-3-[4-AMINO-3-(4-PHENOXYPHENYL)-1H-PYRAZOLO[3,4-D]PYR","address":"30 FORJETT STREET","city":"MUMBAI, MAHARASHTRA.","supplier":"CHANGZHOU SYN THE ALL PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"JOHNSON & JOHNSON","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"10","unit":"GMS","unitRateFc":"2.7","totalValueFC":"133","currency":"USD","unitRateINR":"1104","date":"28-Sep-2023","totalValueINR":"11039.83","totalValueInUsd":"133","indian_port":"Bombay Air","hs_no":"29335990","bill_no":"8053691","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"589 NORTH YULONG ROAD , XINBEI DISTRICT CHANGZHOU 213127, JIANGSUSDNF China","customerAddress":"30 FORJETT STREET"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1699554600,"product":"CHEMICAL : IBRUTINIB","address":"10\/13, NR. M.N. DESAI PETROL PUMP","city":"AHMEDABAD, GUJARAT","supplier":"SHANGHAI ACEBRIGHT PHARMACEUTICALS ","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"SAKAR HEALTHCARE LIMITED","customerCountry":"INDIA","quantity":"0.90","actualQuantity":"0.9","unit":"KGS","unitRateFc":"9000","totalValueFC":"8185.5","currency":"USD","unitRateINR":"757350","date":"10-Nov-2023","totalValueINR":"681615","totalValueInUsd":"8185.5","indian_port":"Ahmedabad Air","hs_no":"29339990","bill_no":"8712930","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"BUILDING NO.5, 1999 ZHANGHENG ROAD,ZHANGJIANG HI-TECH PARK, SHANGHAI201203, CHINA CHINA","customerAddress":"10\/13, NR. M.N. DESAI PETROL PUMP"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1709490600,"product":"IBRUTINIB-(FOC)-FOR TESTING PURPOSE ONLY","address":"M-34, SAKET,","city":"NEW DELHI,DELHI","supplier":"CHEMICAL INDUSTRIES ASSOCIATION","supplierCountry":"ISRAEL","foreign_port":"TEL AVIV YAFO","customer":"TAPI TECHNOLOGY & API SERVICES","customerCountry":"INDIA","quantity":"0.30","actualQuantity":"300","unit":"GMS","unitRateFc":"5","totalValueFC":"1515.6","currency":"USD","unitRateINR":"419.5","date":"04-Mar-2024","totalValueINR":"125850","totalValueInUsd":"1515.6","indian_port":"Delhi Air","hs_no":"29339990","bill_no":"2419643","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ISRAEL","selfForZScoreResived":"Pharma Grade","supplierPort":"TEL AVIV YAFO","supplierAddress":"TEVA API DIVISION NEOT-HOVAV ECOINDUSTRIAL PARK P.O. BOX 2049 BEERSHEVA 8551600 IL","customerAddress":"M-34, SAKET,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1716229800,"product":"IBRUTINIB-FOR TEST OR ANALYSIS PURPOSE ONLY","address":"VILLAGE MANPURA,","city":"","supplier":"GYMA LABORATORIES OF AMERICA","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"PINNACLE LIFE SCIENCE ","customerCountry":"INDIA","quantity":"7.00","actualQuantity":"7","unit":"KGS","unitRateFc":"12000","totalValueFC":"85959.8","currency":"USD","unitRateINR":"1023587.3","date":"21-May-2024","totalValueINR":"7165110.75","totalValueInUsd":"85959.8","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"3595741","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"210 CROSSWAYS PARK DRIVE, SUITE 100WOODBURY NY 11797SDNF US","customerAddress":"VILLAGE MANPURA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722882600,"product":"IBRUTINIB API","address":"F 2, NO.18-17, CITY HOME RESIDENCY,","city":"HYDERABAD, AP.","supplier":"GYMA LABORATORIES OF AMERICA","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"SP ACCURE LABS PVT. LTD","customerCountry":"INDIA","quantity":"6.00","actualQuantity":"6","unit":"KGS","unitRateFc":"15000","totalValueFC":"91258.2","currency":"USD","unitRateINR":"1275768","date":"06-Aug-2024","totalValueINR":"7654608","totalValueInUsd":"91258.2","indian_port":"Hyderabad Air","hs_no":"29335990","bill_no":"4913629","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"210 CROSSWAYS PARK DRIVE, SUITE 100WOODBURY, NY 11797SDNF US","customerAddress":"F 2, NO.18-17, CITY HOME RESIDENCY,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725906600,"product":"(N.C.V) JNJ-54179060-AAA IBRUTINIB API 1-[(3R)-3-[4-AMINO-3-(4-PHENOXYPHENYL)-1H-PYRAZOLO[3,4-D]PYRIMIDIN-1-YL]-1-PIPERI","address":"30 FORJETT STREET","city":"MUMBAI, MAHARASHTRA.","supplier":"CHANGZHOU SYN THE ALL PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"JOHNSON & JOHNSON","customerCountry":"INDIA","quantity":"0.10","actualQuantity":"96","unit":"GMS","unitRateFc":"2.7","totalValueFC":"261.1","currency":"USD","unitRateINR":"228","date":"10-Sep-2024","totalValueINR":"21883.82","totalValueInUsd":"261.1","indian_port":"Bombay Air","hs_no":"29335990","bill_no":"5523025","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"589 NORTH YULONG ROAD , XINBEI DIST RICT CHANGZHOU 213127, JIANGSU Chan gzhou, , China China China","customerAddress":"30 FORJETT STREET"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725906600,"product":"(N.C.V) JNJ-54179060-AAA IBRUTINIB API 1-[(3R)-3-[4-AMINO-3-(4-PHENOXYPHENYL)-1H-PYRAZOLO[3,4-D]PYRIMIDIN-1-YL]-1-PIPERI","address":"30 FORJETT STREET","city":"MUMBAI, MAHARASHTRA.","supplier":"CHANGZHOU SYN THE ALL PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"JOHNSON & JOHNSON","customerCountry":"INDIA","quantity":"0.53","actualQuantity":"530","unit":"GMS","unitRateFc":"2.7","totalValueFC":"1441.7","currency":"USD","unitRateINR":"228","date":"10-Sep-2024","totalValueINR":"120816.95","totalValueInUsd":"1441.7","indian_port":"Bombay Air","hs_no":"29335990","bill_no":"5523025","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"589 NORTH YULONG ROAD , XINBEI DIST RICT CHANGZHOU 213127, JIANGSU Chan gzhou, , China China China","customerAddress":"30 FORJETT STREET"}]
    16-Mar-2021
    31-Dec-2024
    KGS
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    Average Price (USD/KGS)

    Number of Transactions

    Total Quantity (KGS)

    Total Value (USD)

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

    API Imports and Exports

    Importing Country Total Quantity
    (KGS)    		 Average Price
    (USD/KGS)    		 Number of Transactions

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    INTERMEDIATES SUPPLIERS

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    01

    Aarti Pharmalabs

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow
    • fda
    • EDQM
    • WHO-GMP

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

    (S)-BOC-3-hydroxy piperidine

    CAS Number : 143900-44-1

    End Use API : Ibrutinib

    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...

    Aarti Industries Company Banner

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    02

    Aarti Pharmalabs

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow
    • fda
    • EDQM
    • WHO-GMP

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

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

    CAS Number : 330786-24-8

    End Use API : Ibrutinib

    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...

    Aarti Industries Company Banner

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    03

    Aarti Pharmalabs

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow
    • fda
    • EDQM
    • WHO-GMP

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

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

    CAS Number : 1022150-12-4

    End Use API : Ibrutinib

    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...

    Aarti Industries Company Banner

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    04

    Jinan Tantu Chemicals

    China
    CPhI China
    Exhibiting
    arrow
    • fda
    • EDQM
    • WHO-GMP

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

    3-(4-Phenoxyphenyl)-1H- pyrazole and [3,4- d] pyri...

    CAS Number : 330786-24-8

    End Use API : Ibrutinib

    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

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    05

    Tagoor Laboratories

    India
    CPhI China
    Booth #E1Q18
    arrow
    • fda
    • EDQM
    • WHO-GMP

    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, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for...

    Tagoor Laboratories

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    06

    Tagoor Laboratories

    India
    CPhI China
    Booth #E1Q18
    arrow
    • fda
    • EDQM
    • WHO-GMP

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

    1-Boc-3-hydroxypiperidine

    CAS Number : 85275-45-2

    End Use API : Ibrutinib

    About The Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for...

    Tagoor Laboratories

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    07

    Agno Pharma

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

    Agno Pharma

    U.S.A
    BIO Partnering at JPM
    Not Confirmed
    arrow
    • fda
    • EDQM
    • WHO-GMP
    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.

    (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 ...

    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    08

    Anhui HaiKang Pharmaceutical Co. Lt...

    China
    BIO Partnering at JPM
    Not Confirmed
    arrow

    Anhui HaiKang Pharmaceutical Co. Lt...

    China
    BIO Partnering at JPM
    Not Confirmed
    arrow
    • fda
    • EDQM
    • WHO-GMP
    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.

    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...

    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    09

    Anhui HaiKang Pharmaceutical Co. Lt...

    China
    BIO Partnering at JPM
    Not Confirmed
    arrow

    Anhui HaiKang Pharmaceutical Co. Lt...

    China
    BIO Partnering at JPM
    Not Confirmed
    arrow
    • fda
    • EDQM
    • WHO-GMP
    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.

    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...

    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    10

    Anhui HaiKang Pharmaceutical Co. Lt...

    China
    BIO Partnering at JPM
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    Ibrutinib N-3

    CAS Number : 330792-70-6

    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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    ABOUT THIS PAGE

    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, COA and API Price 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, COA and API Price 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 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, API price, 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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