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    Chemistry

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    Also known as: 1257044-40-8, Abt-199, Venclexta, Gdc-0199, Abt199, Abt 199
    Molecular Formula
    C45H50ClN7O7S
    Molecular Weight
    868.4  g/mol
    InChI Key
    LQBVNQSMGBZMKD-UHFFFAOYSA-N
    FDA UNII
    N54AIC43PW
    Venetoclax
    Venetoclax is an orally bioavailable, selective small molecule inhibitor of the anti-apoptotic protein Bcl-2, with potential antineoplastic activity. Venetoclax mimics BH3-only proteins, the native ligands of Bcl-2 and apoptosis activators, by binding to the hydrophobic groove of Bcl-2 proteins thereby repressing Bcl-2 activity and restoring apoptotic processes in tumor cells. Bcl-2 protein is overexpressed in some cancers and plays an important role in the regulation of apoptosis; its expression is associated with increased drug resistance and tumor cell survival. Compared to the Bcl-2 inhibitor navitoclax, this agent does not inhibit bcl-XL and does not cause bcl-XL-mediated thrombocytopenia.
    Venetoclax is a BCL-2 Inhibitor. The mechanism of action of venetoclax is as a P-Glycoprotein Inhibitor. The physiologic effect of venetoclax is by means of Increased Cellular Death.
    1 2D Structure

    Venetoclax

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    4-[4-[[2-(4-chlorophenyl)-4,4-dimethylcyclohexen-1-yl]methyl]piperazin-1-yl]-N-[3-nitro-4-(oxan-4-ylmethylamino)phenyl]sulfonyl-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide
    2.1.2 InChI
    InChI=1S/C45H50ClN7O7S/c1-45(2)15-11-33(39(26-45)31-3-5-34(46)6-4-31)29-51-17-19-52(20-18-51)35-7-9-38(42(24-35)60-36-23-32-12-16-47-43(32)49-28-36)44(54)50-61(57,58)37-8-10-40(41(25-37)53(55)56)48-27-30-13-21-59-22-14-30/h3-10,12,16,23-25,28,30,48H,11,13-15,17-22,26-27,29H2,1-2H3,(H,47,49)(H,50,54)
    2.1.3 InChI Key
    LQBVNQSMGBZMKD-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC1(CCC(=C(C1)C2=CC=C(C=C2)Cl)CN3CCN(CC3)C4=CC(=C(C=C4)C(=O)NS(=O)(=O)C5=CC(=C(C=C5)NCC6CCOCC6)[N+](=O)[O-])OC7=CN=C8C(=C7)C=CN8)C
    2.2 Other Identifiers
    2.2.1 UNII
    N54AIC43PW
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 4-(4-((2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl)methyl)piperazin-1-yl)-n-((3-nitro-4-((tetrahydro-2h-pyran-4-ylmethyl)amino)phenyl)sulfonyl)-2-(1h-pyrrolo(2,3-b)pyridin-5-yloxy)benzamide

    2. Abt-199

    3. Benzamide, 4-(4-((2-(4-chlorophenyl)-4,4-dimethyl-1-cyclohexen-1-yl)methyl)-1-piperazinyl)-n-((3-nitro-4-(((tetrahydro-2h-pyran-4-yl)methyl)amino)phenyl)sulfonyl)-2-(1h-pyrrolo(2,3-b)pyridin-5-yloxy)-

    4. Gdc-0199

    5. Rg-7601

    6. Rg7601

    7. Venclexta

    2.3.2 Depositor-Supplied Synonyms

    1. 1257044-40-8

    2. Abt-199

    3. Venclexta

    4. Gdc-0199

    5. Abt199

    6. Abt 199

    7. Rg7601

    8. Venetoclax (abt199)

    9. Gdc 0199

    10. Rg-7601

    11. Venetoclax; Abt-199

    12. 4-[4-[[2-(4-chlorophenyl)-4,4-dimethylcyclohexen-1-yl]methyl]piperazin-1-yl]-n-[3-nitro-4-(oxan-4-ylmethylamino)phenyl]sulfonyl-2-(1h-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide

    13. Venetoclax (abt-199)

    14. N54aic43pw

    15. Abt-199 (gdc-0199)

    16. 2-(1h-pyrrolo[2,3-b]pyridin-5-yloxy)-4-(4-((2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-enyl)methyl)piperazin-1-yl)-n-(3-nitro-4-((tetrahydro-2h-pyran-4-yl)methy

    17. 4-(4-((2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl)methyl)piperazin-1-yl)-n-((3-nitro-4-((tetrahydro-2h-pyran-4-ylmethyl)amino)phenyl)sulfonyl)-2-(1h-pyrrolo(2,3-b)pyridin-5-yloxy)benzamide

    18. 4-[4-[[2-(4-chlorophenyl)-4,4-dimethyl-1-cyclohexen-1-yl]methyl]-1-piperazinyl]-n-[[3-nitro-4-[[(tetrahydro-2h-pyran-4-yl)methyl]amino]phenyl]sulfonyl]-2-(1h-pyrrolo[2,3-b]pyridin-5-yloxy)-benzamide

    19. Benzamide, 4-(4-((2-(4-chlorophenyl)-4,4-dimethyl-1-cyclohexen-1-yl)methyl)-1-piperazinyl)-n-((3-nitro-4-(((tetrahydro-2h-pyran-4-yl)methyl)amino)phenyl)sulfonyl)-2-(1h-pyrrolo(2,3-b)pyridin-5-yloxy)-

    20. Venclyxto

    21. Bdbm189459

    22. Unii-n54aic43pw

    23. 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-n-({3-nitro-4-[(oxan-4-ylmethyl)amino]benzene}sulfonyl)-2-{1h-pyrrolo[2,3-b]pyridin-5-yloxy}benzamide

    24. 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-n-({3-nitro-4-[(tetrahydro-2h-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1h-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide

    25. 4-{4-[(4'-chloro-5,5-dimethyl[3,4,5,6-tetrahydro[1,1'-biphenyl]]-2-yl)methyl]piperazin-1-yl}-n-(3-nitro-4-{[(oxan-4-yl)methyl]amino}benzene-1-sulfonyl)-2-[(1h-pyrrolo[2,3-b]pyridin-5-yl)oxy]benzamide

    26. Venetoclax [usan:inn]

    27. Venclexta (tn)

    28. Benzamide, 4-[4-[[2-(4-chlorophenyl)-4,4-dimethyl-1-cyclohexen-1-yl]methyl]-1-piperazinyl]-n-[[3-nitro-4-[[(tetrahydro-2h-pyran-4-yl)methyl]amino]phenyl]sulfonyl]-2-(1h-pyrrolo[2,3-b]pyridin-5-yloxy)-

    29. Venetoclax [mi]

    30. Venetoclax(abt-199)

    31. Venetoclax [inn]

    32. Venetoclax [jan]

    33. Venetoclax [usan]

    34. Venetoclax [who-dd]

    35. Mls006010298

    36. Schembl523816

    37. Venetoclax (jan/usan/inn)

    38. Amy343

    39. Gtpl8318

    40. Chembl3137309

    41. Schembl19236295

    42. Venetoclax [orange Book]

    43. Bdbm60828

    44. Dtxsid30154863

    45. Ex-a168

    46. Chebi:133021

    47. Hms3653j06

    48. Hms3745e07

    49. Bcp06811

    50. Bdbm50162774

    51. Mfcd23160052

    52. Nsc766270

    53. Akos025289539

    54. Zinc150338755

    55. Ccg-270543

    56. Cs-1155

    57. Db11581

    58. Ks-1470

    59. Nsc-766270

    60. Sb16499

    61. Ncgc00345789-01

    62. Ncgc00345789-05

    63. Ncgc00345789-10

    64. Ncgc00345789-11

    65. Ac-28754

    66. Da-35360

    67. Hy-15531

    68. Smr004701366

    69. Ft-0699586

    70. S8048

    71. Sw219672-1

    72. J3.516.625d

    73. D10679

    74. Us9174982, 5

    75. A850921

    76. Us9174982, 369

    77. J-005269

    78. Q23671272

    79. 2-((1h-pyrrolo[2,3-b]pyridin-5-yl)oxy)-4-(4-((4'-chloro-5,5-dimethyl-3,4,5,6-tetrahydro-[1,1'-biphenyl]-2-yl)methyl)piperazin-1-yl)-n-((3-nitro-4-(((tetrahydro-2h-pyran-4-yl)methyl)amino)phenyl)sulfonyl)benzamide

    80. 4-(4-((2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl)methyl)piperazin-1-yl)-n-((3-nitro-4-((tetrahydro-2hpyran-4-ylmethyl) Amino)phenyl)sulfonyl)-2-(1h-pyrrolo(2,3-b)pyridin-5-yloxy)benzamide

    81. 4-[4-[[2-(4-chlorophenyl)-4,4-dimethyl-1-cyclohexen-1-yl]methyl]-1-piperazinyl]-n-[[3-nitro-4-[[(tetrahydro-2h-pyran-4-yl)methyl]amino]phenyl]sulfonyl]-2-(1h-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide

    82. 4-[4-[[2-(4-chlorophenyl)-4,4-dimethyl-cyclohexen-1-yl]methyl]piperazin-1-yl]-n-[3-nitro-4-(tetrahydropyran-4-ylmethylamino)phenyl]sulfonyl-2-(1h-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide

    83. 4-{4-[(4'-chloro-5,5-dimethyl[3,4,5,6-tetrahydro[1,1'-biphenyl]]-2-yl)methyl]piperazin-1-yl}-n-[(3-nitro-4-{[(oxan-4-yl

    2.4 Create Date
    2011-01-31
    3 Chemical and Physical Properties
    Molecular Weight 868.4 g/mol
    Molecular Formula C45H50ClN7O7S
    XLogP38.2
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count11
    Rotatable Bond Count12
    Exact Mass867.3180958 g/mol
    Monoisotopic Mass867.3180958 g/mol
    Topological Polar Surface Area183 Ų
    Heavy Atom Count61
    Formal Charge0
    Complexity1640
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Indication

    A BCL-2 inhibitor indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.

    FDA Label

    Venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5. 1).

    Venclyxto in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.

    Venclyxto monotherapy is indicated for the treatment of CLL:

    - in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B cell receptor pathway inhibitor, or

    - in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.

    Venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Venetoclax induces rapid and potent onset apoptosis of CLL cells, powerful enough to act within 24h and to lead to tumor lysis syndrome,,. Selective targeting of BCL2 with venetoclax has demonstrated a manageable safety profile and has been shown to induce significant response in patients with relapsed CLL (chronic lymphocytic leukemia) or SLL (small lymphocytic leukemia), including patients with poor prognostic features. This drug is not expected to have a significant impact on the cardiac QT interval. Venetoclax has demonstrated efficacy in various types of lymphoid malignancies, including relapsed/ refractory CLL harboring deletion 17p, with an overall response rate of approximately 80%.

    5.2 MeSH Pharmacological Classification

    Antineoplastic Agents

    Substances that inhibit or prevent the proliferation of NEOPLASMS. (See all compounds classified as Antineoplastic Agents.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    VENETOCLAX
    5.3.2 FDA UNII
    N54AIC43PW
    5.3.3 Pharmacological Classes
    Increased Cellular Death [PE]; P-Glycoprotein Inhibitors [MoA]; BCL-2 Inhibitor [EPC]
    5.4 ATC Code

    L01XX52

    L - Antineoplastic and immunomodulating agents

    L01 - Antineoplastic agents

    L01X - Other antineoplastic agents

    L01XX - Other antineoplastic agents

    L01XX52 - Venetoclax

    5.5 Absorption, Distribution and Excretion

    Absorption

    Following several oral administrations after a meal, the maximum plasma concentration of venetoclax was reached 5-8 hours after the dose. Venetoclax steady state AUC (area under the curve) increased proportionally over the dose range of 150-800 mg. After a low-fat meal, venetoclax mean ( standard deviation) steady-state Cmax was 2.1 1.1 g/mL and AUC0-24 was 32.8 16.9 gh/mL at the 400 mg once daily dose. When compared with the fasted state, venetoclax exposure increased by 3.4 times when ingested with a low-fat meal and 5.2 times with a high-fat meal. When comparing low versus high fat, the Cmax and AUC were both increased by 50% when ingested with a high-fat meal. The FDA label indicataes that venetoclax should be taken with food,.

    Route of Elimination

    After single oral administration of 200 mg radiolabeled [14C]-venetoclax dose to healthy subjects, >99.9% of the dose was found in feces and <0.1% of the dose was excreted in urine within 9 days, suggesting that hepatic elimination is responsible for the clearance of venetoclax from systemic circulation. Unchanged venetoclax accounted for 20.8% of the radioactive dose excreted in feces.

    Volume of Distribution

    The population estimate for apparent volume of distribution (Vdss/F) of venetoclax ranged from 256-321 L.

    Clearance

    Mainly hepatic.

    5.6 Metabolism/Metabolites

    In vitro studies demonstrated that venetoclax is predominantly metabolized as a substrate of CYP3A4/5,,.

    5.7 Biological Half-Life

    The half-life of venetoclax is reported to be 19-26 hours, after administration of a single 50-mg dose,.

    5.8 Mechanism of Action

    Proteins in the B cell CLL/lymphoma 2 (BCL-2) family are necessary regulators of the apoptotic (anti-cell programmed death) process. This family comprises proapoptotic and prosurvival proteins for various cells. Cancer cells evade apoptosis by inhibiting programmed cell death (apoptosis). The therapeutic potential of directly inhibiting prosurvival proteins was unveiled with the development of navitoclax, a selective inhibitor of both BCL-2 and BCL-2-like 1 (BCL-X(L)), which has demonstrated clinical efficacy in some BCL-2-dependent hematological cancers. Selective inhibition of BCL-2 by venetoclax, sparing BCL-xL enables therapeutic induction of apoptosis without the negative effect of thrombocytopenia,. Venetoclax helps restore the process of apoptosis by binding directly to the BCL-2 protein, displacing pro-apoptotic proteins, leading to mitochondrial outer membrane permeabilization and the activation of caspase enzymes. In nonclinical studies, venetoclax has shown cytotoxic activity in tumor cells that overexpress BCL-2.

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C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"DUBAI","customer":"GULF AGENCY COMPANY DUBAI LLC","customerCountry":"UNITED ARAB EMIRATES","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"14850","totalValueFC":"14652.9","currency":"USD","unitRateINR":1223625,"date":"20-Apr-2024","totalValueINR":"1223625","totalValueInUsd":"14652.9","indian_port":"Hyderabad Air","hs_no":"29337990","bill_no":"9274420","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"UNITED ARAB EMIRATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1715797800,"product":"VENETOCLAX","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. 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AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1716316200,"product":"ACTIVE PHARMACEUTICALS INGREDIENTS (PHARMACEUTICALS RAW MATERIAL FOR PHARMA INDUSTRIES) PRODUCT NAME-VENETOCLAX","address":"ALEMBIC ROAD","city":"GUJARAT","supplier":"ALEMBIC PHARMACEUTICALS LIMITED","supplierCountry":"INDIA","foreign_port":"DUBAI","customer":"TO","customerCountry":"UNITED ARAB EMIRATES","quantity":"0.10","actualQuantity":"0.1","unit":"KGS","unitRateFc":"15000","totalValueFC":"1487.3","currency":"USD","unitRateINR":1239750,"date":"22-May-2024","totalValueINR":"123975","totalValueInUsd":"1487.3","indian_port":"Bombay Air","hs_no":"29359090","bill_no":"1075861","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"UNITED ARAB EMIRATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"ALEMBIC ROAD, GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1719253800,"product":"ACTIVE PHARMACEUTICALS INGREDIENTS -(API) (PHARMACEUTICALS RAW MATERIAL FOR PHARMA INDUSTRIES)PRODUCT NAME - VENETOCLAX","address":"ALEMBIC ROAD","city":"GUJARAT","supplier":"ALEMBIC PHARMACEUTICALS LIMITED","supplierCountry":"INDIA","foreign_port":"ATHENS","customer":"TO THE ORDER OF","customerCountry":"GREECE","quantity":"0.10","actualQuantity":"0.1","unit":"KGS","unitRateFc":"11000","totalValueFC":"980.1","currency":"USD","unitRateINR":818169.49999999988,"date":"25-Jun-2024","totalValueINR":"81816.95","totalValueInUsd":"980.1","indian_port":"Ahmedabad Air","hs_no":"29359090","bill_no":"1933260","productDescription":"API","marketType":"REGULATED MARKET","country":"GREECE","selfForZScoreResived":"Pharma Grade","supplierPort":"Ahmedabad Air","supplierAddress":"ALEMBIC ROAD, GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722277800,"product":"VENETOCLAX","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"LARNACA","customer":"REMEDICA LTD","customerCountry":"CYPRUS","quantity":"0.10","actualQuantity":"0.1","unit":"KGS","unitRateFc":"28000","totalValueFC":"2651.8","currency":"USD","unitRateINR":2216690,"date":"30-Jul-2024","totalValueINR":"221669","totalValueInUsd":"2651.8","indian_port":"Hyderabad Air","hs_no":"29337990","bill_no":"2828003","productDescription":"API","marketType":"REGULATED MARKET","country":"CYPRUS","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":1730399400,"product":"VENETOCLAX IH","address":"HETERO CORPORATE, NO. 7-2-A2,","city":"HYDERABAD","supplier":"HETERO DRUGS","supplierCountry":"INDIA","foreign_port":"NEW YORK","customer":"ACTAVIS INC","customerCountry":"UNITED STATES","quantity":"3.90","actualQuantity":"3.9","unit":"KGS","unitRateFc":"10000","totalValueFC":"38220.1","currency":"USD","unitRateINR":827005.6794871795,"date":"01-Nov-2024","totalValueINR":"3225322.15","totalValueInUsd":"38220.1","indian_port":"Hyderabad Air","hs_no":"29334900","bill_no":"5320899","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"HETERO CORPORATE, NO. 7-2-A2,, HYDERABAD","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717180200,"product":"VENETOCLAX","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"CHANGZHOU PHARMACEUTICAL FACTORY","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"DR. REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"9000","totalValueFC":"18187.7","currency":"USD","unitRateINR":"759150","date":"01-Jun-2024","totalValueINR":"1518300","totalValueInUsd":"18187.7","indian_port":"Hyderabad Air","hs_no":"29359090","bill_no":"3778288","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"NO.518, LAO DONG EAST ROAD, CHANGZHOU JIANGSU 213018, CHINA. Changzhou, , China China","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729103400,"product":"VENETOCLAX COARSER MATERIAL","address":"#28 CANTON ROWS, PETBASHEERBAD","city":"HYDERABAD","supplier":"NANTONG CHANYOO PHARMATECH","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"AIZANT DRUG RESEARCH SOLUTIONS PVT. LTD.","customerCountry":"INDIA","quantity":"0.20","actualQuantity":"0.2","unit":"KGS","unitRateFc":"10000","totalValueFC":"2019.6","currency":"USD","unitRateINR":"848500","date":"17-Oct-2024","totalValueINR":"169700","totalValueInUsd":"2019.6","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"6177634","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO.2 TONGHAI SI ROAD, YANGKOU CHEMI CAL INDUSTRIA PARK, RUDONG COASTAL, ECONOMIC DEVELOPMENT ZONE,NANTONG, CN","customerAddress":"#28 CANTON ROWS, PETBASHEERBAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734719400,"product":"VENETOCLAX VENETOCLAX","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"CHANGZHOU PHARMACEUTICAL FACTORY","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"DR. REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"9000","totalValueFC":"9103.9","currency":"USD","unitRateINR":"773550","date":"21-Dec-2024","totalValueINR":"773550","totalValueInUsd":"9103.9","indian_port":"Hyderabad Air","hs_no":"29359090","bill_no":"7387206","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"NO.518, LAO DONG EAST ROAD, CHANGZH OU JIANGSU 213018, CHINA. Changzhou , , China China","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"}]
    12-Feb-2021
    21-Dec-2024
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    ABOUT THIS PAGE

    Looking for 1257044-40-8 / Venetoclax API manufacturers, exporters & distributors?

    Venetoclax manufacturers, exporters & distributors 1

    62

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

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

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

    API | Excipient name

    Venetoclax

    Synonyms

    1257044-40-8, Abt-199, Venclexta, Gdc-0199, Abt199, Abt 199

    Cas Number

    1257044-40-8

    Unique Ingredient Identifier (UNII)

    N54AIC43PW

    About Venetoclax

    Venetoclax is an orally bioavailable, selective small molecule inhibitor of the anti-apoptotic protein Bcl-2, with potential antineoplastic activity. Venetoclax mimics BH3-only proteins, the native ligands of Bcl-2 and apoptosis activators, by binding to the hydrophobic groove of Bcl-2 proteins thereby repressing Bcl-2 activity and restoring apoptotic processes in tumor cells. Bcl-2 protein is overexpressed in some cancers and plays an important role in the regulation of apoptosis; its expression is associated with increased drug resistance and tumor cell survival. Compared to the Bcl-2 inhibitor navitoclax, this agent does not inhibit bcl-XL and does not cause bcl-XL-mediated thrombocytopenia.

    Venetoclax Manufacturers

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

    Venetoclax Suppliers

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

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

    Venetoclax USDMF

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

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

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

    Venetoclax KDMF

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

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

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

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

    Venetoclax WC

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

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

    Venetoclax 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 Venetoclax as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Venetoclax GMP

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

    Venetoclax CoA

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

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

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