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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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    Aarti Pharmalabs

    India

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

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    American Thoracic Society
    Not Confirmed
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    Virtual BoothAarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 33627

    Submission : 2019-03-26

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    Listed Suppliers

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    01

    LEBSA

    Spain
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    Chemspec Europe
    Attending
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    Virtual BoothLEBSA- Your strategic API source for niche molecules.

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    Venetoclax

    About the Company : Lebsa is an innovative European laboratory that specializes in the synthesis, manufacture and commercialization of APIs with a focus on niche products. With a track record spanning...

    Lebsa is an innovative European laboratory that specializes in the synthesis, manufacture and commercialization of APIs with a focus on niche products. With a track record spanning 70 years, Lebsa has established itself as a reputable player in the global pharmaceutical market, particularly in generic API manufacturing. Headquartered in Barcelona, Spain, Lebsa exports up to 90% of its production. Lebsa's state-of-the-art facilities, located near Barcelona, feature cutting-edge technology, equipment and automated processes. Lebsa has expertise in registering APIs in countries across Europe, Canada, Taiwan, China, Russia, Brazil and Japan.
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    02

    Dr. Reddy's Laboratories

    India
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    CPhI North America
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Venetoclax

    About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...

    Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale
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    03

    Egis Pharmaceuticals PLC

    Hungary
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    Virtual BoothEgis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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    Venetoclax

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

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

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    04

    Faran Shimi Pharmaceutical

    Iran
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    American Thoracic Society
    Not Confirmed
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    Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

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    Venetoclax

    About the Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs)...

    Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs) and finished dosage forms. For the past three years, the company focused on extracting alkaloid opiates, controlled substances, and narcotics. The APIs are widely used by major pharmaceutical companies nationwide and exported to the Middle East. All production adheres to local GMP standards in an SOP-driven environment with modern systems and utilities, ensuring the highest quality and safety.
    Faran Shimi Pharmaceutical

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    05

    Aarti Pharmalabs

    India
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    Not Confirmed
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    Virtual BoothAarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

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    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, corticosteroids, cyto...

    Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, corticosteroids, cytotoxic & oncology products. It has 2 R&D centers & 3 cGMP plants successfully audited by the USFDA, EUGMP, EDQM, KFDA & COFEPRIS. It offers CDMO services for generic APIs & NCEs, intermediates & key building blocks.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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    06

    Shanghai Minbiotech

    China
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    Not Confirmed
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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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    About the Company : ​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...

    ​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company 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.
    Shanghai Minbiotech CB

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    07

    Omgene Life Sciences Pvt. Ltd

    India
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    American Thoracic Society
    Not Confirmed
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    Virtual BoothOmgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

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    About the Company : Omgene Life Sciences Private Limited is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically...

    Omgene Life Sciences Private Limited is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically integrated company, we focus on developing high-quality formulations based on in-house-produced actives. With GMP-certified facilities and partnerships with contract manufacturers, we excel in formulation development for injectables, lyophilized injectables, complex generics, and oral peptide delivery systems, ensuring affordable, top-quality medicines.
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    08

    TAPI Technology & API Services

    Israel
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    TIDES USA
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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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    Venetoclax

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

    Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, driving progress in the pharmaceutical industry. Leveraging our extensive experience and world-class expertise, we deliver one of the most comprehensive API portfolios in the industry with over 350 Products portfolio. Additionally, we provide tailored CDMO services, harnessing our proficiency in diverse technologies to meet our partners' unique needs, ensuring flexibility and excellence in every project.
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    09

    Changzhou Pharmaceutical Factory

    China
    American Thoracic Society
    Not Confirmed
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    Changzhou Pharmaceutical Factory

    China
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    American Thoracic Society
    Not Confirmed
    • 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.
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    Venetoclax

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

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

    Natco Pharma

    India
    American Thoracic Society
    Not Confirmed
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    Natco Pharma

    India
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    Not Confirmed
    • 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.
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    Venetoclax

    About the Company : NATCO PHARMA LIMITED was incorporated in Hyderabad in the year 1981 with an initial investment of INR 3.3 million. With a modest beginning of operations as a single unit with 20 e...

    NATCO PHARMA LIMITED was incorporated in Hyderabad in the year 1981 with an initial investment of INR 3.3 million. With a modest beginning of operations as a single unit with 20 employees, NATCO today has five manufacturing facilities spread across India with dedicated modern research laboratories, capabilities in New Drug Development, etc.NATCO family currently consists of more than 2500 employees, we are consistently ranked among fastest growing pharmaceutical companies in India. NATCO is well recognized for its innovation in Pharmaceutical R&D.
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    API Reference Price

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REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"1.50","actualQuantity":"1.5","unit":"KGS","unitRateFc":"9000","totalValueFC":"13684.3","currency":"USD","unitRateINR":"790200","date":"12-Mar-2025","totalValueINR":"1185300","totalValueInUsd":"13684.3","indian_port":"Hyderabad Air","hs_no":"29359090","bill_no":"8840644","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-Mar-2025
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    Drugs in Development

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    AbbVie Introduces Venetoclax in India for Treatment of AML and CLL

    Details:

    Venetoclax, a first-in-class BCL-2 inhibitor, functions by selectively targeting cancer cells in the blood and bone marrow. It is indicated for AML & CLL.


    Lead Product(s): Venetoclax

    Therapeutic Area: Oncology Brand Name: Venclexta

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable April 21, 2025

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    Lead Product(s) : Venetoclax

    Therapeutic Area : Oncology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    AbbVie Introduces Venetoclax in India for Treatment of AML and CLL

    Details : Venetoclax, a first-in-class BCL-2 inhibitor, functions by selectively targeting cancer cells in the blood and bone marrow. It is indicated for AML & CLL.

    Product Name : Venclexta

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    April 21, 2025

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    AbbVie to Showcase Oncology Portfolio and Pipeline During the 2022 ASCO and EHA Annual Congresses

    Details:

    VENCLEXTA®/VENCLYXTO® (venetoclax) is a first-in-class medicine that selectively binds and inhibits B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis.


    Lead Product(s): Venetoclax,Azacitidine

    Therapeutic Area: Oncology Brand Name: Venclexta

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 05, 2022

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    Lead Product(s) : Venetoclax,Azacitidine

    Therapeutic Area : Oncology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    AbbVie to Showcase Oncology Portfolio and Pipeline During the 2022 ASCO and EHA Annual Congresses

    Details : VENCLEXTA®/VENCLYXTO® (venetoclax) is a first-in-class medicine that selectively binds and inhibits B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, c...

    Product Name : Venclexta

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    December 05, 2022

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    New Data Demonstrates AbbVie's VENCLYXTO®/VENCLEXTA® Combination Sustained Progression-Free Survival in Chronic Lymphocytic Leukemia Patients After Fo...

    Details:

    Data shows that after more than five years of median follow-up (65.4 months), PFS remained significantly superior among patients treated with the VENCLEXTA (Venetoclax) and obinutuzumab combination compared to the chlorambucil and obinutuzumab chemotherapy regimen.


    Lead Product(s): Venetoclax,Obinutuzumab

    Therapeutic Area: Oncology Brand Name: Venclexta

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 06, 2022

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    Lead Product(s) : Venetoclax,Obinutuzumab

    Therapeutic Area : Oncology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    New Data Demonstrates AbbVie's VENCLYXTO®/VENCLEXTA® Combination Sustained Progression-Free Surv...

    Details : Data shows that after more than five years of median follow-up (65.4 months), PFS remained significantly superior among patients treated with the VENCLEXTA (Venetoclax) and obinutuzumab combination compared to the chlorambucil and obinutuzumab chemothera...

    Product Name : Venclexta

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    October 06, 2022

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    Venetoclax (VENCLEXTA®) Granted US FDA Breakthrough Therapy Designation (BTD) in Higher Risk Myelodysplastic Syndrome (MDS)

    Details:

    VENCLEXTA®/VENCLYXTO® (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis.


    Lead Product(s): Venetoclax,Azacitidine

    Therapeutic Area: Oncology Brand Name: Venclexta

    Study Phase: Phase IIIProduct Type: Other Small Molecule

    Sponsor: F. Hoffmann-La Roche

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable July 21, 2021

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    Lead Product(s) : Venetoclax,Azacitidine

    Therapeutic Area : Oncology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : F. Hoffmann-La Roche

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Venetoclax (VENCLEXTA®) Granted US FDA Breakthrough Therapy Designation (BTD) in Higher Risk Myel...

    Details : VENCLEXTA®/VENCLYXTO® (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction proces...

    Product Name : Venclexta

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    July 21, 2021

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    AbbVie's Venetoclax Has Shown Progression-Free Survival in Patients With Chronic Lymphocytic Leukemia After 3 Years of Treatment

    Details:

    In addition, assessment in peripheral blood 30 months after the end of treatment showed that 26.9% of patients treated with VENCLEXTA (venetoclax) still had undetectable MRD (<10-4) compared with 3.2% of patients in the study arm who received obinutuzumab plus chlorambucil.


    Lead Product(s): Venetoclax,Obinutuzumab

    Therapeutic Area: Oncology Brand Name: Venclexta

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: F. Hoffmann-La Roche

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable July 07, 2021

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    AbbVie Inc

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    Lead Product(s) : Venetoclax,Obinutuzumab

    Therapeutic Area : Oncology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : F. Hoffmann-La Roche

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    AbbVie's Venetoclax Has Shown Progression-Free Survival in Patients With Chronic Lymphocytic Leuke...

    Details : In addition, assessment in peripheral blood 30 months after the end of treatment showed that 26.9% of patients treated with VENCLEXTA (venetoclax) still had undetectable MRD (<10-4) compared with 3.2% of patients in the study arm who received obinutuzuma...

    Product Name : Venclexta

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    July 07, 2021

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    CAPTIVATE Study Shows an IMBRUVICA Plus VENCLEXTA/VENCLYXTO Chemotherapy-Free Combination Has Potential to Provide Remission in CLL

    Details:

    Ibrutinib plus venetoclax is an investigational fixed-duration combination. Patients received 3 cycles of ibrutinib lead-in followed by 12 cycles of ibrutinib + venetoclax (Ibr 420 mg/day PO; Ven ramp up to 400 mg/day PO).


    Lead Product(s): Venetoclax,Ibrutinib

    Therapeutic Area: Oncology Brand Name: Venclexta

    Study Phase: Phase IIProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable July 06, 2021

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    Lead Product(s) : Venetoclax,Ibrutinib

    Therapeutic Area : Oncology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    CAPTIVATE Study Shows an IMBRUVICA Plus VENCLEXTA/VENCLYXTO Chemotherapy-Free Combination Has Pote...

    Details : Ibrutinib plus venetoclax is an investigational fixed-duration combination. Patients received 3 cycles of ibrutinib lead-in followed by 12 cycles of ibrutinib + venetoclax (Ibr 420 mg/day PO; Ven ramp up to 400 mg/day PO).

    Product Name : Venclexta

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    July 06, 2021

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    IMBRUVICA Based Combination Regimen First-Line Treatment for Chronic Lymphocytic Leukemia Demonstrates High Rates of Disease Control

    Details:

    Latest data from the CAPTIVATE study underscore that IMBRUVICA in an all-oral fixed-duration combination with venetoclax also delivers a high rate of progression-free survival at two years while enabling treatment-free remission for patients.


    Lead Product(s): Ibrutinib,Venetoclax

    Therapeutic Area: Oncology Brand Name: Imbruvica

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Johnson & Johnson Innovative Medicine

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable May 19, 2021

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    Lead Product(s) : Ibrutinib,Venetoclax

    Therapeutic Area : Oncology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Johnson & Johnson Innovative Medicine

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    IMBRUVICA Based Combination Regimen First-Line Treatment for Chronic Lymphocytic Leukemia Demonstr...

    Details : Latest data from the CAPTIVATE study underscore that IMBRUVICA in an all-oral fixed-duration combination with venetoclax also delivers a high rate of progression-free survival at two years while enabling treatment-free remission for patients.

    Product Name : Imbruvica

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    May 19, 2021

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    AbbVie Gets +Ve CHMP Opinion for VENCLYXTO as a Combination Regimen for Adult Patients with Newly Diagnosed AML Ineligible for Chemotherapy

    Details:

    Positive opinion based on data from the VIALE-A and M14-358 trials, which evaluated the safety, efficacy and pharmacokinetics of VENCLYXTO in combination with hypomethylating agents in adult patients with AML.


    Lead Product(s): Venetoclax,Azacitidine

    Therapeutic Area: Oncology Brand Name: Venclyxto

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable April 23, 2021

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    Lead Product(s) : Venetoclax,Azacitidine

    Therapeutic Area : Oncology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    AbbVie Gets +Ve CHMP Opinion for VENCLYXTO as a Combination Regimen for Adult Patients with Newly ...

    Details : Positive opinion based on data from the VIALE-A and M14-358 trials, which evaluated the safety, efficacy and pharmacokinetics of VENCLYXTO in combination with hypomethylating agents in adult patients with AML.

    Product Name : Venclyxto

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    April 23, 2021

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    Health Canada Approves AbbVie's VENCLEXTA in Combination with Azacitidine Or Low Dose Cytarabine for Untreated Aml Français

    Details:

    In the VIALE-A trial, the median overall survival of patients who received VENCLEXTA plus azacitidine was 14.7 months (11.9, 18.7) vs 9.6 months (7.4, 12.7) in patients who received azacitidine in combination with placebo.


    Lead Product(s): Venetoclax,Azacitidine

    Therapeutic Area: Oncology Brand Name: Venclexta

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Genentech

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 15, 2020

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    Lead Product(s) : Venetoclax,Azacitidine

    Therapeutic Area : Oncology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Genentech

    Deal Size : Inapplicable

    Deal Type : Inapplicable

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    Health Canada Approves AbbVie's VENCLEXTA in Combination with Azacitidine Or Low Dose Cytarabine f...

    Details : In the VIALE-A trial, the median overall survival of patients who received VENCLEXTA plus azacitidine was 14.7 months (11.9, 18.7) vs 9.6 months (7.4, 12.7) in patients who received azacitidine in combination with placebo.

    Product Name : Venclexta

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    December 15, 2020

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    AbbVie's VENCLEXTA® (venetoclax) Receives FDA Full Approval for Acute Myeloid Leukemia (AML)

    Details:

    The FDA approval of VENCLEXTA for newly-diagnosed AML patients who are ineligible for intensive chemotherapy is supported by data from a series of trials including two Phase 3 trials - VIALE-A (M15-656) and VIALE-C (M16-043).


    Lead Product(s): Venetoclax,Cytarabine

    Therapeutic Area: Oncology Brand Name: Venclexta

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 16, 2020

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    Lead Product(s) : Venetoclax,Cytarabine

    Therapeutic Area : Oncology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    AbbVie's VENCLEXTA® (venetoclax) Receives FDA Full Approval for Acute Myeloid Leukemia (AML)

    Details : The FDA approval of VENCLEXTA for newly-diagnosed AML patients who are ineligible for intensive chemotherapy is supported by data from a series of trials including two Phase 3 trials - VIALE-A (M15-656) and VIALE-C (M16-043).

    Product Name : Venclexta

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    October 16, 2020

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    Regulatory Info : RX

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    VENETOCLAX

    Brand Name : VENCLEXTA

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    Approval Date : 2016-04-11

    Application Number : 208573

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    Regulatory Info : Prescription

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    VENETOCLAX

    Brand Name : VENCLEXTA

    Dosage Form : KIT

    Dosage Strength : 50MG

    Packaging : 4 BLISTER PACKS

    Approval Date :

    Application Number : 2458063

    Regulatory Info : Prescription

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    Regulatory Info : Originator

    Registration Country : South Africa

    Venetoclax

    Brand Name : Venclexta 50mg

    Dosage Form : FCT

    Dosage Strength : 50mg

    Packaging : 7X1mg

    Approval Date :

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    Registration Country : South Africa

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    Brand Name : Venclyxto

    Dosage Form : Antic-calc Tablet, Film Coated

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    Brand Name : VENCLEXTA

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    VENETOCLAX

    Brand Name : VENCLEXTA

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    Egypt.png
    Venetoclax API needed in Egypt [ENA22765]
    A company that focuses on research, development & manufacturing of generic, specialty and branded pharmaceutical products is looking for suppliers of Venetoclax API for commercial purposes. The suppliers must support this enquiry with GMP & CoA.
    24 Apr 2025

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    24 Apr 2025

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    Venetoclax API needed in India [ENA21369]
    A CDMO that focuses on manufacturing and development of various finished formulations is looking for suppliers of Venetoclax API. The required quantity is 10 kg for development and 30 kg - 40 kg for exhibit batch. The suppliers must support this enquiry with CEP (optional), EUDMF & CoA.
    09 Dec 2024

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    09 Dec 2024

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    Venetoclax API needed in India [ENA18899]
    A CDMO that focuses on manufacturing and development of various finished formulations is looking for suppliers of Venetoclax API for both commercial & development purposes. The required quantity is 10 kg for development and 30 kg - 40 kg exhibit batch. The suppliers must support this enquiry with EUDMF, CEP & CoA.
    12 Jan 2024

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    12 Jan 2024

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    Ixazomib Citrate & Venetoclax APIs needed in India [ENA13115]
    A CMO that specializes in R&D, manufacturing & marketing of niche finished dosage formulations is looking for suppliers of Ixazomib Citrate & Venetoclax APIs for scale up & exhibit batches. The suppliers must support this enquiry with DMF.
    25 Mar 2022

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    25 Mar 2022

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    Venetoclax (25 kg) API needed in India [ENA07881]
    One of the leading pharmaceutical company in India involved in the manufacturing & distribution of pharmaceutical products is looking for suppliers of Venetoclax (25 kg) API. The suppliers must support this enquiry with GMP.
    13 Jul 2020

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    13 Jul 2020

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    Apalutamide, Cabozantinib malate and other APIs needed in Bangladesh [ENA02773]
    M.R Trading Corporation, Bangladesh is looking for suppliers of following APIs: 1. Apalutamide 2. Cabozantinib malate 3. Ruxolitinib Phosphate 4. Trabectedin INN 5. Venetoclax 6. Aflibercept Interested suppliers can contact Masud via Mob: +880 01725219963 or Email: info@mrtcbd.com.
    28 Nov 2018

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    VENETOCLAX

    US Patent Number : 9174982

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 208573

    Patent Use Code : U-2323

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    Patent Expiration Date : 2030-05-26

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    US Patent Number : 11110087

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 208573

    Patent Use Code : U-3223

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    Patent Expiration Date : 2033-09-06

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    US Patent Number : 11110087

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    US Patent Number : 11590128

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    Patent Expiration Date : 2032-01-29

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    US Patent Number : 8722657

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    Application Number : 208573

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    Patent Expiration Date : 2031-11-21

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    US Patent Number : 10730873

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    Application Number : 208573

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    Patent Expiration Date : 2031-11-21

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    Patent Use Code : U-2537

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    US Patent Number : 9174982

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    Application Number : 208573

    Patent Use Code : U-2323

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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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