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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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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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American Thoracic Society
Not Confirmed
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American Thoracic Society
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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
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Natco Pharma

India
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American Thoracic Society
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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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12-Feb-2021
21-Mar-2025
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Drugs in Development

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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

Abbvie Company Banner

01

AbbVie Inc

U.S.A
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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

Abbvie Company Banner

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

Abbvie Company Banner

02

AbbVie Inc

U.S.A
arrow

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

Abbvie Company Banner

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

Abbvie Company Banner

03

AbbVie Inc

U.S.A
arrow

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

Abbvie Company Banner

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

Abbvie Company Banner

04

AbbVie Inc

U.S.A
arrow

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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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

U.S.A
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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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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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AbbVie Inc

U.S.A
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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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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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AbbVie Inc

U.S.A
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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

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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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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08

AbbVie Inc

U.S.A
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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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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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09

AbbVie Inc

U.S.A
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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

Abbvie Company Banner

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

Abbvie Company Banner

10

AbbVie Inc

U.S.A
arrow

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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FDF Dossiers

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01

AbbVie Inc

U.S.A

VENETOCLAX

Brand Name : VENCLEXTA

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2016-04-11

Application Number : 208573

Regulatory Info : RX

Registration Country : USA

Abbvie Company Banner

02

AbbVie Inc

U.S.A

venetoclax

Brand Name : Venclyxto

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 100 mg

Packaging : Blister, endose

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Abbvie Company Banner

03

AbbVie Inc

U.S.A

venetoclax

Brand Name : Venclyxto

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 50 mg

Packaging : Blister, endose

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Abbvie Company Banner

04

AbbVie Inc

U.S.A

Venetoclaxum

Brand Name : Venclyxto

Dosage Form : Filmtabl

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Abbvie Company Banner

05

AbbVie Inc

U.S.A

Venetoclaxum

Brand Name : Venclyxto

Dosage Form : Filmtabl

Dosage Strength : 50mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Abbvie Company Banner

06

AbbVie Inc

U.S.A

VENETOCLAX

Brand Name : VENCLEXTA

Dosage Form : KIT

Dosage Strength : 50MG

Packaging : 4 BLISTER PACKS

Approval Date :

Application Number : 2458063

Regulatory Info : Prescription

Registration Country : Canada

Abbvie Company Banner

07

AbbVie Inc

U.S.A

Venetoclax

Brand Name : Venclexta 50mg

Dosage Form : FCT

Dosage Strength : 50mg

Packaging : 7X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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08

AbbVie Inc

U.S.A

Venetoclax

Brand Name : Venclexta

Dosage Form :

Dosage Strength :

Packaging : 120

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Abbvie Company Banner

09

AbbVie Inc

U.S.A

Venetoclax

Brand Name : Venclexta

Dosage Form :

Dosage Strength :

Packaging : 120

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Abbvie Company Banner

10

AbbVie Inc

U.S.A

Venetoclax

Brand Name : Venclexta

Dosage Form :

Dosage Strength :

Packaging : 7

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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Europe

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01

AbbVie Inc

U.S.A

venetoclax

Brand Name : Venclyxto

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 10 mg

Packaging : Blister, endose

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Abbvie Company Banner

02

AbbVie Inc

U.S.A

venetoclax

Brand Name : Venclyxto

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 100 mg

Packaging : Blister, endose

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Abbvie Company Banner

03

AbbVie Inc

U.S.A

venetoclax

Brand Name : Venclyxto

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 100 mg

Packaging : Blister, endose

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Abbvie Company Banner

04

AbbVie Inc

U.S.A

venetoclax

Brand Name : Venclyxto

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 100 mg

Packaging : Blister, endose

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Abbvie Company Banner

05

AbbVie Inc

U.S.A

venetoclax

Brand Name : Venclyxto

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 50 mg

Packaging : Blister, endose

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Abbvie Company Banner

06

AbbVie AG

U.S.A

Venetoclaxum

Brand Name : Venclyxto

Dosage Form : Filmtabl

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Abbvie Company Banner

07

AbbVie AG

U.S.A

Venetoclaxum

Brand Name : Venclyxto

Dosage Form : Filmtabl

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Abbvie Company Banner

08

AbbVie AG

U.S.A

Venetoclaxum

Brand Name : Venclyxto

Dosage Form : Filmtabl

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Abbvie Company Banner

09

AbbVie AG

U.S.A

Venetoclaxum

Brand Name : Venclyxto

Dosage Form : Filmtabl

Dosage Strength : 10mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Abbvie Company Banner

10

AbbVie AG

U.S.A

Venetoclaxum

Brand Name : Venclyxto

Dosage Form : Filmtabl

Dosage Strength : 50mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Canada

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01

VENETOCLAX

Brand Name : VENCLEXTA

Dosage Form : TABLET

Dosage Strength : 10MG

Packaging : Feb-14

Approval Date :

Application Number : 2458039

Regulatory Info : Prescription

Registration Country : Canada

Abbvie Company Banner

02

VENETOCLAX

Brand Name : VENCLEXTA

Dosage Form : TABLET

Dosage Strength : 50MG

Packaging : 01-Jul

Approval Date :

Application Number : 2458047

Regulatory Info : Prescription

Registration Country : Canada

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03

VENETOCLAX

Brand Name : VENCLEXTA

Dosage Form : TABLET

Dosage Strength : 100MG

Packaging : 1/120

Approval Date :

Application Number : 2458055

Regulatory Info : Prescription

Registration Country : Canada

Abbvie Company Banner

04

VENETOCLAX

Brand Name : VENCLEXTA

Dosage Form : KIT

Dosage Strength : 10MG

Packaging : 4 BLISTER PACKS

Approval Date :

Application Number : 2458063

Regulatory Info : Prescription

Registration Country : Canada

Abbvie Company Banner

05

VENETOCLAX

Brand Name : VENCLEXTA

Dosage Form : KIT

Dosage Strength : 50MG

Packaging : 4 BLISTER PACKS

Approval Date :

Application Number : 2458063

Regulatory Info : Prescription

Registration Country : Canada

Abbvie Company Banner

06

VENETOCLAX

Brand Name : VENCLEXTA

Dosage Form : KIT

Dosage Strength : 100MG

Packaging : 4 BLISTER PACKS

Approval Date :

Application Number : 2458063

Regulatory Info : Prescription

Registration Country : Canada

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Australia

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01

Venetoclax

Brand Name : Venclexta

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Abbvie Company Banner

02

Venetoclax

Brand Name : Venclexta

Dosage Form :

Dosage Strength :

Packaging : 7

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Abbvie Company Banner

03

Venetoclax

Brand Name : Venclexta

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Abbvie Company Banner

04

Venetoclax

Brand Name : Venclexta

Dosage Form :

Dosage Strength :

Packaging : 120

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Abbvie Company Banner

05

Venetoclax

Brand Name : Venclexta

Dosage Form :

Dosage Strength :

Packaging : 120

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Abbvie Company Banner

06

Venetoclax

Brand Name : Venclexta

Dosage Form :

Dosage Strength :

Packaging : 120

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Abbvie Company Banner

07

Venetoclax

Brand Name : Venclexta

Dosage Form :

Dosage Strength :

Packaging : 2

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Abbvie Company Banner

08

Venetoclax

Brand Name : Venclexta

Dosage Form :

Dosage Strength :

Packaging : 120

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Abbvie Company Banner

09

Venetoclax

Brand Name : Venclexta

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Abbvie Company Banner

10

Venetoclax

Brand Name : Venclexta

Dosage Form :

Dosage Strength :

Packaging : 120

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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Patents & EXCLUSIVITIES

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US Patents

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01

ABBVIE

U.S.A

VENETOCLAX

US Patent Number : 9174982

Drug Substance Claim :

Drug Product Claim :

Application Number : 208573

Patent Use Code : U-2323

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2030-05-26

Abbvie Company Banner

02

ABBVIE

U.S.A

VENETOCLAX

US Patent Number : 11110087

Drug Substance Claim :

Drug Product Claim :

Application Number : 208573

Patent Use Code : U-3223

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2033-09-06

Abbvie Company Banner

03

ABBVIE

U.S.A

VENETOCLAX

US Patent Number : 11110087

Drug Substance Claim :

Drug Product Claim :

Application Number : 208573

Patent Use Code : U-3222

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2033-09-06

Abbvie Company Banner

04

ABBVIE

U.S.A

VENETOCLAX

US Patent Number : 11590128

Drug Substance Claim :

Drug Product Claim :

Application Number : 208573

Patent Use Code : U-3548

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2033-09-06

Abbvie Company Banner

05

ABBVIE

U.S.A

VENETOCLAX

US Patent Number : 11413282

Drug Substance Claim :

Drug Product Claim :

Application Number : 208573

Patent Use Code : U-3412

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2033-09-06

Abbvie Company Banner

06

ABBVIE

U.S.A

VENETOCLAX

US Patent Number : 8722657

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 208573

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2032-01-29

Abbvie Company Banner

07

ABBVIE

U.S.A

VENETOCLAX

US Patent Number : 10730873

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 208573

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2031-11-21

Abbvie Company Banner

08

ABBVIE

U.S.A

VENETOCLAX

US Patent Number : 9174982

Drug Substance Claim :

Drug Product Claim :

Application Number : 208573

Patent Use Code : U-2537

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2030-05-26

Abbvie Company Banner

09

ABBVIE

U.S.A

VENETOCLAX

US Patent Number : 11110087

Drug Substance Claim :

Drug Product Claim :

Application Number : 208573

Patent Use Code : U-3223

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2033-09-06

Abbvie Company Banner

10

ABBVIE

U.S.A

VENETOCLAX

US Patent Number : 9174982

Drug Substance Claim :

Drug Product Claim :

Application Number : 208573

Patent Use Code : U-2323

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2030-05-26

Abbvie Company Banner
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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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