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Also known as: 1231929-97-7, Ly2835219, Verzenio, Ly2835219 free base, Ly-2835219, Unii-60uab198hk
Molecular Formula
C27H32F2N8
Molecular Weight
506.6  g/mol
InChI Key
UZWDCWONPYILKI-UHFFFAOYSA-N
FDA UNII
60UAB198HK

Abemaciclib
Abemaciclib is an orally available cyclin-dependent kinase (CDK) inhibitor that targets the CDK4 (cyclin D1) and CDK6 (cyclin D3) cell cycle pathway, with potential antineoplastic activity. Abemaciclib specifically inhibits CDK4 and 6, thereby inhibiting retinoblastoma (Rb) protein phosphorylation in early G1. Inhibition of Rb phosphorylation prevents CDK-mediated G1-S phase transition, thereby arresting the cell cycle in the G1 phase, suppressing DNA synthesis and inhibiting cancer cell growth. Overexpression of the serine/threonine kinases CDK4/6, as seen in certain types of cancer, causes cell cycle deregulation.
Abemaciclib is a Kinase Inhibitor. The mechanism of action of abemaciclib is as a Kinase Inhibitor.
1 2D Structure

Abemaciclib

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
N-[5-[(4-ethylpiperazin-1-yl)methyl]pyridin-2-yl]-5-fluoro-4-(7-fluoro-2-methyl-3-propan-2-ylbenzimidazol-5-yl)pyrimidin-2-amine
2.1.2 InChI
InChI=1S/C27H32F2N8/c1-5-35-8-10-36(11-9-35)16-19-6-7-24(30-14-19)33-27-31-15-22(29)25(34-27)20-12-21(28)26-23(13-20)37(17(2)3)18(4)32-26/h6-7,12-15,17H,5,8-11,16H2,1-4H3,(H,30,31,33,34)
2.1.3 InChI Key
UZWDCWONPYILKI-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CCN1CCN(CC1)CC2=CN=C(C=C2)NC3=NC=C(C(=N3)C4=CC5=C(C(=C4)F)N=C(N5C(C)C)C)F
2.2 Other Identifiers
2.2.1 UNII
60UAB198HK
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 5-(4-ethylpiperazin-1-ylmethyl)pyridin-2-yl)-(5-fluoro-4-(7-fluoro-3-isopropyl-2-methyl-3h-benzimidazol-5-yl)pyrimidin-2-yl)amine

2. 5-(4-ethylpiperazin-1-ylmethyl)pyridin-2-yl)-(5-fluoro-4-(7-fluoro-3-isopropyl-2-methyl-3h-benzoimidazol-5-yl)pyrimidin-2-yl)amine

3. Abemaciclib Mesylate

4. Ly-2835219

5. Ly2385219

6. Ly2835210

7. Ly2835219

8. Verzenio

2.3.2 Depositor-Supplied Synonyms

1. 1231929-97-7

2. Ly2835219

3. Verzenio

4. Ly2835219 Free Base

5. Ly-2835219

6. Unii-60uab198hk

7. N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1h-benzo[d]imidazol-6-yl)pyrimidin-2-amine

8. N-[5-[(4-ethylpiperazin-1-yl)methyl]pyridin-2-yl]-5-fluoro-4-(7-fluoro-2-methyl-3-propan-2-ylbenzimidazol-5-yl)pyrimidin-2-amine

9. Abemaciclib (ly2835219)

10. 60uab198hk

11. Ly 2835219

12. Hy-16297a

13. Cs-1230

14. 2-pyrimidinamine, N-(5-((4-ethyl-1-piperazinyl)methyl)-2-pyridinyl)-5-fluoro-4-(4-fluoro-2-methyl-1-(1-methylethyl)-1h-benzimidazol-6-yl)

15. N-{5-[(4-ethylpiperazin-1-yl)methyl]pyridin-2-yl}-5-fluoro-4-(7-fluoro-3-isopropyl-2-methyl-1,3-benzodiazol-5-yl)pyrimidin-2-amine

16. N-{5-[(4-ethylpiperazin-1-yl)methyl]pyridin-2-yl}-5-fluoro-4-[4-fluoro-2-methyl-1-(propan-2-yl)-1h-benzimidazol-6-yl]pyrimidin-2-amine

17. Ly2835219 (free Base)

18. Abemaciclib [usan:inn]

19. Abemaciclib,ly2835219

20. Verzenios

21. Rimidin-2-amine

22. Verzenio (tn)

23. 6zv

24. N-{5-[(4-ethylpiperazin-1-yl)methyl]pyridin-2-yl}-5-fluoro-4-[4-fluoro-2-methyl-1-(propan-2-yl)-1h-benzimidazol-6-yl]py Rimidin-2-amine

25. Cdk4/6 Dual Inhibitor

26. Ly2835210

27. Abemaciclib [mi]

28. Abemaciclib [inn]

29. Abemaciclib [jan]

30. Abemaciclib (jan/usan)

31. Abemaciclib [usan]

32. Abemaciclib [who-dd]

33. Gtpl7382

34. Schembl2487229

35. Chembl3301610

36. Abemaciclib [orange Book]

37. Dtxsid20673119

38. Ex-a521

39. Ly 2835219 (free Base)

40. Hms3673i05

41. Bcp13079

42. Ex-a1588

43. Bdbm50110183

44. Mfcd22665744

45. Nsc768073

46. Nsc783671

47. S5716

48. Zinc72318121

49. 1231929-97-7, Verzenio,

50. Akos025404907

51. Ly2835219 Free Base (abemaciclib)

52. Ccg-269750

53. Db12001

54. Nsc-768073

55. Nsc-783671

56. Sb16476

57. Ncgc00351599-02

58. Ncgc00351599-06

59. 5-(4-ethylpiperazin-1-ylmethyl)pyridin-2-yl)-(5-fluoro-4-(7-fluoro-3-isopropyl-2-methyl-3h-benzimidazol-5-yl)pyrimidin-2-yl)amine

60. 5-(4-ethylpiperazin-1-ylmethyl)pyridin-2-yl)-(5-fluoro-4-(7-fluoro-3-isopropyl-2-methyl-3h-benzoimidazol-5-yl)pyrimidin-2-yl)amine

61. Ac-30666

62. As-10230

63. Da-33422

64. Ly2835219 Ms Salt, Abemaciclib Ms Salt

65. Ft-0700134

66. Ly 2835210

67. A12989

68. D10688

69. J-690083

70. Q23901483

71. [5-(4-ethyl-piperazin-1-ylmethyl)-pyridin-2-yl]-[5-fluoro-4-(7-fluoro-3-isopropyl-2-methyl-3h-benzoimidazol-5-yl)-pyrimidin-2-yl]-amine

72. 2-pyrimidinamine, N-[5-[(4-ethyl-1-piperazinyl)methyl]-2-pyridinyl]-5-fluoro-4-[4-fluoro-2-methyl-1-(1-methylethyl)-1h-benzimidazol-6-yl]-

73. 2-pyrimidinamine,n-[5-[(4-ethyl-1-piperazinyl)methyl]-2-pyridinyl]-5-fluoro-4-[4-fluoro-2-methyl-1-(1-methylethyl)-1h-benzimidazol-6-yl]-

74. N-{5-[(4-ethylpiperazin-1-yl)methyl]pyridin-2-yl}-5-fluoro-4-[4-fluoro-2-methyl-1-(propan-2-yl)-1h-benzimidazol-6-yl]py

2.4 Create Date
2010-07-06
3 Chemical and Physical Properties
Molecular Weight 506.6 g/mol
Molecular Formula C27H32F2N8
XLogP33.8
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count9
Rotatable Bond Count7
Exact Mass506.27179938 g/mol
Monoisotopic Mass506.27179938 g/mol
Topological Polar Surface Area75 Ų
Heavy Atom Count37
Formal Charge0
Complexity723
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 Information
1 of 1  
Drug NameVERZENIO
Active IngredientABEMACICLIB
CompanyELI LILLY AND CO (Application Number: N208716. Patent: 7855211)

4.2 Drug Indication

* Indicated in combination with fulvestrant for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. * Inidicated as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.


Early Breast Cancer

Verzenios in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, node positive early breast cancer at high risk of recurrence (see section 5. 1).

In pre or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.

Advanced or Metastatic Breast Cancer

Verzenios is indicated for the treatment of women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.

In pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist.


Treatment of Ewing sarcoma


Treatment of breast cancer


Treatment of high-grade glioma, Treatment of neuroblastoma


5 Pharmacology and Biochemistry
5.1 Pharmacology

In combination with fulvestrant, the progression-free survival for patients with HR-positive, HER2-negative breast cancer was 16.4 months compared to 9.3 months for patients taking a placebo with fulvestrant. As a monotherapy, 19.7% of patients taking abemaciclib achieved complete or partial shrinkage of their tumors for a median 8.6 months after treatment. Abemaciclib induces cell cycle arrest and exerts an antitumor activity in human tumor xenograft models. In patient investigations and a healthy volunteer study, abemaciclib is not shown to induce any clinically significant changes in the QTc interval.


5.2 FDA Pharmacological Classification
5.2.1 Active Moiety
ABEMACICLIB
5.2.2 FDA UNII
60UAB198HK
5.2.3 Pharmacological Classes
Kinase Inhibitors [MoA]; Kinase Inhibitor [EPC]
5.3 ATC Code

L01EF03


L - Antineoplastic and immunomodulating agents

L01 - Antineoplastic agents

L01E - Protein kinase inhibitors

L01EF - Cyclin-dependent kinase (cdk) inhibitors

L01EF03 - Abemaciclib


5.4 Absorption, Distribution and Excretion

Absorption

The plasma concentration of the drug increases in a dose-proportional manner. Following a single oral dose administration of 200 mg abemaciclib, the mean peak plasma concentration (Cmax) of 158 ng/mL is reached after 6 hours. The median time to reach maximum plasma concentration (Tmax) ranges from 4-6 hours following an oral administration of abemaciclib over a range of 50275 mg, but may range up to 24 hours. The absolute bioavailability of the drug is reported to be 45%.


Route of Elimination

Following a single oral dose of 150mg radiolabeled abemaciclib, approximately 81% of the total dose was recovered in feces while 3% of the dose was detected in urine. The majority of the drug is exceted as metabolites.


Volume of Distribution

The geometric mean systemic volume of distribution is approximately 690.3 L (49% CV).


Clearance

The geometric mean hepatic clearance (CL) of abemaciclib in patients was 26.0 L/h (51% CV).


5.5 Metabolism/Metabolites

Abemaciclib mainly undergoes hepatic metabolism mediated by CYP3A4. The major metabolite formed is N-desethylabemaciclib (M2), while other metabolites hydroxyabemaciclib (M20), hydroxy-N-desethylabemaciclib (M18), and an oxidative metabolite (M1) are also formed. M2, M18, and M20 are equipotent to abemaciclib and their AUCs accounted for 25%, 13%, and 26% of the total circulating analytes in plasma, respectively.


5.6 Biological Half-Life

The mean plasma elimination half-life for abemaciclib in patients was 18.3 hours (72% CV).


5.7 Mechanism of Action

Regulation of cell cycle is crucial in maintaining proper cell growth; dysregulated cell cycle signalling pathway is a key component in inducing hyperproliferation of cells and tumor formation in various cancers. G1 to S phase cell cycle progression, or transition through the G1 restriction point (R), is promoted by the retinoblastoma tumor suppressor protein (Rb)-mediated pathway. Activation of Rb-mediated pathway requires the interaction of Cyclin-dependent kinases (CDK) 4 and 6 with D-type cyclins, which drives the formation of active CDK4/CDK6 and subsequent phosphorylation of Rb. Rb is a tumor suppressant protein that inhibits proliferation through binding to and suppressing the activity of the E2F family of transcription factors. However, phosphorylation of Rb relieves suppression of E2F to allow expression of genes required for passage through the restriction point. This leads to increased expression of downstream signalling molecules and activity of protein kinases that promote the cell cycle progression and initiation of DNA replication. Phosphorylation of Rb and other proteins by CDK4/6 additionally leads to transcription of genes involved in cell cycle-independent activities including signal transduction, DNA repair transcriptional control, and mRNA processing. Abemaciclib selectively inhibits CDK4 and CDK6 with low nanomolar potency, inhibits Rb phosphorylation resulting in a G1 arrest and inhibition of proliferation, and its activity is specific for Rb-proficient cells. Unlike other CDK inhibitors such as [DB09073] and [DB11730], abemaciclib exhibits greater selectivity for CDK4 compared to CDK6.


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Abemaciclib

About the Company : Since its inception in 2003, Seqens has evolved into a global leader in pharmaceutical solutions and specialty ingredients. With a strong focus on customer support, Seqens assists ...

Since its inception in 2003, Seqens has evolved into a global leader in pharmaceutical solutions and specialty ingredients. With a strong focus on customer support, Seqens assists in the development, scale-up and manufacturing of drug substances from pre-clinical to commercial stages. Seqens boasts a vast portfolio of APIs and proprietary products while also developing custom solutions and ingredients for the healthcare, electronics and cosmetics industries. It operates 16 industrial plants and 9 R&D centers worldwide. Seqens possesses technologies that enable it to produce complex molecules to meet both small- and large-scale demands.
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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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Abemaciclib

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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Abemaciclib

About the Company : Alembic Pharmaceuticals Limited is a leading pharmaceutical company in India. The Company is vertically integrated with the ability to develop, manufacture and market pharmaceutica...

Alembic Pharmaceuticals Limited is a leading pharmaceutical company in India. The Company is vertically integrated with the ability to develop, manufacture and market pharmaceutical products, pharmaceutical substances and Intermediates.
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Abemaciclib

About the Company : Globe Quimica S.A. is a major Brazilian API producer, GMP certificated by ANVISA, manufactures more than 20 different API's such as Antiretrovirals, Anxiolytic, Antidepressant, Ant...

Globe Quimica S.A. is a major Brazilian API producer, GMP certificated by ANVISA, manufactures more than 20 different API's such as Antiretrovirals, Anxiolytic, Antidepressant, Antithrombotic, Analgesic. In 2012 Globe Quimica has started-up its new API plant for Active Ingredients for Oncologic Drugs.
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Abemaciclib

About the Company : Wuhan Sun-shine chemical Corporation Limited (Shanghai Sun-shine Chemical Technology Corporation Limited) is a high-tech enterprise engaged inR&D and sales of related compounds of ...

Wuhan Sun-shine chemical Corporation Limited (Shanghai Sun-shine Chemical Technology Corporation Limited) is a high-tech enterprise engaged inR&D and sales of related compounds of new drugs, specialty pharmaceutical API, advanced intermediates, organic synthetic masonry, and high-end reagents, etc. The special services we provide include: the technical development of chiral drugs, the development of an active molecular library. Sun-shine chemical has over 1,500m² of operation premises. The R&D laboratory is more than 1,000m² and is equipped with a variety of R&D laboratory equipment.
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API Reference Price

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02-Apr-2024
29-Jan-2025
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INTERMEDIATE SUPPLIERS

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Virtual BoothPorton Pharma Solutions: Value creation via innovation & discovery through technical platforms.

CAS Number : 1180132-17-5

End Use API : Abemaciclib

About The Company : Porton Pharma Solutions Ltd. was founded in 2005, & the company's stock was successfully listed in Shenzhen Stock Exchange in 2014. Our R&D, manufacturing & ope...

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Virtual BoothShandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.

CAS Number : 1180132-17-5

End Use API : Abemaciclib

About The Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe ...

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

CAS Number : 1231930-37-2

End Use API : Abemaciclib

About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...

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

CAS Number : 1180132-17-5

End Use API : Abemaciclib

About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...

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CAS Number : 1231930-33-8

End Use API : Abemaciclib

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

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CAS Number : 1180132-17-5

End Use API : Abemaciclib

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

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CAS Number : CAS-1180132-17-5

End Use API : Abemaciclib

About The Company : We are into manufacturing of bulk drug Intermediates and Active Pharmaceutical Ingredients (API). Our core competence is contract manufacturing for our clients ...

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CAS Number : CAS-1231930-33-8

End Use API : Abemaciclib

About The Company : We are into manufacturing of bulk drug Intermediates and Active Pharmaceutical Ingredients (API). Our core competence is contract manufacturing for our clients ...

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Aventus Labs

India
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Aventus Labs

India
Organic Process R&D
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CAS Number : 149806-06-4

End Use API : Abemaciclib

About The Company : Aventus Labs is a forward-thinking pharmaceutical company committed to developing and delivering high-quality, effective healthcare solutions. With a focus on r...

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CAS Number : CAS-2927-71-1

End Use API : Abemaciclib

About The Company : Hebi Xinhe Pharmaceutical Co., Ltd. is a subsidiary of Tianjin Zhennuo Pharmaceutical Group Co., Ltd., with a registered capital of CNY 100 million. Located in ...

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FDA Orange Book

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ABEMACICLIB

Brand Name : VERZENIO

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG

Approval Date : 2017-09-28

Application Number : 208716

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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ABEMACICLIB

Brand Name : VERZENIO

Dosage Form : TABLET;ORAL

Dosage Strength : 100MG

Approval Date : 2017-09-28

Application Number : 208716

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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euroPLX 87
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ABEMACICLIB

Brand Name : VERZENIO

Dosage Form : TABLET;ORAL

Dosage Strength : 150MG

Approval Date : 2017-09-28

Application Number : 208716

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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ABEMACICLIB

Brand Name : VERZENIO

Dosage Form : TABLET;ORAL

Dosage Strength : 200MG

Approval Date : 2017-09-28

Application Number : 208716

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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euroPLX 87
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ABEMACICLIB

Brand Name : VERZENIO

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG

Approval Date :

Application Number : 208855

RX/OTC/DISCN :

RLD :

TE Code :

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ABEMACICLIB

Brand Name : VERZENIO

Dosage Form : TABLET;ORAL

Dosage Strength : 100MG

Approval Date :

Application Number : 208855

RX/OTC/DISCN :

RLD :

TE Code :

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ABEMACICLIB

Brand Name : VERZENIO

Dosage Form : TABLET;ORAL

Dosage Strength : 150MG

Approval Date :

Application Number : 208855

RX/OTC/DISCN :

RLD :

TE Code :

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ABEMACICLIB

Brand Name : VERZENIO

Dosage Form : TABLET;ORAL

Dosage Strength : 200MG

Approval Date :

Application Number : 208855

RX/OTC/DISCN :

RLD :

TE Code :

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Europe

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Abemaciclibum

Brand Name : Verzenios

Dosage Form : Film-Coated Tablets

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Abemaciclibum

Brand Name : Verzenios

Dosage Form : Film-Coated Tablets

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Abemaciclibum

Brand Name : Verzenios

Dosage Form : Filmtabl

Dosage Strength : 150mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Abemaciclibum

Brand Name : Verzenios

Dosage Form : Filmtabl

Dosage Strength : 150mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Abemaciclibum

Brand Name : Verzenios

Dosage Form : Film-Coated Tablets

Dosage Strength : 50mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Abemaciclibum

Brand Name : Verzenios

Dosage Form : Film-Coated Tablets

Dosage Strength : 50mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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ABOUT THIS PAGE

Looking for 1231929-97-7 / Abemaciclib API manufacturers, exporters & distributors?

Abemaciclib manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Abemaciclib 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 Abemaciclib manufacturer or Abemaciclib supplier for your needs.

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

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

API | Excipient name

Abemaciclib

Synonyms

1231929-97-7, Ly2835219, Verzenio, Ly2835219 free base, Ly-2835219, Unii-60uab198hk

Cas Number

1231929-97-7

Unique Ingredient Identifier (UNII)

60UAB198HK

About Abemaciclib

Abemaciclib is an orally available cyclin-dependent kinase (CDK) inhibitor that targets the CDK4 (cyclin D1) and CDK6 (cyclin D3) cell cycle pathway, with potential antineoplastic activity. Abemaciclib specifically inhibits CDK4 and 6, thereby inhibiting retinoblastoma (Rb) protein phosphorylation in early G1. Inhibition of Rb phosphorylation prevents CDK-mediated G1-S phase transition, thereby arresting the cell cycle in the G1 phase, suppressing DNA synthesis and inhibiting cancer cell growth. Overexpression of the serine/threonine kinases CDK4/6, as seen in certain types of cancer, causes cell cycle deregulation.

N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine Manufacturers

A N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine, including repackagers and relabelers. The FDA regulates N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine 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 N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine Suppliers

A N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine supplier is an individual or a company that provides N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine active pharmaceutical ingredient (API) or N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine finished formulations upon request. The N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine suppliers may include N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine API manufacturers, exporters, distributors and traders.

click here to find a list of N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine USDMF

A N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine DMF (Drug Master File) is a document detailing the whole manufacturing process of N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine active pharmaceutical ingredient (API) in detail. Different forms of N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine DMFs exist exist since differing nations have different regulations, such as N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine DMF submitted to regulatory agencies in the US is known as a USDMF. N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine USDMF includes data on N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine suppliers with USDMF on PharmaCompass.

N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine WC

A N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine written confirmation (N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine WC) is an official document issued by a regulatory agency to a N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine manufacturer, verifying that the manufacturing facility of a N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine APIs or N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine finished pharmaceutical products to another nation, regulatory agencies frequently require a N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine WC (written confirmation) as part of the regulatory process.

click here to find a list of N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine suppliers with Written Confirmation (WC) on PharmaCompass.

N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine 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 N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine 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 N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine 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 N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine suppliers with NDC on PharmaCompass.

N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine GMP

N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine 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 N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine 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 N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine GMP manufacturer or N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine GMP API supplier for your needs.

N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine CoA

A N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine CoA (Certificate of Analysis) is a formal document that attests to N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine's compliance with N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine specifications and serves as a tool for batch-level quality control.

N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine CoA mostly includes findings from lab analyses of a specific batch. For each N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine 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.

N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine may be tested according to a variety of international standards, such as European Pharmacopoeia (N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine EP), N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine 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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