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21 API Suppliers, 3 USDMF, 1 EU WC, 4 NDC API, 18 Listed Suppliers, $ API Reference Price

21 API Suppliers
3 USDMF
1 EU WC
4 NDC API
18 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

29 Drugs in Development

29 Drugs in Development

INTERMEDIATES

15 Intermediates Suppliers

15 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

32 FDF Dossiers, 8 FDA Orange Book, 6 Europe, 4 Canada, 6 Australia, 4 South Africa, 4 Listed Dossiers

32 FDF Dossiers
8 FDA Orange Book
6 Europe
4 Canada
6 Australia
4 South Africa
4 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 SPI Pharma, 2 Seqens, 3 DKSH, 2 Faran Shimi Pharmaceutical, 1 Chynops Pharma, 10 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 3 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 9 BASF, 5 Corel Pharma Chem, 5 DFE Pharma, 1 Finar, 7 Gangwal Chemicals, 3 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 20 Kerry, 4 Microlex e.U, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 2 Pluviaendo, 3 Prachin Chemical, 10 Roquette, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 2 Vasa Pharmachem

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36 Fillers, Diluents & Binders, 21 Coating Systems & Additives, 20 Direct Compression, 18 Disintegrants & Superdisintegrants, 15 Thickeners and Stabilizers, 13 Controlled & Modified Release, 11 Lubricants & Glidants, 11 Co-Processed Excipients, 11 Granulation, 8 Topical, 4 Solubilizers, 4 Chewable & Orodispersible Aids, 4 Parenteral, 4 Film Formers & Plasticizers, 3 Taste Masking, 2 Coloring Agents, 2 Rheology Modifiers, 2 Emulsifying Agents, 2 API Stability Enhancers

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1 US Medicaid Prescriptions, 6 Finished Drug Prices, 5 Annual Reports

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6 Finished Drug Prices
5 Annual Reports

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2 APIs

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17 US Patents, 8 US Exclusivities

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17 US Patents
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Porton Abemaciclib

Synopsis

ACTIVE PHARMA INGREDIENTS

21

API Suppliers

3

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0

JDMF

1

EU WC

0

KDMF

4

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18

Listed Suppliers

API REF. PRICE (USD/KG)

$

$ 17,973

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2

API

0

FDF

15INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

32

FDF Dossiers

8

FDA Orange Book

FDA (Orange Book)

6

Europe

4

Canada

6

Australia

4

South Africa

4

Listed Dossiers

29DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

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17

US Patents

8

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Health Canada Patents

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3

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GLOBAL SALES INFORMATION

US Medicaid (USD)

474,171,738

Annual Reports (USD Million)

9,189

Finished Drug Prices

123 RELATED EXCIPIENT COMPANIES

191EXCIPIENTS BY APPLICATIONS

Chemistry

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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 Formula	C₂₇H₃₂F₂N₈
Molecular Weight	506.6 g/mol
XLogP3	3.8
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	9
Rotatable Bond Count	7
Exact Mass	506.27179938 g/mol
Monoisotopic Mass	506.27179938 g/mol
Topological Polar Surface Area	75 Å²
Heavy Atom Count	37
Formal Charge	0
Complexity	723
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Information

1 of 1
Drug Name	VERZENIO
Active Ingredient	ABEMACICLIB
Company	ELI 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.

API SUPPLIERS

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USDMF

01

Msn Laboratories Private Ltd

India

PharmaVenue

Not Confirmed

02

Msn Laboratories Private Ltd

India

PharmaVenue

Not Confirmed

03

Shandong Anhong Pharmaceutical Co Lt...

China

PharmaVenue

Not Confirmed

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EU WC

01

MSN Laboratories

India

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NDC API

01

Eli Lilly Kinsale Limited

U.S.A

PharmaVenue

Not Confirmed

02

Eli Lilly Kinsale Limited

U.S.A

PharmaVenue

Not Confirmed

03

Lonza AG

U.S.A

PharmaVenue

Not Confirmed

04

MSN Laboratories Private Limited

India

PharmaVenue

Not Confirmed

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API Reference Price

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Abemaciclib Manufacturers

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

Abemaciclib Suppliers

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

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

Abemaciclib USDMF

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

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

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

Abemaciclib WC

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

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

Abemaciclib 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 Abemaciclib as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Abemaciclib GMP

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

Abemaciclib CoA

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

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

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