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Cabergoline

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

26 API Suppliers, 11 USDMF, 5 CEP/COS, 1 JDMF, 3 EU WC, 1 KDMF, 5 NDC API, 17 Listed Suppliers, $ API Reference Price

26 API Suppliers
11 USDMF
5 CEP/COS
1 JDMF
3 EU WC
1 KDMF
5 NDC API
17 Listed Suppliers
$ API Reference Price

INTERMEDIATES

2 Intermediates Suppliers

2 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

90 FDF Dossiers, 10 FDA Orange Book, 58 Europe, 2 Canada, 9 Australia, 4 South Africa, 7 Listed Dossiers

90 FDF Dossiers
10 FDA Orange Book
58 Europe
2 Canada
9 Australia
4 South Africa
7 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 Evonik, 1 SPI Pharma, 3 Faran Shimi Pharmaceutical, 9 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 BASF, 6 DFE Pharma, 3 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 25 Kerry, 10 Microlex e.U, 1 Pharmatrans-Sanaq, 3 Pluviaendo, 3 Prachin Chemical, 9 Roquette, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

46 Fillers, Diluents & Binders, 23 Direct Compression, 14 Co-Processed Excipients, 14 Disintegrants & Superdisintegrants, 13 Granulation, 11 Lubricants & Glidants, 10 Thickeners and Stabilizers, 5 Controlled & Modified Release, 3 Taste Masking, 3 Coating Systems & Additives, 2 Rheology Modifiers, 2 Chewable & Orodispersible Aids, 1 Emulsifying Agents, 1 Parenteral, 1 Film Formers & Plasticizers

excipientsByApplications
46 Fillers, Diluents & Binders
23 Direct Compression
14 Co-Processed Excipients
14 Disintegrants & Superdisintegrants
13 Granulation
11 Lubricants & Glidants
10 Thickeners and Stabilizers
5 Controlled & Modified Release
3 Taste Masking
3 Coating Systems & Additives
2 Rheology Modifiers
2 Chewable & Orodispersible Aids
1 Emulsifying Agents
1 Parenteral
1 Film Formers & Plasticizers

DIGITAL CONTENT

5 NEWS #PharmaBuzz

media
5 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 25 Finished Drug Prices

globalSalesInformation
1 US Medicaid Prescriptions
25 Finished Drug Prices

MARKET PLACE

10 APIs, 5 FDF Dossiers, 1 Intermediates

marketPlace
10 APIs
5 FDF Dossiers
1 Intermediates

REF. STANDARDS & IMPURITIES

1 EDQM , 1 USP , 1 Others

otherSolutions
1 EDQM
1 USP
1 Others

Lifecare Cabergoline

Synopsis

ACTIVE PHARMA INGREDIENTS

26

API Suppliers

11

USDMF

5

CEP/COS

CEP/COS Certifications

1

JDMF

3

EU WC

1

KDMF

5

NDC API

0

VMF

17

Listed Suppliers

API REF. PRICE (USD/KG)

$

$ 260,006

MARKET PLACE

10

API

5

FDF

2INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

90

FDF Dossiers

10

FDA Orange Book

FDA (Orange Book)

58

Europe

2

Canada

9

Australia

4

South Africa

7

Listed Dossiers

0 DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

1

EDQM

1

USP

0

JP

1

Others

PATENTS & EXCLUSIVITIES

0

US Patents

0

US Exclusivities

0

Health Canada Patents

DIGITAL CONTENT

0

Data Compilation #PharmaFlow

0

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

5

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

9,805,491

Annual Reports (USD Million)

NA

Finished Drug Prices

99 RELATED EXCIPIENT COMPANIES

149EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 81409-90-7, Dostinex, Cabaser, Cabergolinum [latin], Cabergolina [spanish], Cabergolinum

Molecular Formula

C₂₆H₃₇N₅O₂

Molecular Weight

451.6 g/mol

InChI Key

KORNTPPJEAJQIU-KJXAQDMKSA-N

FDA UNII

LL60K9J05T

Cabergoline

An ergoline derivative and dopamine D2-agonist that inhibits PROLACTIN secretion. It is used in the management of HYPERPROLACTINEMIA, and to suppress lactation following childbirth for medical reasons. Cabergoline is also used in the management of PARKINSON DISEASE.

Cabergoline is an Ergot Derivative.

1 2D Structure

Cabergoline

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(6aR,9R,10aR)-N-[3-(dimethylamino)propyl]-N-(ethylcarbamoyl)-7-prop-2-enyl-6,6a,8,9,10,10a-hexahydro-4H-indolo[4,3-fg]quinoline-9-carboxamide

2.1.2 InChI

InChI=1S/C26H37N5O2/c1-5-11-30-17-19(25(32)31(26(33)27-6-2)13-8-12-29(3)4)14-21-20-9-7-10-22-24(20)18(16-28-22)15-23(21)30/h5,7,9-10,16,19,21,23,28H,1,6,8,11-15,17H2,2-4H3,(H,27,33)/t19-,21-,23-/m1/s1

2.1.3 InChI Key

KORNTPPJEAJQIU-KJXAQDMKSA-N

2.1.4 Canonical SMILES

CCNC(=O)N(CCCN(C)C)C(=O)C1CC2C(CC3=CNC4=CC=CC2=C34)N(C1)CC=C

2.1.5 Isomeric SMILES

CCNC(=O)N(CCCN(C)C)C(=O)[C@@H]1C[C@H]2[C@@H](CC3=CNC4=CC=CC2=C34)N(C1)CC=C

2.2 Other Identifiers

2.2.1 UNII

LL60K9J05T

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 1-((6-allylergolin-8beta-yl)carbonyl)-1-(3-(dimethylamino)propyl)-3-ethylurea

2. 1-ethyl-2-(3'-dimethylaminopropyl)-3-(6'-allylergoline-8'-beta-carbonyl)urea Diphosphate

3. Cabaser

4. Cabaseril

5. Cabergoline Diphosphate

6. Dostinex

7. Fce 21336

8. Fce-21336

9. Galastop

2.3.2 Depositor-Supplied Synonyms

1. 81409-90-7

2. Dostinex

3. Cabaser

4. Cabergolinum [latin]

5. Cabergolina [spanish]

6. Cabergolinum

7. Cabergolina

8. Fce-21336

9. Fce 21336

10. Velactis

11. 1-((6-allylergolin-8beta-yl)carbonyl)-1-(3-(dimethylamino)propyl)-3-ethylurea

12. Cabaseril

13. Chebi:3286

14. Ll60k9j05t

15. Dsstox_cid_2719

16. 1-[(6-allylergoline-8beta-yl)carbonyl]-1-[3-(dimethylamino)propyl]-3-ethylurea

17. 1-ethyl-3-(3'-dimethylamionpropyl)-2-(6'-allylergoline-8'beta-carbonyl)urea

18. (8r)-6-allyl-n-[3-(dimethylamino)propyl]-n-(ethylcarbamoyl)ergoline-8-carboxamide

19. Dsstox_rid_76698

20. Dsstox_gsid_22719

21. (6ar,9r,10ar)-7-allyl-n-(3-(dimethylamino)propyl)-n-(ethylcarbamoyl)-4,6,6a,7,8,9,10,10a-octahydroindolo[4,3-fg]quinoline-9-carboxamide

22. (8beta)-n-[3-(dimethylamino)propyl]-n-[(ethylamino)carbonyl]-6-(2-propenyl)-ergoline-8-carboxamide

23. Sogilen

24. Dostinex (tn)

25. 1-[3-(dimethylamino)propyl]-3-ethyl-1-{[(2r,4r,7r)-6-(prop-2-en-1-yl)-6,11-diazatetracyclo[7.6.1.0^{2,7}.0^{12,16}]hexadeca-1(16),9,12,14-tetraen-4-yl]carbonyl}urea

26. Cabaser (tn)

27. Cas-81409-90-7

28. Sr-05000001493

29. Brn 6020775

30. Unii-ll60k9j05t

31. Caberlin

32. Ncgc00167821-01

33. Cabergoline [usan:usp:inn:ban]

34. Cg-101

35. Mfcd00867887

36. Cabergoline [mi]

37. Cabergoline [inn]

38. Cabergoline [jan]

39. Cabergoline [usan]

40. Gtpl37

41. Cabergoline [vandf]

42. Cabergoline [mart.]

43. Schembl42292

44. Cabergoline [usp-rs]

45. Cabergoline [who-dd]

46. (8beta)-n-[3-(dimethylamino)propyl]-n-(ethylcarbamoyl)-6-(prop-2-en-1-yl)ergoline-8-carboxamide

47. Bidd:gt0775

48. Cabergoline (jan/usp/inn)

49. Chembl1201087

50. Dtxsid6022719

51. Cabergoline, >=98% (hplc)

52. Cabergoline [orange Book]

53. Cabergoline [ep Monograph]

54. Hms2090a09

55. Hms3886h05

56. Cabergoline [usp Monograph]

57. Zinc3800008

58. Tox21_112589

59. Bdbm50426497

60. S5842

61. Akos015961587

62. Tox21_112589_1

63. Db00248

64. Fce-21336fce-21336

65. Cabergoline [ema Epar Veterinary]

66. Ncgc00344544-01

67. (8beta)-n-[3-(dimethylamino)propyl]-n-[(ethylamino)carbonyl]-6-prop-2-en-1-ylergoline-8-carboxamide

68. Ac-26126

69. Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-n-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)-

70. Ergoline-8beta-carboxamide, N-(3-(dimethylamino)propyl)-n-((ethylamino)carbonyl)-6-(2-propenyl)-

71. Hy-15296

72. C08187

73. D00987

74. F17353

75. Ab01275484-01

76. 409c907

77. Q423308

78. Sr-05000001493-1

79. Sr-05000001493-2

80. Brd-k86882815-001-01-6

81. Cabergoline, European Pharmacopoeia (ep) Reference Standard

82. Cabergoline, United States Pharmacopeia (usp) Reference Standard

83. Ethyl4-methyl-2-pyridin-3-yl-1,3-thiazole-5-carboxylate

84. 1-((6-allylergolin-8.beta.-yl)carbonyl)-1-(3-(dimethylamino)propyl)-3-ethylurea

85. 6-allyl-n-[3-(dimethylamino)propyl]-n-[(ethylamino)carbonyl]-ergoline-8beta-carboxamide

86. N-[3-(dimethylamino)propyl]-n-(ethylcarbamoyl)-6-allyl-ergoline-8beta-carboxamide

87. (6ar,9r,10ar)-n-[3-(dimethylamino)propyl]-n-(ethylcarbamoyl)-7-prop-2-enyl-6,6a,8,9,10,10a-hexahydro-4h-indolo[4,3-fg]quinoline-9-carboxamide

88. (9r,10ar)-7-allyl-n-(3-(dimethylamino)propyl)-n-(ethylcarbamoyl)-4,6,6a,7,8,9,10,10a-octahydroindolo[4,3-fg]quinoline-9-carboxamide

89. Ergoline-8.beta.-carboxamide, N-(3-(dimethylamino)propyl)-n-((ethylamino)carbonyl)-6-(2-propenyl)-

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₂₆H₃₇N₅O₂
Molecular Weight	451.6 g/mol
XLogP3	3.4
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	4
Rotatable Bond Count	8
Exact Mass	451.29472544 g/mol
Monoisotopic Mass	451.29472544 g/mol
Topological Polar Surface Area	71.7 Å²
Heavy Atom Count	33
Formal Charge	0
Complexity	713
Isotope Atom Count	0
Defined Atom Stereocenter Count	3
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 2
Drug Name	Cabergoline
PubMed Health	Cabergoline (By mouth)
Drug Classes	Antiparkinsonian, Prolactin Secretion Inhibitor
Drug Label	Cabergoline tablets contain cabergoline, a dopamine receptor agonist. The chemical name for cabergoline is 1-[(6-Allylergolin-8-yl)carbonyl]-1-[3-(dimethylamino)propyl]-3-ethylurea. Its molecular formula is C26H37N5O2, and its molecular weight is 4...
Active Ingredient	Cabergoline
Dosage Form	Tablet
Route	Oral
Strength	0.5mg
Market Status	Prescription
Company	Mylan Pharms; Ivax Sub Teva Pharms; Actavis Labs Fl; Apotex; Par Pharm; Impax Labs

2 of 2
Drug Name	Cabergoline
PubMed Health	Cabergoline (By mouth)
Drug Classes	Antiparkinsonian, Prolactin Secretion Inhibitor
Drug Label	Cabergoline tablets contain cabergoline, a dopamine receptor agonist. The chemical name for cabergoline is 1-[(6-Allylergolin-8-yl)carbonyl]-1-[3-(dimethylamino)propyl]-3-ethylurea. Its molecular formula is C26H37N5O2, and its molecular weight is 4...
Active Ingredient	Cabergoline
Dosage Form	Tablet
Route	Oral
Strength	0.5mg
Market Status	Prescription
Company	Mylan Pharms; Ivax Sub Teva Pharms; Actavis Labs Fl; Apotex; Par Pharm; Impax Labs

4.2 Drug Indication

For the treatment of hyperprolactinemic disorders, either idiopathic or due to prolactinoma (prolactin-secreting adenomas). May also be used to manage symptoms of Parkinsonian Syndrome as monotherapy during initial symptomatic management or as an adjunct to levodopa therapy during advanced stages of disease.

For use in the herd management programme of dairy cows as an aid in the abrupt drying-off by reducing milk production to:

- reduce milk leakage at drying off;

- reduce the risk of new intramammary infections during the dry period;

- reduce discomfort.

5 Pharmacology and Biochemistry

5.1 Pharmacology

Cabergoline stimulates centrally-located dopaminergic receptors resulting in a number of pharmacologic effects. Five dopamine receptor types from two dopaminergic subfamilies have been identified. The dopaminergic D1 receptor subfamily consists of D₁ and D₅ subreceptors, which are associated with dyskinesias. The dopaminergic D2 receptor subfamily consists of D₂, D₃ and D₄ subreceptors, which are associated with improvement of symptoms of movement disorders. Thus, agonist activity specific for D2 subfamily receptors, primarily D₂ and D₃ receptor subtypes, are the primary targets of dopaminergic antiparkinsonian agents. It is thought that postsynaptic D2 stimulation is primarily responsible for the antiparkinsonian effect of dopamine agonists, while presynaptic D2 stimulation confers neuroprotective effects. This semisynthetic ergot derivative exhibits potent agonist activity on dopamine D₂- and D₃-receptors. It also exhibits: agonist activity (in order of decreasing binding affinities) on 5-hydroxytryptamine (5-HT)_2B, 5-HT_2A, 5-HT_1D, dopamine D₄, 5-HT_1A, dopamine D₁, 5-HT_1B and 5-HT_2C receptors and antagonist activity on α_2B, α_2A, and α_2C receptors. Parkinsonian Syndrome manifests when approximately 80% of dopaminergic activity in the nigrostriatal pathway of the brain is lost. As this striatum is involved in modulating the intensity of coordinated muscle activity (e.g. movement, balance, walking), loss of activity may result in dystonia (acute muscle contraction), Parkinsonism (including symptoms of bradykinesia, tremor, rigidity, and flattened affect), akathesia (inner restlessness), tardive dyskinesia (involuntary muscle movements usually associated with long-term loss of dopaminergic activity), and neuroleptic malignant syndrome, which manifests when complete blockage of nigrostriatal dopamine occurs. High dopaminergic activity in the mesolimbic pathway of the brain causes hallucinations and delusions; these side effects of dopamine agonists are manifestations seen in patients with schizophrenia who have overractivity in this area of the brain. The hallucinogenic side effects of dopamine agonists may also be due to 5-HT_2A agonism. The tuberoinfundibular pathway of the brain originates in the hypothalamus and terminates in the pituitary gland. In this pathway, dopamine inhibits lactotrophs in anterior pituitary from secreting prolactin. Increased dopaminergic activity in the tuberoinfundibular pathway inhibits prolactin secretion.

5.2 MeSH Pharmacological Classification

Antiparkinson Agents

Agents used in the treatment of Parkinson's disease. The most commonly used drugs act on the dopaminergic system in the striatum and basal ganglia or are centrally acting muscarinic antagonists. (See all compounds classified as Antiparkinson Agents.)

Dopamine Agonists

Drugs that bind to and activate dopamine receptors. (See all compounds classified as Dopamine Agonists.)

5.3 FDA Pharmacological Classification

5.3.1 Active Moiety

CABERGOLINE

5.3.2 FDA UNII

LL60K9J05T

5.3.3 Pharmacological Classes

Ergot Derivative [EPC]; Ergolines [CS]

5.4 ATC Code

QG02CB03

G02CB03

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

G - Genito urinary system and sex hormones

G02 - Other gynecologicals

G02C - Other gynecologicals

G02CB - Prolactine inhibitors

G02CB03 - Cabergoline

N - Nervous system

N04 - Anti-parkinson drugs

N04B - Dopaminergic agents

N04BC - Dopamine agonists

N04BC06 - Cabergoline

5.5 Absorption, Distribution and Excretion

Absorption

First-pass effect is seen, however the absolute bioavailability is unknown.

Route of Elimination

After oral dosing of radioactive cabergoline to five healthy volunteers, approximately 22% and 60% of the dose was excreted within 20 days in the urine and feces, respectively. Less than 4% of the dose was excreted unchanged in the urine.

Clearance

renal cl=0,008 L/min

nonrenal cl=3.2 L/min

5.6 Metabolism/Metabolites

Hepatic. Cabergoline is extensively metabolized, predominately via hydrolysis of the acylurea bond of the urea moiety. Cytochrome P-450 mediated metabolism appears to be minimal. The main metabolite identified in urine is 6-allyl-8b-carboxy-ergoline (4-6% of dose). Three other metabolites were identified urine (less than 3% of dose).

5.7 Biological Half-Life

The elimination half-life is estimated from urinary data of 12 healthy subjects to range between 63 to 69 hours.

5.8 Mechanism of Action

The dopamine D₂ receptor is a 7-transmembrane G-protein coupled receptor associated with G_i proteins. In lactotrophs, stimulation of dopamine D₂ causes inhibition of adenylyl cyclase, which decreases intracellular cAMP concentrations and blocks IP3-dependent release of Ca²⁺ from intracellular stores. Decreases in intracellular calcium levels may also be brought about via inhibition of calcium influx through voltage-gated calcium channels, rather than via inhibition of adenylyl cyclase. Additionally, receptor activation blocks phosphorylation of p42/p44 MAPK and decreases MAPK/ERK kinase phosphorylation. Inhibition of MAPK appears to be mediated by c-Raf and B-Raf-dependent inhibition of MAPK/ERK kinase. Dopamine-stimulated growth hormone release from the pituitary gland is mediated by a decrease in intracellular calcium influx through voltage-gated calcium channels rather than via adenylyl cyclase inhibition. Stimulation of dopamine D₂ receptors in the nigrostriatal pathway leads to improvements in coordinated muscle activity in those with movement disorders. Cabergoline is a long-acting dopamine receptor agonist with a high affinity for D2 receptors. Receptor-binding studies indicate that cabergoline has low affinity for dopamine D1, α₁,- and α₂- adrenergic, and 5-HT₁- and 5-HT₂-serotonin receptors.

API SUPPLIERS

01

Lifecare Laboratories Pvt Ltd

India

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

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Not Confirmed

Lifecare Labs has been developing innovative products in specialist areas of medicine.

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India

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LifeCare Laboratories

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02

CF Pharma

Hungary

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

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Not Confirmed

CF Pharma- skilled & highly experienced European API producer based in Hungary.

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Hungary

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AUDIT

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03

Jai Radhe Sales

India

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

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Not Confirmed

Jai Radhe Sales is your partner for all your sourcing needs.

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LGM Pharma

U.S.A

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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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Deccan Nutraceuticals Pvt. Ltd

India

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

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Not Confirmed

Deccan Nutraceuticals: A global leader in the integrated development, manufacturing, and marketing of pharmaceutical products.

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06

HRV Global Life Sciences

India

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HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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07

TAPI Technology & API Services

Israel

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

TAPI offers customized CDMO Solutions for API development and manufacturing services.

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08

Gedeon Richter

Hungary

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09

Pfizer Inc

U.S.A

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10

Resolution Chemicals Limited

United Kingdom

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API Reference Price

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FLOOR,,BAL R AJESHWAR ROAD, MODEL TOWN,"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1636914600,"product":"CABERGOLINE","address":"SPARC TANDALJA","city":"VADODARA","supplier":"TEVA API","supplierCountry":"CZECH REPUBLIC","foreign_port":"NA","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"INDIA","quantity":"0.22","actualQuantity":"0.22","unit":"KGS","unitRateFc":"375000","totalValueFC":"83695","currency":"USD","unitRateINR":"28331250","date":"15-Nov-2021","totalValueINR":"6232875","totalValueInUsd":"83695","indian_port":"DELHI AIR","hs_no":"29419090","bill_no":"6261106","productDescription":"API","marketType":"REGULATED MARKET","country":"CZECH REPUBLIC","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"SPARC TANDALJA"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1637519400,"product":"CABERGOLINE - QUANTITY - 0.550 KGS - FOC - (FREE SUPPLY OF RAW MATERIAL AGAINST EXPORT ORDER).","address":"CENTAUR HOUSE, SHANTI NAGAR,,VAKOL A, SANTACRUZ - 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D6 D8, SY.NO. 234\/2,234\/3,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1719858600,"product":"CABERGOLINE(702350)","address":"FLAT NO 305, TARA TOWERS, SALEEM NAGAR, MALAKPET, HEYDERABAD","city":"HYDERABAD","supplier":"TEVA API","supplierCountry":"NETHERLANDS","foreign_port":"PRAGUE - RUZYNE","customer":"RITSA PHARMA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.21","actualQuantity":"0.21","unit":"KGS","unitRateFc":"350000","totalValueFC":"74123.3","currency":"USD","unitRateINR":"29505000","date":"02-Jul-2024","totalValueINR":"6196050","totalValueInUsd":"74123.3","indian_port":"Hyderabad Air","hs_no":"29182990","bill_no":"4290760","productDescription":"API","marketType":"REGULATED MARKET","country":"NETHERLANDS","selfForZScoreResived":"Pharma Grade","supplierPort":"PRAGUE - RUZYNE","supplierAddress":"Piet Hein Building, Piet Heinkade107,1019 GM AmsterdamThe Netherlands NL","customerAddress":"FLAT NO 305, TARA TOWERS, SALEEM NAGAR, MALAKPET, HEYDERABAD"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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ABOUT THIS PAGE

Cabergoline Manufacturers

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

Cabergoline Suppliers

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

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

Cabergoline USDMF

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

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

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

Cabergoline JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Cabergoline Drug Master File in Japan (Cabergoline JDMF) empowers Cabergoline API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Cabergoline JDMF during the approval evaluation for pharmaceutical products. At the time of Cabergoline JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Cabergoline suppliers with JDMF on PharmaCompass.

Cabergoline KDMF

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

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

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

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

Cabergoline CEP

A Cabergoline CEP of the European Pharmacopoeia monograph is often referred to as a Cabergoline Certificate of Suitability (COS). The purpose of a Cabergoline CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cabergoline EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cabergoline to their clients by showing that a Cabergoline CEP has been issued for it. The manufacturer submits a Cabergoline CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cabergoline CEP holder for the record. Additionally, the data presented in the Cabergoline CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cabergoline DMF.

A Cabergoline CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cabergoline CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Cabergoline suppliers with CEP (COS) on PharmaCompass.

Cabergoline WC

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

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

Cabergoline 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 Cabergoline as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Cabergoline GMP

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

Cabergoline CoA

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

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

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