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    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 Weight 451.6 g/mol
    Molecular Formula C26H37N5O2
    XLogP33.4
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count4
    Rotatable Bond Count8
    Exact Mass451.29472544 g/mol
    Monoisotopic Mass451.29472544 g/mol
    Topological Polar Surface Area71.7 Ų
    Heavy Atom Count33
    Formal Charge0
    Complexity713
    Isotope Atom Count0
    Defined Atom Stereocenter Count3
    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 2  
    Drug NameCabergoline
    PubMed HealthCabergoline (By mouth)
    Drug ClassesAntiparkinsonian, Prolactin Secretion Inhibitor
    Drug LabelCabergoline 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 IngredientCabergoline
    Dosage FormTablet
    RouteOral
    Strength0.5mg
    Market StatusPrescription
    CompanyMylan Pharms; Ivax Sub Teva Pharms; Actavis Labs Fl; Apotex; Par Pharm; Impax Labs

    2 of 2  
    Drug NameCabergoline
    PubMed HealthCabergoline (By mouth)
    Drug ClassesAntiparkinsonian, Prolactin Secretion Inhibitor
    Drug LabelCabergoline 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 IngredientCabergoline
    Dosage FormTablet
    RouteOral
    Strength0.5mg
    Market StatusPrescription
    CompanyMylan 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-HT2A, 5-HT1D, dopamine D4, 5-HT1A, dopamine D1, 5-HT1B and 5-HT2C receptors and antagonist activity on α2B, α2A, and α2C 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-HT2A 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 Gi 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.

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    Gedeon Richter

    Hungary

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

    PEGS Boston Summit
    Not Confirmed
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    Gedeon Richter

    Hungary

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

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    PEGS Boston Summit
    Not Confirmed
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 18199

    Submission : 2005-03-21

    Status : Inactive

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
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    USDMF

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    01

    Tapi Nl Bv

    Israel
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    FCE Pharma
    Attending
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    • EDQM
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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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    GDUFA

    DMF Review : Complete

    Rev. Date : 2012-11-02

    Pay. Date : 2012-11-13

    DMF Number : 18113

    Submission : 2005-02-21

    Status : Active

    Type : II

    TAPI Company Banner

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    02

    Antibioticos Spa

    Italy

    USDMF

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    PEGS Boston Summit
    Not Confirmed

    02

    Antibioticos Spa

    Italy
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    PEGS Boston Summit
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 7533

    Submission : 1988-05-23

    Status : Inactive

    Type : II

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    03

    Antibioticos Spa

    Italy

    USDMF

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    PEGS Boston Summit
    Not Confirmed

    03

    Antibioticos Spa

    Italy
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    PEGS Boston Summit
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 7534

    Submission : 1988-05-23

    Status : Inactive

    Type : II

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    04

    PEGS Boston Summit
    Not Confirmed

    04

    Apotex Pharmachem India Pvt Ltd

    Canada
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    PEGS Boston Summit
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 26235

    Submission : 2012-07-13

    Status : Inactive

    Type : II

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    05

    PEGS Boston Summit
    Not Confirmed

    05

    Apotex Pharmachem India Pvt Ltd

    Canada
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    PEGS Boston Summit
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 22620

    Submission : 2009-03-13

    Status : Inactive

    Type : II

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    06

    PEGS Boston Summit
    Not Confirmed

    06

    Finetech Pharmaceutical Ltd

    Israel
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    PEGS Boston Summit
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15423

    Submission : 2001-04-30

    Status : Active

    Type : II

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    07

    Gedeon Richter Plc

    Hungary

    USDMF

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    PEGS Boston Summit
    Not Confirmed

    07

    Gedeon Richter Plc

    Hungary
    arrow
    PEGS Boston Summit
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 18199

    Submission : 2005-03-21

    Status : Inactive

    Type : II

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    08

    Ivax Cr

    U.S.A

    USDMF

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    PEGS Boston Summit
    Not Confirmed

    08

    Ivax Cr

    U.S.A
    arrow
    PEGS Boston Summit
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15933

    Submission : 2002-03-18

    Status : Inactive

    Type : II

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    09

    Pfizer Inc

    U.S.A

    USDMF

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    PEGS Boston Summit
    Not Confirmed

    09

    Pfizer Inc

    U.S.A
    arrow
    PEGS Boston Summit
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 28742

    Submission : 2014-12-12

    Status : Inactive

    Type : II

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    10

    Resolution Chemicals Ltd

    United Kingdom

    USDMF

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    PEGS Boston Summit
    Not Confirmed

    10

    Resolution Chemicals Ltd

    United Kingdom
    arrow
    PEGS Boston Summit
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 18972

    Submission : 2005-11-25

    Status : Inactive

    Type : II

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    CEP/COS

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    LIFECARE LABORATORIES PRIVATE LIMIT...

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

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      Cabergoline

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      CEP 2023-093 - Rev 00
      Valid
      Chemical
      2026-03-12
      1773
      LifeCare Laboratories

      01

      LIFECARE LABORATORIES PRIVATE LIMIT...

      India
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      CPhI China
      Attending
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      Virtual BoothLifecare Labs has been developing innovative products in specialist areas of medicine.

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      Certificate Number : CEP 2023-093 - Rev 00

      Status : Valid

      Issue Date : 2026-03-12

      Type : Chemical

      Substance Number : 1773

      LifeCare Laboratories

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      TAPI CZECH INDUSTRIES S.R.O. Opava ...

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      • EDQM
      • fda
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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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      CEP 2006-170 - Rev 05
      Valid
      Chemical
      2024-12-17
      1773
      TAPI Company Banner

      02

      TAPI CZECH INDUSTRIES S.R.O. Opava ...

      Israel
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      FCE Pharma
      Attending
      • fda
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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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      Cabergoline

      Certificate Number : CEP 2006-170 - Rev 05

      Status : Valid

      Issue Date : 2024-12-17

      Type : Chemical

      Substance Number : 1773

      TAPI Company Banner

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      APOTEX PHARMACHEM INDIA PVT. LTD Ba...

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      • WHO-GMP
      • fda
      • EDQM
      • WHO-GMP
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      Flag Canada
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      CEP 2013-047 - Rev 03
      Valid
      Chemical
      2024-06-26
      1773
      blank

      03

      APOTEX PHARMACHEM INDIA PVT. LTD Ba...

      Canada
      PEGS Boston Summit
      Not Confirmed
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      APOTEX PHARMACHEM INDIA PVT. LTD Ba...

      Canada
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      PEGS Boston Summit
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP
      Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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      Cabergoline

      Certificate Number : CEP 2013-047 - Rev 03

      Status : Valid

      Issue Date : 2024-06-26

      Type : Chemical

      Substance Number : 1773

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      FINETECH PHARMACEUTICAL, LTD. Neshe...

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        Flag Israel
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        Cabergoline, Amorphous

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        R1-CEP 2008-235 - Rev 01
        Valid
        Chemical
        2016-03-11
        1773
        blank

        04

        FINETECH PHARMACEUTICAL, LTD. Neshe...

        Israel
        PEGS Boston Summit
        Not Confirmed
        arrow

        FINETECH PHARMACEUTICAL, LTD. Neshe...

        Israel
        arrow
        PEGS Boston Summit
        Not Confirmed
        • fda
        • EDQM
        • WHO-GMP
        Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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        Cabergoline, Amorphous

        Certificate Number : R1-CEP 2008-235 - Rev 01

        Status : Valid

        Issue Date : 2016-03-11

        Type : Chemical

        Substance Number : 1773

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        Pharmacia & Upjohn SpA Milano IT

        Contact Supplier
        • FDA
        • EDQM
        • WHO-GMP
        • fda
        • EDQM
        • WHO-GMP
        Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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        Flag U.S.A
        Virtual Booth Virtual Booth
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        Cabergoline

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        R0-CEP 2001-110 - Rev 01
        Expired
        TSE
        2005-03-10
        2007-08-19
        1773
        blank

        05

        Pharmacia & Upjohn SpA Milano IT

        U.S.A
        PEGS Boston Summit
        Not Confirmed
        arrow

        Pharmacia & Upjohn SpA Milano IT

        U.S.A
        arrow
        PEGS Boston Summit
        Not Confirmed
        • fda
        • EDQM
        • WHO-GMP
        Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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        Certificate Number : R0-CEP 2001-110 - Rev 01

        Status : Expired

        Issue Date : 2005-03-10

        Type : TSE

        Substance Number : 1773

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        YS LIFE SCIENCE Co. Ltd. Hwaseong-s...

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        Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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        Flag South Korea
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        Cabergoline

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        CEP 2008-091 - Rev 01
        Valid
        Chemical
        2023-10-23
        1773
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        06

        YS LIFE SCIENCE Co. Ltd. Hwaseong-s...

        South Korea
        PEGS Boston Summit
        Not Confirmed
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        YS LIFE SCIENCE Co. Ltd. Hwaseong-s...

        South Korea
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        PEGS Boston Summit
        Not Confirmed
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        Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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        Certificate Number : CEP 2008-091 - Rev 01

        Status : Valid

        Issue Date : 2023-10-23

        Type : Chemical

        Substance Number : 1773

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        Listed Suppliers

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        01

        Lifecare Laboratories Pvt Ltd

        India
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        CPhI China
        Attending
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        Virtual BoothLifecare Labs has been developing innovative products in specialist areas of medicine.

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        Cabergoline

        About the Company : Lifecare Labs manufactures bulk drugs (APIs) and intermediates in line with stringent quality standards. The company focuses on delivering cost-effective solutions while meeting cu...

        Lifecare Labs manufactures bulk drugs (APIs) and intermediates in line with stringent quality standards. The company focuses on delivering cost-effective solutions while meeting customer requirements and building long-term partnerships. With state-of-the-art manufacturing facilities and dedicated production units, Lifecare Labs emphasizes quality, operational excellence, and responsible business practices, serving pharmaceutical markets with a commitment to reliability and sustainability. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
        LifeCare Laboratories

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        02

        Alven Laboratories

        Czech Republic
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        CPhI Milan
        Attending
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        Virtual BoothTrusted Partner for Innovative, Sustainable, and High-Quality API Development and Production.

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        Cabergoline

        About the Company : Alven Laboratories is a pharmaceutical company focused on the development, scale-up, and production of original and generic Active Pharmaceutical Ingredients (APIs). With expertise...

        Alven Laboratories is a pharmaceutical company focused on the development, scale-up, and production of original and generic Active Pharmaceutical Ingredients (APIs). With expertise in complex molecule chemistry and organic synthesis, the company delivers cost-efficient and technologically advanced solutions. Its cGMP-compliant facility supports efficient manufacturing with an emphasis on environmental sustainability, offering reliable and flexible services from early development through commercial production. Note:Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
        AlvenLab

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        03

        LGM Pharma

        U.S.A
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        CPhI North America
        Booth #730
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        Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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        Cabergoline

        About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...

        LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product CDMO, offering formulation, analytical method development and testing, regulatory support, and commercial manufacturing. Supported by a network of over 220 accredited cGMP manufacturing partners and more than 100,000 sq. ft. of FDA-inspected cGMP manufacturing and warehouse space, LGM delivers secure, end-to-end solutions across multiple dosage forms. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
        LGM Pharma CB

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        04

        Jai Radhe Sales

        India
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        PEGS Boston Summit
        Not Confirmed
        • fda
        • EDQM
        • WHO-GMP

        Virtual BoothJai Radhe Sales is your partner for all your sourcing needs.

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        Cabergoline

        About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...

        Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and regulatory support, and strives for global standards. Known for quality and affordability, it has established a niche through innovative methods and exports to nearly every continent. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
        Jai Radhe Sales

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        05

        Deccan Nutraceuticals Pvt. Ltd

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

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        About the Company : Deccan Nutraceuticals Pvt. Ltd. (DNPL) is a group company of Alkaloids Corporation (India), was founded in 2001 and operates from a 22,000 sq. m. facility in Pune (India). Their co...

        Deccan Nutraceuticals Pvt. Ltd. (DNPL) is a group company of Alkaloids Corporation (India), was founded in 2001 and operates from a 22,000 sq. m. facility in Pune (India). Their commitment to quality and adherence to CGMP are integral to their operations. The company has been successfully audited by USFDA (5 times) and EDQM (2 times). The company manufactures high quality phytochemicals, semi-synthetic and synthetic APIs. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
        Deccan Nutraceuticals

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        06

        HRV Pharma

        India
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        PEGS Boston Summit
        Not Confirmed
        • fda
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        • WHO-GMP

        Virtual BoothHRV Pharma - Market Expansion Leader in Pharmaceuticals.

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        Cabergoline

        About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...

        HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing, manufacturing, and supply services to support partners entering new markets worldwide. HRV Pharma works closely with major pharma and food additive companies and represents over 30 Indian drugmakers, primarily serving Europe, the US, and the Middle East. Headquartered in India, it operates offices in the US, Switzerland, Dubai, Lithuania, and Turkey. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
        HRV Global Life Sciences

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        07

        Tenatra Exports

        India
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        PEGS Boston Summit
        Not Confirmed
        • fda
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        • WHO-GMP

        Virtual BoothTenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.

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        About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...

        Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opportunities grew, it was felt that the proprietorship firm had outlived its usefulness and that it needed a corporate structure. So, Tenatra Exports Private Limited was incorporated in 2002. Since then, the company has come a long way, gaining valuable experience and knowledge in the fields of chemicals and pharmaceuticals in India. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
        Tenatra

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        08

        TAPI Technology & API Services

        Israel
        arrow
        FCE Pharma
        Attending
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        • WHO-GMP

        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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        About the Company : Founded in 1935, TAPI Technology & API Services has a long legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios ...

        Founded in 1935, TAPI Technology & API Services has a long legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios with over 350 products, alongside tailored CDMO services. Leveraging deep expertise and diverse technologies, we deliver flexible, high-quality solutions to meet our partners’ needs. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.
        TAPI Company Banner

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        09

        Willow Birch Pharma

        U.S.A
        arrow
        Compounding Pharmacy Compliance
        Attending
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        • WHO-GMP

        Virtual BoothWillow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.

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        Cabergoline

        About the Company : Willow Birch Pharma, Inc. is a premier supplier of bulk APIs to North American Compounding Pharmacies, sourcing from FDA registered and GMP manufacturers. With licenses in all 50 s...

        Willow Birch Pharma, Inc. is a premier supplier of bulk APIs to North American Compounding Pharmacies, sourcing from FDA registered and GMP manufacturers. With licenses in all 50 states as a drug wholesaler and NABP accreditation since 2007, Willow Birch Pharma delivers top-quality products at competitive prices with unparalleled service and regulatory support nationwide. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
        Company Banner

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        10

        Anthem Biosciences

        India
        PEGS Boston Summit
        Not Confirmed
        arrow

        Anthem Biosciences

        India
        arrow
        PEGS Boston Summit
        Not Confirmed
        • fda
        • EDQM
        • WHO-GMP
        Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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        Cabergoline

        About the Company : Anthem Biosciences is a leading contract research and innovation service provider (CRISP) in Bengaluru, India, which manufactures novel drug actives. Established in 2007, it specia...

        Anthem Biosciences is a leading contract research and innovation service provider (CRISP) in Bengaluru, India, which manufactures novel drug actives. Established in 2007, it specializes in both biological and chemistry-based products and services. It has a strong track record in drug and product development, and supports development, optimization and testing of various compounds including proteins, monoclonal antibodies, peptides, large & small molecules and toxins. Inspected by USFDA, Japan’s PMDA, EU QPs, it develops nutritional products using organic synthesis and offers quality control and regulatory compliance assistance to clients.
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        APOTEX INC

        Canada
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        APOTEX INC

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        CABERGOLINE

        Brand Name : APO-CABERGOLINE

        Dosage Form : TABLET

        Dosage Strength : 0.5MG

        Packaging : 8

        Approval Date :

        Application Number : 2455897

        Regulatory Info : PRESCRIPTION

        Registration Country : Canada

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        JAMP PHARMA CORPORATION

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        JAMP PHARMA CORPORATION

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        CABERGOLINE

        Brand Name : JAMP CABERGOLINE

        Dosage Form : TABLET

        Dosage Strength : 0.5MG

        Packaging :

        Approval Date :

        Application Number : 2549611

        Regulatory Info : PRESCRIPTION

        Registration Country : Canada

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        PFIZER CANADA ULC

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        PFIZER CANADA ULC

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        CABERGOLINE

        Brand Name : DOSTINEX

        Dosage Form : TABLET

        Dosage Strength : 0.5MG

        Packaging : 8

        Approval Date :

        Application Number : 2242471

        Regulatory Info : PRESCRIPTION

        Registration Country : Canada

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        NEWS #PharmaBuzz

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        Skg Pharma's Generic Cabergoline Receives Approval in US
        Skg Pharma's Generic Cabergoline Receives Approval in US

        25 Jun 2024

        // FDA

        https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218618

        FDA
        25 Jun 2024
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        CF Pharma received HALAL certification
        CF Pharma received HALAL certification

        06 Jul 2019

        // PRESS RELEASE

        http://cfpharma.hu/archive/cf-pharma-received-halal-certification-copy-copy/

        PRESS RELEASE
        06 Jul 2019
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        Ingenus Pharms' Generic Cabergoline Receives Approval in US
        Ingenus Pharms' Generic Cabergoline Receives Approval in US

        06 Aug 2018

        // FDA

        https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204735

        FDA
        06 Aug 2018
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        Eisai Acquires All Global Development & Marketing Rights For Lorcaserin HCI
        Eisai Acquires All Global Development & Marketing Rights For Lorcaserin HCI

        05 Jan 2017

        // PR NEWSWIRE

        http://www.prnewswire.com/news-releases/eisai-acquires-all-global-development-and-marketing-rights-for-chronic-weight-management-treatment-lorcaserin-hci-300385785.html

        PR NEWSWIRE
        05 Jan 2017
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        Drug Giant Pfizer Forced to Recall Medicines without Childproof Caps
        Drug Giant Pfizer Forced to Recall Medicines without Childproof Caps

        11 Mar 2015

        // Samantha Landy HERALD SUN

        http://www.heraldsun.com.au/news/victoria/drug-giant-pfizer-forced-to-recall-medicines-without-childproof-caps/story-fni0fit3-1227259055670

        Samantha Landy HERALD SUN
        11 Mar 2015
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        APIs

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        Cabergoline (100 g) API needed in the U.S.A [ENA25970]
        A compounding pharmacy that focuses on various finished dosage formulations is looking for suppliers of Cabergoline (100 g) API for development purposes. The suppliers must support this enquiry with CoA.
        30 Apr 2026

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        30 Apr 2026

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        30 Apr 2026

        india-flag.png
        Cabergoline API needed in India [ENA25498]
        A company that focuses on the development and manufacturing of various finished formulations is looking for suppliers of Cabergoline API for development purposes. The suppliers must support this enquiry with CoA.
        10 Mar 2026

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        10 Mar 2026

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        10 Mar 2026

        SaudiArabia.png
        Cabergoline (100 g - 200 g) API needed in Saudi Arabia [ENA22057]
        A company that focuses on manufacturing of various finished formulations is looking for suppliers of Cabergoline (100 g - 200 g) API for commercial purposes. The suppliers must support this enquiry with CEP, DMF & CoA.
        13 Feb 2025

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        13 Feb 2025

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        13 Feb 2025

        india-flag.png
        Cabergoline (20 g) API needed in India [ENA16319]
        A company that deals in the distribution of various pharmaceutical products is looking for suppliers of Cabergoline (20 g) API for commercial purposes. The suppliers must support this enquiry with CoA.
        07 Feb 2023

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        07 Feb 2023

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        Reply Comment (9)

        07 Feb 2023

        China.png
        Cabergoline (MOQ) API needed in China [ENA13710]
        A pharmaceutical company that focused in research, development and manufacturing of injections, cartridges and gels is looking for suppliers of Cabergoline (MOQ) API for development purpose. The suppliers must support this enquiry with DMF, CEP & CoA.
        21 May 2022

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        21 May 2022

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        21 May 2022

        Iraq.png
        Various APIs needed in Iraq [ENA09081]
        A biopharmaceutical company focused on the discovery, development and commercialization of various medicines is looking for suppliers of Various Reference Standard APIs. The required quantity is 50 mg each. 1. Standard reference for Paracetamol 2. Standard reference for Cholecalciferol 3. Standard reference for Cabergoline
        18 Nov 2020

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        18 Nov 2020

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        18 Nov 2020

        Iran.png
        EP/USP grade Cabergoline (1000 g) API needed in Iran [ENA05968]
        A chemical and pharmaceutical procuring and marketing company in Iran is looking for suppliers of EP/USP grade Cabergoline (1000 g) API. The supplier must support this enquiry with CoA.
        06 Dec 2019

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        06 Dec 2019

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        06 Dec 2019

        Moldova.png
        Cabergoline, Clomiphene and other APIs needed in Moldova [ENA05222]
        A leading pharmaceutical company involved in development and production of high-quality drugs in the form of soft dosage forms is looking for suppliers of APIs mentioned below. The supplier must support this enquiry with CoA, ASMF, and GMP. 1. Cabergoline 2. Clomiphene 3. Desogestrel 4. Dienogest 5. Drospirenone 6. Dydrogesterone 7. Estradiol 8. Ethinyl Estradiol 9. Levonorgestrel 10. Levothyroxine 11. Mifepristone 12. Misoprostol 13. Norethisterone.
        21 Sep 2019

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        21 Sep 2019

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        21 Sep 2019

        Canada.png
        Cabergoline and various other APIs needed in Canada [ENA04140]
        A global supplier of high quality raw materials, carrying a full line of pharmaceutical ingredients, nutraceuticals, natural herbal extracts, specialty & fine chemicals, as well as custom designed products for all industries worldwide is looking for the suppliers of the following products: 1. Cabergoline: 500 mg, 1 g, 5 g 2. Lactulose: 100 g, 200 g, 500 g, 1 kg 3. Niclosamide: 100 g, 500 g, 1 kg, 5 kg 4. Aminophylline: 500 g, 1 kg, 5 kg, 10 kg 5. Sodium Tetradecyl Sulfate: 25 g, 100 g, 500 g 6. Glucagon: 25 g, 50 g, 100 g 7. Cholestyramine: 5 kg, 10 kg, 25 kg, 50 kg 8. Minoxidil: 500 g, 1 kg, 5 kg 9. Isoflupredone Acetate: 100 g, 500 g, 1 kg, 2 kg 10. Chloro-m-cresol: 10 g, 50 g, 100 g, 500 g Suppliers must support with CoA of current batch and shelf life (3-5 years preferable); and US FDA registration of the company required.
        10 May 2019

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        10 May 2019

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        10 May 2019

        Canada.png
        Cycloserine and other APIs needed in Canada [ENA04079]
        A global supplier of high quality raw materials, carrying a full line of pharmaceutical ingredients, nutraceuticals, natural herbal extracts, specialty & fine chemicals, as well as custom designed products for all industries worldwide is looking forthe suppliers ofthe following products: 1. Cycloserine- Qty: 1 kg, 5 kg 2. Cabergoline- Qty: 50 g, 100 g, 500 g, 1 kg 3. Oxibendazole - Qty:500 g, 1 kg, 5 kg 4. Hydroxocobalamin HCl- Qty: 100 g, 500 g, 1 kg, 3 kg 5. Phenoxybenzamine HCl- Qty: 500 g, 1 kg, 2 kg 6. Thiamine HCl- Qty: 5 kg, 10 kg, 25 kg, 50 kg 7. Phenylpropanolamine- Qty: 1 kg, 2 kg, 5 kg Suppliers must support with USFDA registration and CoA.
        03 May 2019

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        03 May 2019

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        03 May 2019

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        REF. STANDARDS & IMPURITIES

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        ABOUT THIS PAGE

        Looking for 81409-90-7 / Cabergoline API manufacturers, exporters & distributors?

        Cabergoline manufacturers, exporters & distributors 1

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        PharmaCompass offers a list of Cabergoline API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Cabergoline manufacturer or Cabergoline supplier for your needs.

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

        API | Excipient name

        Cabergoline

        Synonyms

        81409-90-7, Dostinex, Cabaser, Cabergolinum [latin], Cabergolina [spanish], Cabergolinum

        Cas Number

        81409-90-7

        Unique Ingredient Identifier (UNII)

        LL60K9J05T

        About 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.

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

        A Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)-, including repackagers and relabelers. The FDA regulates Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- 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 Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.

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

        A Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- supplier is an individual or a company that provides Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- active pharmaceutical ingredient (API) or Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- finished formulations upon request. The Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- suppliers may include Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- API manufacturers, exporters, distributors and traders.

        click here to find a list of Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.

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

        A Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- DMF (Drug Master File) is a document detailing the whole manufacturing process of Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- active pharmaceutical ingredient (API) in detail. Different forms of Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- DMFs exist exist since differing nations have different regulations, such as Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- USDMF, ASMF (EDMF), JDMF, CDMF, etc.

        A Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- DMF submitted to regulatory agencies in the US is known as a USDMF. Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- USDMF includes data on Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)-'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- USDMF is kept confidential to protect the manufacturer’s intellectual property.

        click here to find a list of Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- suppliers with USDMF on PharmaCompass.

        Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- 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 Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- Drug Master File in Japan (Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- JDMF) empowers Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- 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 Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- JDMF during the approval evaluation for pharmaceutical products. At the time of Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- 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 Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- suppliers with JDMF on PharmaCompass.

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

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

        Pharmaceutical companies submit a Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- Drug Master File in Korea (Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)-. The MFDS reviews the Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- KDMF as part of the drug registration process and uses the information provided in the Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- KDMF to evaluate the safety and efficacy of the drug.

        After submitting a Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- 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 Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- API can apply through the Korea Drug Master File (KDMF).

        click here to find a list of Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- suppliers with KDMF on PharmaCompass.

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

        A Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- CEP of the European Pharmacopoeia monograph is often referred to as a Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- Certificate of Suitability (COS). The purpose of a Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- to their clients by showing that a Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- CEP has been issued for it. The manufacturer submits a Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- CEP holder for the record. Additionally, the data presented in the Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- DMF.

        A Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- 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 Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- suppliers with CEP (COS) on PharmaCompass.

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

        A Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- written confirmation (Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- WC) is an official document issued by a regulatory agency to a Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- manufacturer, verifying that the manufacturing facility of a Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- APIs or Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- finished pharmaceutical products to another nation, regulatory agencies frequently require a Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- WC (written confirmation) as part of the regulatory process.

        click here to find a list of Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- suppliers with Written Confirmation (WC) on PharmaCompass.

        Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- 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 Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- as an active pharmaceutical ingredient (API).

        Finished drug products

        The FDA updates the NDC directory daily. The NDC numbers for Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- 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 Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- 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 Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- NDC to their finished compounded human drug products, they may choose to do so.

        click here to find a list of Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- suppliers with NDC on PharmaCompass.

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

        Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- 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 Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- GMP manufacturer or Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- GMP API supplier for your needs.

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

        A Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- CoA (Certificate of Analysis) is a formal document that attests to Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)-'s compliance with Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- specifications and serves as a tool for batch-level quality control.

        Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- CoA mostly includes findings from lab analyses of a specific batch. For each Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- 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.

        Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- may be tested according to a variety of international standards, such as European Pharmacopoeia (Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- EP), Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ergoline-8-carboxamide, N-(3-(dimethylamino)propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)-, (8-beta)- 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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