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    Chemistry

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    Also known as: 130929-57-6, Comtess, Comtan, Entacaponum, Or-611, Entacapona
    Molecular Formula
    C14H15N3O5
    Molecular Weight
    305.29  g/mol
    InChI Key
    JRURYQJSLYLRLN-BJMVGYQFSA-N
    FDA UNII
    4975G9NM6T
    Entacapone
    Entacapone is a nitrocatechol compound with anti-parkinsonian property. Entacapone is a selective and reversible inhibitor of catechol-O-methyltransferase (COMT), which catalyzes the transfer of the methyl group of S-adenosyl-L-methionine to the phenolic group of substrates that contain a catechol structure including dihydroxyphenylalanine (DOPA), catecholamines (dopamine, norepinephrine, and epinephrine) and their hydroxylated metabolites. When administered in conjunction with dopaminergic agents such as L-DOPA, entacapone prevents the metabolism and inactivation of adjunct drugs, thereby increasing the bioavailability of these compounds by facilitating their passage across the blood-brain barrier.
    Entacapone is a Catechol-O-Methyltransferase Inhibitor. The mechanism of action of entacapone is as a Catechol O-Methyltransferase Inhibitor.
    1 2D Structure

    Entacapone

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylprop-2-enamide
    2.1.2 InChI
    InChI=1S/C14H15N3O5/c1-3-16(4-2)14(20)10(8-15)5-9-6-11(17(21)22)13(19)12(18)7-9/h5-7,18-19H,3-4H2,1-2H3/b10-5+
    2.1.3 InChI Key
    JRURYQJSLYLRLN-BJMVGYQFSA-N
    2.1.4 Canonical SMILES
    CCN(CC)C(=O)C(=CC1=CC(=C(C(=C1)O)O)[N+](=O)[O-])C#N
    2.1.5 Isomeric SMILES
    CCN(CC)C(=O)/C(=C/C1=CC(=C(C(=C1)O)O)[N+](=O)[O-])/C#N
    2.2 Other Identifiers
    2.2.1 UNII
    4975G9NM6T
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 2-cyano-n,n-diethyl-3-(3,4-dihydroxy-5-nitrophenyl)propenamide

    2. Comtan

    3. Comtess

    4. Or 611

    5. Or-611

    2.3.2 Depositor-Supplied Synonyms

    1. 130929-57-6

    2. Comtess

    3. Comtan

    4. Entacaponum

    5. Or-611

    6. Entacapona

    7. (e)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-n,n-diethylacrylamide

    8. 116314-67-1

    9. Entacapone Teva

    10. Entacapone Orion

    11. (e)-alpha-cyano-n,n-diethyl-3,4-dihydroxy-5-nitrocinnamamide

    12. (e)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-n,n-diethylprop-2-enamide

    13. (2e)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-n,n-diethylprop-2-enamide

    14. Chembl953

    15. 2-propenamide, 2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-n,n-diethyl-

    16. Chebi:4798

    17. 2-cyano-n,n-diethyl-3-(3,4-dihydroxy-5-nitrophenyl)propenamide

    18. N,n-diethyl-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl) Acrylamide

    19. 4975g9nm6t

    20. (2e)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-n,n-diethyl-2-propenamide

    21. Entacaponum [inn-latin]

    22. Entacapone Sodium

    23. Entacapona [inn-spanish]

    24. Ncgc00164555-01

    25. Entacom

    26. 2-propenamide, 2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-n,n-diethyl-, (2e)-

    27. Dsstox_cid_26439

    28. Dsstox_rid_81615

    29. Dsstox_gsid_46439

    30. Or 611

    31. (e)-entacapone

    32. (~{e})-2-cyano-~{n},~{n}-diethyl-3-[3-nitro-4,5-bis(oxidanyl)phenyl]prop-2-enamide

    33. Comtan (tn)

    34. Cas-130929-57-6

    35. Sr-05000001452

    36. (e)-2-cyano-3-(3,4-dihydroxy-5-nitro-phenyl)-n,n-diethyl-prop-2-enamide

    37. Unii-4975g9nm6t

    38. Com-998

    39. Entacapone [usan:usp:inn:ban]

    40. Entacapone [mi]

    41. Entacapone [inn]

    42. Entacapone [jan]

    43. Entacapone [usan]

    44. (e)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-n,n-diethyl-2-propenamide

    45. Entacapone [vandf]

    46. Entacapone [mart.]

    47. Entacapone [usp-rs]

    48. Entacapone [who-dd]

    49. Schembl34504

    50. Schembl34505

    51. Bidd:gt0026

    52. Entacapone [ema Epar]

    53. 2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-n,n-diethyl-2-propenamide

    54. Entacapone (jp17/usp/inn)

    55. Gtpl6647

    56. Dtxsid5046439

    57. Entacapone [orange Book]

    58. Schembl13596593

    59. Hsdb 8251

    60. Entacapone [ep Monograph]

    61. Entacapone [usp Monograph]

    62. Hms2089o16

    63. Hms3713b20

    64. Hms3885k09

    65. Or611

    66. Stalevo Component Entacapone

    67. Corbilta Component Entacapone

    68. Ex-a1130

    69. Tox21_112184

    70. Ac-393

    71. Bdbm50108879

    72. Mfcd00866580

    73. S3147

    74. Zinc35342787

    75. Akos015907685

    76. Akos015965009

    77. Entacapone Component Of Stalevo

    78. Tox21_112184_1

    79. Bcp9000645

    80. Ccg-213064

    81. Cs-1266

    82. Db00494

    83. Entacapone Component Of Corbilta

    84. Ncgc00164555-02

    85. Ncgc00164555-03

    86. Ncgc00164555-10

    87. Hy-14280

    88. E0961

    89. Sw199035-2

    90. C07943

    91. D00781

    92. Ab01275450-01

    93. Ab01275450_02

    94. Ab01275450_03

    95. 929e576

    96. A806167

    97. A922031

    98. Q416444

    99. J-005902

    100. J-008069

    101. Sr-05000001452-1

    102. Sr-05000001452-2

    103. Sr-05000001452-3

    104. Brd-k83636919-001-01-4

    105. Levodopa/carbidopa/entacapone Orion Component Entacapone

    106. (e)-n,n-diethyl-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)acrylamide

    107. Entacapone Component Of Levodopa/carbidopa/entacapone Orion

    108. (e)-.alpha.-cyano-n,n-diethyl-3,4-dihydroxy-5-nitrocinnamamide

    109. (e)-n, N-diethyl-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)acrylamide

    110. (e)-2-cyano-n,n-diethyl-3-[3-nitro-4,5-bis(oxidanyl)phenyl]prop-2-enamide

    111. 2-propenamide,2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-n,n-diethyl-,(2e)-

    112. Pd9

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 305.29 g/mol
    Molecular Formula C14H15N3O5
    XLogP32.1
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count6
    Rotatable Bond Count4
    Exact Mass305.10117059 g/mol
    Monoisotopic Mass305.10117059 g/mol
    Topological Polar Surface Area130 Ų
    Heavy Atom Count22
    Formal Charge0
    Complexity500
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count1
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameComtan
    PubMed HealthEntacapone (By mouth)
    Drug ClassesAntiparkinsonian
    Drug LabelComtan (entacapone) is available as tablets containing 200-mg entacapone.Entacapone is an inhibitor of catechol-O-methyltransferase (COMT), used in the treatment of Parkinson's Disease as an adjunct to levodopa/carbidopa therapy. It is a nitrocatec..
    Active IngredientEntacapone
    Dosage FormTablet
    RouteOral
    Strength200mg
    Market StatusPrescription
    CompanyOrion Pharma

    2 of 4  
    Drug NameEntacapone
    PubMed HealthEntacapone (By mouth)
    Drug ClassesAntiparkinsonian
    Drug LabelEntacapone is available as tablets containing 200-mg entacapone.Entacapone is an inhibitor of catechol-O-methyltransferase (COMT), used in the treatment of Parkinsons Disease as an adjunct to levodopa/carbidopa therapy. It is a nitrocatechol struc...
    Active IngredientEntacapone
    Dosage FormTablet
    RouteOral
    Strength200mg
    Market StatusPrescription
    CompanyMylan Pharms; Wockhardt; Sun Pharma Global

    3 of 4  
    Drug NameComtan
    PubMed HealthEntacapone (By mouth)
    Drug ClassesAntiparkinsonian
    Drug LabelComtan (entacapone) is available as tablets containing 200-mg entacapone.Entacapone is an inhibitor of catechol-O-methyltransferase (COMT), used in the treatment of Parkinson's Disease as an adjunct to levodopa/carbidopa therapy. It is a nitrocatec..
    Active IngredientEntacapone
    Dosage FormTablet
    RouteOral
    Strength200mg
    Market StatusPrescription
    CompanyOrion Pharma

    4 of 4  
    Drug NameEntacapone
    PubMed HealthEntacapone (By mouth)
    Drug ClassesAntiparkinsonian
    Drug LabelEntacapone is available as tablets containing 200-mg entacapone.Entacapone is an inhibitor of catechol-O-methyltransferase (COMT), used in the treatment of Parkinsons Disease as an adjunct to levodopa/carbidopa therapy. It is a nitrocatechol struc...
    Active IngredientEntacapone
    Dosage FormTablet
    RouteOral
    Strength200mg
    Market StatusPrescription
    CompanyMylan Pharms; Wockhardt; Sun Pharma Global

    4.2 Therapeutic Uses

    Antiparkinson Agents; Enzyme Inhibitors

    National Library of Medicine's Medical Subject Headings. Entacapone. Online file (MeSH, 2015). Available from, as of May 1, 2015: https://www.nlm.nih.gov/mesh/2014/mesh_browser/MBrowser.html

    /CLINICAL TRIALS/ ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. The Web site is maintained by the National Library of Medicine (NLM) and the National Institutes of Health(NIH). Each ClinicalTrials.gov record presents summary information about a study protocol and includes the following: Disease or condition; Intervention (for example, the medical product, behavior, or procedure being studied); Title, description, and design of the study; Requirements for participation (eligibility criteria); Locations where the study is being conducted; Contact information for the study locations; and Links to relevant information on other health Web sites, such as NLM's MedlinePlus for patient health information and PubMed for citations and abstracts for scholarly articles in the field of medicine. Entacapone is included in the database.

    NIH/NLM; ClinicalTrials.Gov. Available from, as of July 18, 2015: https://clinicaltrials.gov/search/intervention=entacapone

    Comtan is indicated as an adjunct to levodopa and carbidopa to treat end-of-dose "wearing-off" in patients with Parkinson's disease. /Included in US product label/

    NIH; DailyMed. Current Medication Information for Comtan (Entacapone) Tablet, Film Coated (Updated: July 2014). Available from, as of June 4, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b1aceb59-9be8-43b8-83d6-81e05e4b51e4

    Stalevo, a combination drug consisting of levodopa, carbidopa (dopa decarboxylase inhibitor), and entacapone (catechol-O-methyltransferase-COMT inhibitor) is indicated for the treatment of Parkinson's disease. Stalevo can be used: to substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products. To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose "wearing-off" and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias. /Included in US product label/

    NIH; DailyMed. Current Medication Information for Stalevo (Carbidopa, Levodopa and Entacapone) Tablet, Film Coated (Updated: August 2014). Available from, as of May 4, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5edfc3e7-f80d-47ee-897a-c02ff4eb3e74

    Parkinson's disease (PD) is a neurodegenerative disorder characterized by a variety of motor symptoms including freezing of gait (FOG), in which walking is transiently halted as if the patient's feet were 'glued to the ground'. Treatment of FOG is still challenging. Although L-threo-3,4-dihydroxyphenylserine (L-DOPS), a precursor of noradrenaline, has been on the market in Japan because of its beneficial effect for FOG, clinical use of L-DOPS has been far from satisfying. However, the fact that there were some responders to L-DOPS encouraged us to hypothesize that the enhancement of L-DOPS concentration in the brain by the co-administration of L-DOPS and a catechol-O-methyl transferase (COMT) inhibitor, which is expected to interrupt L-DOPS metabolism in the peripheral circulation, would be beneficial for FOG. Based on our hypothesis, we conducted a preliminary study with a small number of participants with FOG. Of the 16 PD patients with FOG who completed this study, group 1 (n=6) received L-DOPS co-administered with entacapone, which is a COMT inhibitor used worldwide as an anti-parkinson drug, group 2 (n=5) received entacapone alone, and group 3 (n=5) received L-DOPS alone. Only the patients in group 1 showed a significant improvement in FOG. Moreover, the beneficial effect was observed only in patients with levodopa-resistant FOG. This result supports our hypothesis, at least in patients with levodopa-resistant FOG, and shows that the co-administration of L-DOPS and entacapone could be a new strategy for FOG treatment.

    PMID:23265352 Fukada K et al; Med Hypotheses 80 (2): 209-12 (2013)

    4.3 Drug Warning

    Diarrhea was reported in 10% of patients receiving entacapone in clinical studies, and about 2% of patients required discontinuance of the drug because of diarrhea. Diarrhea generally was of mild to moderate intensity, but severe diarrhea, which required hospitalization, may occur rarely. Diarrhea generally occurs during the first 4-12 weeks of entacapone therapy, but may occur as early as the first week or as late as several months following initiation of entacapone therapy. Diarrhea generally resolved following discontinuance of the drug.

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 2649

    Findings from an FDA-conducted meta-analysis suggest that patients receiving combined therapy with levodopa, carbidopa, and entacapone may be at increased risk of cardiovascular events (i.e., myocardial infarction, stroke, cardiovascular death) compared with those receiving levodopa-carbidopa. The meta-analysis combined cardiovascular-related findings from 15 clinical trials that compared the combination of levodopa, carbidopa, and entacapone with levodopa-carbidopa and found a small but statistically significant increase in the risk of cardiovascular events in those receiving the levodopa, carbidopa, and entacapone regimen (relative risk: 2.46). However, the increased risk was driven largely by data from a single trial (STRIDE-PD); when this trial was removed from the analysis, the results were no longer significant. Various factors make it difficult to draw firm conclusions from this meta-analysis. Many of the trials included in the analysis had a duration of less than 6 months (possibly not long enough to detect cardiovascular risk) and were not specifically designed to evaluate cardiovascular safety. In addition, the majority of patients had preexisting cardiovascular risk factors. At this time, FDA has not concluded that combined therapy with levodopa, carbidopa, and entacapone is associated with an increased risk of cardiovascular events and is continuing to review the available data related to this safety concern. Patients currently receiving entacapone as an adjunct to levodopa-carbidopa (either separately or as a fixed-combination preparation) should continue to take the drugs as prescribed unless otherwise instructed by a clinician. Cardiac function should be monitored regularly in such patients, particularly in those with a history of cardiovascular disease.

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 2648

    Dopaminergic therapy in Parkinson's disease patients has been associated with orthostatic hypotension. Entacapone enhances levodopa bioavailability and, therefore, might be expected to increase the occurrence of orthostatic hypotension. In controlled studies, approximately 1.2% and 0.8% of 200 mg entacapone and placebo patients, respectively, reported at least one episode of syncope. Reports of syncope were generally more frequent in patients in both treatment groups who had an episode of documented hypotension.

    NIH; DailyMed. Current Medication Information for Comtan (Entacapone) Tablet, Film Coated (Updated: July 2014). Available from, as of June 4, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b1aceb59-9be8-43b8-83d6-81e05e4b51e4

    Postmarketing reports indicate that patients may experience new or worsening mental status and behavioral changes, which may be severe, including psychotic-like behavior during Comtan treatment or after starting or increasing the dose of Comtan. Other drugs prescribed to improve the symptoms of Parkinson's disease can have similar effects on thinking and behavior. Abnormal thinking and behavior can cause paranoid ideation, delusions, hallucinations, confusion, disorientation, aggressive behavior, agitation, and delirium. Psychotic-like behaviors were also observed during the clinical development of Comtan. Patients with a major psychotic disorder should ordinarily not be treated with Comtan because of the risk of exacerbating psychosis. In addition, certain medications used to treat psychosis may exacerbate the symptoms of Parkinson's disease and may decrease the effectiveness of Comtan.

    NIH; DailyMed. Current Medication Information for Comtan (Entacapone) Tablet, Film Coated (Updated: July 2014). Available from, as of June 4, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b1aceb59-9be8-43b8-83d6-81e05e4b51e4

    For more Drug Warnings (Complete) data for ENTACAPONE (22 total), please visit the HSDB record page.

    4.4 Drug Indication

    Used as an adjunct to levodopa / carbidopa in the symptomatic treatment of patients with idiopathic Parkinson's Disease who experience the signs and symptoms of end-of-dose "wearing-off".

    FDA Label

    Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in adult patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.

    Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.

    Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in adult patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.

    Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in adult patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Entacapone is structurally and pharmacologically related to tolcapone, but unlike tolcapone, is not associated with hepatotoxicity. Entacapone is used in the treatment of Parkinson’s disease as an adjunct to levodopa/carbidopa therapy. Entacapone selectively and reversiblly inhibits catechol-O-methyltransferase (COMT). In mammals, COMT is distributed throughout various organs with the highest activities in the liver and kidney. COMT also occurs in the heart, lung, smooth and skeletal muscles, intestinal tract, reproductive organs, various glands, adipose tissue, skin, blood cells and neuronal tissues, especially in glial cells. COMT catalyzes the transfer of the methyl group of S-adenosyl-L-methionine to the phenolic group of substrates that contain a catechol structure. Physiological substrates of COMT include dopa, catecholamines (dopamine, norepinephrine, and epinephrine) and their hydroxylated metabolites. The function of COMT is the elimination of biologically active catechols and some other hydroxylated metabolites. COMT is responsible for the elimination of biologically active catechols and some other hydroxylated metabolites. In the presence of a decarboxylase inhibitor, COMT becomes the major metabolizing enzyme for levodopa, catalyzing the it to 3-methoxy-4-hydroxy-L-phenylalanine (3-OMD) in the brain and periphery.

    5.2 MeSH Pharmacological Classification

    Catechol O-Methyltransferase Inhibitors

    Compounds and drugs that inhibit or block the activity of CATECHOL O-METHYLTRANSFERASE enzymes. Drugs in this class are used in management of central nervous system disorders such as PARKINSON DISEASE. (See all compounds classified as Catechol O-Methyltransferase Inhibitors.)

    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.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    ENTACAPONE
    5.3.2 FDA UNII
    4975G9NM6T
    5.3.3 Pharmacological Classes
    Catechol-O-Methyltransferase Inhibitor [EPC]; Catechol O-Methyltransferase Inhibitors [MoA]
    5.4 ATC Code

    N04BX02

    N04BX02

    N04BX02

    N04BX02

    N - Nervous system

    N04 - Anti-parkinson drugs

    N04B - Dopaminergic agents

    N04BX - Other dopaminergic agents

    N04BX02 - Entacapone

    5.5 Absorption, Distribution and Excretion

    Absorption

    Entacapone is rapidly absorbed (approximately 1 hour). The absolute bioavailability following oral administration is 35%.

    Route of Elimination

    Entacapone is almost completely metabolized prior to excretion, with only a very small amount (0.2% of dose) found unchanged in urine. As only about 10% of the entacapone dose is excreted in urine as parent compound and conjugated glucuronide, biliary excretion appears to be the major route of excretion of this drug.

    Volume of Distribution

    20 L

    Clearance

    850 mL/min

    In rats and in humans, the absolute bioavailability was dose-dependent and ranged from 20% to 55%, following single dose of 10, 65 and 400 mg/kg, in rats and from 29% to 49%, following single dose of 5, 25, 50, 100, 200, 400 and 800 mg, in humans.

    European Medicines Agency (EMA), Committee for Medicinal Products for Human Use (CHMP), European Public Assessment Report (EPAR): Comtan (Entacapone), Scientific Discussion p.4 (2005). Available from, as of June 5, 2015: https://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion/human/000171/WC500033075.pdf

    Absorption of unchanged entacapone after single oral administration is quite rapid both in rats and in dogs. Two peaks in plasma concentrations, occurring at 5-15 minutes and at 3-5 hours post dose, were found in rats indicating that entacapone is subject to enterohepatic circulation and a single peak at 3 hours was found in dogs. A transformation of entacapone to its (Z)-isomer took place in both species studied, the transformation being minimal in rats but quite noticeable in dogs.

    European Medicines Agency (EMA), Committee for Medicinal Products for Human Use (CHMP), European Public Assessment Report (EPAR): Comtan (Entacapone), Scientific Discussion p.4 (2005). Available from, as of June 5, 2015: https://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion/human/000171/WC500033075.pdf

    /MILK/ In animal studies, entacapone was excreted into maternal rat milk.

    NIH; DailyMed. Current Medication Information for Comtan (Entacapone) Tablet, Film Coated (Updated: July 2014). Available from, as of June 4, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b1aceb59-9be8-43b8-83d6-81e05e4b51e4

    In rats and dogs, entacapone metabolites are predominantly excreted in the feces (two thirds as glucuronide or sulfate conjugates) and one third in the urine with less than 1.5% of the dose as unchanged entacapone. After the first hour 30-45% of the dose was recovered in the bile, with an enterohepatic circulation accounting for about 10% of the given radioactivity.

    European Medicines Agency (EMA), Committee for Medicinal Products for Human Use (CHMP), European Public Assessment Report (EPAR): Comtan (Entacapone), Scientific Discussion p.4 (2005). Available from, as of June 5, 2015: https://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion/human/000171/WC500033075.pdf

    For more Absorption, Distribution and Excretion (Complete) data for ENTACAPONE (8 total), please visit the HSDB record page.

    5.6 Metabolism/Metabolites

    Metabolized via isomerization to the cis-isomer, followed by direct glucuronidation of the parent and cis-isomer.

    In rats and dogs, entacapone metabolites are predominantly excreted in the feces (two thirds as glucuronide or sulfate conjugates) and one third in the urine with less than 1.5% of the dose as unchanged entacapone. After the first hour 30-45% of the dose was recovered in the bile, with an enterohepatic circulation accounting for about 10% of the given radioactivity.

    European Medicines Agency (EMA), Committee for Medicinal Products for Human Use (CHMP), European Public Assessment Report (EPAR): Comtan (Entacapone), Scientific Discussion p.4 (2005). Available from, as of June 5, 2015: https://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion/human/000171/WC500033075.pdf

    Entacapone is extensively metabolised in the liver in all species including humans, the main metabolic pathway being glucuronidation, sulfation and isomerisation from (E)- to (Z)-isomer (active metabolite). Similar pathways across species are the reduction of the C-C double bond of the side chain (less important in rat and in man) and the hydrolysis to 3,4-dihydroxy-5-nitrobenzaldehyde. The dissimilarities consists of amide N-dealkylation, nitro reduction and O-methylation (only in rats), amide hydrolysis and nitrile hydrolysis (only in dogs) and oxidative hydrolysis of one of the ethyl groups of the diethylamide group (only in man).

    European Medicines Agency (EMA), Committee for Medicinal Products for Human Use (CHMP), European Public Assessment Report (EPAR): Comtan (Entacapone), Scientific Discussion p.4 (2005). Available from, as of June 5, 2015: https://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion/human/000171/WC500033075.pdf

    Entacapone is almost completely metabolized prior to excretion, with only a very small amount (0.2% of dose) found unchanged in urine. The main metabolic pathway is isomerization to the cis-isomer, followed by direct glucuronidation of the parent and cis-isomer; the glucuronide conjugate is inactive.

    NIH; DailyMed. Current Medication Information for Comtan (Entacapone) Tablet, Film Coated (Updated: July 2014). Available from, as of June 4, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b1aceb59-9be8-43b8-83d6-81e05e4b51e4

    Entacapone undergoes extensive metabolism, mainly in the liver. The main metabolic pathway of entacapone in humans is the isomerization to the cis-isomer, followed by direct glucuronidation of the parent and cis-isomer; the glucuronide conjugate is inactive.

    Health Canada; Product Monograph for Comtan (Entacapone), Drug Identification Number (DIN): 02243763 (Date of Revision: November 18, 2013). Available from, as of June 5, 2015: https://webprod5.hc-sc.gc.ca/dpd-bdpp/start-debuter.do?lang=eng

    Entacapone has known human metabolites that include Entacapone 3-o-glucuronide.

    S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560

    5.7 Biological Half-Life

    0.4-0.7 hour

    The elimination of entacapone is biphasic, with an elimination half-life of 0.4 hour to 0.7 hour based on the beta-phase and 2.4 hours based on the gamma-phase.

    NIH; DailyMed. Current Medication Information for Comtan (Entacapone) Tablet, Film Coated (Updated: July 2014). Available from, as of June 4, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b1aceb59-9be8-43b8-83d6-81e05e4b51e4

    The overall elimination half-life of entacapone ranged from 30 minutes to 1 hour in dogs and from 1.5 to 3 hours in man.

    European Medicines Agency (EMA), Committee for Medicinal Products for Human Use (CHMP), European Public Assessment Report (EPAR): Comtan (Entacapone), Scientific Discussion p.4 (2005). Available from, as of June 5, 2015: https://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion/human/000171/WC500033075.pdf

    5.8 Mechanism of Action

    The mechanism of action of entacapone is believed to be through its ability to inhibit COMT in peripheral tissues, altering the plasma pharmacokinetics of levodopa. When entacapone is given in conjunction with levodopa and an aromatic amino acid decarboxylase inhibitor, such as carbidopa, plasma levels of levodopa are greater and more sustained than after administration of levodopa and an aromatic amino acid decarboxylase inhibitor alone. It is believed that at a given frequency of levodopa administration, these more sustained plasma levels of levodopa result in more constant dopaminergic stimulation in the brain, leading to a greater reduction in the manifestations of parkinsonian syndrome.

    Comtan (entacapone) is a reversible, selective and mainly peripherally acting inhibitor of catechol-O-methyltransferase (COMT). Comtan has no antiparkinsonian effect of its own and is designed for concomitant administration with levodopa preparations. COMT catalyzes the transfer of the methyl group of S-adenosyl-L-methionine to the phenolic group of substrates that contain a cathecol structure. Physiological substrates of COMT include dopa, catecholamines (dopamine, norepinephrine, epinephrine) and their hydroxylated metabolites. In the presence of a dopa decarboxylase (DDC) inhibitor, COMT becomes the major enzyme which is responsible for the metabolism of levodopa to 3-methoxy-4-hydroxy-l-phenylalanine (3-OMD). The mechanism of action of entacapone is believed to be related to its ability to inhibit COMT and thereby alter the plasma pharmacokinetics of levodopa. When administered with levodopa and a DDC inhibitor (carbidopa or benserazide), entacapone decreases the degradation of levodopa in the peripheral tissues further by inhibiting the metabolism of levodopa to 3-OMD through the COMT pathway. This leads to more sustained plasma concentrations of levodopa. It is believed that at a given frequency of levodopa administration, these more sustained plasma levels of levodopa result in more constant dopaminergic stimulation in the brain leading to greater effects on the signs and symptoms of Parkinson's Disease. The higher levodopa levels also lead to increased levodopa adverse effects, sometimes requiring a decrease in the dose of levodopa.

    Health Canada; Product Monograph for Comtan (Entacapone), Drug Identification Number (DIN): 02243763 (Date of Revision: November 18, 2013). Available from, as of June 5, 2015: https://webprod5.hc-sc.gc.ca/dpd-bdpp/start-debuter.do?lang=eng

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    About the Company : Cohance Lifesciences is a leading CDMO and API platform delivering products and services across the full molecule lifecycle, from development to commercialization. With strong expe...

    Cohance Lifesciences is a leading CDMO and API platform delivering products and services across the full molecule lifecycle, from development to commercialization. With strong expertise in complex chemistries, we provide end-to-end CDMO solutions to global innovators. As a global API player, we serve customers in nearly 60 countries with 80+ molecules, supported by robust R&D, regulatory capabilities, and advanced manufacturing infrastructure, including strong backward-integrated pellet manufacturing. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Cohance

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    04

    Jai Radhe Sales

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

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    Entacapone

    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

    Malladi Drugs & Pharmaceuticals Lim...

    India
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    Not Confirmed
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    Virtual BoothMalladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.

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    Entacapone

    About the Company : Malladi Drugs & Pharmaceuticals Ltd, founded in 1980 by Mr. M L N Sastry, is a leader in manufacturing ephedrine and pseudoephedrine salts. It is now the top API manufacturer in th...

    Malladi Drugs & Pharmaceuticals Ltd, founded in 1980 by Mr. M L N Sastry, is a leader in manufacturing ephedrine and pseudoephedrine salts. It is now the top API manufacturer in the cough and cold segment, with strong presence in antihistamines, anti-convulsants, anti-depressants, and anxiolytics. Malladi exports to around 60 countries, with over 85% revenue from exports, and its facilities are approved by FDA, EDQM, KFDA, TGA, and other agencies. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Malladi

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    06

    HRV Pharma

    India
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    Not Confirmed
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    Virtual BoothHRV Pharma - Market Expansion Leader in Pharmaceuticals.

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    Entacapone

    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

    Neuland Laboratories

    India
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    Exhibiting
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    Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

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    Entacapone

    About the Company : Neuland Laboratories, established in 1984 and headquartered in Hyderabad, is a publicly listed company offering solutions for pharmaceutical chemistry needs—from library compound...

    Neuland Laboratories, established in 1984 and headquartered in Hyderabad, is a publicly listed company offering solutions for pharmaceutical chemistry needs—from library compounds to NCEs and advanced intermediates. It manufactures APIs and intermediates in USFDA-approved facilities, applying advanced process chemistry in a regulatory-compliant environment for clinical and commercial stages. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Neuland

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    08

    Tenatra Exports

    India
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    Not Confirmed
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    Virtual BoothTenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.

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    Entacapone

    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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    09

    Guangzhou Tosun Pharmaceutical

    China
    IMCAS World Congress
    Not Confirmed
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    Guangzhou Tosun Pharmaceutical

    China
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    Not Confirmed
    • fda
    • EDQM
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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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    Entacapone

    About the Company : Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Ex...

    Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Excipients, Herbal extracts, Formulation of Chinese & Western Medicine. With abundant economic strength, the group has successfully developed to a pharmaceutical group enterprise wich intergrets operation of medicine & related products, processing & manufacturing, and importation & exportation together.
    blank

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    10

    Progress Life Sciences

    India
    IMCAS World Congress
    Not Confirmed
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    Progress Life Sciences

    India
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    Not Confirmed
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    • 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.
    Post an Enquiry Post an Enquiry
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    Entacapone

    About the Company : Progress is a company led by professionals, established by technocrats with a vision for global business expansion. Our headquarters are located in Vashi, Mumbai, with a manufactur...

    Progress is a company led by professionals, established by technocrats with a vision for global business expansion. Our headquarters are located in Vashi, Mumbai, with a manufacturing unit in Pune, Maharashtra. We operate in five key verticals, including Active Pharmaceutical Ingredients (APIs), Intermediates & Specialty Chemicals, and Finished Dosage Formulations. Our approach is centered around innovation, aiming to excel in our segment. Backward integration of API and FDF serves as key growth drivers, and we employ flow chemistry and micro reactors for pioneering innovations.
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    API Reference Price

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    13-Jan-2022
    30-Dec-2025
    KGS
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    DOSAGE - TABLET;ORAL - 200MG

    USFDA APPLICATION NUMBER - 20796

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    DOSAGE - TABLET;ORAL - 12.5MG;200MG;50MG

    USFDA APPLICATION NUMBER - 21485

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    DOSAGE - TABLET;ORAL - 18.75MG;200MG;75MG

    USFDA APPLICATION NUMBER - 21485

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    DOSAGE - TABLET;ORAL - 25MG;200MG;100MG

    USFDA APPLICATION NUMBER - 21485

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    DOSAGE - TABLET;ORAL - 31.25MG;200MG;125MG

    USFDA APPLICATION NUMBER - 21485

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    DOSAGE - TABLET;ORAL - 37.5MG;200MG;150MG

    USFDA APPLICATION NUMBER - 21485

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    DOSAGE - TABLET;ORAL - 50MG;200MG;200MG

    USFDA APPLICATION NUMBER - 21485

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

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

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

    API | Excipient name

    Entacapone

    Synonyms

    130929-57-6, Comtess, Comtan, Entacaponum, Or-611, Entacapona

    Cas Number

    130929-57-6

    Unique Ingredient Identifier (UNII)

    4975G9NM6T

    About Entacapone

    Entacapone is a nitrocatechol compound with anti-parkinsonian property. Entacapone is a selective and reversible inhibitor of catechol-O-methyltransferase (COMT), which catalyzes the transfer of the methyl group of S-adenosyl-L-methionine to the phenolic group of substrates that contain a catechol structure including dihydroxyphenylalanine (DOPA), catecholamines (dopamine, norepinephrine, and epinephrine) and their hydroxylated metabolites. When administered in conjunction with dopaminergic agents such as L-DOPA, entacapone prevents the metabolism and inactivation of adjunct drugs, thereby increasing the bioavailability of these compounds by facilitating their passage across the blood-brain barrier.

    (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide Manufacturers

    A (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide, including repackagers and relabelers. The FDA regulates (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide 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 (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide Suppliers

    A (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide supplier is an individual or a company that provides (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide active pharmaceutical ingredient (API) or (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide finished formulations upon request. The (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide suppliers may include (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide API manufacturers, exporters, distributors and traders.

    click here to find a list of (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide USDMF

    A (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide DMF (Drug Master File) is a document detailing the whole manufacturing process of (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide active pharmaceutical ingredient (API) in detail. Different forms of (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide DMFs exist exist since differing nations have different regulations, such as (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide DMF submitted to regulatory agencies in the US is known as a USDMF. (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide USDMF includes data on (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide suppliers with USDMF on PharmaCompass.

    (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide 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 (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide Drug Master File in Japan ((E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide JDMF) empowers (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide 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 (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide JDMF during the approval evaluation for pharmaceutical products. At the time of (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide 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 (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide suppliers with JDMF on PharmaCompass.

    (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide KDMF

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

    Pharmaceutical companies submit a (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide Drug Master File in Korea ((E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide. The MFDS reviews the (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide KDMF as part of the drug registration process and uses the information provided in the (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide KDMF to evaluate the safety and efficacy of the drug.

    After submitting a (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide 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 (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide suppliers with KDMF on PharmaCompass.

    (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide CEP

    A (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide CEP of the European Pharmacopoeia monograph is often referred to as a (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide Certificate of Suitability (COS). The purpose of a (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide to their clients by showing that a (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide CEP has been issued for it. The manufacturer submits a (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide CEP (COS) as part of the market authorization procedure, and it takes on the role of a (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide CEP holder for the record. Additionally, the data presented in the (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide DMF.

    A (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide 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 (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide suppliers with CEP (COS) on PharmaCompass.

    (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide WC

    A (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide written confirmation ((E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide WC) is an official document issued by a regulatory agency to a (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide manufacturer, verifying that the manufacturing facility of a (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide APIs or (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide finished pharmaceutical products to another nation, regulatory agencies frequently require a (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide WC (written confirmation) as part of the regulatory process.

    click here to find a list of (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide suppliers with Written Confirmation (WC) on PharmaCompass.

    (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide 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 (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide 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 (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide 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 (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide suppliers with NDC on PharmaCompass.

    (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide GMP

    (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide 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 (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide 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 (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide GMP manufacturer or (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide GMP API supplier for your needs.

    (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide CoA

    A (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide CoA (Certificate of Analysis) is a formal document that attests to (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide's compliance with (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide specifications and serves as a tool for batch-level quality control.

    (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide CoA mostly includes findings from lab analyses of a specific batch. For each (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide 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.

    (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide may be tested according to a variety of international standards, such as European Pharmacopoeia ((E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide EP), (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide JP (Japanese Pharmacopeia) and the US Pharmacopoeia ((E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide 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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