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    Chemistry

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    Also known as: 138729-47-2, Lunesta, (s)-zopiclone, Estorra, Esopiclone, (+)-zopiclone
    Molecular Formula
    C17H17ClN6O3
    Molecular Weight
    388.8  g/mol
    InChI Key
    GBBSUAFBMRNDJC-INIZCTEOSA-N
    FDA UNII
    UZX80K71OE
    Eszopiclone
    A pyridine, pyrazine, and piperazine derivative that is used as a HYPNOTIC AND SEDATIVE in the treatment of INSOMNIA.
    1 2D Structure

    Eszopiclone

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    [(7S)-6-(5-chloropyridin-2-yl)-5-oxo-7H-pyrrolo[3,4-b]pyrazin-7-yl] 4-methylpiperazine-1-carboxylate
    2.1.2 InChI
    InChI=1S/C17H17ClN6O3/c1-22-6-8-23(9-7-22)17(26)27-16-14-13(19-4-5-20-14)15(25)24(16)12-3-2-11(18)10-21-12/h2-5,10,16H,6-9H2,1H3/t16-/m0/s1
    2.1.3 InChI Key
    GBBSUAFBMRNDJC-INIZCTEOSA-N
    2.1.4 Canonical SMILES
    CN1CCN(CC1)C(=O)OC2C3=NC=CN=C3C(=O)N2C4=NC=C(C=C4)Cl
    2.1.5 Isomeric SMILES
    CN1CCN(CC1)C(=O)O[C@H]2C3=NC=CN=C3C(=O)N2C4=NC=C(C=C4)Cl
    2.2 Other Identifiers
    2.2.1 UNII
    UZX80K71OE
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Estorra

    2. Lunesta

    2.3.2 Depositor-Supplied Synonyms

    1. 138729-47-2

    2. Lunesta

    3. (s)-zopiclone

    4. Estorra

    5. Esopiclone

    6. (+)-zopiclone

    7. Eszopiclon

    8. Eszopiclone Civ

    9. Sep-190

    10. Zopiclone S-form

    11. [(7s)-6-(5-chloropyridin-2-yl)-5-oxo-7h-pyrrolo[3,4-b]pyrazin-7-yl] 4-methylpiperazine-1-carboxylate

    12. Chebi:53760

    13. (+)-(5s)-6-(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5h-pyrrolo(3,4-b)pyrazin-5-yl 4-methylpiperazine-1-carboxylate

    14. Sep-225441

    15. Uzx80k71oe

    16. (5s)-6-(5-chloropyrid-2-yl)-5-(4-methylpiperazin-1-yl)carbonyloxy-7-oxo-6,7-dihydro-5h-pyrrolo[3,4-b]pyrazine

    17. 1-piperazinecarboxylic Acid, 4-methyl-, (5s)-6-(5-chloro-2-pyridinyl)-6,7-dihydro-7-oxo-5h-pyrrolo(3,4-b)pyrazin-5-yl Ester

    18. Gsk-1755165

    19. Ncgc00159515-02

    20. Dsstox_cid_26086

    21. Dsstox_rid_81327

    22. Dsstox_gsid_46086

    23. Eszopiclone [usan:inn]

    24. (5s)-6-(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5h-pyrrolo(3,4-b)pyrazin-5-yl 4-methylpiperazine-1-carboxylate

    25. (5s)-6-(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5h-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate

    26. Lunivia

    27. (s)-eszopiclone

    28. Estorra (tn)

    29. Lunesta (tn)

    30. Cas-138729-47-2

    31. Hsdb 7472

    32. Sr-05000001914

    33. Dea No. 2784

    34. Unii-uzx80k71oe

    35. Zopiclon

    36. Eszopiclone [usan]

    37. Ks-1055

    38. Sep-0227018

    39. Sep-0227108

    40. (s)-(+)-zopiclone

    41. Eszopiclone [inn]

    42. Eszopiclone [jan]

    43. Eszopiclone [hsdb]

    44. Eszopiclone [vandf]

    45. Eszopiclone ( S-zopiclone)

    46. Chembl1522

    47. Eszopiclone [mart.]

    48. Schembl28657

    49. Eszopiclone [who-dd]

    50. Mls001165744

    51. Eszopiclone (jan/usp/inn)

    52. Spectrum1505188

    53. Zopiclone S-form [mi]

    54. Gtpl7429

    55. Dtxsid8046086

    56. Eszopiclone [orange Book]

    57. Eszopiclone Civ [usp-rs]

    58. Hms2864o09

    59. Hms3259b17

    60. Hms3264f04

    61. Eszopiclone [usp Monograph]

    62. Bcp04910

    63. Tox21_111733

    64. Bdbm50247998

    65. Mfcd03700720

    66. Zinc19632834

    67. Akos015895596

    68. Tox21_111733_1

    69. Ac-5546

    70. Ac-5547

    71. Ccg-213172

    72. Db00402

    73. Nc00663

    74. Ncgc00159515-03

    75. (s)-6-(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5h-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate

    76. [(7s)-6-(5-chloro-2-pyridyl)-5-oxo-7h-pyrrolo[3,4-b]pyrazin-7-yl] 4-methylpiperazine-1-carboxylate

    77. Smr000550478

    78. En300-52506

    79. D02624

    80. Ab00828423_06

    81. 729e472

    82. A807426

    83. Q413184

    84. Sr-05000001914-1

    85. Sr-05000001914-2

    86. Eszopiclone, (+)-zopiclone, (s)-zopiclone, Estorra (r)-isomer

    87. (+)-(5s)-6-(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5h-pyrrolo[3,4-b]pyrazin-5-yl-4-methylpiperazine-1-carboxylate

    88. (s)-4-methylpiperazine-1-carboxylic Acid 6-(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5h-pyrrolo[3,4-b]pyrazin-5-yl Ester

    89. (s)-6-(5-chloro-2-pyridinyl)- 7-oxo- 6,7-dihydro- 5h-pyrrolo[3,4-b]pyrazin-5-yl- 4-methyl- 1-piperazinecarboxylate

    90. 1-piperazinecarobxylic Acid,4-methyl-,(5s)-6-(5-chloro-2-pyridinyl)-6,7-dihydro-7-oxo-5h-pyrrolo[3,4-b]pyrazin-5-yl Ester

    91. 1140433-81-3

    2.4 Create Date
    2005-07-09
    3 Chemical and Physical Properties
    Molecular Weight 388.8 g/mol
    Molecular Formula C17H17ClN6O3
    XLogP30.5
    Hydrogen Bond Donor Count0
    Hydrogen Bond Acceptor Count7
    Rotatable Bond Count3
    Exact Mass388.1050661 g/mol
    Monoisotopic Mass388.1050661 g/mol
    Topological Polar Surface Area91.8 Ų
    Heavy Atom Count27
    Formal Charge0
    Complexity573
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    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 4  
    Drug NameEszopiclone
    PubMed HealthEszopiclone (By mouth)
    Drug ClassesNonbarbiturate Hypnotic
    Drug LabelLUNESTA (eszopiclone) is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-(5S)-6-(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b] pyrazin-5-yl 4-met...
    Active IngredientEszopiclone
    Dosage FormTablet
    RouteOral
    Strength2mg; 1mg; 3mg
    Market StatusPrescription
    CompanyMylan Pharms; Glenmark Generics; Teva; Lupin; Dr Reddys Labs; Orchid Hlthcare; Sun Pharma Global; Roxane

    2 of 4  
    Drug NameLunesta
    PubMed HealthEszopiclone (By mouth)
    Drug ClassesNonbarbiturate Hypnotic
    Drug LabelLUNESTA (eszopiclone) is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-(5S)-6-(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b] pyrazin-5-yl 4-met...
    Active IngredientEszopiclone
    Dosage FormTablet
    RouteOral
    Strength1mg; 2mg; 3mg
    Market StatusPrescription
    CompanySunovion Pharms

    3 of 4  
    Drug NameEszopiclone
    PubMed HealthEszopiclone (By mouth)
    Drug ClassesNonbarbiturate Hypnotic
    Drug LabelLUNESTA (eszopiclone) is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-(5S)-6-(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b] pyrazin-5-yl 4-met...
    Active IngredientEszopiclone
    Dosage FormTablet
    RouteOral
    Strength2mg; 1mg; 3mg
    Market StatusPrescription
    CompanyMylan Pharms; Glenmark Generics; Teva; Lupin; Dr Reddys Labs; Orchid Hlthcare; Sun Pharma Global; Roxane

    4 of 4  
    Drug NameLunesta
    PubMed HealthEszopiclone (By mouth)
    Drug ClassesNonbarbiturate Hypnotic
    Drug LabelLUNESTA (eszopiclone) is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-(5S)-6-(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b] pyrazin-5-yl 4-met...
    Active IngredientEszopiclone
    Dosage FormTablet
    RouteOral
    Strength1mg; 2mg; 3mg
    Market StatusPrescription
    CompanySunovion Pharms

    4.2 Therapeutic Uses

    Hypnotics and Sedatives; Sedative-hypnotic

    National Library of Medicine's Medical Subject Headings online file (MeSH, 2006)

    Eszopiclone is indicated for the treatment of insomnia. /Included in US product label/

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 1411

    Eszopiclone is a nonbenzodiazepine hypnotic with a chemical structure unrelated to pyrazolopyrimidines, imidazopyridines, benzodiazepines, barbiturates,or other drugs with hypnotic properties.

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 1411

    4.3 Drug Warning

    Since sleep disturbances may be a manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after careful evaluation of the patient. The failure of insomnia to remit after 7-10 days of therapy may indicate the presence of an underlying psychiatric and/or medical condition requiring evaluation.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 2501

    Sedative and hypnotic agents are associated with numerous abnormal thought and behavioral processes (e.g., decreased inhibition, agitation, bizarre behavior, hallucinations, depersonalization, depression, suicidal ideation); many are similar to manifestations of alcohol intoxication or effects associated with other CNS depressants. Studies demonstrate short-term amnesic effects with eszopiclone. As with other sedative and hypnotic agents, emergence of new psychiatric abnormalities during eszopiclone therapy requires evaluation.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 2501

    Studies using relatively high eszopiclone dosages (e.g., 2-4 times the recommended hypnotic dosage) in individuals with a history of benzodiazepine abuse suggest that the abuse potential of eszopiclone is similar to that of benzodiazepines (e.g., diazepam); caution is advised in patients with a history of drug or alcohol dependence or abuse.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 2501

    Physical dependence results in the manifestation of withdrawal symptoms (e.g., anxiety) upon rapid dose decrease or abrupt discontinuance of many sedative and hypnotic drugs, including eszopiclone. Clinical trials of eszopiclone did not reveal evidence of a serious withdrawal syndrome; however, anxiety, abnormal dreams, nausea, and upset stomach were reported at an incidence of 2% or less after placebo substitution within 48 hours following the last dose of the drug.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 2501

    For more Drug Warnings (Complete) data for ESZOPICLONE (16 total), please visit the HSDB record page.

    4.4 Minimum/Potential Fatal Human Dose

    Considering the man's weakened physical condition, 90 mg could represent a minimum lethal zopiclone dose. /Steroisomer/

    PMID:9068198 Meatherall RC et al; J Forensic Sci 42 (2): 340-3 (1997)

    4.5 Drug Indication

    Eszopiclone is indicated for the treatment of insomnia.

    Treatment of insomnia

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Eszopiclone rapidly induces sleep and decreases sleep latency. It also aids in the maintenance of sleep, preventing frequent awakenings. This drug has shown anticonvulsant and muscle relaxant properties in animals but is used in humans for its sedating effects. Eszopiclone is a central nervous system depressant with various effects. These include changes in alertness and motor coordination and the risk of next morning impairment, increasing with the amount of eszopiclone administered. Exercise caution and advise against driving a motor vehicle or activities that require full mental alertness the next morning. Complex sleep behaviors may result from eszopiclone use. Eszopiclone should be discontinued in these cases. Avoid the use of alcohol and other CNS depressants when eszopiclone is administered. Advise patients to skip the eszopiclone dose if alcohol has been consumed before bed or during the evening. Use the smallest dose of eszopiclone as possible, especially in elderly patients, who may experience exaggerated drug effects. Though the potential for dependence and abuse with eszopiclone is lower than for other hypnotic drugs, this drug has been abused and is known to cause dependence.

    5.2 MeSH Pharmacological Classification

    Hypnotics and Sedatives

    Drugs used to induce drowsiness or sleep or to reduce psychological excitement or anxiety. (See all compounds classified as Hypnotics and Sedatives.)

    5.3 ATC Code

    N - Nervous system

    N05 - Psycholeptics

    N05C - Hypnotics and sedatives

    N05CF - Benzodiazepine related drugs

    N05CF04 - Eszopiclone

    5.4 Absorption, Distribution and Excretion

    Absorption

    Eszopiclone is rapidly absorbed and the peak concentration is reached within about 1 hour after oral administration. The mean AUC after a 3 mg dose of eszopiclone was 278 ng/mL h. The consumption of a high-fat has been shown to slow absorption. Steady-state concentrations of eszopiclone are reached within 24-48 hours.

    Route of Elimination

    Only about 10% of an eszopiclone dose is found excreted in the urine as the parent drug. As much as 75% of an orally administered dose of racemic zopiclone as is found to be excreted in the urine in the form of metabolites. Eszopiclone, the S-isomer of racemic zopiclone, would likely show the same excretion pattern.

    Volume of Distribution

    The volume of distribution of eszopiclone is estimated at 89.9L

    Clearance

    The mean clearance of eszopiclone in young, healthy volunteers was 184 mL/min in one pharmacokinetic study.

    Eszopiclone is rapidly absorbed following oral administration. Peak plasma concentrations are achieved within approximately 1 hour after oral administration. Eszopiclone is weakly bound to plasma protein (52-59%). The large free fraction suggests that eszopiclone disposition should not be affected by drug-drug interactions caused by protein binding. The blood-to-plasma ratio for eszopiclone is less than one, indicating no selective uptake by red blood cells.

    Physicians Desk Reference 60th ed, Thomson PDR, Montvale, NJ 2006., p. 3139

    Onset of action may be reduced if taken with or immediately after a high-fat or heavy meal.

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 1411

    Up to 75% of an oral dose of racemic zopiclone is excreted in the urine, primarily as metabolites. A similar excretion profile would be expected for eszopiclone, the S-isomer of racemic zopiclone. Less than 10% of the orally administered eszopiclone dose is excreted in the urine as parent drug.

    Physicians Desk Reference 60th ed, Thomson PDR, Montvale, NJ 2006., p. 3139

    It is not known whether eszopiclone is distributed into milk; however, racemic zopiclone is distributed into milk. Use in nursing women is not recommended.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 2501

    For more Absorption, Distribution and Excretion (Complete) data for ESZOPICLONE (7 total), please visit the HSDB record page.

    5.5 Metabolism/Metabolites

    Following oral administration, eszopiclone is extensively biotransformed and the major metabolites are S-desmethylzopiclone and zopiclone-N-oxide, which are largely inactive.. The enzymes involved in the metabolism of eszopiclone are CYP3A (the primary metabolizing enzyme), CYP2C8, and CYP2E1. The N-oxide derivative shows weak pharmacological activity in animals. The N-desmethyl metabolite is pharmacologically active.

    Extensively metabolized by CYP3A4 and CYP2E1 via oxidation and demethylation. The two primary metabolites are (S)-zopiclone-N-oxide (inactive) and (S)-N-demethylzopiclone which binds to GABA receptors with lower potency then eszopiclone.

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 1411

    Eszopiclone has known human metabolites that include N-desmethyl-zopiclone and N-oxide-zopiclone.

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

    5.6 Biological Half-Life

    The half-life is 6.1 hours in healthy patients but is prolonged in various patients, including those with hepatic impairment, elderly patients, in addition to those taking CYP3A enzyme inhibiting drugs.

    Eszopiclone has an intermediate duration of action (i.e., possesses a half-life of approximately 5-7 hours).

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 2501

    5.7 Mechanism of Action

    The exact mechanism of action of eszopiclone is unknown at this time but is thought to occur via binding with the GABA receptor complexes at binding sites located near benzodiazepine receptors, possibly explaining its hypnotic and sedative effects. It has particular affinity for GABA-A (or GABAA) receptor subunits 1, 3 and 5. Eszopiclone increases GABA-A channel currents significantly. GABA-A channels are major inhibitory channels that cause CNS depression when their receptors are activated.

    Eszopiclone, the S-enantiomer of zopiclone (not commercially available in the US), is a sedative and hypnotic agent that is structurally unrelated to benzadiazepines and other sedative and hypnotic agents that are commercially available in the US, including barbiturates, imidazopyridines (e.g., zolpidem), and pyrazolopyrimidines (e.g., zaleplon). Eszopiclone is pharmacologically similar to zaleplon and zolpidem; all of these agents have been shown to interact with the CNS gamma-aminobutyric acid (GABA) receptor complex at binding domains located close to or allosterically coupled to benzodiazepine receptors.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 2501

    The precise mechanism of action of eszopiclone as a hypnotic is unknown. Its pharmalogic effect is believed to result from its interaction with GABA-receptor complexes at binding domains located close to or allosterically coupled to benzodiazepine receptors.

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 1411

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LIMITED","supplierCountry":"INDIA","foreign_port":"GUARULHOS","customer":"M\/S . . .","customerCountry":"BRAZIL","quantity":"53.25","actualQuantity":"53.25","unit":"KGS","unitRateFc":"6500","totalValueFC":"342250.9","currency":"USD","unitRateINR":542383.661971831,"date":"19-Nov-2024","totalValueINR":"28881930","totalValueInUsd":"342250.9","indian_port":"Bombay Air","hs_no":"29335990","bill_no":"5723262","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"ACME PLAZA, ANDHERI KURLA ROAD,, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732732200,"product":"ESZOPICLONE USP","address":"209, JHALAWAR,,PATANWALA ESTATE,","city":"MUMBAI,MAHARASHTRA","supplier":"PRECISE BIO PHARMA PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"GUATEMALA CITY","customer":"TO THE ORDER OF...","customerCountry":"GUATEMALA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"2850","totalValueFC":"5313.5","currency":"USD","unitRateINR":224199.5,"date":"28-Nov-2024","totalValueINR":"448399","totalValueInUsd":"5313.5","indian_port":"Bombay Air","hs_no":"29333929","bill_no":"5982085","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"GUATEMALA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"209, JHALAWAR,,PATANWALA ESTATE,, MUMBAI,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732732200,"product":"ESZOPICLONE USP","address":"209, JHALAWAR,,PATANWALA ESTATE,","city":"MUMBAI,MAHARASHTRA","supplier":"PRECISE BIO PHARMA PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"GUATEMALA CITY","customer":"TO THE ORDER OF...","customerCountry":"GUATEMALA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"2850","totalValueFC":"5621","currency":"USD","unitRateINR":237173.20000000001,"date":"28-Nov-2024","totalValueINR":"474346.4","totalValueInUsd":"5621","indian_port":"Bombay Air","hs_no":"29333929","bill_no":"5985296","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"GUATEMALA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"209, JHALAWAR,,PATANWALA ESTATE,, MUMBAI,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732905000,"product":"ESZOPICLONE","address":"8-3-166\/6 7, IIND FLOOR,SREE ARCADE","city":"HYDERABAD-AP","supplier":"SYMED LABS","supplierCountry":"INDIA","foreign_port":"BARCELONA","customer":"AIRPHARM","customerCountry":"SPAIN","quantity":"22.92","actualQuantity":"22.92","unit":"KGS","unitRateFc":"2920.5","totalValueFC":"66049.4","currency":"USD","unitRateINR":243184.69022687606,"date":"30-Nov-2024","totalValueINR":"5573793.1","totalValueInUsd":"66049.4","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"6052339","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"8-3-166\/6 7, IIND FLOOR,SREE ARCADE, HYDERABAD-AP","customerAddress":""}]
    01-Feb-2021
    30-Nov-2024
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 1MG

    USFDA APPLICATION NUMBER - 21476

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    USFDA APPLICATION NUMBER - 21476

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    DOSAGE - TABLET;ORAL - 3MG

    USFDA APPLICATION NUMBER - 21476

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    ABOUT THIS PAGE

    Eszopiclone Manufacturers

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

    Eszopiclone Suppliers

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

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

    Eszopiclone USDMF

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

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

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

    Eszopiclone 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 Eszopiclone Drug Master File in Japan (Eszopiclone JDMF) empowers Eszopiclone 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 Eszopiclone JDMF during the approval evaluation for pharmaceutical products. At the time of Eszopiclone 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 Eszopiclone suppliers with JDMF on PharmaCompass.

    Eszopiclone WC

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

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

    Eszopiclone 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 Eszopiclone as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Eszopiclone GMP

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

    Eszopiclone CoA

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

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

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