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1. 6-(5-chloro-2-pyridyl)-6,7-dihydro- 7-oxo-5h-pyrrolo(3,4-b)pyrazin-5-yl 4-methyl-1- Piperazinecarboxylate
2. Imovane
3. Limovan
4. Nu-zopiclone
5. Optidorm
6. Ratio-zopiclone
7. Rhovane
8. Rp 27 267
9. Siaten
10. Somnosan
11. Ximovan
12. Zileze
13. Zimoclone
14. Zimovane
15. Zop
16. Zopi-puren
17. Zopicalm
18. Zopicalma
19. Zopiclodura
20. Zopiclon Abz
21. Zopiclon Al
22. Zopiclon Azu
23. Zopiclon Beta
24. Zopiclon Stada
25. Zopiclon Tad
26. Zopiclon Von Ct
27. Zopiclon-neuraxpharm
28. Zopiclon-ratiopharm
29. Zopiclon-teva
30. Zopitan
31. Zorclone
1. 43200-80-2
2. Imovane
3. Zimovane
4. Amoban
5. (+-)-zopiclone
6. Zopiclona
7. Zopiclonum
8. Zopiclonum [inn-latin]
9. Zopiclona [inn-spanish]
10. Rp-27267
11. [6-(5-chloropyridin-2-yl)-5-oxo-7h-pyrrolo[3,4-b]pyrazin-7-yl] 4-methylpiperazine-1-carboxylate
12. Rp 27267
13. 6-(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5h-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate
14. Chebi:32315
15. Amovane
16. Nsc-758463
17. Mls000083579
18. 03a5orl08q
19. 1-piperazinecarboxylic Acid, 4-methyl-, 6-(5-chloro-2-pyridinyl)-6,7-dihydro-7-oxo-5h-pyrrolo(3,4-b)pyrazin-5-yl Ester
20. 1-piperazinecarboxylic Acid, 4-methyl-, 6-(5-chloro-2-pyridinyl)-6,7-dihydro-7-oxo-5h-pyrrolo[3,4-b]pyrazin-5-yl Ester
21. 6-(5-chloro-2-pyridinyl)-7-oxo-6,7-dihydro-5h-pyrrolo[3,4-b]pyrazin-5-yl 4-methyl-1-piperazinecarboxylate
22. Ximovan
23. 4-methyl-1-piperazinecarboxylic Acid Ester With 6-(5-chloro-2-pyridyl)-6,7-dihydro-7-hydroxy-5h-pyrrolo(3,4-b)pyrazin-5-one
24. Zopiclone (1.0 Mg/ml In Acetonitrile)
25. Smr000048685
26. Zopiclone [ban:inn:jan]
27. 6-(5-chloropyrid-2-yl)-5-(4-methylpiperazin-1-yl)carbonyloxy-7-oxo-6,7-dihydro-5h-pyrrolo[3,4-b]pyrazine
28. Zopiclone (tn)
29. Amoban (tn)
30. Zopiclone (jan/inn)
31. Sr-01000000090
32. Einecs 256-138-9
33. Dea No. 2784
34. Brn 0768704
35. Unii-03a5orl08q
36. Zopiclone [inn:ban:jan]
37. S-zopiclone
38. Zimovane Ls
39. 6-(5-chloropyrid-2-yl)-5-(4-methylpiperazin-1-yl)carbonyloxy-7-oxo-6,7-dihydro-5h-pyrrolo(3,4-b)pyrazine
40. Mfcd00133931
41. (+/-)-zopiclone
42. Zileze 7.5
43. Zileze 3.75
44. Zopiclone [inn]
45. Zopiclone [jan]
46. Zopiclone [mi]
47. Opera_id_1759
48. 27267 R.p.
49. Biomol-nt_000284
50. Zopiclone [mart.]
51. Z 4900
52. Zopiclone [who-dd]
53. Lopac0_001270
54. Schembl44419
55. Mls000028547
56. Mls001201837
57. Mls001304058
58. Bpbio1_001146
59. Chembl135400
60. Gtpl7430
61. Zopiclone [ep Impurity]
62. Dtxsid4041155
63. Zopiclone [ep Monograph]
64. Hms3267i08
65. Hms3713h22
66. Hms3746i05
67. Pharmakon1600-01503425
68. Bcp28513
69. Hy-b0741
70. Bbl010797
71. Bdbm50248251
72. Nsc758463
73. Stk599439
74. Zopiclone 1.0 Mg/ml In Acetonitrile
75. Akos005520380
76. Bcp9000663
77. Ccg-205343
78. Db01198
79. Nsc 758463
80. Ncgc00016108-04
81. Ncgc00016108-05
82. Ncgc00016108-06
83. Ncgc00024993-03
84. Ncgc00024993-04
85. Vs-02685
86. Sbi-0051236.p002
87. Eu-0101270
88. D01372
89. 200z802
90. Q220426
91. Sr-01000000090-2
92. Sr-01000000090-4
93. Sr-01000000090-6
94. Sr-01000000090-7
95. W-106239
96. Brd-a34309505-001-08-5
97. Brd-a34309505-001-10-1
98. Zopiclone, British Pharmacopoeia (bp) Reference Standard
99. Zopiclone, European Pharmacopoeia (ep) Reference Standard
100. (rs)-6-(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5h-pyrrolo[3,4-b]pyrazine-5-yl 4-methylpiperazine-1-carboxylate
101. 1169825-88-0
102. 4-methyl-1-piperazinecarboxylic Acid 6-(5-chloro-2-pyridinyl)-6,7-dihydro-7-oxo-5h-pyrrolo(3,4-b)pyrazin-5-yl Ester
103. 4-methyl-1-piperazinecarboxylic Acid 6-(5-chloro-2-pyridinyl)-6,7-dihydro-7-oxo-5h-pyrrolo[3,4-b] Pyrazin-5-yl Ester
104. 4-methyl-piperazine-1-carboxylic Acid 6-(5-chloro-pyridin-2-yl)-7-oxo-6,7-dihydro-5h-pyrrolo[3,4-b]pyrazin-5-yl Ester
105. 6-(5-chloropyridin-2-yl)-7-oxo-5h,6h,7h-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate
| Molecular Weight | 388.8 g/mol |
|---|---|
| Molecular Formula | C17H17ClN6O3 |
| XLogP3 | 0.5 |
| Hydrogen Bond Donor Count | 0 |
| Hydrogen Bond Acceptor Count | 7 |
| Rotatable Bond Count | 3 |
| Exact Mass | 388.1050661 g/mol |
| Monoisotopic Mass | 388.1050661 g/mol |
| Topological Polar Surface Area | 91.8 Ų |
| Heavy Atom Count | 27 |
| Formal Charge | 0 |
| Complexity | 573 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 1 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
For the short-term treatment of insomnia.
Zopiclone is a nonbenzodiazepine hypnotic from the pyrazolopyrimidine class and is indicated for the short-term treatment of insomnia. While Zopiclone is a hypnotic agent with a chemical structure unrelated to benzodiazepines, barbiturates, or other drugs with known hypnotic properties, it interacts with the gamma-aminobutyric acid-benzodiazepine (GABABZ) receptor complex. Subunit modulation of the GABABZ receptor chloride channel macromolecular complex is hypothesized to be responsible for some of the pharmacological properties of benzodiazepines, which include sedative, anxiolytic, muscle relaxant, and anticonvulsive effects in animal models. Zopiclone binds selectively to the brain alpha subunit of the GABA A omega-1 receptor.
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.)
N05CF01
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
N - Nervous system
N05 - Psycholeptics
N05C - Hypnotics and sedatives
N05CF - Benzodiazepine related drugs
N05CF01 - Zopiclone
Absorption
Rapidly absorbed following oral administration.
Extensively metabolized in the liver via decarboxylation (major pathway), demethylation, and side chain oxidation. Metabolites include an N-oxide derivative (weakly active; approximately 12% of a dose) and an N-desmethyl metabolite (inactive; approximately 16%). Approximately 50% of a dose is converted to other inactive metabolites via decarboxylation. Hepatic microsomal enzymes are apparently not involved in zopiclone clearance.
Elimination half life is approximately 5 hours (range 3.8 to 6.5 hours) and is prolonged to 11.9 hours in patients with hepatic insufficiency.
Zopiclone exerts its action by binding on the benzodiazepine receptor complex and modulation of the GABABZ receptor chloride channel macromolecular complex. Both zopiclone and benzodiazepines act indiscriminately at the benzodiazepine binding site on 1, 2, 3 and 5 GABAA containing receptors as full agonists causing an enhancement of the inhibitory actions of GABA to produce the therapeutic (hypnotic and anxiolytic) and adverse effects of zopiclone.
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Imovane
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 5 mg
Packaging : Blister
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Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Imovane
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 5 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Imovane
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 5 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Imovane
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 7.5 mg
Packaging : Blister
Approval Date :
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Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Imovane
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 7.5 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Imovane
Dosage Form : Tablet, film-coated
Dosage Strength : 5 mg
Packaging : Blisterpakning 10item
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Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Imovane
Dosage Form : Tablet, film-coated
Dosage Strength : 7.5 mg
Packaging : Blisterpakning 10item
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Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
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Registration Country : Switzerland
Brand Name : Zopiclone Zentiva
Dosage Form : Filmtablet
Dosage Strength : 7.5mg
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Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
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Registration Country : Switzerland
Brand Name : Zopiclone Zentiva
Dosage Form : Film-Coated Tablets
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Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
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Registration Country : Switzerland
Brand Name : Zopiclone Zentiva
Dosage Form : Film-Coated Tablets
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ABOUT THIS PAGE
A Zopiclone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zopiclone, including repackagers and relabelers. The FDA regulates Zopiclone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zopiclone 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 Zopiclone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Zopiclone supplier is an individual or a company that provides Zopiclone active pharmaceutical ingredient (API) or Zopiclone finished formulations upon request. The Zopiclone suppliers may include Zopiclone API manufacturers, exporters, distributors and traders.
click here to find a list of Zopiclone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Zopiclone DMF (Drug Master File) is a document detailing the whole manufacturing process of Zopiclone active pharmaceutical ingredient (API) in detail. Different forms of Zopiclone DMFs exist exist since differing nations have different regulations, such as Zopiclone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Zopiclone DMF submitted to regulatory agencies in the US is known as a USDMF. Zopiclone USDMF includes data on Zopiclone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Zopiclone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Zopiclone suppliers with USDMF on PharmaCompass.
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 Zopiclone Drug Master File in Japan (Zopiclone JDMF) empowers Zopiclone 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 Zopiclone JDMF during the approval evaluation for pharmaceutical products. At the time of Zopiclone 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 Zopiclone suppliers with JDMF on PharmaCompass.
A Zopiclone CEP of the European Pharmacopoeia monograph is often referred to as a Zopiclone Certificate of Suitability (COS). The purpose of a Zopiclone CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Zopiclone EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Zopiclone to their clients by showing that a Zopiclone CEP has been issued for it. The manufacturer submits a Zopiclone CEP (COS) as part of the market authorization procedure, and it takes on the role of a Zopiclone CEP holder for the record. Additionally, the data presented in the Zopiclone CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Zopiclone DMF.
A Zopiclone CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Zopiclone 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 Zopiclone suppliers with CEP (COS) on PharmaCompass.
A Zopiclone written confirmation (Zopiclone WC) is an official document issued by a regulatory agency to a Zopiclone manufacturer, verifying that the manufacturing facility of a Zopiclone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Zopiclone APIs or Zopiclone finished pharmaceutical products to another nation, regulatory agencies frequently require a Zopiclone WC (written confirmation) as part of the regulatory process.
click here to find a list of Zopiclone suppliers with Written Confirmation (WC) on PharmaCompass.
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 Zopiclone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Zopiclone API and other APIs are published in this directory by the FDA.
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 Zopiclone 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.
The NDC directory also contains data on finished compounded human drug products that contain Zopiclone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Zopiclone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Zopiclone suppliers with NDC on PharmaCompass.
Zopiclone 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 Zopiclone 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 Zopiclone GMP manufacturer or Zopiclone GMP API supplier for your needs.
A Zopiclone CoA (Certificate of Analysis) is a formal document that attests to Zopiclone's compliance with Zopiclone specifications and serves as a tool for batch-level quality control.
Zopiclone CoA mostly includes findings from lab analyses of a specific batch. For each Zopiclone 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.
Zopiclone may be tested according to a variety of international standards, such as European Pharmacopoeia (Zopiclone EP), Zopiclone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Zopiclone USP).
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