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1. Anxyrex
2. Apo Bromazepam
3. Apo-bromazepam
4. Beta, Bromazepam
5. Bromalich
6. Bromaz 1a Pharma
7. Bromazanil
8. Bromazep Von Ct
9. Bromazepam Al
10. Bromazepam Beta
11. Bromazepam Heumann
12. Bromazepam Neuraxpharm
13. Bromazepam Ratiopharm
14. Bromazepam-neuraxpharm
15. Bromazepam-ratiopharm
16. Durazanil
17. Gen Bromazepam
18. Gen-bromazepam
19. Lexatin
20. Lexomil
21. Lexotan
22. Lexotanil
23. Ro 5-3350
24. Ro 53350
25. Von Ct, Bromazep
1. Lexotanil
2. Compedium
3. Durazanil
4. Lectopam
5. Lexotan
6. Creosedin
7. Lexaurin
8. Lexilium
9. Lekotam
10. Lexomil
11. 1812-30-2
12. Calmepam
13. Compendium
14. Normoc
15. La Xvii
16. Ro 5-3350
17. Bromazepamum [inn-latin]
18. Lexatin
19. 7-bromo-5-(2-pyridyl)-3h-1,4-benzodiazepin-2(1h)-one
20. 7-bromo-1,3-dihydro-5-(2-pyridyl)-2h-1,4-benzodiazepin-2-one
21. Bromazepam Civ
22. 2h-1,4-benzodiazepin-2-one, 7-bromo-1,3-dihydro-5-(2-pyridinyl)-
23. Nsc 140669
24. 7-bromo-5-pyridin-2-yl-1,3-dihydro-1,4-benzodiazepin-2-one
25. Ultramidol
26. 7-bromo-1,3-dihydro-5-(2-pyridyl)-2h-1,4-benzdiazepin-2-one
27. Nsc-140669
28. 1,3-dihydro-7-bromo-5-(2-pyridyl)-2h-1,4-benzodiazepin-2-one
29. 2h-1,4-benzodiazepin-2-one, 1,3-dihydro-7-bromo-5-(2-pyridyl)-
30. X015l14v0o
31. 2h-1,4-benzodiazepin-2-one, 7-bromo-1,3-dihydro-5-(2-pyridyl)-
32. 7-bromo-5-(2-pyridyl)-3h-1,4-benzodiaxepin-2(1h)-one
33. Bromazepamum
34. Bromazepamum [latin]
35. Ro-5-3350
36. Bromazepam [usan:inn:ban:jan]
37. Lectopam (tn)
38. Einecs 217-322-4
39. Ro 53350
40. Ro 4-9253
41. Brn 0618645
42. 7-bromo-5-[2-pyridyl]-3h-1,4-benzodiaxepin-2[1h]-one
43. Unii-x015l14v0o
44. Dea No. 2748
45. Bromazepam [mi]
46. Bromazepam [inn]
47. Bromazepam [jan]
48. Bromazepam [usan]
49. Bromazepam [mart.]
50. Bromazepam [who-dd]
51. Schembl43933
52. 5-26-05-00078 (beilstein Handbook Reference)
53. Mls003899212
54. Bromazepam, Analytical Standard
55. Chembl277062
56. Zinc1051
57. Bromazepam (jp17/usan/inn)
58. Bromazepam Civ [usp-rs]
59. Chebi:31302
60. Bromazepam [ep Monograph]
61. Dtxsid40171081
62. 7-bromo-1,4-benzodiazepin-2-one
63. Bromazepam 0.1 Mg/ml In Methanol
64. Bromazepam 1.0 Mg/ml In Methanol
65. Nsc140669
66. Db01558
67. Smr000058724
68. Wln: T67 Gmv Jn Ihj Ce K- Bt6nj
69. D01245
70. 2h-1, 7-bromo-1,3-dihydro-5-(2-pyridyl)-
71. 2h-1, 7-bromo-1,3-dihydro-5-(2-pyridinyl)-
72. 812b302
73. Bromazepam, Drug Standard, 1.0 Mg/ml In Methanol
74. Q422435
75. Bromazepam, European Pharmacopoeia (ep) Reference Standard
76. Bromazepam, United States Pharmacopeia (usp) Reference Standard
77. 7-bromo-5-(pyridin-2-yl)-1h-benzo[e][1,4]diazepin-2(3h)-one
78. 7-bromo-5-(pyridin-2-yl)-2,3-dihydro-1h-1,4-benzodiazepin-2-one
79. (e)-7-bromo-5-(pyridin-2-yl)-1h-benzo[e][1,4]diazepin-2(3h)-one
80. 7-bromo-5-(2-pyridinyl)-1,3-dihydro-2h-1,4-benzodiazepin-2-one #
81. Bromazepam Solution, 1.0 Mg/ml In Methanol, Ampule Of 1 Ml, Certified Reference Material
| Molecular Weight | 316.15 g/mol |
|---|---|
| Molecular Formula | C14H10BrN3O |
| XLogP3 | 1.7 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 3 |
| Rotatable Bond Count | 1 |
| Exact Mass | 315.00072 g/mol |
| Monoisotopic Mass | 315.00072 g/mol |
| Topological Polar Surface Area | 54.4 Ų |
| Heavy Atom Count | 19 |
| Formal Charge | 0 |
| Complexity | 385 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
For the short-term treatment of insomnia, short-term treatment of anxiety or panic attacks, if a benzodiazepine is required, and the alleviation of the symptoms of alcohol- and opiate-withdrawal.
Bromazepam is a lipophilic, long-acting benzodiazepine and with sedative, hypnotic, anxiolytic and skeletal muscle relaxant properties. It does not possess any antidepressant qualities. Bromazepam, like other benzodiazepines, presents a risk of abuse, misuse, and dependence. According to many psychiatric experts, Bromazepam has a greater abuse potential than other benzodiazepines because of fast resorption and rapid onset of action.
GABA Modulators
Substances that do not act as agonists or antagonists but do affect the GAMMA-AMINOBUTYRIC ACID receptor-ionophore complex. GABA-A receptors (RECEPTORS, GABA-A) appear to have at least three allosteric sites at which modulators act: a site at which BENZODIAZEPINES act by increasing the opening frequency of GAMMA-AMINOBUTYRIC ACID-activated chloride channels; a site at which BARBITURATES act to prolong the duration of channel opening; and a site at which some steroids may act. GENERAL ANESTHETICS probably act at least partly by potentiating GABAergic responses, but they are not included here. (See all compounds classified as GABA Modulators.)
Anti-Anxiety Agents
Agents that alleviate ANXIETY, tension, and ANXIETY DISORDERS, promote sedation, and have a calming effect without affecting clarity of consciousness or neurologic conditions. ADRENERGIC BETA-ANTAGONISTS are commonly used in the symptomatic treatment of anxiety but are not included here. (See all compounds classified as Anti-Anxiety Agents.)
N05BA08
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
N05B - Anxiolytics
N05BA - Benzodiazepine derivatives
N05BA08 - Bromazepam
Absorption
Bioavailability is 84% following oral administration. The time to peak plasma level is 1 - 4 hours. Bromazepam is generally well absorbed after oral administration.
Route of Elimination
Urine (69%), as metabolites
Volume of Distribution
1.56 L/kg
Clearance
0.82 mL/min/kg.
Hepatically, via oxidative pathways (via an enzyme belonging to the Cytochrome P450 family of enzymes). One of the main metabolites is 3-hydroxybromazepam. It is pharmacologically active and the half life is similar to that of the parent compound.
Bromazepam has known human metabolites that include 3-Hydroxybromazepam.
S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560
10-20 hours
Bromazepam binds to the GABA-A receptor producing a conformational change and potentiating its inhibitory effects. Other neurotransmitters are not influenced.
API SUPPLIERS
Nortec Quimica is the largest API manufacturer in Latin America.
Certificate Number : R1-CEP 1998-150 - Rev 02
Issue Date : 2007-07-03
Type : Chemical
Substance Number : 879
Status : Withdrawn by EDQM F...
Certificate Number : R1-CEP 2004-034 - Rev 02
Issue Date : 2014-02-24
Type : Chemical
Substance Number : 879
Status : Valid
Registration Number : 220MF10166
Registrant's Address : Viale Milano 26 36075 Montecchio Maggiore Vicenza, Italy
Initial Date of Registration : 2008-07-24
Latest Date of Registration : --
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2021-04-16
Registration Number : 20210416-209-J-848
Manufacturer Name : FIS Fabbrica Italiana Sintetici SpA
Manufacturer Address : Viale Milano, 26-36075 MONTECCHIO MAGGIORE (VI), Italy
Certificate Number : CEP 2004-172 - Rev 04
Issue Date : 2023-10-19
Type : Chemical
Substance Number : 879
Status : Valid
Date of Issue : 2022-06-08
Valid Till : 2025-06-25
Written Confirmation Number : WC-0107
Address of the Firm :
Certificate Number : R1-CEP 2005-073 - Rev 01
Issue Date : 2016-03-03
Type : Chemical
Substance Number : 879
Status : Withdrawn by Holder
Certificate Number : R1-CEP 2008-318 - Rev 01
Issue Date : 2017-12-20
Type : Chemical
Substance Number : 879
Status : Valid
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ABOUT THIS PAGE
A Bromazepam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bromazepam, including repackagers and relabelers. The FDA regulates Bromazepam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bromazepam 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 Bromazepam manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bromazepam supplier is an individual or a company that provides Bromazepam active pharmaceutical ingredient (API) or Bromazepam finished formulations upon request. The Bromazepam suppliers may include Bromazepam API manufacturers, exporters, distributors and traders.
click here to find a list of Bromazepam suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Bromazepam Drug Master File in Japan (Bromazepam JDMF) empowers Bromazepam 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 Bromazepam JDMF during the approval evaluation for pharmaceutical products. At the time of Bromazepam 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 Bromazepam suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Bromazepam Drug Master File in Korea (Bromazepam KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Bromazepam. The MFDS reviews the Bromazepam KDMF as part of the drug registration process and uses the information provided in the Bromazepam KDMF to evaluate the safety and efficacy of the drug.
After submitting a Bromazepam 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 Bromazepam API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Bromazepam suppliers with KDMF on PharmaCompass.
A Bromazepam CEP of the European Pharmacopoeia monograph is often referred to as a Bromazepam Certificate of Suitability (COS). The purpose of a Bromazepam CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Bromazepam EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Bromazepam to their clients by showing that a Bromazepam CEP has been issued for it. The manufacturer submits a Bromazepam CEP (COS) as part of the market authorization procedure, and it takes on the role of a Bromazepam CEP holder for the record. Additionally, the data presented in the Bromazepam CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Bromazepam DMF.
A Bromazepam CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Bromazepam 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 Bromazepam suppliers with CEP (COS) on PharmaCompass.
A Bromazepam written confirmation (Bromazepam WC) is an official document issued by a regulatory agency to a Bromazepam manufacturer, verifying that the manufacturing facility of a Bromazepam active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Bromazepam APIs or Bromazepam finished pharmaceutical products to another nation, regulatory agencies frequently require a Bromazepam WC (written confirmation) as part of the regulatory process.
click here to find a list of Bromazepam suppliers with Written Confirmation (WC) on PharmaCompass.
Bromazepam 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 Bromazepam 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 Bromazepam GMP manufacturer or Bromazepam GMP API supplier for your needs.
A Bromazepam CoA (Certificate of Analysis) is a formal document that attests to Bromazepam's compliance with Bromazepam specifications and serves as a tool for batch-level quality control.
Bromazepam CoA mostly includes findings from lab analyses of a specific batch. For each Bromazepam 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.
Bromazepam may be tested according to a variety of international standards, such as European Pharmacopoeia (Bromazepam EP), Bromazepam JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bromazepam USP).
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