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1. (endo,syn)-(+-)-3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-8-azoniabicyclo(3.2.1)octane
2. Atrovent
3. Ipratropium
4. Ipratropium Bromide Anhydrous
5. Ipratropium Bromide Monohydrate
6. Ipratropium Bromide, (endo,anti)-isomer
7. Ipratropium Bromide, (exo,syn)-isomer
8. Ipratropium Bromide, Endo-isomer
9. Itrop
10. N Isopropylatropine
11. N-isopropylatropine
12. Sch 1000
13. Sch 1178
14. Sch-1000
15. Sch-1178
16. Sch1000
17. Sch1178
1. 22254-24-6
2. Atrovent
3. Itrop
4. Ipratropiumbromid
5. Bromure D'ipratropium
6. Bromuro De Ipratropio
7. Sch 1000
8. 8-isopropylnoratropine Methobromide
9. Ipratropium Bromide [inn]
10. Ipratropium Bromide'
11. Ipratropii Bromidum
12. N-isopropylnoratropinium Bromomethylate
13. Ipratropium Bromide Anhydrous
14. Vjv4x1p2z1
15. Mls000069557
16. 60251-88-9
17. Ipratropiumbromide
18. Smr000058764
19. (1r,5s)-3-((3-hydroxy-2-phenylpropanoyl)oxy)-8-isopropyl-8-methyl-8-azabicyclo[3.2.1]octan-8-ium Bromide
20. 24358-20-1
21. Ipratropium Bromide Monohydrate
22. 8-azoniabicyclo[3.2.1]octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, Bromide (1:1), (3-exo,8-syn)-
23. Rel-(1r,3r,5s,8r)-3-((3-hydroxy-2-phenylpropanoyl)oxy)-8-isopropyl-8-methyl-8-azabicyclo[3.2.1]octan-8-ium Bromide
24. Atem
25. 66985-17-9
26. Ipratropiumbromid [german]
27. Unii-vjv4x1p2z1
28. Ipratropii Bromidum [inn-latin]
29. Prestwick_279
30. Bromure D'ipratropium [inn-french]
31. Einecs 244-873-8
32. Einecs 261-098-0
33. Einecs 262-128-5
34. Bromuro De Ipratropio [inn-spanish]
35. Opera_id_1621
36. Schembl3852
37. Schembl3854
38. Schembl107906
39. (1s,3s,5r)-3-tropyloxy-8-isopropyltropanium Bromide
40. Ipratropium Bromide (anhydrous)
41. Chembl1464005
42. Ipratropium Bromide [mi]
43. Regid_for_cid_657308
44. Schembl16762661
45. Chebi:46659
46. Dtxsid10860753
47. Dtxsid60858923
48. Hms2234j05
49. Einecs 246-197-9
50. Bdbm50021892
51. Ipratropium Bromide [who-dd]
52. Mfcd00069291
53. Akos015895324
54. Akos030485952
55. (8r)-3-alpha-hydroxy-8-isopropyl-1-alpha-h,5-alpha-h-tropiumbromide-(+-)-tropate
56. 3-alpha-hydroxy-8-isopropyl-1-alpha-h,5-alpha-h-tropanium Bromide (+-)-tropate
57. (endo,anti)-(1)-3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-isopropyl-8-methyl-8-azoniabicyclo(3.2.1)octane Bromide
58. (exo,syn)-(1)-3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-isopropyl-8-methyl-8-azoniabicyclo(3.2.1)octane Bromide
59. Bi164579
60. N-isopropylnortropine Tropate Methobromide
61. C74140
62. T72808
63. Q424294
64. 3alpha-hydroxy-8-isopropyl-1alphah,5alphah-tropanium Bromide (+-)-tropate
65. 1-alpha-h,5-alpha-h-tropanium, 3-alpha-hydroxy-8-isopropyl-, Bromide, (+-)-tropate
66. (1r,3r,5s)-3-(3-hydroxy-2-phenylpropanoyloxy)-8-isopropyl-8-methyl-8-azoniabicyclo[3.2.1]octane Bromide
67. (3-endo,8-syn)-3-[(3-hydroxy-2-phenylpropanoyl)oxy]-8-isopropyl-8-methyl-8-azoniabicyclo[3.2.1]octane Bromide
68. (endo,syn)-(+-)-3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-8-azoniabicyclo[3.2.1]octane Bromide
69. 8-azoniabicyclo(3.2.1)octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, Bromide, Endo-
70. Endo-3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-isopropyl-8-methyl-8-azoniabicyclo(3.2.1)octane Bromide
71. Rel-(1r,3r,5s,8s)-3-((3-hydroxy-2-phenylpropanoyl)oxy)-8-isopropyl-8-methyl-8-azabicyclo[3.2.1]octan-8-ium Bromide
| Molecular Weight | 412.4 g/mol |
|---|---|
| Molecular Formula | C20H30BrNO3 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 4 |
| Rotatable Bond Count | 6 |
| Exact Mass | 411.14091 g/mol |
| Monoisotopic Mass | 411.14091 g/mol |
| Topological Polar Surface Area | 46.5 Ų |
| Heavy Atom Count | 25 |
| Formal Charge | 0 |
| Complexity | 430 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 2 |
| Undefined Atom Stereocenter Count | 1 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 4 | |
|---|---|
| Drug Name | Atrovent |
| PubMed Health | Ipratropium (Into the nose) |
| Drug Classes | Nasal Agent |
| Drug Label | The active ingredient in ATROVENT Nasal Spray is ipratropium bromide (as the monohydrate). It is an anticholinergic agent chemically described as 8-azoniabicyclo[3.2.1]octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide m... |
| Active Ingredient | Ipratropium bromide |
| Dosage Form | Spray, metered |
| Route | Nasal |
| Strength | 0.042mg/spray; 0.021mg/spray |
| Market Status | Prescription |
| Company | Boehringer Ingelheim |
| 2 of 4 | |
|---|---|
| Drug Name | Ipratropium bromide |
| PubMed Health | Ipratropium |
| Drug Classes | Bronchodilator, Nasal Agent |
| Drug Label | The active ingredient in Ipratropium Bromide Nasal Solution 0.03% (Nasal Spray) is ipratropium bromide monohydrate. It is an anticholinergic agent chemically described as 8-azoniabicyclo [3.2.1] octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-... |
| Active Ingredient | Ipratropium bromide |
| Dosage Form | Spray, metered; Solution |
| Route | Nasal; Inhalation |
| Strength | 0.042mg/spray; 0.02%; 0.021mg/spray |
| Market Status | Prescription |
| Company | Ritedose; Nephron; Mylan Speclt; Roxane; Watson Labs; Bausch And Lomb; Landela Pharm |
| 3 of 4 | |
|---|---|
| Drug Name | Atrovent |
| PubMed Health | Ipratropium (Into the nose) |
| Drug Classes | Nasal Agent |
| Drug Label | The active ingredient in ATROVENT Nasal Spray is ipratropium bromide (as the monohydrate). It is an anticholinergic agent chemically described as 8-azoniabicyclo[3.2.1]octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide m... |
| Active Ingredient | Ipratropium bromide |
| Dosage Form | Spray, metered |
| Route | Nasal |
| Strength | 0.042mg/spray; 0.021mg/spray |
| Market Status | Prescription |
| Company | Boehringer Ingelheim |
| 4 of 4 | |
|---|---|
| Drug Name | Ipratropium bromide |
| PubMed Health | Ipratropium |
| Drug Classes | Bronchodilator, Nasal Agent |
| Drug Label | The active ingredient in Ipratropium Bromide Nasal Solution 0.03% (Nasal Spray) is ipratropium bromide monohydrate. It is an anticholinergic agent chemically described as 8-azoniabicyclo [3.2.1] octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-... |
| Active Ingredient | Ipratropium bromide |
| Dosage Form | Spray, metered; Solution |
| Route | Nasal; Inhalation |
| Strength | 0.042mg/spray; 0.02%; 0.021mg/spray |
| Market Status | Prescription |
| Company | Ritedose; Nephron; Mylan Speclt; Roxane; Watson Labs; Bausch And Lomb; Landela Pharm |
Bronchodilator Agents
Agents that cause an increase in the expansion of a bronchus or bronchial tubes. (See all compounds classified as Bronchodilator Agents.)
Cholinergic Antagonists
Drugs that bind to but do not activate CHOLINERGIC RECEPTORS, thereby blocking the actions of ACETYLCHOLINE or cholinergic agonists. (See all compounds classified as Cholinergic Antagonists.)
R03BB01
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
R - Respiratory system
R01 - Nasal preparations
R01A - Decongestants and other nasal preparations for topical use
R01AX - Other nasal preparations
R01AX03 - Ipratropium bromide
R - Respiratory system
R03 - Drugs for obstructive airway diseases
R03B - Other drugs for obstructive airway diseases, inhalants
R03BB - Anticholinergics
R03BB01 - Ipratropium bromide
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DOSAGE - SPRAY, METERED;NASAL - 0.021MG/SPRAY...DOSAGE - SPRAY, METERED;NASAL - 0.021MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20393
DOSAGE - SPRAY, METERED;NASAL - 0.042MG/SPRAY...DOSAGE - SPRAY, METERED;NASAL - 0.042MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20394
DOSAGE - SOLUTION;INHALATION - EQ 0.083% BASE...DOSAGE - SOLUTION;INHALATION - EQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20950
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A COMBIVENT-1 supplier is an individual or a company that provides COMBIVENT-1 active pharmaceutical ingredient (API) or COMBIVENT-1 finished formulations upon request. The COMBIVENT-1 suppliers may include COMBIVENT-1 API manufacturers, exporters, distributors and traders.
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A COMBIVENT-1 DMF (Drug Master File) is a document detailing the whole manufacturing process of COMBIVENT-1 active pharmaceutical ingredient (API) in detail. Different forms of COMBIVENT-1 DMFs exist exist since differing nations have different regulations, such as COMBIVENT-1 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A COMBIVENT-1 DMF submitted to regulatory agencies in the US is known as a USDMF. COMBIVENT-1 USDMF includes data on COMBIVENT-1's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The COMBIVENT-1 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 COMBIVENT-1 Drug Master File in Japan (COMBIVENT-1 JDMF) empowers COMBIVENT-1 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 COMBIVENT-1 JDMF during the approval evaluation for pharmaceutical products. At the time of COMBIVENT-1 JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a COMBIVENT-1 Drug Master File in Korea (COMBIVENT-1 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of COMBIVENT-1. The MFDS reviews the COMBIVENT-1 KDMF as part of the drug registration process and uses the information provided in the COMBIVENT-1 KDMF to evaluate the safety and efficacy of the drug.
After submitting a COMBIVENT-1 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 COMBIVENT-1 API can apply through the Korea Drug Master File (KDMF).
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A COMBIVENT-1 CEP of the European Pharmacopoeia monograph is often referred to as a COMBIVENT-1 Certificate of Suitability (COS). The purpose of a COMBIVENT-1 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of COMBIVENT-1 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of COMBIVENT-1 to their clients by showing that a COMBIVENT-1 CEP has been issued for it. The manufacturer submits a COMBIVENT-1 CEP (COS) as part of the market authorization procedure, and it takes on the role of a COMBIVENT-1 CEP holder for the record. Additionally, the data presented in the COMBIVENT-1 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the COMBIVENT-1 DMF.
A COMBIVENT-1 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. COMBIVENT-1 CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A COMBIVENT-1 written confirmation (COMBIVENT-1 WC) is an official document issued by a regulatory agency to a COMBIVENT-1 manufacturer, verifying that the manufacturing facility of a COMBIVENT-1 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting COMBIVENT-1 APIs or COMBIVENT-1 finished pharmaceutical products to another nation, regulatory agencies frequently require a COMBIVENT-1 WC (written confirmation) as part of the regulatory process.
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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 COMBIVENT-1 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for COMBIVENT-1 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 COMBIVENT-1 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 COMBIVENT-1 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a COMBIVENT-1 NDC to their finished compounded human drug products, they may choose to do so.
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COMBIVENT-1 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 COMBIVENT-1 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 COMBIVENT-1 GMP manufacturer or COMBIVENT-1 GMP API supplier for your needs.
A COMBIVENT-1 CoA (Certificate of Analysis) is a formal document that attests to COMBIVENT-1's compliance with COMBIVENT-1 specifications and serves as a tool for batch-level quality control.
COMBIVENT-1 CoA mostly includes findings from lab analyses of a specific batch. For each COMBIVENT-1 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.
COMBIVENT-1 may be tested according to a variety of international standards, such as European Pharmacopoeia (COMBIVENT-1 EP), COMBIVENT-1 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (COMBIVENT-1 USP).
