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1. 7,8-dimethoxy-3-(3-(((4,5-dimethoxybenzocyclobutan-1-yl)methyl)methylamino)propyl)-1,3,4,5-tetrahydro-2h-benzazepin-2-one
2. Corlanor
3. Ivabradine
4. S 16257
5. S 16257 2
6. S 16257-2
7. S 162572
8. S 16260 2
9. S 16260-2
10. S 162602
11. S-16257
12. S-16257-2
13. S-16260-2
14. S16257
15. S162572
16. S162602
1. 148849-67-6
2. Ivabradine Hcl
3. Procoralan
4. Corlentor
5. Corlanor
6. Ivabradine (hydrochloride)
7. Tp19837bzk
8. (s)-3-(3-(((3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl)methyl)(methyl)amino)propyl)-7,8-dimethoxy-1,3,4,5-tetrahydro-2h-benzo[d]azepin-2-one Hydrochloride
9. Ivabradine Hydrochloride [usan]
10. Chebi:85969
11. Amg 998
12. Amg-998
13. S-16257-2
14. 2h-3-benzazepin-2-one, 3-[3-[[[(7s)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl]methylamino]propyl]-1,3,4,5-tetrahydro-7,8-dimethoxy-, Hydrochloride (1:1)
15. Ncgc00181343-01
16. 148849-67-6 (hcl)
17. (s)-3-(3-(((3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl)methyl)(methyl)amino)propyl)-7,8-dimethoxy-4,5-dihydro-1h-benzo[d]azepin-2(3h)-one Hydrochloride
18. 3-[3-[[[(7s)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl]methylamino]propyl]-1,3,4,5-tetrahydro-7,8-dimethoxy-2h-3-benzazepin-2-one Hydrochloride
19. Ivabradinehydrochloride
20. Ivabradine Hcl (procoralan)
21. S16257
22. Unii-tp19837bzk
23. Corlentor (tn)
24. Corlanor (tn)
25. 2h-3-benzazepin-2-one, 3-(3-((((7s)-3,4-dimethoxybicyclo(4.2.0)octa-1,3,5-trien-7-yl)methyl)methylamino)propyl)-1,3,4,5-tetrahydro-7,8-dimethoxy-, Hydrochloride (1:1)
26. 3-(3-((((7s)-3,4-dimethoxybicyclo(4.2.0)octa-1,3,5-trien-7-yl)methyl)methylamino)propyl)-1,3,4,5-tetrahydro-7,8-dimethoxy-2h-3-benzazepin-2-one Hydrochloride
27. Coralan (tn)
28. Ivabrandine Hydrochloride
29. Ivabradine Monohydrochloride
30. Dsstox_cid_26913
31. Dsstox_rid_82011
32. Dsstox_gsid_46913
33. Schembl23470
34. Mls006010110
35. Ivabradine Hydrochloride- Bio-x
36. Chembl2145077
37. Dtxsid2046913
38. Hy-b0162a
39. 3-[3-[[(7s)-3,4-dimethoxy-7-bicyclo[4.2.0]octa-1,3,5-trienyl]methyl-methylamino]propyl]-7,8-dimethoxy-2,5-dihydro-1h-3-benzazepin-4-one;hydrochloride
40. Bcp05218
41. Tox21_112802
42. Ac-543
43. Ivabradine Hydrochloride (jan/usan)
44. Ivabradine Hydrochloride [mi]
45. Mfcd00929899
46. S2086
47. Ivabradine Hydrochloride [jan]
48. Akos015849582
49. Akos016002249
50. Bcp9000798
51. Ccg-269739
52. Cs-1994
53. Gs-3584
54. Ivabradine Hydrochloride [who-dd]
55. (7,8-dimethoxy 3-(3-(((1s)-(4,5-dimethoxybenzocyclobutan-1-yl)methyl)methylamino)propyl)-1,3,4,5-tetrahydro-2h-benzazepin-2-one Hydrochloride
56. (s)-3-(3-(((4,5-dimethoxy-1,2-dihydrocyclobutabenzen-1-yl)methyl)(methyl)amino)propyl)-7,8-dimethoxy-4,5-dihydro-1h-benzo[d]azepin-2(3h)-one Hydrochloride
57. Bi164596
58. Smr004701246
59. Ivabradine Hydrochloride [ema Epar]
60. Ivabradine Hydrochloride, >=98% (hplc)
61. Am20090729
62. B1360
63. Cas-148849-67-6
64. I0847
65. Ivabradine Hydrochloride [orange Book]
66. D08095
67. 974i008
68. J-008523
69. J-521616
70. Q27158823
71. (+)-s16257
72. 2h-3-benzazepin-2-one, 3-(3-((((7s)-3,4-dimethoxybicyclo(4.2.0)octa-1,3,5-trien-7-yl)methyl)methylamino)propyl)-1,3,4,5-tetrahydro-7,8-dimethoxy-, Monohydrochloride
73. 2h-3-benzazepin-2-one, 3-(3-(((3,4-dimethoxybicyclo(4.2.0)octa-1,3,5-trien-7-yl)methyl)methylamino)propyl)-1,3,4,5-tetrahydro-7,8-dimethoxy-, Monohydrochloride, (s)-
74. 3-[3-({[(7s)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl}(methyl)amino)propyl]-7,8-dimethoxy-2,3,4,5-tetrahydro-1h-3-benzazepin-2-one Hydrochloride
75. 3-[3-[[(8s)-3,4-dimethoxy-8-bicyclo[4.2.0]octa-1,3,5-trienyl]methyl-methylamino]propyl]-7,8-dimethoxy-2,5-dihydro-1h-3-benzazepin-4-one Hydrochloride
76. 3-[3-[[(8s)-3,4-dimethoxy-8-bicyclo[4.2.0]octa-1,3,5-trienyl]methyl-methylamino]propyl]-7,8-dimethoxy-2,5-dihydro-1h-3-benzazepin-4-one Hydrochloride3-[3-[[(8s)-3,4-dimethoxy-8-bicyclo[4.2.0]octa-1,3,
77. 3-{3-[{[(7s)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]-methyl}(methyl)amino]propyl}-7,8-dimethoxy-1,3,4,5-tetrahydro-2h-3-benzazepin-2-one Hydrochloride
78. 3-{3-[{[(7s)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl}(methyl)amino]propyl}-7,8-dimethoxy-1,3,4,5-tetrahydro-2h-3-benzazepin-2-one--hydrogen Chloride (1/1)
79. N-{[(7s)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl}-3-(7,8-dimethoxy-2-oxo-1,2,4,5-tetrahydro-3h-3-benzazepin-3-yl)-n-methylpropan-1-aminium Chloride
| Molecular Weight | 505.0 g/mol |
|---|---|
| Molecular Formula | C27H37ClN2O5 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 6 |
| Rotatable Bond Count | 10 |
| Exact Mass | 504.2391000 g/mol |
| Monoisotopic Mass | 504.2391000 g/mol |
| Topological Polar Surface Area | 60.5 Ų |
| Heavy Atom Count | 35 |
| Formal Charge | 0 |
| Complexity | 663 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 1 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
Symptomatic treatment of chronic stable angina pectoris Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate 70 bpm. Ivabradine is indicated:
- in adults unable to tolerate or with a contra-indication to the use of beta-blockers
or
- in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose. Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.
* Symptomatic treatment of chronic stable angina pectoris:
Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate 70 bpm. Ivabradine is indicated:
- in adults unable to tolerate or with a contraindication to the use of beta-blockers
- or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose.
* Treatment of chronic heart failure:
Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.
Symptomatic treatment of chronic stable angina pectoris
Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate 70 bpm. Ivabradine is indicated:
- in adults unable to tolerate or with a contraindication to the use of beta-blockers
- or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose.
Treatment of chronic heart failure
Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.
* Symptomatic treatment of chronic stable angina pectoris:
Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate 70 bpm.
Ivabradine is indicated:
- in adults unable to tolerate or with a contra-indication to the use of beta-blockers
- or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose.
* Treatment of chronic heart failure:
Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated. (see section 5. 1)
Symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate 70 bpm. Ivabradine is indicated: - in adults unable to tolerate or with a contra-indication to the use of beta-blockers - or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose. Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.
Treatment of angina pectoris, Treatment of chronic heart failure, Treatment of coronary artery disease
Treatment of angina pectoris, Treatment of chronic heart failure, Treatment of coronary artery disease
Cardiovascular Agents
Agents that affect the rate or intensity of cardiac contraction, blood vessel diameter, or blood volume. (See all compounds classified as Cardiovascular Agents.)
C01EB17
C01EB17
C01EB17
C01EB17
C01EB17
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GDUFA
DMF Review : Complete
Rev. Date : 2020-08-12
Pay. Date : 2020-07-22
DMF Number : 32074
Submission : 2017-09-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28658
Submission : 2014-09-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-11-05
Pay. Date : 2018-09-21
DMF Number : 33077
Submission : 2018-09-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33377
Submission : 2018-12-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-02-04
Pay. Date : 2018-12-04
DMF Number : 33368
Submission : 2018-12-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32420
Submission : 2018-02-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32616
Submission : 2019-10-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-17
Pay. Date : 2019-03-19
DMF Number : 33246
Submission : 2018-10-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27979
Submission : 2014-03-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-03-01
Pay. Date : 2018-10-19
DMF Number : 33213
Submission : 2018-10-15
Status : Active
Type : II
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ABOUT THIS PAGE
49
PharmaCompass offers a list of Ivabradine Hydrochloride 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 Ivabradine Hydrochloride manufacturer or Ivabradine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ivabradine Hydrochloride manufacturer or Ivabradine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Ivabradine Hydrochloride API Price utilized in the formulation of products. Ivabradine Hydrochloride API Price is not always fixed or binding as the Ivabradine Hydrochloride Price is obtained through a variety of data sources. The Ivabradine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ivabradine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ivabradine Hydrochloride, including repackagers and relabelers. The FDA regulates Ivabradine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ivabradine Hydrochloride 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 Ivabradine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ivabradine Hydrochloride supplier is an individual or a company that provides Ivabradine Hydrochloride active pharmaceutical ingredient (API) or Ivabradine Hydrochloride finished formulations upon request. The Ivabradine Hydrochloride suppliers may include Ivabradine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Ivabradine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ivabradine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Ivabradine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Ivabradine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Ivabradine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ivabradine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Ivabradine Hydrochloride USDMF includes data on Ivabradine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ivabradine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ivabradine Hydrochloride 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 Ivabradine Hydrochloride Drug Master File in Japan (Ivabradine Hydrochloride JDMF) empowers Ivabradine Hydrochloride 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 Ivabradine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Ivabradine Hydrochloride 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 Ivabradine Hydrochloride 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 Ivabradine Hydrochloride Drug Master File in Korea (Ivabradine Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ivabradine Hydrochloride. The MFDS reviews the Ivabradine Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Ivabradine Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ivabradine Hydrochloride 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 Ivabradine Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ivabradine Hydrochloride suppliers with KDMF on PharmaCompass.
A Ivabradine Hydrochloride written confirmation (Ivabradine Hydrochloride WC) is an official document issued by a regulatory agency to a Ivabradine Hydrochloride manufacturer, verifying that the manufacturing facility of a Ivabradine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ivabradine Hydrochloride APIs or Ivabradine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Ivabradine Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Ivabradine Hydrochloride 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 Ivabradine Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ivabradine Hydrochloride 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 Ivabradine Hydrochloride 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 Ivabradine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ivabradine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ivabradine Hydrochloride suppliers with NDC on PharmaCompass.
Ivabradine Hydrochloride 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 Ivabradine Hydrochloride 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 Ivabradine Hydrochloride GMP manufacturer or Ivabradine Hydrochloride GMP API supplier for your needs.
A Ivabradine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Ivabradine Hydrochloride's compliance with Ivabradine Hydrochloride specifications and serves as a tool for batch-level quality control.
Ivabradine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Ivabradine Hydrochloride 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.
Ivabradine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Ivabradine Hydrochloride EP), Ivabradine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ivabradine Hydrochloride USP).
