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Chemistry

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Also known as: 148849-67-6, Ivabradine hcl, Procoralan, Corlentor, Corlanor, Ivabradine (hydrochloride)
Molecular Formula
C27H37ClN2O5
Molecular Weight
505.0  g/mol
InChI Key
HLUKNZUABFFNQS-ZMBIFBSDSA-N
FDA UNII
TP19837BZK

Ivabradine Hydrochloride
A benzazepine derivative and selective HYPERPOLARIZATION-ACTIVATED CYCLIC NUCLEOTIDE-GATED CHANNELS inhibitor that lowers the heart rate. It is used in the treatment of CHRONIC STABLE ANGINA in patients unable to take BETA-ADRENERGIC BLOCKERS, and in the treatment of HEART FAILURE.
1 2D Structure

Ivabradine Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
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
2.1.2 InChI
InChI=1S/C27H36N2O5.ClH/c1-28(17-21-11-20-14-25(33-4)26(34-5)16-22(20)21)8-6-9-29-10-7-18-12-23(31-2)24(32-3)13-19(18)15-27(29)30;/h12-14,16,21H,6-11,15,17H2,1-5H3;1H/t21-;/m1./s1
2.1.3 InChI Key
HLUKNZUABFFNQS-ZMBIFBSDSA-N
2.1.4 Canonical SMILES
CN(CCCN1CCC2=CC(=C(C=C2CC1=O)OC)OC)CC3CC4=CC(=C(C=C34)OC)OC.Cl
2.1.5 Isomeric SMILES
CN(CCCN1CCC2=CC(=C(C=C2CC1=O)OC)OC)C[C@H]3CC4=CC(=C(C=C34)OC)OC.Cl
2.2 Other Identifiers
2.2.1 UNII
TP19837BZK
2.3 Synonyms
2.3.1 MeSH Synonyms

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

2.3.2 Depositor-Supplied Synonyms

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

2.4 Create Date
2005-08-09
3 Chemical and Physical Properties
Molecular Weight 505.0 g/mol
Molecular Formula C27H37ClN2O5
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count6
Rotatable Bond Count10
Exact Mass504.2391000 g/mol
Monoisotopic Mass504.2391000 g/mol
Topological Polar Surface Area60.5 Ų
Heavy Atom Count35
Formal Charge0
Complexity663
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Indication

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


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

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.)


5.2 ATC Code

C01EB17


C01EB17


C01EB17


C01EB17


C01EB17


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Ivabradine Hydrochloride IH

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Ivabradine Hydrochloride

About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
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Ivabradine Hydrochloride

About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
HRV Global Life Sciences

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothTagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.

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Ivabradine Hydrochloride

About the Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for critical and high-g...

Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for critical and high-growth therapeutic areas, with an emphasis on affordability, quality and timely delivery. It also provides end-to-end CDMO services. Headquartered in Hyderabad, Tagoor Labs is a fast-growing Indian pharma company that serves both branded and generic companies worldwide. The company’s organizational function includes R&D, supply chain, manufacturing, quality testing, quality assurance, regulatory affairs, marketing & sales, and packaging & warehousing departments.
Tagoor Laboratories

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothTenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.

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Ivabradine Hydrochloride

About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...

Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opportunities grew, it was felt that the proprietorship firm had outlived its usefulness and that it needed a corporate structure. So, Tenatra Chemie Private Limited (TCPL) was incorporated in 2002. Since then, the company has come a long way, gaining valuable experience and knowledge in the fields of chemicals and pharmaceuticals in India.
Tenatra

06

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Ivabradine

About the Company : Anax Laboratories was established in 2012 as a custom synthesis laboratories specializing in synthesis of wide range of organic compounds to cater the needs of pharmaceutical and c...

Anax Laboratories was established in 2012 as a custom synthesis laboratories specializing in synthesis of wide range of organic compounds to cater the needs of pharmaceutical and chemical industries. Anax Laboratories is strategically located in hyderabad,the pharma capital of india , surrounded by high repute R&D institutes and companies. Anax Laboratories has cutting edge, modern organic synthesis and analytical lab to develop novel and established organic compounds. Anax Laboratories is guided by strong scientific advisory board from high repute R&D institutes like IICT, CCMB and also professors from universities in India and abroad.
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07

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IVABRADINE HYDROCHLORIDE

About the Company : Beijing Lunarsun pharma is a professional manufacturer of API and intermediates. The factory is approved by US FDA. According to EU and US FDA's requirement, we supply following AP...

Beijing Lunarsun pharma is a professional manufacturer of API and intermediates. The factory is approved by US FDA. According to EU and US FDA's requirement, we supply following APIs and their intermediates with good quality and competitive price: Aztreonam,Doripenem, Dronedarone Hcl ,Erlotinib HCL, Febuxostat,Gemcitabine HCL, Ivabradine, Imatinib mesylate, Mecobalamin,Moxifloxacin, Nelarabine,Pemetrexed disodium, Posaconazole, Temozolomide, Voriconazole, Tebipenem pivoxil.NOTE: Products covered by valid patents in any country are not offered or supplied to these countries for commercial purpose.
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08

CHEMO

Spain
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CHEMO

Spain
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IVABRADINE HYDROCHLORIDE

About the Company : More than 35 years of dedication to quality, service and pursuit of excellence, CHEMO was founded by Hugo Sigman, M.D., and Silvia Gold, Biochemist, in Spain (Barcelona), in 1977, ...

More than 35 years of dedication to quality, service and pursuit of excellence, CHEMO was founded by Hugo Sigman, M.D., and Silvia Gold, Biochemist, in Spain (Barcelona), in 1977, and starts business activities trading with pharmaceutical raw materials. In the 80's, the company expanded its operations into the Industrial Business, developing and manufacturing active pharmaceutical ingredients (APIs) in Italy (Industriale Chimica) and in Spain (Quimica Sintetica). In the 90's, CHEMO starts developing and manufacturing high quality and technology finished dosage forms (FDFs).
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09

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Ivabradine HCl

About the Company : Dalian Richon Chem. Co., Ltd is a high-tech enterprise professionally involved in research and development, manufacturing process and sales service of pharmaceutical intermediates ...

Dalian Richon Chem. Co., Ltd is a high-tech enterprise professionally involved in research and development, manufacturing process and sales service of pharmaceutical intermediates and APIs. It has passed ISO9001:2000 international quality management system certificate. Its business scope includes development and manufacturing of APIs and pharmaceutical intermediates, contract development and manufacturing for domestic and international pharmaceutical companies, technical consultation, service and transfer.
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10

Lewens Labs

India
CRS
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Lewens Labs

India
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Ivabradine Hydrochloride

About the Company : Lewens Labs finds its roots in 4 years of engineering during which we saw a dream to carve out a niche for ourselves in Pharmaceutical Industry. As a part of the final year project...

Lewens Labs finds its roots in 4 years of engineering during which we saw a dream to carve out a niche for ourselves in Pharmaceutical Industry. As a part of the final year project, We worked on cost reduction of “Aceclofenac” which fetched us four national awards including one from Consultancy Development Center, Government of India. At Lewens, We aim to develop and provide quality,cost effective and sustainable solutions to our Customers by empowering people to think beyond the traditional norms of Chemistry and Engineering to come up with different and innovative solutions to the problems.
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11-Jan-2022
22-May-2025
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01

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Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

Grade : Oral

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ABOUT THIS PAGE

Looking for 148849-67-6 / Ivabradine Hydrochloride API manufacturers, exporters & distributors?

Ivabradine Hydrochloride manufacturers, exporters & distributors 1

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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.

API | Excipient name

Ivabradine Hydrochloride

Synonyms

148849-67-6, Ivabradine hcl, Procoralan, Corlentor, Corlanor, Ivabradine (hydrochloride)

Cas Number

148849-67-6

Unique Ingredient Identifier (UNII)

TP19837BZK

About Ivabradine Hydrochloride

A benzazepine derivative and selective HYPERPOLARIZATION-ACTIVATED CYCLIC NUCLEOTIDE-GATED CHANNELS inhibitor that lowers the heart rate. It is used in the treatment of CHRONIC STABLE ANGINA in patients unable to take BETA-ADRENERGIC BLOCKERS, and in the treatment of HEART FAILURE.

CORLANOR Manufacturers

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

CORLANOR Suppliers

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

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

CORLANOR USDMF

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

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

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

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

CORLANOR KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a CORLANOR Drug Master File in Korea (CORLANOR KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of CORLANOR. The MFDS reviews the CORLANOR KDMF as part of the drug registration process and uses the information provided in the CORLANOR KDMF to evaluate the safety and efficacy of the drug.

After submitting a CORLANOR 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 CORLANOR API can apply through the Korea Drug Master File (KDMF).

click here to find a list of CORLANOR suppliers with KDMF on PharmaCompass.

CORLANOR WC

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

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

CORLANOR 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 CORLANOR as an active pharmaceutical ingredient (API).

Finished drug products

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

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

CORLANOR GMP

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

CORLANOR CoA

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

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

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