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1. ((4-(1,4,5,6-tetrahydro-4-methyl-6-oxo-3-pyridazinyl)phenyl)hydrazono)propanedinitrile
2. Dextrosimendan
3. Or 1259
4. Or 1855
5. Or-1259
6. Or-1855
7. Simadax
8. Simendan
1. 141505-33-1
2. Simdax
3. (r)-simendan
4. (-)-or-1259
5. Or-1259
6. Simendan, (r)-
7. Chebi:50567
8. 2-[[4-[(4r)-4-methyl-6-oxo-4,5-dihydro-1h-pyridazin-3-yl]phenyl]hydrazinylidene]propanedinitrile
9. Nsc-759644
10. Levosimedan
11. C6t4514l4e
12. Or1259
13. (r)-((4-(1,4,5,6-tetrahydro-4-methyl-6-oxo-3-pyridazinyl)phenyl)hydrazono) Propanedintrile
14. (r)-n-(4-(4-methyl-6-oxo-1,4,5,6-tetrahydropyridazin-3-yl)phenyl)carbonohydrazonoyl Dicyanide
15. Levosimendan [inn]
16. Dsstox_cid_26445
17. Dsstox_rid_81620
18. Mesoxalonitrile (p-((r)-1,4,5,6-tetrahydro-4-methyl-6-oxo-pyridazinyl)phenyl)hydrazone
19. Dsstox_gsid_46445
20. Levosimendanum
21. Smr002529692
22. Simdax (tn)
23. Cas-141505-33-1
24. Levosimendan (usan/inn)
25. Levosimendan [usan:inn]
26. Or 1259
27. Unii-c6t4514l4e
28. ((4-(1,4,5,6-tetrahydro-4-methyl-6-oxo-3-pyridazinyl)phenyl)hydrazono)propanedinitrile
29. Levosimendan- Bio-x
30. Levosimendan [mi]
31. Levosimendan [usan]
32. Mesoxalonitrile (-)-(p((r)-1,4,5,6-tetrahydro-4-methyl-6-oxo-3-pyridazinyl)phenyl)hydrazone
33. Schembl83243
34. Levosimendan [mart.]
35. Mls003899227
36. Mls006010741
37. Levosimendan [who-dd]
38. Chembl2051955
39. Dtxsid9046445
40. Levosimendan, >=98% (hplc)
41. Hms3264g03
42. Hms3884n17
43. Kuc109648n
44. Pharmakon1600-01502356
45. Act02710
46. Bcp07048
47. Zinc3915645
48. Tox21_112191
49. Tox21_113768
50. Bdbm50469700
51. Mfcd00867135
52. Nsc759644
53. S2446
54. Akos015895214
55. Tox21_112191_1
56. Ac-1752
57. Am84381
58. Ccg-213048
59. Db00922
60. Ds-8918
61. Nsc 759644
62. ({4-[(4r)-4-methyl-6-oxo-1,4,5,6-tetrahydropyridazin-3-yl]phenyl}hydrazono)propanedintrile
63. 2-[[4-[(4r)-4-methyl-6-oxo-4,5-dihydro-1h-pyridazin-3-yl]phenyl]hydrazono]propanedinitrile
64. Ksc-210-010
65. Ncgc00253641-01
66. Ncgc00263564-01
67. Ncgc00263564-02
68. Bm164625
69. Hy-14286
70. L0320
71. Sw219172-1
72. A11874
73. D04720
74. N12889
75. Ab01562970_01
76. Ab01562970_02
77. 741l087
78. A807767
79. Q162541
80. Sr-01000931342
81. Sr-01000931342-2
82. 1-beta-d-ribofuranose-1h-1,2,4-triazole-3-methylcarbonate
83. (r)-(4-(4-methyl-6-oxo-1,4,5,6-tetrahydropyridazin-3-yl)phenyl)carbonohydrazonoyl Dicyanide
84. (r)-n-(4-(4-methyl-6-oxo-1,4,5,6-tetrahydropyridazin-3-yl)phenyl)carbonohydrazonoyldicyanide
85. 1-cyano-n-{4-[(4r)-4-methyl-6-oxo-1,4,5,6-tetrahydropyridazin-3-yl]phenyl}methanecarbohydrazonoyl Cyanide
86. 2-(2-(4-((4r)-1,4,5,6-tetrahydro-4-methyl-6-oxo-3-pyridazinyl)phenyl)hydrazinylidene)propanedinitrile
87. Mesoxalonitrile (-)-(p((r)-1,4,5,6-tetrahydro-4-methyl-6- Oxo-3-pyridazinyl)phenyl)hydrazone
88. Propanedinitrile, ((4-(1,4,5,6-tetrahydro-4-methyl-6-oxo-3-pyridazinyl)phenyl)hydrazono)-, (r)-
89. Propanedinitrile, 2-(2-(4-((4r)-1,4,5,6-tetrahydro-4-methyl-6-oxo-3-pyridazinyl)phenyl)hydrazinylidene)-
Molecular Weight | 280.28 g/mol |
---|---|
Molecular Formula | C14H12N6O |
XLogP3 | 2.3 |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 6 |
Rotatable Bond Count | 3 |
Exact Mass | 280.10725903 g/mol |
Monoisotopic Mass | 280.10725903 g/mol |
Topological Polar Surface Area | 113 Ų |
Heavy Atom Count | 21 |
Formal Charge | 0 |
Complexity | 549 |
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 | 1 |
For short term treatment of acutely decompensated severe chronic heart failure (CHF). Also being investigated for use/treatment in heart disease.
Levosimendan is a new Ca2+-sensitizing inotropic agent. Ca2+ sensitizers represent a new class of inotropic agents, which overcome the disadvantages associated with currently available inotropic agents in as they are not associated with an increased risk of arrhythmias, cell injury and death due to Ca2+ overload in myocardial cells; they do not increase the activation energy; and they have the potential to reverse contractile dysfunction under pathophysiologic conditions, such as acidosis or myocardial stunning. Levosimendan has not been approved for use in the U.S. or Canada.
Vasodilator Agents
Drugs used to cause dilation of the blood vessels. (See all compounds classified as Vasodilator Agents.)
Cardiotonic Agents
Agents that have a strengthening effect on the heart or that can increase cardiac output. They may be CARDIAC GLYCOSIDES; SYMPATHOMIMETICS; or other drugs. They are used after MYOCARDIAL INFARCT; CARDIAC SURGICAL PROCEDURES; in SHOCK; or in congestive heart failure (HEART FAILURE). (See all compounds classified as Cardiotonic Agents.)
Phosphodiesterase 3 Inhibitors
Compounds that specifically inhibit PHOSPHODIESTERASE 3. (See all compounds classified as Phosphodiesterase 3 Inhibitors.)
C - Cardiovascular system
C01 - Cardiac therapy
C01C - Cardiac stimulants excl. cardiac glycosides
C01CX - Other cardiac stimulants
C01CX08 - Levosimendan
Absorption
The bioavailability of oral levosimendan is 85 ± 6% in healthy volunteers and 84 ± 4% in patients.
Complete metabolism, with some active metabolites (OR-1855 and OR-1896) possibly extending the drug's haemodynamic effects.
Eliminination half-life is approximately 1 hour.
Levosimendan appears to increase myofilament calcium sensitivity by binding to cardiac troponin C in a calcium-dependent manner. This stabilizes the calcium-induced conformational change of troponin C, thereby (1) changing actin-myosin cross-bridge kinetics apparently without increasing the cycling rate of the cross-bridges or myocardial ATP consumption, (2) increasing the effects of calcium on cardiac myofilaments during systole and (3) improving contraction at low energy cost (inotropic effect). Calcium concentration and, therefore, sensitization decline during diastole, allowing normal or improved diastolic relaxation. Levosimendan also leads to vasodilation through the opening of ATP-sensitive potassium channels. By these inotropic and vasodilatory actions, levosimendan increases cardiac output without increasing myocardial oxygen demand. Levosimendan also has a selective phosphodiesterase (PDE)-III inhibitory action that may contribute to the inotropic effect of this compound under certain experimental conditions. It has been reported that levosimendan may act preferentially as a Ca2+ sensitizer at lower concentrations, whereas at higher concentrations its action as a PDE-III inhibitor becomes more prominent in experimental animals and humans.
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12960
Submission : 1998-04-24
Status : Active
Type : II
Available Reg Filing : ASMF |
Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.
Reliable Spanish CDMO Delivering High-Quality APIs and Intermediates with Excellence, Flexibility, and Regulatory Compliance.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37514
Submission : 2022-09-29
Status : Active
Type : II
Date of Issue : 2022-07-28
Valid Till : 2025-07-02
Written Confirmation Number : WC-0227n
Address of the Firm :
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Details:
Amendment to the existing agreement gives Tenax rights to develop and commercialize in the United States and Canada an oral formulation of levosimendan for use with Type 2 pulmonary hypertension in heart failure patients with PH-HFpEF, or other heart related indications.
Lead Product(s): Levosimendan
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: ODM-109
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Tenax Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement October 15, 2020
Lead Product(s) : Levosimendan
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Tenax Therapeutics
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Details : Amendment to the existing agreement gives Tenax rights to develop and commercialize in the United States and Canada an oral formulation of levosimendan for use with Type 2 pulmonary hypertension in heart failure patients with PH-HFpEF, or other heart rel...
Product Name : ODM-109
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
October 15, 2020
Details:
TNX-103 (levosimendan) is an oral PDE3, small molecule drug candidate, which is currently being evaluated for the treatment of patients with PH-HFpEF.
Lead Product(s): Levosimendan
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: TNX-103
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 05, 2025
Lead Product(s) : Levosimendan
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Tenax Expands Phase 3 for TNX-103 in PH-HFpEF Treatment
Details : TNX-103 (levosimendan) is an oral PDE3, small molecule drug candidate, which is currently being evaluated for the treatment of patients with PH-HFpEF.
Product Name : TNX-103
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 05, 2025
Details:
The Company intends to use the net proceeds to advance its ongoing and planned Phase 3 clinical trials, including TNX-103 (oral levosimendan) in patients with PH-HFpEF.
Lead Product(s): Levosimendan
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: TNX-103
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Leerink Partners
Deal Size: $25.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement March 05, 2025
Lead Product(s) : Levosimendan
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Leerink Partners
Deal Size : $25.0 million
Deal Type : Private Placement
Tenax Therapeutics Announces $25 Million Private Placement
Details : The Company intends to use the net proceeds to advance its ongoing and planned Phase 3 clinical trials, including TNX-103 (oral levosimendan) in patients with PH-HFpEF.
Product Name : TNX-103
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
March 05, 2025
Details:
The funding will support the advancement of oral TNX-103 (levosimendan) phase 3 development program for the treatment of Pulmonary Hypertension Due to Heart Failure with Preserved Ejection Fraction.
Lead Product(s): Levosimendan
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: TNX-103
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: BVF Partners
Deal Size: $100.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement December 08, 2024
Lead Product(s) : Levosimendan
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : BVF Partners
Deal Size : $100.0 million
Deal Type : Private Placement
Tenax Therapeutics Closes $100M Private Placement to Accelerate Levosimendan Phase 3
Details : The funding will support the advancement of oral TNX-103 (levosimendan) phase 3 development program for the treatment of Pulmonary Hypertension Due to Heart Failure with Preserved Ejection Fraction.
Product Name : TNX-103
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
December 08, 2024
Details:
The company intends to use the net proceeds for the clinical development of TNX-103 (levosimendan) for the treatment of pulmonary hypertension and heart failure with preserved ejection fraction.
Lead Product(s): Levosimendan
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: TNX-103
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Roth Capital Partners
Deal Size: $9.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering August 02, 2024
Lead Product(s) : Levosimendan
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Roth Capital Partners
Deal Size : $9.0 million
Deal Type : Public Offering
Tenax Therapeutics Announces Pricing of Approximately $9 Million Public Offering
Details : The company intends to use the net proceeds for the clinical development of TNX-103 (levosimendan) for the treatment of pulmonary hypertension and heart failure with preserved ejection fraction.
Product Name : TNX-103
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
August 02, 2024
Details:
TNX-103 (levosimendan) is in Phase 3 trials for pulmonary hypertension in heart failure with preserved ejection fraction, acting as a potassium ATP channel activator.
Lead Product(s): Levosimendan
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: TNX-103
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 02, 2024
Lead Product(s) : Levosimendan
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Tenax Therapeutics Enrolls First Patient in Phase 3 LEVEL Study Of TNX-103
Details : TNX-103 (levosimendan) is in Phase 3 trials for pulmonary hypertension in heart failure with preserved ejection fraction, acting as a potassium ATP channel activator.
Product Name : TNX-103
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 02, 2024
Details:
The Company intends to use the net proceeds from the private placement to complete its ongoing late-stage clinical trial studies with Patients for the treatment of PH-HFpEF.
Lead Product(s): Levosimendan
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: TNX-103
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: BVF Partners
Deal Size: $100.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement June 08, 2024
Lead Product(s) : Levosimendan
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : BVF Partners
Deal Size : $100.0 million
Deal Type : Private Placement
Tenax Therapeutics Announces Oversubscribed $100 Million Private Placement
Details : The Company intends to use the net proceeds from the private placement to complete its ongoing late-stage clinical trial studies with Patients for the treatment of PH-HFpEF.
Product Name : TNX-103
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
June 08, 2024
Details:
Under the license agreement, Tenax will be developing and commercializing the TNX-103 (levosimendan) for the treatment of pulmonary hypertension with heart failure with preserved ejection fraction.
Lead Product(s): Levosimendan
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: TNX-103
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Orion Corporation
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement February 20, 2024
Lead Product(s) : Levosimendan
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Orion Corporation
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Tevogen Bio Prepares to Launch Genetic Predisposition Study for TVGN 489 in Long COVID
Details : Under the license agreement, Tenax will be developing and commercializing the TNX-103 (levosimendan) for the treatment of pulmonary hypertension with heart failure with preserved ejection fraction.
Product Name : TNX-103
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
February 20, 2024
Details:
TNX-103 (levosimendan), is an oral, small molecule, unique potassium ATP channel activator and calcium sensitizer, being developed for Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction. There are currently no FDA approved treatments for PH-HFpEF.
Lead Product(s): Levosimendan
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: TNX-103
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 13, 2023
Lead Product(s) : Levosimendan
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : TNX-103 (levosimendan), is an oral, small molecule, unique potassium ATP channel activator and calcium sensitizer, being developed for Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction. There are currently no FDA approved treatme...
Product Name : TNX-103
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 13, 2023
Details:
TNX-103 (levosimendan), is an oral, small molecule, unique potassium ATP channel activator and calcium sensitizer, being developed for Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction. There are currently no FDA approved treatments for PH-HFpEF.
Lead Product(s): Levosimendan
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: TNX-103
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 31, 2023
Lead Product(s) : Levosimendan
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : TNX-103 (levosimendan), is an oral, small molecule, unique potassium ATP channel activator and calcium sensitizer, being developed for Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction. There are currently no FDA approved treatme...
Product Name : TNX-103
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 31, 2023
Regulatory Info :
Registration Country : Sweden
Brand Name : Simdax
Dosage Form : CONCENTRATE FOR SOLUTION FOR INFUSION
Dosage Strength : 2.5 MG / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Norway
Brand Name : Simdax
Dosage Form : Concentrate to the infusion fluid, resolution
Dosage Strength : 2.5 mg/ml
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Simdax
Dosage Form : Concentrate to the infusion fluid, resolution
Dosage Strength : 2.5 mg/ml
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Global Sales Information
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ABOUT THIS PAGE
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PharmaCompass offers a list of Levosimendan 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 Levosimendan manufacturer or Levosimendan supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Levosimendan manufacturer or Levosimendan supplier.
PharmaCompass also assists you with knowing the Levosimendan API Price utilized in the formulation of products. Levosimendan API Price is not always fixed or binding as the Levosimendan Price is obtained through a variety of data sources. The Levosimendan Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Levosimendan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levosimendan, including repackagers and relabelers. The FDA regulates Levosimendan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levosimendan 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 Levosimendan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Levosimendan supplier is an individual or a company that provides Levosimendan active pharmaceutical ingredient (API) or Levosimendan finished formulations upon request. The Levosimendan suppliers may include Levosimendan API manufacturers, exporters, distributors and traders.
click here to find a list of Levosimendan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Levosimendan DMF (Drug Master File) is a document detailing the whole manufacturing process of Levosimendan active pharmaceutical ingredient (API) in detail. Different forms of Levosimendan DMFs exist exist since differing nations have different regulations, such as Levosimendan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Levosimendan DMF submitted to regulatory agencies in the US is known as a USDMF. Levosimendan USDMF includes data on Levosimendan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Levosimendan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Levosimendan suppliers with USDMF on PharmaCompass.
A Levosimendan written confirmation (Levosimendan WC) is an official document issued by a regulatory agency to a Levosimendan manufacturer, verifying that the manufacturing facility of a Levosimendan active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Levosimendan APIs or Levosimendan finished pharmaceutical products to another nation, regulatory agencies frequently require a Levosimendan WC (written confirmation) as part of the regulatory process.
click here to find a list of Levosimendan suppliers with Written Confirmation (WC) on PharmaCompass.
Levosimendan 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 Levosimendan 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 Levosimendan GMP manufacturer or Levosimendan GMP API supplier for your needs.
A Levosimendan CoA (Certificate of Analysis) is a formal document that attests to Levosimendan's compliance with Levosimendan specifications and serves as a tool for batch-level quality control.
Levosimendan CoA mostly includes findings from lab analyses of a specific batch. For each Levosimendan 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.
Levosimendan may be tested according to a variety of international standards, such as European Pharmacopoeia (Levosimendan EP), Levosimendan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Levosimendan USP).