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1. Adempas
2. Bay 63-2521
3. Bay-63-2521
1. 625115-55-1
2. Adempas
3. Bay 63-2521
4. Riociguat (bay 63-2521)
5. Bay-63-2521
6. Ru3fe2y4xi
7. Methyl (4,6-diamino-2-(1-(2-fluorobenzyl)-1h-pyrazolo[3,4-b]pyridin-3-yl)pyrimidin-5-yl)(methyl)carbamate
8. Methyl N-[4,6-diamino-2-[1-[(2-fluorophenyl)methyl]pyrazolo[3,4-b]pyridin-3-yl]pyrimidin-5-yl]-n-methylcarbamate
9. Chebi:76018
10. 1304478-72-5
11. N-[4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1h-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]-n-methylcarbamic Acid Methyl Ester
12. Methyl N-(4,6-diamino-2-{1-((2-fluorophenyl)methyl)-1h-pyrazolo(3,4-b)pyridin-3-yl}pyrimidin-5-yl)-n-methylcarbamate
13. Methyl N-(4,6-diamino-2-{1-[(2-fluorophenyl)methyl]-1h-pyrazolo[3,4-b]pyridin-3-yl}pyrimidin-5-yl)-n-methylcarbamate
14. Riociguat [inn]
15. Methyl ~{n}-[4,6-bis(azanyl)-2-[1-[(2-fluorophenyl)methyl]pyrazolo[3,4-b]pyridin-3-yl]pyrimidin-5-yl]-~{n}-methyl-carbamate
16. Methyl 4,6-diamino-2-(1-(2-fluorobenzyl)-1h-pyrazolo(3,4-b)pyridin-3-yl)-5-pyrimidinyl(methyl)carbamate
17. Unii-ru3fe2y4xi
18. Riociguatum
19. Riociguate
20. Riociguat [usan:inn:jan]
21. Riocguat-d3
22. Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1h-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl(methyl)carbamate
23. Methyl N-(4,6-diamino-2-(1-((2-fluorophenyl)methyl)-1h-pyrazolo(3,4-b)pyridin-3-yl)pyrimidin-5-yl)-n-methylcarbamate
24. Adempas (tn)
25. Bay 632521
26. Riociguat [jan]
27. Riociguat [mi]
28. Riociguat [usan]
29. Riociguat [vandf]
30. Riociguat [usp-rs]
31. Riociguat [who-dd]
32. Bay 63-2521,riociguat
33. Riociguat (jan/usan/inn)
34. Schembl245457
35. Gtpl5257
36. Riociguat [orange Book]
37. Chembl2107834
38. Riociguat [ep Monograph]
39. Amy4218
40. Dtxsid50978109
41. Riociguat [usp Monograph]
42. Bcp04750
43. Bcp23980
44. Ex-a2023
45. Zinc3819392
46. Riociguat,cas:625115-55-1
47. Mfcd19443708
48. S8135
49. Akos015900718
50. Akos032950011
51. Bay-632521
52. Bcp9000382
53. Ccg-268912
54. Cs-0584
55. Db08931
56. Pb25734
57. Ncgc00379065-03
58. Ncgc00379065-04
59. Ncgc00379065-05
60. [4,6-diamino-2-[1-(2-fluorobenzyl)-1h-pyrazolo[3,4-b]pyridin-3-yl]pyrimidin-5-yl]methylcarbamic Acid Methyl Ester
61. Ac-27647
62. As-19299
63. Hy-14779
64. Bcp0726000023
65. Db-073136
66. Ft-0760451
67. Bay 63-2521;bay 632521
68. D09572
69. Bay 63-2521; Bay 632521
70. 115r551
71. Q2154494
72. Bay 63-2521-d3; Bay 632521-d3; Methyl [4,6-diamino-2-[1-(2-fluorobenzyl)-1h-pyrazolo[3,4-b]pyridin-3-yl]pyrimidin-5-yl]methylcarbamate-d3
73. Carbamic Acid, (4,6-diamino-2-(1-((2-fluorophenyl)methyl)-1h-pyrazolo(3,4-b)pyridin-3-yl)-5-pyrimidinyl)methyl-, Methyl Ester
74. Carbamic Acid, N-(4,6-diamino-2-(1-((2-fluorophenyl)methyl)-1h-pyrazolo(3,4-b)pyridin-3-yl)-5-pyrimidinyl)-n-methyl-, Methyl Ester
75. Gzo
76. Methyl {4,6-diamino-2-[1-(2-fluorobenzyl)-1h-pyrazolo[3,4-b]pyridin-3-yl]pyrimidin-5-yl}methylcarbamate
77. Methyl N-[4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1h-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]-n-methyl-carbaminate
Molecular Weight | 422.4 g/mol |
---|---|
Molecular Formula | C20H19FN8O2 |
XLogP3 | 1.6 |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 9 |
Rotatable Bond Count | 5 |
Exact Mass | 422.16150004 g/mol |
Monoisotopic Mass | 422.16150004 g/mol |
Topological Polar Surface Area | 138 Ų |
Heavy Atom Count | 31 |
Formal Charge | 0 |
Complexity | 618 |
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 |
1 of 2 | |
---|---|
Drug Name | Adempas |
PubMed Health | Riociguat (By mouth) |
Drug Classes | Cardiovascular Agent |
Drug Label | Adempas (riociguat) is a tablet for oral administration. Riociguat is methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridin-3-yl]-5-pyrimidinyl(methyl)carbamate with the following structural formula:C20H19FN8O2Riociguat is a white to ye... |
Active Ingredient | Riociguat |
Dosage Form | Tablet |
Route | Oral |
Strength | 2.5mg; 1.5mg; 0.5mg; 2mg; 1mg |
Market Status | Prescription |
Company | Bayer Hlthcare |
2 of 2 | |
---|---|
Drug Name | Adempas |
PubMed Health | Riociguat (By mouth) |
Drug Classes | Cardiovascular Agent |
Drug Label | Adempas (riociguat) is a tablet for oral administration. Riociguat is methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridin-3-yl]-5-pyrimidinyl(methyl)carbamate with the following structural formula:C20H19FN8O2Riociguat is a white to ye... |
Active Ingredient | Riociguat |
Dosage Form | Tablet |
Route | Oral |
Strength | 2.5mg; 1.5mg; 0.5mg; 2mg; 1mg |
Market Status | Prescription |
Company | Bayer Hlthcare |
Riociguat is indicated for the treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH), (WHO Group 4) after surgical treatment, or inoperable CTEPH, to improve exercise capacity and WHO functional class. Riociguat is indicated for the treatment of adults with pulmonary arterial hypertension (PAH), (WHO Group 1), to improve exercise capacity, WHO functional class and to delay clinical worsening. Efficacy was shown in patients on Riociguat monotherapy or in combination with endothelin receptor antagonists or prostanoids. Studies establishing effectiveness included predominately patients with WHO functional class IIIII and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (25%).
FDA Label
Chronic thromboembolic pulmonary hypertension (CTEPH)
Adempas is indicated for the treatment of adult patients with WHO Functional Class (FC) II to III with
- inoperable CTEPH,
- persistent or recurrent CTEPH after surgical treatment,
to improve exercise capacity (see section 5. 1).
Pulmonary arterial hypertension (PAH)
Adempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the
treatment of adult patients with pulmonary arterial hypertension (PAH) with WHO Functional Class
(FC) II to III to improve exercise capacity.
Efficacy has been shown in a PAH population including aetiologies of idiopathic or heritable PAH or
PAH associated with connective tissue disease (see section 5. 1).
Enzyme Activators
Compounds or factors that act on a specific enzyme to increase its activity. (See all compounds classified as Enzyme Activators.)
C02KX05
C - Cardiovascular system
C02 - Antihypertensives
C02K - Other antihypertensives
C02KX - Antihypertensives for pulmonary arterial hypertension
C02KX05 - Riociguat
Absorption
The pharmacokinetics of riociguant are dose proportional from 0.5 mg to 2.5 mg. The absolute bioavailability is approximately 94%. After oral administration, peak plasma concentrations were achieved within 1.5 hours. Food does not affect the bioavailability of riociguat.
Route of Elimination
Riociguat is eliminated in the urine (40%) and feces (53%), largely as metabolites.
Volume of Distribution
Volume of distribution at steady state = 30 L
The active metabolite (M1) of riociguat is 1/3 to 1/10 as potent as riociguat.
About 12 hours in patients and 7 hours in healthy subjects.
Riociguat is a stimulator of soluble guanylate cyclase (sGC), an enzyme in the cardiopulmonary system and the receptor for nitric oxide (NO). When NO binds to sGC, the enzyme catalyzes synthesis of the signaling molecule cyclic guanosine monophosphate (cGMP). Intracellular cGMP plays an important role in regulating processes that influence vascular tone, proliferation, fibrosis and inflammation. Pulmonary hypertension is associated with endothelial dysfunction, impaired synthesis of nitric oxide and insufficient stimulation of the NO-sGC-cGMP pathway. Riociguat has a dual mode of action. It sensitizes sGC to endogenous NO by stabilizing the NO-sGC binding. Riociguat also directly stimulates sGC via a different binding site, independently of NO. Riociguat stimulates the NO-sGC-cGMP pathway and leads to increased generation of cGMP with subsequent vasodilation.
GDUFA
DMF Review : Complete
Rev. Date : 2017-07-18
Pay. Date : 2017-06-28
DMF Number : 31665
Submission : 2017-06-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-06-01
Pay. Date : 2017-05-18
DMF Number : 31092
Submission : 2016-12-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-09-15
Pay. Date : 2023-08-08
DMF Number : 38372
Submission : 2023-07-01
Status : Active
Type : II
Riociguat, Modification I, Micronised
Certificate Number : CEP 2023-191 - Rev 00
Status : Valid
Issue Date : 2025-02-11
Type : Chemical
Substance Number : 3078
Date of Issue : 2022-06-17
Valid Till : 2025-07-02
Written Confirmation Number : WC-0082
Address of the Firm : API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, G...
Date of Issue : 2019-07-26
Valid Till : 2022-08-08
Written Confirmation Number : WC-0383
Address of the Firm : Sy. No.455/A, 455/AA, 455/E & 455/EE Chandampet Village Shankarampet Mandal Meda...
NDC Package Code : 46708-894
Start Marketing Date : 2017-04-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 69766-021
Start Marketing Date : 2016-12-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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PharmaCompass offers a list of Riociguat 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 Riociguat manufacturer or Riociguat supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Riociguat manufacturer or Riociguat supplier.
PharmaCompass also assists you with knowing the Riociguat API Price utilized in the formulation of products. Riociguat API Price is not always fixed or binding as the Riociguat Price is obtained through a variety of data sources. The Riociguat Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Riociguat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Riociguat, including repackagers and relabelers. The FDA regulates Riociguat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Riociguat 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 Riociguat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Riociguat supplier is an individual or a company that provides Riociguat active pharmaceutical ingredient (API) or Riociguat finished formulations upon request. The Riociguat suppliers may include Riociguat API manufacturers, exporters, distributors and traders.
click here to find a list of Riociguat suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Riociguat DMF (Drug Master File) is a document detailing the whole manufacturing process of Riociguat active pharmaceutical ingredient (API) in detail. Different forms of Riociguat DMFs exist exist since differing nations have different regulations, such as Riociguat USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Riociguat DMF submitted to regulatory agencies in the US is known as a USDMF. Riociguat USDMF includes data on Riociguat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Riociguat USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Riociguat suppliers with USDMF on PharmaCompass.
A Riociguat CEP of the European Pharmacopoeia monograph is often referred to as a Riociguat Certificate of Suitability (COS). The purpose of a Riociguat CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Riociguat EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Riociguat to their clients by showing that a Riociguat CEP has been issued for it. The manufacturer submits a Riociguat CEP (COS) as part of the market authorization procedure, and it takes on the role of a Riociguat CEP holder for the record. Additionally, the data presented in the Riociguat CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Riociguat DMF.
A Riociguat CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Riociguat 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 Riociguat suppliers with CEP (COS) on PharmaCompass.
A Riociguat written confirmation (Riociguat WC) is an official document issued by a regulatory agency to a Riociguat manufacturer, verifying that the manufacturing facility of a Riociguat active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Riociguat APIs or Riociguat finished pharmaceutical products to another nation, regulatory agencies frequently require a Riociguat WC (written confirmation) as part of the regulatory process.
click here to find a list of Riociguat 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 Riociguat as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Riociguat 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 Riociguat 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 Riociguat and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Riociguat NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Riociguat suppliers with NDC on PharmaCompass.
Riociguat 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 Riociguat 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 Riociguat GMP manufacturer or Riociguat GMP API supplier for your needs.
A Riociguat CoA (Certificate of Analysis) is a formal document that attests to Riociguat's compliance with Riociguat specifications and serves as a tool for batch-level quality control.
Riociguat CoA mostly includes findings from lab analyses of a specific batch. For each Riociguat 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.
Riociguat may be tested according to a variety of international standards, such as European Pharmacopoeia (Riociguat EP), Riociguat JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Riociguat USP).