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1. 141625-93-6
2. Dronedarone Hcl
3. N-(2-butyl-3-(4-(3-(dibutylamino)propoxy)benzoyl)benzofuran-5-yl)methanesulfonamide Hydrochloride
4. Dronedarone, Hcl
5. Dronedarone (hydrochloride)
6. Dronedarone Hydrochloride [usan]
7. Sr33598b
8. Sr33589 Hydrochloride
9. Dronedarone Hcl (multaq)
10. Fa36dv299q
11. N-[2-butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]-1-benzofuran-5-yl]methanesulfonamide;hydrochloride
12. Sr-33598b
13. 141625-93-6 (hcl); 141626-36-0 (free Base).
14. Methanesulfonamide, N-(2-butyl-3-(4-(3-(dibutylamino)propoxy)benzoyl)-5-benzofuranyl)-, Monohydrochloride
15. N-(2-butyl-3-(4-(3-(dibutylamino)propoxy)benzoyl)-benzofuran-5-yl)methanesulfonamide Hydrochloride
16. N-(2-butyl-3-(4-(3-(dibutylamino)proproxy)benzoyl)benzofuran-5-yl) Methanesulfonamide-, Monohydrochloride
17. N-[2-butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]-5-benzofuranyl]methanesulfonamide Hydrochloride
18. Smr003500707
19. Unii-fa36dv299q
20. Dronedarone Hcl
21. Mfcd00914940
22. Multaq (tn)
23. N-(2-butyl-3-(4-(3-(dibutylamino)propoxy)benzoyl)-5-benzofuranyl)methanesulfonamide Monohydrochloride
24. Dronedarone Hydrocholoride
25. 4ch-007232
26. Mls004774028
27. Mls006011986
28. Schembl223035
29. Chembl1201729
30. Dronedarone Hydrochloride (usp)
31. Dronedarone Hydrochloride- Bio-x
32. Dtxsid30161779
33. Bcp22474
34. S2114
35. Dronedarone Hydrochloride [mi]
36. Akos005145691
37. Ac-5011
38. Ccg-270168
39. Cs-0712
40. Ks-1260
41. Dronedarone Hydrochloride [mart.]
42. Bd164395
43. Dronedarone Hydrochloride [usp-rs]
44. Dronedarone Hydrochloride [who-dd]
45. Hy-75839
46. N-(2-butyl-3-{4-[3-(dibutylamino)propoxy]benzoyl}-1-benzofuran-5-yl)methanesulfonamide Hydrochloride
47. Dronedarone Hydrochloride, >=98% (hplc)
48. D4689
49. Ft-0667799
50. Sw219413-1
51. D03914
52. Dronedarone Hydrochloride [ep Monograph]
53. Dronedarone Hydrochloride [orange Book]
54. Dronedarone Hydrochloride [usp Monograph]
55. A807785
56. J-007525
57. J-520429
58. Q27277877
59. Z1550675452
60. Dronedarone Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)
61. Dronedarone Hydrochloride, United States Pharmacopeia (usp) Reference Standard
62. N-[2-butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]benzofuran-5-yl]methanesulfonamide Hcl
63. 2-n-butyl 3-[4-(3-di-n-butylamino-propoxy)benzoyl] 5-methylsulfonamido Benzofuran Hydrochloride
64. Methanesulfonamide, N-[2-butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]-5-benzofuranyl]-, Hydrochloride (1:1)
Molecular Weight | 593.2 g/mol |
---|---|
Molecular Formula | C31H45ClN2O5S |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 7 |
Rotatable Bond Count | 18 |
Exact Mass | 592.2737714 g/mol |
Monoisotopic Mass | 592.2737714 g/mol |
Topological Polar Surface Area | 97.2 Ų |
Heavy Atom Count | 40 |
Formal Charge | 0 |
Complexity | 800 |
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 | 2 |
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-01
Pay. Date : 2013-05-07
DMF Number : 26479
Submission : 2013-05-02
Status : Active
Type : II
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18409
Submission : 2005-06-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-30
Pay. Date : 2013-06-24
DMF Number : 25669
Submission : 2012-02-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-19
Pay. Date : 2013-06-24
DMF Number : 26976
Submission : 2013-03-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-12
Pay. Date : 2013-05-24
DMF Number : 26085
Submission : 2012-06-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-11
Pay. Date : 2013-04-08
DMF Number : 26901
Submission : 2013-03-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27088
Submission : 2013-05-08
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-19
Pay. Date : 2013-06-19
DMF Number : 26963
Submission : 2013-06-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-27
Pay. Date : 2013-04-03
DMF Number : 26956
Submission : 2013-03-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26023
Submission : 2012-04-25
Status : Inactive
Type : II
Certificate Number : CEP 2020-051 - Rev 01
Status : Valid
Issue Date : 2024-01-16
Type : Chemical
Substance Number : 3039
Certificate Number : R0-CEP 2020-266 - Rev 01
Status : Valid
Issue Date : 2023-04-27
Type : Chemical
Substance Number : 3039
Certificate Number : R0-CEP 2019-341 - Rev 00
Status : Valid
Issue Date : 2023-04-11
Type : Chemical
Substance Number : 3039
Certificate Number : R0-CEP 2020-033 - Rev 00
Status : Valid
Issue Date : 2022-08-09
Type : Chemical
Substance Number : 3039
Certificate Number : CEP 2022-277 - Rev 00
Status : Valid
Issue Date : 2024-03-12
Type : Chemical
Substance Number : 3039
Date of Issue : 2024-04-23
Valid Till : 2027-04-22
Written Confirmation Number : WC-0170
Address of the Firm : Plot No. 41, 42/2, 42/1/B, 43, 40, 59, 58 GIDC, Vapi, Dist: Valsad -396195, Guja...
Date of Issue : 2025-08-22
Valid Till : 2028-08-21
Written Confirmation Number : WC-0082
Address of the Firm : Karakhadi, Plot No. 842-843, At - Karakhdi, Tal. - Padra, Dist -Vadodara, Gujara...
Date of Issue : 2022-07-06
Valid Till : 2025-06-25
Written Confirmation Number : WC-0057n
Address of the Firm : Plot No. 3109, GIDC, Industrial Estate Ankleshwar, Distt- Bharuch - 393002, Guja...
Dronedarone Hydrochloride Ph.Eur
Date of Issue : 2025-07-11
Valid Till : 2028-06-25
Written Confirmation Number : WC-0023
Address of the Firm : Sy. No\'s. 52,53,58,59,61 to 78, 127 & 128, Pydibhimavaram Village & Sy. No\'s. ...
Dronedarone Hydrochloride Ph.Eur/USP
Date of Issue : 2022-09-19
Valid Till : 2025-07-02
Written Confirmation Number : WC-0119
Address of the Firm : Plot No. 35, 36, 38, 39, 40, 49, 50 & 51, Phase-IV, IDA, Jeedimetla, Medchal-Mal...
Dronedarone Hydrochloride USP/IH
Date of Issue : 2025-08-08
Valid Till : 2028-08-07
Written Confirmation Number : WC-0424
Address of the Firm : Plot No. N-61, Additional Ambernath, Ambernath (East), Dist Thane, Ambernath —...
Dronedarone Hydrochloride IH/Ph. Eur
Date of Issue : 2025-07-07
Valid Till : 2028-07-14
Written Confirmation Number : WC-0021
Address of the Firm : Sy. Nos, 317,320,321,322,323,604 & 605, Pincode-502329, Rudraram (Village), Pata...
NDC Package Code : 66039-879
Start Marketing Date : 2012-06-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 59651-094
Start Marketing Date : 2024-01-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 14593-866
Start Marketing Date : 2023-12-25
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 42413-0060
Start Marketing Date : 2017-12-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (36.215kg/36.215kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 14501-0063
Start Marketing Date : 2010-11-08
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 66022-0118
Start Marketing Date : 2009-07-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65015-799
Start Marketing Date : 2015-01-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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26
PharmaCompass offers a list of Dronedarone 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 Dronedarone Hydrochloride manufacturer or Dronedarone Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dronedarone Hydrochloride manufacturer or Dronedarone Hydrochloride supplier.
PharmaCompass also assists you with knowing the Dronedarone Hydrochloride API Price utilized in the formulation of products. Dronedarone Hydrochloride API Price is not always fixed or binding as the Dronedarone Hydrochloride Price is obtained through a variety of data sources. The Dronedarone Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Dronedarone Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dronedarone Hydrochloride, including repackagers and relabelers. The FDA regulates Dronedarone Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dronedarone 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 Dronedarone Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dronedarone Hydrochloride supplier is an individual or a company that provides Dronedarone Hydrochloride active pharmaceutical ingredient (API) or Dronedarone Hydrochloride finished formulations upon request. The Dronedarone Hydrochloride suppliers may include Dronedarone Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Dronedarone Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dronedarone Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Dronedarone Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Dronedarone Hydrochloride DMFs exist exist since differing nations have different regulations, such as Dronedarone Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dronedarone Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Dronedarone Hydrochloride USDMF includes data on Dronedarone Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dronedarone Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dronedarone Hydrochloride suppliers with USDMF on PharmaCompass.
A Dronedarone Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Dronedarone Hydrochloride Certificate of Suitability (COS). The purpose of a Dronedarone Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dronedarone Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dronedarone Hydrochloride to their clients by showing that a Dronedarone Hydrochloride CEP has been issued for it. The manufacturer submits a Dronedarone Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dronedarone Hydrochloride CEP holder for the record. Additionally, the data presented in the Dronedarone Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dronedarone Hydrochloride DMF.
A Dronedarone Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dronedarone Hydrochloride 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 Dronedarone Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Dronedarone Hydrochloride written confirmation (Dronedarone Hydrochloride WC) is an official document issued by a regulatory agency to a Dronedarone Hydrochloride manufacturer, verifying that the manufacturing facility of a Dronedarone Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dronedarone Hydrochloride APIs or Dronedarone Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Dronedarone Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Dronedarone 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 Dronedarone Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dronedarone 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 Dronedarone 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 Dronedarone Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dronedarone Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dronedarone Hydrochloride suppliers with NDC on PharmaCompass.
Dronedarone 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 Dronedarone 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 Dronedarone Hydrochloride GMP manufacturer or Dronedarone Hydrochloride GMP API supplier for your needs.
A Dronedarone Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Dronedarone Hydrochloride's compliance with Dronedarone Hydrochloride specifications and serves as a tool for batch-level quality control.
Dronedarone Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Dronedarone 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.
Dronedarone Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Dronedarone Hydrochloride EP), Dronedarone Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dronedarone Hydrochloride USP).