Synopsis
Synopsis
0
CEP/COS
0
VMF
0
EDQM
0
USP
0
JP
0
Others
0
Canada
0
South Africa
0
Listed Dossiers
0
FDF
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
1. (s)-2-((4-(3-fluorobenzoxy)benzyl)amino)propanamide
2. 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide
3. Fbap Methanesulfonate
4. Fce 26743
5. Fce 28073
6. Fce-26743
7. Fce-28073
8. Nw-1015
9. Pnu 151774e
10. Pnu-151774e
11. Safinamide
12. Safinamide Methanesulfonate
13. Xadago
1. 202825-46-5
2. Safinamide Mesilate
3. (s)-2-((4-((3-fluorobenzyl)oxy)benzyl)amino)propanamide Methanesulfonate
4. Pnu-151774e
5. Nw-1015
6. Safinamide (mesylate)
7. Safinamide Methanesulfonate
8. Pnu 151774e
9. Safinamide Mesylate [usan]
10. Fce-28073
11. Nw 1015
12. Safinamide Methansulfonate
13. Ys90v3dtx0
14. Propanamide, 2-[[[4-[(3-fluorophenyl)methoxy]phenyl]methyl]amino]-, (2s)-, Methanesulfonate (1:1)
15. 202825-46-5 (mesylate)
16. Safinamide Mesilate (jan)
17. Safinamide Mesylate (usan)
18. Safinamide Mesilate [jan]
19. (s)-2-((4-((3-fluorobenzyl)oxy)benzyl)-amino)propanamide Methanesulfonate
20. Chembl48582
21. (s)-2-[[4-[(3-fluorobenzyl)oxy]benzyl]amino]propanamide Methanesulfonate
22. Unii-ys90v3dtx0
23. Fce-28073(r-isomer)
24. Safinamidemesylate
25. Equfina (tn)
26. Xadago (tn)
27. Safinamide Mesylate Salt
28. Emd 1195686 Mesylate
29. Mls006010740
30. Schembl1665715
31. Dtxsid80942414
32. Hms3884o17
33. Safinamide Mesylate (fce28073)
34. Amy38833
35. Bcp16018
36. Ex-a2640
37. Hy-70057a
38. Mfcd15145475
39. S1472
40. Safinamide Mesilate [who-dd]
41. Akos015902297
42. Ccg-268636
43. Safinamide Methanesulfonate [mi]
44. Safinamide Mesylate [orange Book]
45. Ac-27739
46. As-75602
47. Pnu-151774e,fce28073
48. Smr004701699
49. Safinamide Mesylate Salt, >=98% (hplc)
50. Cs-0006742
51. Sw219452-1
52. D10191
53. J-013174
54. Q27294690
55. (s)-2[4-(3-fluorobenzyloxy)benzylamino]propanamide Methanesulfonate
56. (s)-(+)-2-(4-(3-fluorobenzyloxy) Benzylamino)propanamide, Methanesulfonate
57. (s)-2-((4-((3-fluorobenzyl)oxy)benzyl)amino)propanamidemethanesulfonate
58. (s)-2-[4-(3-fluorobenzyloxy)benzylamino]propanamide Methanesulfonate
59. (2s)-2-[[4-[(3-fluorophenyl)methoxy]phenyl]methylamino]propanamide;methanesulfonic Acid
60. Propanamide, 2-(((4-((3-fluorophenyl)methoxy)phenyl)methyl)amino)-, (s)-, Monomethanesulfonate
Molecular Weight | 398.5 g/mol |
---|---|
Molecular Formula | C18H23FN2O5S |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 7 |
Rotatable Bond Count | 7 |
Exact Mass | 398.13117117 g/mol |
Monoisotopic Mass | 398.13117117 g/mol |
Topological Polar Surface Area | 127 Ų |
Heavy Atom Count | 27 |
Formal Charge | 0 |
Complexity | 438 |
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 |
Xadago is indicated for the treatment of adult patients with idiopathic Parkinsons disease (PD) as add-on therapy to a stable dose of Levodopa (L-dopa) alone or in combination with other PD medicinal products in mid-to late-stage fluctuating patients.
N04B
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
---|
Upgrade, download data, analyse, strategize, subscribe with us
Regulatory Info : RX
Registration Country : USA
Brand Name : XADAGO
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 50MG BASE
Packaging :
Approval Date : 2017-03-21
Application Number : 207145
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : SAFINAMIDE MESYLATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 100MG BASE
Packaging :
Approval Date : 2024-12-31
Application Number : 215978
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : SAFINAMIDE MESYLATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 50MG BASE
Packaging :
Approval Date : 2024-04-25
Application Number : 215739
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : SAFINAMIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number : 215945
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : Australia
Brand Name : Xadago
Dosage Form :
Dosage Strength :
Packaging : 30
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Xadago
Dosage Form :
Dosage Strength :
Packaging : 30
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Sweden
Brand Name : Xadago
Dosage Form : FILM COATED PILL
Dosage Strength : 100 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Italy
Brand Name : Xadago
Dosage Form : Safinamide 100Mg 30 Joined' Oral Use
Dosage Strength : 30 cpr riv 100 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Xadago
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 100 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Switzerland
Brand Name : Xadago
Dosage Form : Film-Coated Tablets
Dosage Strength : 100mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
DRUG PRODUCT COMPOSITIONS
Related Excipient Companies
Excipients by Applications
Global Sales Information
Market Place
Patents & EXCLUSIVITIES
ABOUT THIS PAGE
15
PharmaCompass offers a list of Safinamide Mesylate 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 Safinamide Mesylate manufacturer or Safinamide Mesylate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Safinamide Mesylate manufacturer or Safinamide Mesylate supplier.
PharmaCompass also assists you with knowing the Safinamide Mesylate API Price utilized in the formulation of products. Safinamide Mesylate API Price is not always fixed or binding as the Safinamide Mesylate Price is obtained through a variety of data sources. The Safinamide Mesylate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide, including repackagers and relabelers. The FDA regulates 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide 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 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide supplier is an individual or a company that provides 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide active pharmaceutical ingredient (API) or 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide finished formulations upon request. The 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide suppliers may include 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide API manufacturers, exporters, distributors and traders.
click here to find a list of 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide DMF (Drug Master File) is a document detailing the whole manufacturing process of 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide active pharmaceutical ingredient (API) in detail. Different forms of 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide DMFs exist exist since differing nations have different regulations, such as 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide DMF submitted to regulatory agencies in the US is known as a USDMF. 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide USDMF includes data on 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide 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 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide Drug Master File in Japan (2-(4-(3-fluorobenzyloxy)benzylamino)propionamide JDMF) empowers 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide 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 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide JDMF during the approval evaluation for pharmaceutical products. At the time of 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide 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 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide 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 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide Drug Master File in Korea (2-(4-(3-fluorobenzyloxy)benzylamino)propionamide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide. The MFDS reviews the 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide KDMF as part of the drug registration process and uses the information provided in the 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide KDMF to evaluate the safety and efficacy of the drug.
After submitting a 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide 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 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide suppliers with KDMF on PharmaCompass.
A 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide written confirmation (2-(4-(3-fluorobenzyloxy)benzylamino)propionamide WC) is an official document issued by a regulatory agency to a 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide manufacturer, verifying that the manufacturing facility of a 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide APIs or 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide finished pharmaceutical products to another nation, regulatory agencies frequently require a 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide WC (written confirmation) as part of the regulatory process.
click here to find a list of 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide 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 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide 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 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide 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 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide suppliers with NDC on PharmaCompass.
2-(4-(3-fluorobenzyloxy)benzylamino)propionamide 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 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide 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 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide GMP manufacturer or 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide GMP API supplier for your needs.
A 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide CoA (Certificate of Analysis) is a formal document that attests to 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide's compliance with 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide specifications and serves as a tool for batch-level quality control.
2-(4-(3-fluorobenzyloxy)benzylamino)propionamide CoA mostly includes findings from lab analyses of a specific batch. For each 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide 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.
2-(4-(3-fluorobenzyloxy)benzylamino)propionamide may be tested according to a variety of international standards, such as European Pharmacopoeia (2-(4-(3-fluorobenzyloxy)benzylamino)propionamide EP), 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (2-(4-(3-fluorobenzyloxy)benzylamino)propionamide USP).