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    Chemistry

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    Also known as: 202825-46-5, Safinamide mesilate, (s)-2-((4-((3-fluorobenzyl)oxy)benzyl)amino)propanamide methanesulfonate, Pnu-151774e, Nw-1015, Safinamide (mesylate)
    Molecular Formula
    C18H23FN2O5S
    Molecular Weight
    398.5  g/mol
    InChI Key
    YKOCHIUQOBQIAC-YDALLXLXSA-N
    FDA UNII
    YS90V3DTX0
    Safinamide Mesylate
    1 2D Structure

    Safinamide Mesylate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (2S)-2-[[4-[(3-fluorophenyl)methoxy]phenyl]methylamino]propanamide;methanesulfonic acid
    2.1.2 InChI
    InChI=1S/C17H19FN2O2.CH4O3S/c1-12(17(19)21)20-10-13-5-7-16(8-6-13)22-11-14-3-2-4-15(18)9-14;1-5(2,3)4/h2-9,12,20H,10-11H2,1H3,(H2,19,21);1H3,(H,2,3,4)/t12-;/m0./s1
    2.1.3 InChI Key
    YKOCHIUQOBQIAC-YDALLXLXSA-N
    2.1.4 Canonical SMILES
    CC(C(=O)N)NCC1=CC=C(C=C1)OCC2=CC(=CC=C2)F.CS(=O)(=O)O
    2.1.5 Isomeric SMILES
    C[C@@H](C(=O)N)NCC1=CC=C(C=C1)OCC2=CC(=CC=C2)F.CS(=O)(=O)O
    2.2 Other Identifiers
    2.2.1 UNII
    YS90V3DTX0
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    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

    2.3.2 Depositor-Supplied Synonyms

    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

    2.4 Create Date
    2005-08-09
    3 Chemical and Physical Properties
    Molecular Weight 398.5 g/mol
    Molecular Formula C18H23FN2O5S
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count7
    Rotatable Bond Count7
    Exact Mass398.13117117 g/mol
    Monoisotopic Mass398.13117117 g/mol
    Topological Polar Surface Area127 Ų
    Heavy Atom Count27
    Formal Charge0
    Complexity438
    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

    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.

    5 Pharmacology and Biochemistry
    5.1 FDA Pharmacological Classification
    5.1.1 Pharmacological Classes
    Monoamine Oxidase Type B Inhibitor [EPC]; Monoamine Oxidase-B Inhibitors [MoA]; Breast Cancer Resistance Protein Inhibitors [MoA]
    5.2 ATC Code

    N04B

    API Reference Price

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    SAFINAMIDE MESYLATE

    Brand Name : XADAGO

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    Approval Date : 2017-03-21

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    SAFINAMIDE

    Brand Name : SAFINAMIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 100MG

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    Approval Date :

    Application Number : 215945

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    Registration Country : USA

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    safinamide

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    Packaging : 30

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    safinamidmesilat

    Brand Name : Xadago

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    Safinamide Mesylate

    Brand Name : Xadago

    Dosage Form : Safinamide 100Mg 30 Joined' Oral Use

    Dosage Strength : 30 cpr riv 100 mg

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    Registration Country : Italy

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    Registration Country : Norway

    Safinamide Mesylate

    Brand Name : Xadago

    Dosage Form : Antic-calc Tablet, Film Coated

    Dosage Strength : 100 mg

    Packaging : Blister

    Approval Date :

    Application Number :

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    Registration Country : Norway

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    Dosage Form : Film-Coated Tablets

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    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    DOSAGE - TABLET;ORAL - EQ 100MG BASE

    USFDA APPLICATION NUMBER - 207145

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    DOSAGE - TABLET;ORAL - EQ 50MG BASE

    USFDA APPLICATION NUMBER - 207145

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    ABOUT THIS PAGE

    Looking for 202825-46-5 / Safinamide Mesylate API manufacturers, exporters & distributors?

    Safinamide Mesylate manufacturers, exporters & distributors 1

    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.

    API | Excipient name

    Safinamide Mesylate

    Synonyms

    202825-46-5, Safinamide mesilate, (s)-2-((4-((3-fluorobenzyl)oxy)benzyl)amino)propanamide methanesulfonate, Pnu-151774e, Nw-1015, Safinamide (mesylate)

    Cas Number

    202825-46-5

    Unique Ingredient Identifier (UNII)

    YS90V3DTX0

    2-(4-(3-fluorobenzyloxy)benzylamino)propionamide Manufacturers

    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.

    2-(4-(3-fluorobenzyloxy)benzylamino)propionamide Suppliers

    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.

    2-(4-(3-fluorobenzyloxy)benzylamino)propionamide USDMF

    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.

    2-(4-(3-fluorobenzyloxy)benzylamino)propionamide 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 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.

    2-(4-(3-fluorobenzyloxy)benzylamino)propionamide KDMF

    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.

    2-(4-(3-fluorobenzyloxy)benzylamino)propionamide WC

    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.

    2-(4-(3-fluorobenzyloxy)benzylamino)propionamide 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 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide as an active pharmaceutical ingredient (API).

    Finished drug products

    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.

    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 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.

    Compounded drug products

    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 GMP

    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.

    2-(4-(3-fluorobenzyloxy)benzylamino)propionamide CoA

    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).

    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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