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    Chemistry

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    Also known as: 162359-56-0, Fty720, Fingolimod hcl, Gilenia, Gilenya, Fty 720
    Molecular Formula
    C19H34ClNO2
    Molecular Weight
    343.9  g/mol
    InChI Key
    SWZTYAVBMYWFGS-UHFFFAOYSA-N
    FDA UNII
    G926EC510T
    Fingolimod Hydrochloride
    A sphingosine-derivative and IMMUNOSUPPRESSIVE AGENT that blocks the migration and homing of LYMPHOCYTES to the CENTRAL NERVOUS SYSTEM through its action on SPHINGOSINE 1-PHOSPHATE RECEPTORS. It is used in the treatment of MULTIPLE SCLEROSIS.
    1 2D Structure

    Fingolimod Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol;hydrochloride
    2.1.2 InChI
    InChI=1S/C19H33NO2.ClH/c1-2-3-4-5-6-7-8-17-9-11-18(12-10-17)13-14-19(20,15-21)16-22;/h9-12,21-22H,2-8,13-16,20H2,1H3;1H
    2.1.3 InChI Key
    SWZTYAVBMYWFGS-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CCCCCCCCC1=CC=C(C=C1)CCC(CO)(CO)N.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    G926EC510T
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 2-amino-2-(2-(4-octylphenyl)ethyl)-1,3-propanediol Hydrochloride

    2. Fingolimod

    3. Fty 720

    4. Fty-720

    5. Fty720

    6. Gilenia

    7. Gilenya

    2.3.2 Depositor-Supplied Synonyms

    1. 162359-56-0

    2. Fty720

    3. Fingolimod Hcl

    4. Gilenia

    5. Gilenya

    6. Fty 720

    7. Fty-720

    8. Fingolimod (hydrochloride)

    9. Fingolimod (fty720) Hcl

    10. 2-amino-2-(4-octylphenethyl)propane-1,3-diol Hydrochloride

    11. Fingolimod, Hcl

    12. Fty720 Hydrochloride

    13. Fingolimod Hydrochloride [usan]

    14. 2-amino-2-(2-(4-octylphenyl)ethyl)-1,3-propanediol Hydrochloride

    15. Fty720 Free Base

    16. Chebi:63112

    17. Fingolimod Hydrochlorid

    18. 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol;hydrochloride

    19. Fingolimod (as Hydrochloride)

    20. Fty-720 Hydrochloride

    21. 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol Hydrochloride

    22. G926ec510t

    23. Mfcd00939512

    24. 2-amino-2-(2-(4-octylphenyl)ethyl)propane-1,3-diol Hydrochloride

    25. Gilenya (tn)

    26. 1,3-propanediol, 2-amino-2-(2-(4-octylphenyl)ethyl)-, Hydrochloride

    27. 1,3-propanediol, 2-amino-2-[2-(4-octylphenyl)ethyl]-, Hydrochloride

    28. 2-amino-2-[2-(4-octylphenyl)ethyl]-1,3-propanediol, Hydrochloride

    29. Fty-720a

    30. Fingolimod (fty720)

    31. Imusera

    32. Unii-g926ec510t

    33. 2-amino-2-[2-(4-octylphenyl)ethyl]-1,3-propanediol Hydrochloride

    34. Fty720,fingolimod

    35. Fingolimodhydrochloride

    36. Fin;limod Hydrochloride

    37. Fty720 - Fingolimod

    38. Fingolimod Hclfty-720

    39. Epitope Id:156573

    40. Schembl81362

    41. Mls006010179

    42. Chembl544665

    43. Fingolimod Hydrochloride- Bio-x

    44. Dtxsid00167364

    45. Ex-a960

    46. Tdi-132

    47. Bcpp000225

    48. Bcp01808

    49. 2-amino-2-[2-(4-octyl-phenyl)-ethyl]-propane-1,3-diol Hcl

    50. Fingolimod Hydrochloride (jan/usan)

    51. Fingolimod Hydrochloride [mi]

    52. S5002

    53. Fingolimod Hydrochloride [jan]

    54. Akos005145784

    55. Ac-1929

    56. Am84549

    57. Bcp9000705

    58. Ccg-265016

    59. Cs-0114

    60. Ks-1172

    61. Fingolimod Hydrochloride [usp-rs]

    62. Fingolimod Hydrochloride [who-dd]

    63. Bf164458

    64. Hy-12005

    65. Smr004701287

    66. Sy057854

    67. Db-014816

    68. A8548

    69. F1018

    70. Ft-0643569

    71. Sw219384-1

    72. Ec-000.2314

    73. Fingolimod Hydrochloride [orange Book]

    74. A25158

    75. D04187

    76. Fingolimod Hydrochloride [ep Monograph]

    77. Fingolimod Hydrochloride [usp Monograph]

    78. 359f560

    79. Sr-01000942237

    80. Q-101363

    81. Sr-01000942237-2

    82. Q27132395

    83. 2-(4-octylphenethyl)-2-aminopropane-1,3-diol Hydrochloride

    84. 2-amino-2-[2-(4-octylphenyl) Ethyl]-1,3-propanediol Hydrochloride

    85. 2-amino-2-[2-(4-octylphenyl)-ethyl]-1,3-propanediol Hydrochloride

    86. [1-hydroxy-2-(hydroxymethyl)-4-(4-octylphenyl)butan-2-yl]azanium;chloride

    87. 2-amino-2-[2-(4-n-octylphenyl)ethyl]propane-1,3-diol Hydrochloride

    88. 2-amino-2-[2-(4-octyl-phenyl)-ethyl]-propane -1,3-diol Hydrochloride

    89. 2-amino-2-[2-(4-octyl-phenyl)-ethyl]-propane-1,3-diol Hydrochloride

    90. 1,3-propanediol, 2-amino-2-[2-(4-octylphenyl)ethyl]-, Hydrochloride (1:1)

    2.4 Create Date
    2005-08-08
    3 Chemical and Physical Properties
    Molecular Weight 343.9 g/mol
    Molecular Formula C19H34ClNO2
    Hydrogen Bond Donor Count4
    Hydrogen Bond Acceptor Count3
    Rotatable Bond Count12
    Exact Mass343.2278070 g/mol
    Monoisotopic Mass343.2278070 g/mol
    Topological Polar Surface Area66.5 Ų
    Heavy Atom Count23
    Formal Charge0
    Complexity258
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameGilenya
    PubMed HealthFingolimod (By mouth)
    Drug ClassesImmune Modulator
    Drug LabelFingolimod is a sphingosine 1-phosphate receptor modulator.Chemically, fingolimod is 2-amino-2-[2-(4-octylphenyl)ethyl]propan-1,3-diol hydrochloride. Its structure is shown below: Fingolimod hydrochloride is a white to practically white powder that i...
    Active IngredientFingolimod
    Dosage FormCapsule
    RouteOral
    Strength0.5mg
    Market StatusPrescription
    CompanyNovartis

    2 of 2  
    Drug NameGilenya
    PubMed HealthFingolimod (By mouth)
    Drug ClassesImmune Modulator
    Drug LabelFingolimod is a sphingosine 1-phosphate receptor modulator.Chemically, fingolimod is 2-amino-2-[2-(4-octylphenyl)ethyl]propan-1,3-diol hydrochloride. Its structure is shown below: Fingolimod hydrochloride is a white to practically white powder that i...
    Active IngredientFingolimod
    Dosage FormCapsule
    RouteOral
    Strength0.5mg
    Market StatusPrescription
    CompanyNovartis

    4.2 Drug Indication

    Gilenya is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult patients and paediatric patients aged 10 years and older:

    - Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 and 5. 1).

    or

    - Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Sphingosine 1 Phosphate Receptor Modulators

    Agents that affect the function of G-protein coupled SPHINGOSINE 1-PHOSPHATE RECEPTORS. Their binding to the receptors blocks lymphocyte migration and are often used as IMMUNOSUPPRESSANTS. (See all compounds classified as Sphingosine 1 Phosphate Receptor Modulators.)

    Immunosuppressive Agents

    Agents that suppress immune function by one of several mechanisms of action. Classical cytotoxic immunosuppressants act by inhibiting DNA synthesis. Others may act through activation of T-CELLS or by inhibiting the activation of HELPER CELLS. While immunosuppression has been brought about in the past primarily to prevent rejection of transplanted organs, new applications involving mediation of the effects of INTERLEUKINS and other CYTOKINES are emerging. (See all compounds classified as Immunosuppressive Agents.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Sphingosine 1-phosphate Receptor Modulator [EPC]; Sphingosine 1-Phosphate Receptor Modulators [MoA]
    5.3 ATC Code

    L04AA27

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D6 D8, SY.NO. 234\/2,234\/3,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1726684200,"product":"FINGOLIMOD HYDROCHLORIDE","address":"20TH K M, HOSUR ROAD,,ELECTRONIC C","city":"BANGALORE,KARNATAKA","supplier":"BIOCON LIMITED SEZ UNIT","supplierCountry":"INDIA","foreign_port":"BANGALORE","customer":"BIOCON LIMITED","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"59081.3","totalValueFC":"59855.9","currency":"USD","unitRateINR":"5016000","date":"19-Sep-2024","totalValueINR":"5016000","totalValueInUsd":"59855.9","indian_port":"Biocon-SEZ","hs_no":"29221990","bill_no":"5684690","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BANGALORE","supplierAddress":"PLOT NOS. 2,3,4 & 5, PHASE - IV, BOMMASANDRA-JIGANI LINK ROAD, BOMMA SDNF India","customerAddress":"20TH K M, HOSUR ROAD,,ELECTRONIC C"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1726857000,"product":"FINGOLIMOD HYDROCHLORIDE","address":"20TH K M, HOSUR ROAD,,ELECTRONIC C","city":"BANGALORE,KARNATAKA","supplier":"BIOCON LIMITED","supplierCountry":"INDIA","foreign_port":"BANGALORE","customer":"BIOCON LIMITED","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"59290.8","totalValueFC":"59855.9","currency":"USD","unitRateINR":"5016000","date":"21-Sep-2024","totalValueINR":"5016000","totalValueInUsd":"59855.9","indian_port":"Biocon-SEZ","hs_no":"29221990","bill_no":"5722782","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BANGALORE","supplierAddress":"SPECIAL ECONOMIC ZONE PLOT NOS. 2,3,4 & 5, PHASE - IV, SDNF India","customerAddress":"20TH K M, HOSUR ROAD,,ELECTRONIC C"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728239400,"product":"FINGOLIMOD HYDROCHLORIDE","address":"HETERO CORPORATE, NO. 7-2-A2,,INDU","city":"HYDERABAD,TELANGANA","supplier":"HONOUR LAB LIMITED SEZ","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"HETERO LABS LIMITED","customerCountry":"INDIA","quantity":"0.09","actualQuantity":"0.09","unit":"KGS","unitRateFc":"70713","totalValueFC":"6426.5","currency":"USD","unitRateINR":"6000000","date":"07-Oct-2024","totalValueINR":"540000","totalValueInUsd":"6426.5","indian_port":"Vizag-HIPL SEZ","hs_no":"29221190","bill_no":"5986360","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"PLOT NO 4, HETERO INFRASTUCTURE SEZ N.NARASAPURAM VILLAGE, NAKKAPALLY M SDNF India","customerAddress":"HETERO CORPORATE, NO. 7-2-A2,,INDU"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731436200,"product":"FINGOLIMOD HCL IMPURITY - 3 ACETAMIDE","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"DRREDDY'S LABORATORIES LTD","supplierCountry":"INDIA","foreign_port":"VISAKHAPATNAM SEZ","customer":"DRREDDY'S LABORATORIES LTD","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.01","unit":"GMS","unitRateFc":"1173.7","totalValueFC":"11.9","currency":"USD","unitRateINR":"100000","date":"13-Nov-2024","totalValueINR":"1000","totalValueInUsd":"11.9","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29339990","bill_no":"6654373","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"VISAKHAPATNAM SEZ","supplierAddress":"FTO -7, PLOT NO.P1 TO P9, V.S.E.Z., DUVVADA, VISAKHAPATNAM SDNF India","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733855400,"product":"FINGOLIMOD FINGOLIMOD","address":"PLOT NO 2A & 2B, BIOTECH PARK,,PHA","city":"HYDERABAD,TELANGANA","supplier":"MAPRIMED SA","supplierCountry":"ARGENTINA","foreign_port":"BUENOS AIRES, BA","customer":"CHEMO INDIA FORMULATION PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.96","actualQuantity":"0.963","unit":"KGS","unitRateFc":"91200","totalValueFC":"88529.5","currency":"USD","unitRateINR":"7811280","date":"11-Dec-2024","totalValueINR":"7522262.64","totalValueInUsd":"88529.5","indian_port":"Hyderabad Air","hs_no":"29221990","bill_no":"7171513","productDescription":"API","marketType":"","country":"ARGENTINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BUENOS AIRES, BA","supplierAddress":"MURGUIONDO 2011 Cl440CNS BUENOS AIRES ARGENTINA AR","customerAddress":"PLOT NO 2A & 2B, BIOTECH PARK,,PHA"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1744137000,"product":"FINGOLIMOD HYDROCHLORIDE PH. EUR","address":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,","city":"HYDERABAD,TELANGANA","supplier":"DRREDDY'S LABORATORIES LTD","supplierCountry":"INDIA","foreign_port":"VISAKHAPATNAM SEZ","customer":"DRREDDY'S LABORATORIES LTD","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.001","unit":"KGS","unitRateFc":"57921","totalValueFC":"58.6","currency":"USD","unitRateINR":"5016000","date":"09-Apr-2025","totalValueINR":"5016","totalValueInUsd":"58.6","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29339990","bill_no":"9377360","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"VISAKHAPATNAM SEZ","supplierAddress":"FTO -7, PLOT NO.P1 TO P9, V.S.E.Z., DUVVADA,VISAKHAPATNAM SDNF India","customerAddress":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,"}]
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    ABOUT THIS PAGE

    Looking for 162359-56-0 / Fingolimod Hydrochloride API manufacturers, exporters & distributors?

    Fingolimod Hydrochloride manufacturers, exporters & distributors 1

    47

    PharmaCompass offers a list of Fingolimod 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 Fingolimod Hydrochloride manufacturer or Fingolimod Hydrochloride supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fingolimod Hydrochloride manufacturer or Fingolimod Hydrochloride supplier.

    PharmaCompass also assists you with knowing the Fingolimod Hydrochloride API Price utilized in the formulation of products. Fingolimod Hydrochloride API Price is not always fixed or binding as the Fingolimod Hydrochloride Price is obtained through a variety of data sources. The Fingolimod Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Fingolimod Hydrochloride

    Synonyms

    162359-56-0, Fty720, Fingolimod hcl, Gilenia, Gilenya, Fty 720

    Cas Number

    162359-56-0

    Unique Ingredient Identifier (UNII)

    G926EC510T

    About Fingolimod Hydrochloride

    A sphingosine-derivative and IMMUNOSUPPRESSIVE AGENT that blocks the migration and homing of LYMPHOCYTES to the CENTRAL NERVOUS SYSTEM through its action on SPHINGOSINE 1-PHOSPHATE RECEPTORS. It is used in the treatment of MULTIPLE SCLEROSIS.

    162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 Manufacturers

    A 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720, including repackagers and relabelers. The FDA regulates 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 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 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 Suppliers

    A 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 supplier is an individual or a company that provides 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 active pharmaceutical ingredient (API) or 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 finished formulations upon request. The 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 suppliers may include 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 API manufacturers, exporters, distributors and traders.

    click here to find a list of 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 USDMF

    A 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 DMF (Drug Master File) is a document detailing the whole manufacturing process of 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 active pharmaceutical ingredient (API) in detail. Different forms of 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 DMFs exist exist since differing nations have different regulations, such as 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 DMF submitted to regulatory agencies in the US is known as a USDMF. 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 USDMF includes data on 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 suppliers with USDMF on PharmaCompass.

    162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 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 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 Drug Master File in Japan (162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 JDMF) empowers 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 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 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 JDMF during the approval evaluation for pharmaceutical products. At the time of 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 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 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 suppliers with JDMF on PharmaCompass.

    162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 CEP

    A 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 CEP of the European Pharmacopoeia monograph is often referred to as a 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 Certificate of Suitability (COS). The purpose of a 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 to their clients by showing that a 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 CEP has been issued for it. The manufacturer submits a 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 CEP (COS) as part of the market authorization procedure, and it takes on the role of a 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 CEP holder for the record. Additionally, the data presented in the 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 DMF.

    A 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 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 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 suppliers with CEP (COS) on PharmaCompass.

    162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 WC

    A 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 written confirmation (162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 WC) is an official document issued by a regulatory agency to a 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 manufacturer, verifying that the manufacturing facility of a 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 APIs or 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 finished pharmaceutical products to another nation, regulatory agencies frequently require a 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 WC (written confirmation) as part of the regulatory process.

    click here to find a list of 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 suppliers with Written Confirmation (WC) on PharmaCompass.

    162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 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 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 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 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 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 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 suppliers with NDC on PharmaCompass.

    162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 GMP

    162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 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 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 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 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 GMP manufacturer or 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 GMP API supplier for your needs.

    162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 CoA

    A 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 CoA (Certificate of Analysis) is a formal document that attests to 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720's compliance with 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 specifications and serves as a tool for batch-level quality control.

    162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 CoA mostly includes findings from lab analyses of a specific batch. For each 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 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.

    162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 may be tested according to a variety of international standards, such as European Pharmacopoeia (162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 EP), 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 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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