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    Chemistry

    Click the arrow to open the dropdown
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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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AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732818600,"product":"FINGOLIMOD HYDROCHLORIDE","address":"8-3-166\/7\/1, HETERO HOUSE,","city":"HYDERABAD, AP.","supplier":"HONOUR LAB LTD","supplierCountry":"INDIA","foreign_port":"ATHINAI","customer":"GENEPHARM S.A","customerCountry":"GREECE","quantity":"0.30","actualQuantity":"0.3","unit":"KGS","unitRateFc":"85000","totalValueFC":"24716.4","currency":"USD","unitRateINR":6952573.333333334,"date":"29-Nov-2024","totalValueINR":"2085772","totalValueInUsd":"24716.4","indian_port":"Vizag-HIPL SEZ","hs_no":"29221190","bill_no":"6008852","productDescription":"API","marketType":"REGULATED MARKET","country":"GREECE","selfForZScoreResived":"Pharma Grade","supplierPort":"Vizag-HIPL SEZ","supplierAddress":"8-3-166\/7\/1, HETERO HOUSE,, HYDERABAD, AP.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733337000,"product":"ACTIVE PHARMACEUTICALS INGREDIENTS API (PHARMACEUTICALS RAW MATERIAL PHARMA INDUSTRIES)FINGOLIMOD HYDROCHLORIDE - PH.EUR","address":"ALEMBIC ROAD","city":"GUJARAT","supplier":"ALEMBIC PHARMACEUTICALS LIMITED","supplierCountry":"INDIA","foreign_port":"ISTANBUL","customer":"TO THE ORDER OF","customerCountry":"TURKEY","quantity":"0.20","actualQuantity":"0.2","unit":"KGS","unitRateFc":"170000","totalValueFC":"33246.7","currency":"USD","unitRateINR":14124671.449999999,"date":"05-Dec-2024","totalValueINR":"2824934.29","totalValueInUsd":"33246.7","indian_port":"Ahmedabad Air","hs_no":"29349990","bill_no":"6201417","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"TURKEY","selfForZScoreResived":"Pharma Grade","supplierPort":"Ahmedabad Air","supplierAddress":"ALEMBIC ROAD, GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733337000,"product":"ACTIVE PHARMACEUTICALS INGREDIENTS API(PHARMACEUTICALS RAW MATERIAL PHARMA INDUSTRIES)FINGOLIMOD HYDROCHLORIDE - PH.EUR","address":"ALEMBIC ROAD","city":"GUJARAT","supplier":"ALEMBIC PHARMACEUTICALS LIMITED","supplierCountry":"INDIA","foreign_port":"ISTANBUL","customer":"TO THE ORDER OF","customerCountry":"TURKEY","quantity":"0.06","actualQuantity":"0.055","unit":"KGS","unitRateFc":"170000","totalValueFC":"9095.3","currency":"USD","unitRateINR":14051199.272727272,"date":"05-Dec-2024","totalValueINR":"772815.96","totalValueInUsd":"9095.3","indian_port":"Ahmedabad Air","hs_no":"29349990","bill_no":"6201392","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"TURKEY","selfForZScoreResived":"Pharma Grade","supplierPort":"Ahmedabad Air","supplierAddress":"ALEMBIC ROAD, GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733423400,"product":"ACTIVE PHARMACEUTICAL INGREDIENT (PHARMACEUTICAL RAW MATERIAL FOR PHARMA INDUSTRY GRADE- FINGOLIMOD HYDROCHLORIDE PH.EUR","address":"ALEMBIC ROAD","city":"GUJARAT","supplier":"ALEMBIC PHARMACEUTICALS LIMITED","supplierCountry":"INDIA","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"TO THE ORDER OF","customerCountry":"GERMANY","quantity":"0.50","actualQuantity":"0.5","unit":"KGS","unitRateFc":"140000","totalValueFC":"68956.2","currency":"USD","unitRateINR":11718279.439999999,"date":"06-Dec-2024","totalValueINR":"5859139.72","totalValueInUsd":"68956.2","indian_port":"Ahmedabad Air","hs_no":"29349990","bill_no":"6236065","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"Ahmedabad Air","supplierAddress":"ALEMBIC ROAD, GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733769000,"product":"ACTIVE PHARMACEUTICALS INGREDIENTS?(API)(PHARMACEUTICALS RAW MATERIAL FOR PHARMAIND.) FINGOLIMOD HYDROCHLORIDE PH.EUR","address":"ALEMBIC ROAD","city":"GUJARAT","supplier":"ALEMBIC PHARMACEUTICALS LIMITED","supplierCountry":"INDIA","foreign_port":"N\/A","customer":"TO THE ORDER OF.","customerCountry":"SLOVENIA","quantity":"0.43","actualQuantity":"0.428","unit":"KGS","unitRateFc":"184285.3","totalValueFC":"77881.8","currency":"USD","unitRateINR":15461538.948598132,"date":"10-Dec-2024","totalValueINR":"6617538.67","totalValueInUsd":"77881.8","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"6331804","productDescription":"API","marketType":"REGULATED MARKET","country":"SLOVENIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"ALEMBIC ROAD, GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734287400,"product":"ACTIVE PHARMACEUTICALS INGREDIENTS (API) EXPORT INVOICE NUMBER : F32518003700 DT. 16.12.2024 FINGOLIMOD HYDROCHLORIDE","address":"PLOT 170-172, CHANDRAMOULI,INDUSTR","city":"SOLAPUR,MAHARASHTRA","supplier":"GLENMARK PHARMACEUTICALS","supplierCountry":"INDIA","foreign_port":"TORONTO","customer":"TO THE ORDER","customerCountry":"CANADA","quantity":"0.10","actualQuantity":"0.1","unit":"KGS","unitRateFc":"299831.3","totalValueFC":"29605.9","currency":"USD","unitRateINR":25155850,"date":"16-Dec-2024","totalValueINR":"2515585","totalValueInUsd":"29605.9","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"6496048","productDescription":"API","marketType":"REGULATED MARKET","country":"CANADA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"PLOT 170-172, CHANDRAMOULI,INDUSTR, SOLAPUR,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734546600,"product":"ACTIVE PHARMA INGREDIENTS (PHARMACEUTICALS RAW MATERIAL FOR PHARMA INDUSTRIES) PRODUCT - FINGOLIMOD HYDROCHLORIDE USP","address":"ALEMBIC ROAD","city":"GUJARAT","supplier":"ALEMBIC PHARMACEUTICALS LIMITED","supplierCountry":"INDIA","foreign_port":"AMMAN","customer":"TO THE ORDER OF","customerCountry":"JORDAN","quantity":"0.10","actualQuantity":"0.1","unit":"KGS","unitRateFc":"118938.3","totalValueFC":"11744.2","currency":"USD","unitRateINR":9978923.3999999985,"date":"19-Dec-2024","totalValueINR":"997892.34","totalValueInUsd":"11744.2","indian_port":"Ahmedabad Air","hs_no":"29349990","bill_no":"6579836","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"JORDAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Ahmedabad Air","supplierAddress":"ALEMBIC ROAD, GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1735324200,"product":"FINGOLIMOD HYDROCHLORIDE","address":"20TH K M, HOSUR ROAD,,ELECTRONIC C","city":"BANGALORE,KARNATAKA","supplier":"BIOCON","supplierCountry":"INDIA","foreign_port":"ALGER (ALGIERS)","customer":"N\/A","customerCountry":"ALGERIA","quantity":"0.35","actualQuantity":"350","unit":"GMS","unitRateFc":"119","totalValueFC":"41305.5","currency":"USD","unitRateINR":10027.677142857143,"date":"28-Dec-2024","totalValueINR":"3509687","totalValueInUsd":"41305.5","indian_port":"Biocon-SEZ","hs_no":"29221990","bill_no":"6853085","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ALGERIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Biocon-SEZ","supplierAddress":"20TH K M, HOSUR ROAD,,ELECTRONIC C, BANGALORE,KARNATAKA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1735583400,"product":"FINGOLIMOD HYDROCHLORIDE","address":"20TH K M, HOSUR ROAD,,ELECTRONIC C","city":"BANGALORE,KARNATAKA","supplier":"BIOCON","supplierCountry":"INDIA","foreign_port":"EL QAHIRA (CAIRO)","customer":"XXA PXXRMAXXOR XXARMXXEUTXXALIXXUSTXXES","customerCountry":"EGYPT","quantity":"0.22","actualQuantity":"215","unit":"GMS","unitRateFc":"118.5","totalValueFC":"25258.5","currency":"USD","unitRateINR":9982.2558139534885,"date":"31-Dec-2024","totalValueINR":"2146185","totalValueInUsd":"25258.5","indian_port":"Biocon-SEZ","hs_no":"29221990","bill_no":"4004952","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"EGYPT","selfForZScoreResived":"Pharma Grade","supplierPort":"Biocon-SEZ","supplierAddress":"20TH K M, HOSUR ROAD,,ELECTRONIC C, BANGALORE,KARNATAKA","customerAddress":""},{"dataSource":"API Import","activeIngredients":"FINGOLIMOD HYDROCHLORIDE","year":"2021","qtr":"Q2","strtotime":1619634600,"product":"FINGOLIMOD HYDROCHLORIDE","address":"PLOT NO 2A & 2B, BIOTECH PARK,,PHA SE II, LALGADI MALAKPET,","city":"HYDERABAD,TELANGANA","supplier":"CHEMO","supplierCountry":"ARGENTINA","foreign_port":"BUENOS AIRES BA","customer":"CHEMO","customerCountry":"INDIA","quantity":"0.28","actualQuantity":"0.282","unit":"KGS","unitRateFc":"96617","totalValueFC":"28267.4","currency":"USD","unitRateINR":"7462700","date":"29-Apr-2021","totalValueINR":"2104481.4","totalValueInUsd":"28267.4","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"3751298","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ARGENTINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BUENOS AIRES BA","supplierAddress":"","customerAddress":"PLOT NO 2A & 2B, BIOTECH PARK,,PHA SE II, LALGADI MALAKPET,"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q2","strtotime":1620671400,"product":"FINGOLIMOD HCI","address":"SANDOZ BAUG, KOLSHETTHANE","city":"THANE,MAHARASHTRA","supplier":"SANDOZ B2B","supplierCountry":"SLOVENIA","foreign_port":"LJUBLJANA - BRNIK","customer":"NOVARTIS PHARMACEUTICALS CORPORATION","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"1.5","unit":"GMS","unitRateFc":"3477.3","totalValueFC":"6426.5","currency":"EUR","unitRateINR":"313823.9","date":"11-May-2021","totalValueINR":"470735.88","totalValueInUsd":"6426.5","indian_port":"HYDERABAD AIR","hs_no":"29221990","bill_no":"3907126","productDescription":"API","marketType":"REGULATED MARKET","country":"SLOVENIA","selfForZScoreResived":"Pharma Grade","supplierPort":"LJUBLJANA - BRNIK","supplierAddress":"","customerAddress":"SANDOZ BAUG, KOLSHETTHANE"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1688149800,"product":"FINGOLIMOD HYDROCHLORIDE (QTY 1 X 300 MG, VALUE: USD 2380)(FOC)","address":"P.NO. D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,","city":"TURKAPALLY-V SHAMIRPET HYDERABAD,TE","supplier":"USP","supplierCountry":"CHINA","foreign_port":"NA","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.0003","unit":"KGS","unitRateFc":"7933333.3","totalValueFC":"2458.6","currency":"USD","unitRateINR":"673560099.8","date":"01-Jul-2023","totalValueINR":"202068.307","totalValueInUsd":"2458.6","indian_port":"HYDERABAD AIR","hs_no":"29221990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"P.NO. D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1692124200,"product":"FINGOLIMOD HYDROCHLORIDE","address":"VILLAGE NAG KALAN,MAJITHA ROAD,MAJ ITHA","city":"AMRITSAR","supplier":"M S YUANFANG CHEMICALS LIMITED","supplierCountry":"CHINA","foreign_port":"NA","customer":"KWALITY PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"10","unit":"GMS","unitRateFc":"50","totalValueFC":"494.5","currency":"USD","unitRateINR":"4055.4","date":"16-Aug-2023","totalValueINR":"40964","totalValueInUsd":"494.5","indian_port":"DELHI AIR","hs_no":"29339990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"VILLAGE NAG KALAN,MAJITHA ROAD,MAJ ITHA"},{"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","supplierCountry":"INDIA","foreign_port":"BANGALORE","customer":"BIOCON","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":1731436200,"product":"FINGOLIMOD HCL IMPURITY - 2 PALMITAMIDE","address":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,","city":"HYDERABAD,TELANGANA","supplier":"DR. REDDY\\'S LABORATORIES","supplierCountry":"INDIA","foreign_port":"VISAKHAPATNAM SEZ","customer":"DR. REDDY\\'S LABORATORIES","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":1731954600,"product":"FINGOLIMOD HYDROCHLORIDE","address":"20TH K M, HOSUR ROAD,,ELECTRONIC C","city":"BANGALORE,KARNATAKA","supplier":"BIOCON LIMITED SEZ UNIT","supplierCountry":"INDIA","foreign_port":"BIOCON SEZ BANGALORE","customer":"BIOCON","customerCountry":"INDIA","quantity":"0.88","actualQuantity":"0.883","unit":"KGS","unitRateFc":"58804.2","totalValueFC":"52485.2","currency":"USD","unitRateINR":"5016000","date":"19-Nov-2024","totalValueINR":"4429128","totalValueInUsd":"52485.2","indian_port":"Biocon-SEZ","hs_no":"29221990","bill_no":"6765002","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BIOCON SEZ 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"}]
    15-Jan-2021
    31-Dec-2024
    KGS
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    ABOUT THIS PAGE

    gilenya Manufacturers

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

    gilenya Suppliers

    A gilenya supplier is an individual or a company that provides gilenya active pharmaceutical ingredient (API) or gilenya finished formulations upon request. The gilenya suppliers may include gilenya API manufacturers, exporters, distributors and traders.

    click here to find a list of gilenya suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    gilenya USDMF

    A gilenya DMF (Drug Master File) is a document detailing the whole manufacturing process of gilenya active pharmaceutical ingredient (API) in detail. Different forms of gilenya DMFs exist exist since differing nations have different regulations, such as gilenya USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A gilenya DMF submitted to regulatory agencies in the US is known as a USDMF. gilenya USDMF includes data on gilenya's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The gilenya USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of gilenya suppliers with USDMF on PharmaCompass.

    gilenya 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 gilenya Drug Master File in Japan (gilenya JDMF) empowers gilenya 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 gilenya JDMF during the approval evaluation for pharmaceutical products. At the time of gilenya 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 gilenya suppliers with JDMF on PharmaCompass.

    gilenya CEP

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

    A gilenya CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. gilenya 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 gilenya suppliers with CEP (COS) on PharmaCompass.

    gilenya WC

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

    click here to find a list of gilenya suppliers with Written Confirmation (WC) on PharmaCompass.

    gilenya 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 gilenya as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for gilenya 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 gilenya 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 gilenya and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a gilenya NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of gilenya suppliers with NDC on PharmaCompass.

    gilenya GMP

    gilenya 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 gilenya 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 gilenya GMP manufacturer or gilenya GMP API supplier for your needs.

    gilenya CoA

    A gilenya CoA (Certificate of Analysis) is a formal document that attests to gilenya's compliance with gilenya specifications and serves as a tool for batch-level quality control.

    gilenya CoA mostly includes findings from lab analyses of a specific batch. For each gilenya 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.

    gilenya may be tested according to a variety of international standards, such as European Pharmacopoeia (gilenya EP), gilenya JP (Japanese Pharmacopeia) and the US Pharmacopoeia (gilenya 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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