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    Chemistry

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    Also known as: 145202-66-0, Maxalt, Rizatriptan (benzoate), Maxalt-mlt, Mk 462, Mk-462
    Molecular Formula
    C22H25N5O2
    Molecular Weight
    391.5  g/mol
    InChI Key
    JPRXYLQNJJVCMZ-UHFFFAOYSA-N
    FDA UNII
    WR978S7QHH
    Rizatriptan Benzoate
    Rizatriptan Benzoate is the benzoate salt form of rizatriptan, a member of the triptan class agents with anti-migraine property. Rizatriptan benzoate selectively binds to and activates serotonin (5-HT) 1B receptors expressed in intracranial arteries, and to 5-HT 1D receptors located on peripheral trigeminal sensory nerve terminals in the meninges and central terminals in brain stem sensory nuclei. Receptor binding results in constriction of cranial vessels and inhibition of nociceptive transmission, thereby providing relief of migraine headaches. Rizatriptan benzoate may also relief migraine headaches by inhibition of pro-inflammatory neuropeptide release.
    1 2D Structure

    Rizatriptan Benzoate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    benzoic acid;N,N-dimethyl-2-[5-(1,2,4-triazol-1-ylmethyl)-1H-indol-3-yl]ethanamine
    2.1.2 InChI
    InChI=1S/C15H19N5.C7H6O2/c1-19(2)6-5-13-8-17-15-4-3-12(7-14(13)15)9-20-11-16-10-18-20;8-7(9)6-4-2-1-3-5-6/h3-4,7-8,10-11,17H,5-6,9H2,1-2H3;1-5H,(H,8,9)
    2.1.3 InChI Key
    JPRXYLQNJJVCMZ-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CN(C)CCC1=CNC2=C1C=C(C=C2)CN3C=NC=N3.C1=CC=C(C=C1)C(=O)O
    2.2 Other Identifiers
    2.2.1 UNII
    WR978S7QHH
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. L 705,126

    2. L 705126

    3. L-705,126

    4. L-705126

    5. Maxalt

    6. Mk 0462

    7. Mk 462

    8. Mk-0462

    9. Mk-462

    10. N,n-dimethyl-2-(5-(1,2,4-triazol-1-ylmethyl)-1h-indole-3-yl)ethylamine

    11. Rizatriptan

    2.3.2 Depositor-Supplied Synonyms

    1. 145202-66-0

    2. Maxalt

    3. Rizatriptan (benzoate)

    4. Maxalt-mlt

    5. Mk 462

    6. Mk-462

    7. Mk-0462

    8. 2-(5-((1h-1,2,4-triazol-1-yl)methyl)-1h-indol-3-yl)-n,n-dimethylethanamine Benzoate

    9. Nsc-758919

    10. Wr978s7qhh

    11. Rizatriptan Benzoate (maxalt)

    12. N,n-dimethyl-2-[5-(1,2,4-triazol-1-ylmethyl)-1h-indol-3-yl]ethylamine Benzoate

    13. 3-(2-(dimethylamino)ethyl)-5-(1h-1,2,4-triazol-1-ylmethyl)indole Monobenzoate

    14. 1h-indole-3-ethanamine, N,n-dimethyl-5-(1h-1,2,4-triazol-1-ylmethyl)-, Monobenzoate

    15. 2-(5-((1h-1,2,4-triazol-1-yl)methyl)-1h-indol-3-yl)-n,n-dimethylethan-1-amine Benzoate

    16. Benzoic Acid;n,n-dimethyl-2-[5-(1,2,4-triazol-1-ylmethyl)-1h-indol-3-yl]ethanamine

    17. Rizatriptanbenzoate

    18. N,n-dimethyl-5-(1h-1,2,4-triazol-1-ylmethyl)-1h-indole-3-ethanamine Benzoate

    19. Rizatriptan Benzoate [usan]

    20. Mk 0462

    21. Unii-wr978s7qhh

    22. L 705126

    23. L 705,126

    24. L-705,126

    25. Rizatriptan Benzoate [usan:usp]

    26. Rizatrimptan Benzoate

    27. Rizatriptane Benzoate

    28. Rizatriptan, Benzoate

    29. Mk-462 Benzoate

    30. Schembl41226

    31. Mls001424197

    32. Chebi:8875

    33. Rizatriptan Benzoate Salt

    34. Chembl1201032

    35. Rizatriptan Benzoate (jan/usp)

    36. Amy8935

    37. Dtxsid20162937

    38. Rhb-103

    39. Rizatriptan Benzoate [mi]

    40. Hms2051b16

    41. Hms2093k08

    42. Hms2235m18

    43. Hms3369i15

    44. Hms3393b16

    45. Hms3655k09

    46. Hms3715d08

    47. Hms3884k21

    48. Pharmakon1600-01505189

    49. Rizatriptan Benzoate [jan]

    50. Act04340

    51. Bcp02149

    52. Hy-b0206

    53. Int-0008

    54. Rizatriptan Benzoate [vandf]

    55. Ac-734

    56. Mfcd00866224

    57. Nsc758919

    58. Rizatriptan Benzoate [mart.]

    59. Rizatriptan Benzoate [usp-rs]

    60. Rizatriptan Benzoate [who-dd]

    61. Akos015855933

    62. Ab07521

    63. Ccg-101039

    64. Ks-1189

    65. Nc00289

    66. Nsc 758919

    67. Rizatriptan Benzoate [orange Book]

    68. Smr000525252

    69. Rizatriptan Benzoate [ep Monograph]

    70. Db-015783

    71. Rizatriptan Benzoate [usp Monograph]

    72. Rizatriptan Benzoate Salt, >=98% (hplc)

    73. Ft-0631171

    74. R0107

    75. R0181

    76. S1607

    77. Sw197669-2

    78. D00675

    79. 202r660

    80. A808337

    81. Sr-01000763588

    82. J-008071

    83. J-524222

    84. Sr-01000763588-3

    85. Q27292788

    86. Rizatriptan Benzoate, European Pharmacopoeia (ep) Reference Standard

    87. Rizatriptan Benzoate, United States Pharmacopeia (usp) Reference Standard

    88. Dimethyl-[2-(5-[1,2,4]triazol-1-ylmethyl-1h-indol-3-yl)-ethyl]-amine Benzoate

    89. N,n-dimethyl-2-[5-(1,2,4-triazol-1-ylmethyl)-1h-indol-3-yl]ethanamine Benzoate

    90. Rizatriptan For System Suitability, European Pharmacopoeia (ep) Reference Standard

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 391.5 g/mol
    Molecular Formula C22H25N5O2
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count6
    Exact Mass391.20082506 g/mol
    Monoisotopic Mass391.20082506 g/mol
    Topological Polar Surface Area87 Ų
    Heavy Atom Count29
    Formal Charge0
    Complexity412
    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 4  
    Drug NameMaxalt
    PubMed HealthRizatriptan (By mouth)
    Drug ClassesAntimigraine
    Drug LabelMAXALTCOPYRIGHT 1998, 2006 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.All rights reserved contains rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist.Rizatriptan benzoate is described chemical
    Active IngredientRizatriptan benzoate
    Dosage FormTablet
    RouteOral
    Strengtheq 5mg base; eq 10mg base
    Market StatusPrescription
    CompanyMerck

    2 of 4  
    Drug NameRizatriptan benzoate
    Drug LabelMAXALTCOPYRIGHT 1998, 2006 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.All rights reserved contains rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist.Rizatriptan benzoate is described chemical
    Active IngredientRizatriptan benzoate
    Dosage FormTablet; Tablet, orally disintegrating
    RouteOral
    Strengtheq 5mg base; eq 10mg base
    Market StatusPrescription
    CompanyMylan Pharms; Apotex; Aurobindo Pharma; Natco Pharma; Sandoz; Invagen Pharms; Cipla; Sun Pharma Global; Glenmark Generics; Emcure Pharms; Teva Pharms; Macleods Pharms

    3 of 4  
    Drug NameMaxalt
    PubMed HealthRizatriptan (By mouth)
    Drug ClassesAntimigraine
    Drug LabelMAXALTCOPYRIGHT 1998, 2006 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.All rights reserved contains rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist.Rizatriptan benzoate is described chemical
    Active IngredientRizatriptan benzoate
    Dosage FormTablet
    RouteOral
    Strengtheq 5mg base; eq 10mg base
    Market StatusPrescription
    CompanyMerck

    4 of 4  
    Drug NameRizatriptan benzoate
    Drug LabelMAXALTCOPYRIGHT 1998, 2006 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.All rights reserved contains rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist.Rizatriptan benzoate is described chemical
    Active IngredientRizatriptan benzoate
    Dosage FormTablet; Tablet, orally disintegrating
    RouteOral
    Strengtheq 5mg base; eq 10mg base
    Market StatusPrescription
    CompanyMylan Pharms; Apotex; Aurobindo Pharma; Natco Pharma; Sandoz; Invagen Pharms; Cipla; Sun Pharma Global; Glenmark Generics; Emcure Pharms; Teva Pharms; Macleods Pharms

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Serotonin Receptor Agonists

    Endogenous compounds and drugs that bind to and activate SEROTONIN RECEPTORS. Many serotonin receptor agonists are used as ANTIDEPRESSANTS; ANXIOLYTICS; and in the treatment of MIGRAINE DISORDERS. (See all compounds classified as Serotonin Receptor Agonists.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Serotonin 1d Receptor Agonists [MoA]; Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]; Serotonin 1b Receptor Agonists [MoA]

    API Reference Price

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NO.37, BOMBAY ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723919400,"product":"RIZATRIPTAN BENZOATE USP (MICRONISED)","address":"3, BOTAWALA BLDG., 1ST FLOOR,","city":"FORT, MUMBAI MAHARASHTRA","supplier":"NISHCHEM INTERNATIONAL PVT. LTD","supplierCountry":"INDIA","foreign_port":"BIRGUNJ","customer":"TO THE ORDER OF NATIONAL HEALTHCARE","customerCountry":"NEPAL","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"440000","totalValueFC":"10491.4","currency":"INR","unitRateINR":440000.01000000001,"date":"18-Aug-2024","totalValueINR":"880000.02","totalValueInUsd":"10491.4","indian_port":"Raxaul","hs_no":"29252990","bill_no":"3297515","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"NEPAL","selfForZScoreResived":"Micronized","supplierPort":"Raxaul","supplierAddress":"3, BOTAWALA BLDG., 1ST FLOOR,, FORT, MUMBAI MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724351400,"product":"RIZATRIPTAN BENZOATE","address":"Floor No.22, Plot No.1, Survey No.83\/1, Galaxy Tower","city":"Hyderabad","supplier":"APITORIA PHARMA PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"MILAN - MALPENSA","customer":"OLD PHARMA INTERNATIONAL ","customerCountry":"ITALY","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"8500","totalValueFC":"91882.5","currency":"EUR","unitRateINR":770697.35199999996,"date":"23-Aug-2024","totalValueINR":"7706973.52","totalValueInUsd":"91882.5","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"3433353","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"Floor No.22, Plot No.1, Survey No.83\/1, Galaxy Tower, Hyderabad","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724351400,"product":"RIZATRIPTAN BENZOATE USP","address":"7-2-A2, HETERO CORPORATE,","city":"HYDERABAD, TELANGANA","supplier":"HETERO DRUGS","supplierCountry":"INDIA","foreign_port":"BAGHD\u00bfD","customer":"SAMA ALFAYHAA PHARMACEUTICAL","customerCountry":"IRAQ","quantity":"0.50","actualQuantity":"0.5","unit":"KGS","unitRateFc":"3100","totalValueFC":"1455","currency":"USD","unitRateINR":244084,"date":"23-Aug-2024","totalValueINR":"122042","totalValueInUsd":"1455","indian_port":"Vizag-HIPL SEZ","hs_no":"29339990","bill_no":"3416574","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"IRAQ","selfForZScoreResived":"Pharma Grade","supplierPort":"Vizag-HIPL SEZ","supplierAddress":"7-2-A2, HETERO CORPORATE,, HYDERABAD, TELANGANA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727375400,"product":"ACTIVE PHARMACEUTICALS INGREDIENTS (API) EXPORT INVOICE NUMBER : F32518002301 DT. 20.09.2024 RIZATRIPTAN BENZOATE","address":"PLOT 170-172, CHANDRAMOULI,INDUSTR","city":"SOLAPUR,MAHARASHTRA","supplier":"GLENMARK PHARMACEUTICALS","supplierCountry":"INDIA","foreign_port":"ISTANBUL","customer":"TO THE ORDER","customerCountry":"TURKEY","quantity":"22.94","actualQuantity":"22.94","unit":"KGS","unitRateFc":"4000","totalValueFC":"90531.5","currency":"USD","unitRateINR":330717.04446381866,"date":"27-Sep-2024","totalValueINR":"7586649","totalValueInUsd":"90531.5","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"4379353","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"TURKEY","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"PLOT 170-172, CHANDRAMOULI,INDUSTR, SOLAPUR,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727634600,"product":"RIZATRIPTAN BENZOATE PH.EUR (TAX INVOICENO: B\/EX\/24-25\/122 DT: 28-09-2024)","address":"PLOT NO.19-III, ROAD NO.71, OPP.","city":"JUBILEE HILLS, HYDERABAD. AP","supplier":"SMS PHARMACEUTICALS","supplierCountry":"INDIA","foreign_port":"ATHENS","customer":"PHARMATHEN SA","customerCountry":"GREECE","quantity":"30.00","actualQuantity":"30","unit":"KGS","unitRateFc":"6500","totalValueFC":"192618.1","currency":"USD","unitRateINR":538054.38099999994,"date":"30-Sep-2024","totalValueINR":"16141631.43","totalValueInUsd":"192618.1","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"4453402","productDescription":"API","marketType":"REGULATED MARKET","country":"GREECE","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO.19-III, ROAD NO.71, OPP., JUBILEE HILLS, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732041000,"product":"RIZATRIPTAN BENZOATE USP (TAX INVOICE NO:120 DT:16.11.2024)","address":"PLOT NO.146A, PHASE-II,","city":"HYDERABAD. AP","supplier":"AZAKEM LABS PRIVATE ","supplierCountry":"INDIA","foreign_port":"KATHMANDU - TRIBHUVA","customer":"PANAS PHARMACEUTICALS PVT. ","customerCountry":"NEPAL","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"450000","totalValueFC":"5262.7","currency":"INR","unitRateINR":444110,"date":"20-Nov-2024","totalValueINR":"444110","totalValueInUsd":"5262.7","indian_port":"Hyderabad Air","hs_no":"29252990","bill_no":"5757224","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"NEPAL","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO.146A, PHASE-II,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733250600,"product":"RIZATRIPTAN BENZOATE USP","address":"7-2-A2, HETERO CORPORATE,","city":"HYDERABAD, TELANGANA","supplier":"HETERO DRUGS","supplierCountry":"INDIA","foreign_port":"GUARULHOS APT\/S\u00c3O PAULO, SP","customer":"N\/A","customerCountry":"BRAZIL","quantity":"6.00","actualQuantity":"6","unit":"KGS","unitRateFc":"9000","totalValueFC":"53130","currency":"USD","unitRateINR":752400,"date":"04-Dec-2024","totalValueINR":"4514400","totalValueInUsd":"53130","indian_port":"Vizag-HIPL SEZ","hs_no":"29339990","bill_no":"6168111","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"Vizag-HIPL SEZ","supplierAddress":"7-2-A2, HETERO CORPORATE,, HYDERABAD, TELANGANA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1735497000,"product":"RIZATRIPTAN BENZOATE USP","address":"PLOT NO.19-III, ROAD NO.71, OPP.","city":"JUBILEE HILLS, HYDERABAD. AP","supplier":"SMS PHARMACEUTICALS","supplierCountry":"INDIA","foreign_port":"TORONTO","customer":"SHANDEX WAREHOUSE","customerCountry":"CANADA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"8050","totalValueFC":"398431.4","currency":"USD","unitRateINR":677086.27980000002,"date":"30-Dec-2024","totalValueINR":"33854313.99","totalValueInUsd":"398431.4","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"6870259","productDescription":"API","marketType":"REGULATED MARKET","country":"CANADA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO.19-III, ROAD NO.71, OPP., JUBILEE HILLS, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q3","strtotime":1627237800,"product":"RIZATRIPTAN BENZOATE( RE-IMPORT FOR REPROCESS & RE-EXPORT VIDE SB NO.1513403 DT.19.02.2020","address":"NATCO HOUSE, ROAD NO.2,BANJARA HILLS,","city":"HYDERABAD, A.P.","supplier":"ACTAVIS INC","supplierCountry":"INDIA","foreign_port":"","customer":"NATCO PHARMA","customerCountry":"INDIA","quantity":"6.68","actualQuantity":"6.682","unit":"KGS","unitRateFc":"12000","totalValueFC":"82608.5","currency":"USD","unitRateINR":"921362.6","date":"26-Jul-2021","totalValueINR":"6156544.68","totalValueInUsd":"82608.5","indian_port":"HYDERABAD AIR","hs_no":"29335990","bill_no":"4821583","productDescription":"Re-export","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"","supplierAddress":"","customerAddress":"NATCO HOUSE, ROAD NO.2,BANJARA HILLS,"}]
    06-Jan-2021
    30-Dec-2024
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - FILM;ORAL - EQ 10MG BASE

    USFDA APPLICATION NUMBER - 205394

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    DOSAGE - TABLET;ORAL - EQ 10MG BASE

    USFDA APPLICATION NUMBER - 20864

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    DOSAGE - TABLET;ORAL - EQ 5MG BASE **Federal ...DOSAGE - TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20864

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    DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - EQ 10MG BASE

    USFDA APPLICATION NUMBER - 20865

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    DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20865

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    ABOUT THIS PAGE

    Rizatriptan Manufacturers

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

    Rizatriptan Suppliers

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

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

    Rizatriptan USDMF

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

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

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

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

    Rizatriptan CEP

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

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

    Rizatriptan WC

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

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

    Rizatriptan 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 Rizatriptan as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Rizatriptan GMP

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

    Rizatriptan CoA

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

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

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