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    Also known as: 191217-81-9, Mirapex, (s)-n6-propyl-4,5,6,7-tetrahydrobenzo[d]thiazole-2,6-diamine dihydrochloride hydrate, Pramipexole 2hcl monohydrate, Pramipexole hydrochloride, Sifrol
    Molecular Formula
    C10H21Cl2N3OS
    Molecular Weight
    302.3  g/mol
    InChI Key
    APVQOOKHDZVJEX-QTPLPEIMSA-N
    FDA UNII
    3D867NP06J
    Pramipexole Dihydrochloride
    A benzothiazole derivative and dopamine agonist with antioxidant properties that is used in the treatment of PARKINSON DISEASE and RESTLESS LEGS SYNDROME.
    1 2D Structure

    Pramipexole Dihydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (6S)-6-N-propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine;hydrate;dihydrochloride
    2.1.2 InChI
    InChI=1S/C10H17N3S.2ClH.H2O/c1-2-5-12-7-3-4-8-9(6-7)14-10(11)13-8;;;/h7,12H,2-6H2,1H3,(H2,11,13);2*1H;1H2/t7-;;;/m0.../s1
    2.1.3 InChI Key
    APVQOOKHDZVJEX-QTPLPEIMSA-N
    2.1.4 Canonical SMILES
    CCCNC1CCC2=C(C1)SC(=N2)N.O.Cl.Cl
    2.1.5 Isomeric SMILES
    CCCN[C@H]1CCC2=C(C1)SC(=N2)N.O.Cl.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    3D867NP06J
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 2 Amino 6 Propylaminotetrahydrobenzothiazole

    2. 2-amino-4,5,6,7-tetrahydro-6-propylaminobenzothiazole

    3. 2-amino-6-propylaminotetrahydrobenzothiazole

    4. 4,5,6,7-tetrahydro-n6-propyl-2,6-benzothiazole-diamine

    5. 6,7-tetrahydro-n6-propyl-2,6-benzothiazolediamine Dihydrochloride Monohydrate

    6. Dexpramipexole

    7. Kns 760704

    8. Kns-760704

    9. Kns760704

    10. Mirapex

    11. Pramipexol

    12. Pramipexol Dihydrobromide, (+-)-isomer

    13. Pramipexol Dihydrochloride, (s)-isomer

    14. Pramipexol, (+-)-isomer

    15. Pramipexol, (r)-isomer

    16. Pramipexole

    17. Pramipexole Dihydrochloride

    18. Pramipexole Dihydrochloride Anhydrous

    19. Pramipexole Hydrochloride Monohydrate

    20. Sifrol

    21. Snd 919

    22. Snd 919cl2x

    23. Snd-919

    24. Snd-919cl2x

    25. Snd919cl2x

    2.3.2 Depositor-Supplied Synonyms

    1. 191217-81-9

    2. Mirapex

    3. (s)-n6-propyl-4,5,6,7-tetrahydrobenzo[d]thiazole-2,6-diamine Dihydrochloride Hydrate

    4. Pramipexole 2hcl Monohydrate

    5. Pramipexole Hydrochloride

    6. Sifrol

    7. Daquiran

    8. Pramipexole Hydrochloride Hydrate

    9. Pramipexole Teva

    10. Pramipexole Accord

    11. Snd919cl2y

    12. Bi-sifrol

    13. Pnu-98528e

    14. 191712-81-9

    15. (s)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole Dihydrochloride Monohydrate

    16. Pramipexole Dihydrochloride [usan]

    17. Chebi:51147

    18. 3d867np06j

    19. Oprymea

    20. Pramipexole (dihydrochloride Hydrate)

    21. Snd-919cl2y

    22. (6s)-6-n-propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine;hydrate;dihydrochloride

    23. Pramipexole Hydrochloride Hydrate (jan)

    24. Pramipexole Dihydrochloride Anhydrous

    25. Pramipexole Hydrochloride Hydrate [jan]

    26. Pramipexole Hcl Hydrate

    27. Unii-3d867np06j

    28. Pramipexole Dihydrochloride Hydrate

    29. Pramipexole Hydrate Dihydrochloride

    30. Pnu 98528e

    31. Mirapex (tn)

    32. Pramipexole Dihydrochloride [usan:usp]

    33. Dsstox_cid_24227

    34. Dsstox_rid_80129

    35. Dsstox_gsid_44227

    36. Chembl3182733

    37. Dtxsid1044227

    38. Hy-b0410a

    39. Pramipexole Dihydrochloride (usp)

    40. Pramipexole Hydrochloride Monohydrate

    41. Tox21_302316

    42. Mfcd02183927

    43. S2011

    44. Akos015917338

    45. Ccg-267486

    46. Ks-1308

    47. 2,6-benzothiazolediamine, 4,5,6,7-tetrahydro-n6-propyl-, Dihydrochloride, Monohydrate, (6s)-

    48. Ncgc00255978-01

    49. Pramipexole Hydrochloride [mart.]

    50. 112gi013

    51. Bp162212

    52. Bp164285

    53. Pramipexole Dihydrochloride [vandf]

    54. Cas-191217-81-9

    55. Cs-0013154

    56. Sw197453-5

    57. (s)-pramipexole 2hcl Monohydrate - Ep Grade

    58. Pramipexole Dihydrochloride Monohydrate- Bio-x

    59. D00559

    60. T72003

    61. Pramipexole Dihydrochloride [orange Book]

    62. A846638

    63. Pramipexole Dihydrochloride [usp Monograph]

    64. J-012354

    65. Pramipexole Dihydrochloride Monohydrate [mi]

    66. Q27888021

    67. Pramipexole Dihydrochloride Monohydrate [ema Epar]

    68. Pramipexole Dihydrochloride Monohydrate [usp-rs]

    69. Pramipexole Dihydrochloride Monohydrate [who-dd]

    70. Pramipexole Dihydrochloride Monohydrate [ep Monograph]

    71. (6s)-n(6)-propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine Dihydrochloride Hydrate

    72. (s)-2-amino-4,5,6,7-tetrahydro-6(propylamino)benzothiazole Dihydrochloride Monohydrate

    73. (s)-n6-propyl-4,5,6,7-tetrahydrobenzo[d]thiazole-2,6-diamine 2hcl Hydrate

    74. (s)-n6-propyl-4,5,6,7-tetrahydrobenzo[d]thiazole-2,6-diaminedihydrochloridehydrate

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 302.3 g/mol
    Molecular Formula C10H21Cl2N3OS
    Hydrogen Bond Donor Count5
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count3
    Exact Mass301.0782389 g/mol
    Monoisotopic Mass301.0782389 g/mol
    Topological Polar Surface Area80.2 Ų
    Heavy Atom Count17
    Formal Charge0
    Complexity188
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count4
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameMirapex
    PubMed HealthPramipexole (By mouth)
    Drug ClassesAntiparkinsonian
    Drug LabelMIRAPEX tablets contain pramipexole, a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C10 H17 N3 S 2...
    Active IngredientPramipexole dihydrochloride
    Dosage FormTablet
    RouteOral
    Strength0.5mg; 1mg; 0.25mg; 0.75mg; 1.5mg; 0.125mg
    Market StatusPrescription
    CompanyBoehringer Ingelheim

    2 of 4  
    Drug NamePramipexole dihydrochloride
    Drug LabelMIRAPEX tablets contain pramipexole, a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C10 H17 N3 S 2...
    Active IngredientPramipexole dihydrochloride
    Dosage FormTablet, extended release; Tablet
    RouteOral
    Strength0.5mg; 1mg; 0.25mg; 0.75mg; 3.75mg; 1.5mg; 4.5mg; 2.25mg; 0.375mg; 3mg; 0.125mg
    Market StatusPrescription
    CompanyAnchen Pharms; Alembic; Breckenridge Pharm; Apotex; Aurobindo Pharma; Sun Pharm Inds; Torrent Pharms; Sandoz; Actavis Grp Ptc; Watson Labs; Strides Pharma; Glenmark Generics; Teva Pharms; Macleods Pharms; Zydus Pharms Usa; Mylan; Barr

    3 of 4  
    Drug NameMirapex
    PubMed HealthPramipexole (By mouth)
    Drug ClassesAntiparkinsonian
    Drug LabelMIRAPEX tablets contain pramipexole, a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C10 H17 N3 S 2...
    Active IngredientPramipexole dihydrochloride
    Dosage FormTablet
    RouteOral
    Strength0.5mg; 1mg; 0.25mg; 0.75mg; 1.5mg; 0.125mg
    Market StatusPrescription
    CompanyBoehringer Ingelheim

    4 of 4  
    Drug NamePramipexole dihydrochloride
    Drug LabelMIRAPEX tablets contain pramipexole, a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C10 H17 N3 S 2...
    Active IngredientPramipexole dihydrochloride
    Dosage FormTablet, extended release; Tablet
    RouteOral
    Strength0.5mg; 1mg; 0.25mg; 0.75mg; 3.75mg; 1.5mg; 4.5mg; 2.25mg; 0.375mg; 3mg; 0.125mg
    Market StatusPrescription
    CompanyAnchen Pharms; Alembic; Breckenridge Pharm; Apotex; Aurobindo Pharma; Sun Pharm Inds; Torrent Pharms; Sandoz; Actavis Grp Ptc; Watson Labs; Strides Pharma; Glenmark Generics; Teva Pharms; Macleods Pharms; Zydus Pharms Usa; Mylan; Barr

    4.2 Drug Indication

    Sifrol is indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i. e. over the course of the disease, though to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or 'on-off' fluctuations).

    Sifrol is indicated for symptomatic treatment of moderate to severe idiopathic restless-legs syndrome in dosages up to 0. 54 mg of base (0. 75 mg of salt).

    Mirapexin is indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i. e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or 'on-off' fluctuations).

    Mirapexin is indicated for symptomatic treatment of moderate to severe idiopathic restless-legs syndrome in dosages up to 0. 54 mg of base (0. 75 mg of salt).

    Oprymea is indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i. e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or "on off" fluctuations).

    Oprymea is indicated in adults for symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in doses up to 0. 54 mg of base (0. 75 mg of salt) (see section 4. 2).

    Pramipexole Teva is indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i. e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or 'on-off' fluctuations).

    Pramipexole Teva is indicated in adults for symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in doses up to 0. 54 mg of base (0. 75 mg of salt) (see section 4. 2).

    Pramipexole Accord is indicated in adults for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i. e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or 'on-off' fluctuations).

    DAQUIRAN tablets are indicated for treatment of the signs and symptoms of advanced idiopathic Parkinson's disease in combination with levodopa, i. e. over the course of the disease, when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or "on off" fluctuations).

    Combined vocal and multiple motor tic disorder (de la Tourette), Restless Legs Syndrome

    Combined vocal and multiple motor tic disorder (de la Tourette), Restless Legs Syndrome

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Antiparkinson Agents

    Agents used in the treatment of Parkinson's disease. The most commonly used drugs act on the dopaminergic system in the striatum and basal ganglia or are centrally acting muscarinic antagonists. (See all compounds classified as Antiparkinson Agents.)

    Antioxidants

    Naturally occurring or synthetic substances that inhibit or retard oxidation reactions. They counteract the damaging effects of oxidation in animal tissues. (See all compounds classified as Antioxidants.)

    Dopamine Agonists

    Drugs that bind to and activate dopamine receptors. (See all compounds classified as Dopamine Agonists.)

    5.2 ATC Code

    N04BC05

    N04BC05

    N04BC05

    N04BC05

    N04BC05

    N04BC05

    API Reference Price

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INCHEON INT\\'","customer":"SUNGWOO CHEMICAL","customerCountry":"KOREA, REPUBLIC OF","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"11250","totalValueFC":"22040.4","currency":"USD","unitRateINR":950260.88500000001,"date":"08-Jan-2025","totalValueINR":"1900521.77","totalValueInUsd":"22040.4","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"7103875","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","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":"2025","qtr":"Q1","strtotime":1736447400,"product":"PRAMIPEXOLE DIHCL MONOHYDRATE PH.EUR","address":"7-2-A2, HETERO CORPORATE,","city":"HYDERABAD-A.P.","supplier":"HETERO DRUGS","supplierCountry":"INDIA","foreign_port":"TORONTO","customer":"APOTEX INC","customerCountry":"CANADA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"14000","totalValueFC":"27449.3","currency":"USD","unitRateINR":1183467.5,"date":"10-Jan-2025","totalValueINR":"2366935","totalValueInUsd":"27449.3","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"7198457","productDescription":"API","marketType":"REGULATED MARKET","country":"CANADA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"7-2-A2, HETERO CORPORATE,, HYDERABAD-A.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737052200,"product":"PRAMIPEXOLE DIHYDROCHLORIDE (EXPORT INVOICE NO:NL\/EXP24-25\/850 DT:16\/01\/2025)","address":"FLAT NO.404 TO 406,4TH FLOOR,VIJAY","city":"HYDERABAD.AP","supplier":"NOSCH LABS PVT","supplierCountry":"INDIA","foreign_port":"HAMBURG - 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    04-Jan-2021
    15-Feb-2025
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 0.125MG **Federal Regi...DOSAGE - TABLET;ORAL - 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20667

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    DOSAGE - TABLET;ORAL - 0.25MG **Federal Regis...DOSAGE - TABLET;ORAL - 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20667

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    DOSAGE - TABLET;ORAL - 0.5MG **Federal Regist...DOSAGE - TABLET;ORAL - 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20667

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    DOSAGE - TABLET;ORAL - 0.75MG **Federal Regis...DOSAGE - TABLET;ORAL - 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20667

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    DOSAGE - TABLET;ORAL - 1.5MG **Federal Regist...DOSAGE - TABLET;ORAL - 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20667

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    DOSAGE - TABLET;ORAL - 1MG **Federal Register...DOSAGE - TABLET;ORAL - 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20667

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    ABOUT THIS PAGE

    Looking for 191217-81-9 / Pramipexole API manufacturers, exporters & distributors?

    Pramipexole manufacturers, exporters & distributors 1

    51

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

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

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

    API | Excipient name

    Pramipexole

    Synonyms

    191217-81-9, Mirapex, (s)-n6-propyl-4,5,6,7-tetrahydrobenzo[d]thiazole-2,6-diamine dihydrochloride hydrate, Pramipexole 2hcl monohydrate, Pramipexole hydrochloride, Sifrol

    Cas Number

    191217-81-9

    Unique Ingredient Identifier (UNII)

    3D867NP06J

    About Pramipexole

    A benzothiazole derivative and dopamine agonist with antioxidant properties that is used in the treatment of PARKINSON DISEASE and RESTLESS LEGS SYNDROME.

    Sifrol Manufacturers

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

    Sifrol Suppliers

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

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

    Sifrol USDMF

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

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

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

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

    Sifrol KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Sifrol Drug Master File in Korea (Sifrol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sifrol. The MFDS reviews the Sifrol KDMF as part of the drug registration process and uses the information provided in the Sifrol KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Sifrol 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 Sifrol API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Sifrol suppliers with KDMF on PharmaCompass.

    Sifrol CEP

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

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

    Sifrol WC

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

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

    Sifrol 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 Sifrol as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Sifrol GMP

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

    Sifrol CoA

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

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

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