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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
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
Molecular Weight | 302.3 g/mol |
---|---|
Molecular Formula | C10H21Cl2N3OS |
Hydrogen Bond Donor Count | 5 |
Hydrogen Bond Acceptor Count | 5 |
Rotatable Bond Count | 3 |
Exact Mass | 301.0782389 g/mol |
Monoisotopic Mass | 301.0782389 g/mol |
Topological Polar Surface Area | 80.2 Ų |
Heavy Atom Count | 17 |
Formal Charge | 0 |
Complexity | 188 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 1 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 4 |
1 of 4 | |
---|---|
Drug Name | Mirapex |
PubMed Health | Pramipexole (By mouth) |
Drug Classes | Antiparkinsonian |
Drug Label | MIRAPEX 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 Ingredient | Pramipexole dihydrochloride |
Dosage Form | Tablet |
Route | Oral |
Strength | 0.5mg; 1mg; 0.25mg; 0.75mg; 1.5mg; 0.125mg |
Market Status | Prescription |
Company | Boehringer Ingelheim |
2 of 4 | |
---|---|
Drug Name | Pramipexole dihydrochloride |
Drug Label | MIRAPEX 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 Ingredient | Pramipexole dihydrochloride |
Dosage Form | Tablet, extended release; Tablet |
Route | Oral |
Strength | 0.5mg; 1mg; 0.25mg; 0.75mg; 3.75mg; 1.5mg; 4.5mg; 2.25mg; 0.375mg; 3mg; 0.125mg |
Market Status | Prescription |
Company | Anchen 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 Name | Mirapex |
PubMed Health | Pramipexole (By mouth) |
Drug Classes | Antiparkinsonian |
Drug Label | MIRAPEX 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 Ingredient | Pramipexole dihydrochloride |
Dosage Form | Tablet |
Route | Oral |
Strength | 0.5mg; 1mg; 0.25mg; 0.75mg; 1.5mg; 0.125mg |
Market Status | Prescription |
Company | Boehringer Ingelheim |
4 of 4 | |
---|---|
Drug Name | Pramipexole dihydrochloride |
Drug Label | MIRAPEX 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 Ingredient | Pramipexole dihydrochloride |
Dosage Form | Tablet, extended release; Tablet |
Route | Oral |
Strength | 0.5mg; 1mg; 0.25mg; 0.75mg; 3.75mg; 1.5mg; 4.5mg; 2.25mg; 0.375mg; 3mg; 0.125mg |
Market Status | Prescription |
Company | Anchen 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 |
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
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.)
N04BC05
N04BC05
N04BC05
N04BC05
N04BC05
N04BC05
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Pramipexole dihydrochloride monohydrate
Brand Name : Pramipexol Zentiva
Dosage Form : Tabl
Dosage Strength : 0.25mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Pramipexole dihydrochloride monohydrate
Brand Name : Pramipexol Zentiva
Dosage Form : Tab
Dosage Strength : 0.25mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Pramipexole dihydrochloride monohydrate
Brand Name : Pramipexol Zentiva
Dosage Form : Tab
Dosage Strength : 0.5mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Pramipexole dihydrochloride monohydrate
Brand Name : Pramipexol Zentiva
Dosage Form : Tabl
Dosage Strength : 1mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Pramipexole dihydrochloride monohydrate
Brand Name : Pramipexole ER Zentiva
Dosage Form : Ret Tabl
Dosage Strength : 0.375mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Pramipexole dihydrochloride monohydrate
Brand Name : Pramipexole ER Zentiva
Dosage Form : Ret Tabl
Dosage Strength : 0.75mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Pramipexole dihydrochloride monohydrate
Brand Name : Pramipexole ER Zentiva
Dosage Form : Ret Tabl
Dosage Strength : 0.75mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Pramipexole dihydrochloride monohydrate
Brand Name : Pramipexole ER Zentiva
Dosage Form : Ret Tabl
Dosage Strength : 1.5mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Pramipexole dihydrochloride monohydrate
Brand Name : Pramipexole ER Zentiva
Dosage Form : Ret Tabl
Dosage Strength : 3mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Pramipexole dihydrochloride monohydrate
Brand Name : Pramipexole ER Zentiva
Dosage Form : Ret Tabl
Dosage Strength : 4.5mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
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ANALYTICAL
ABOUT THIS PAGE
A Pramipexole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pramipexole, including repackagers and relabelers. The FDA regulates Pramipexole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pramipexole 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 Pramipexole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pramipexole supplier is an individual or a company that provides Pramipexole active pharmaceutical ingredient (API) or Pramipexole finished formulations upon request. The Pramipexole suppliers may include Pramipexole API manufacturers, exporters, distributors and traders.
click here to find a list of Pramipexole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pramipexole DMF (Drug Master File) is a document detailing the whole manufacturing process of Pramipexole active pharmaceutical ingredient (API) in detail. Different forms of Pramipexole DMFs exist exist since differing nations have different regulations, such as Pramipexole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pramipexole DMF submitted to regulatory agencies in the US is known as a USDMF. Pramipexole USDMF includes data on Pramipexole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pramipexole USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pramipexole suppliers with USDMF on PharmaCompass.
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 Pramipexole Drug Master File in Japan (Pramipexole JDMF) empowers Pramipexole 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 Pramipexole JDMF during the approval evaluation for pharmaceutical products. At the time of Pramipexole 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 Pramipexole suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Pramipexole Drug Master File in Korea (Pramipexole KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Pramipexole. The MFDS reviews the Pramipexole KDMF as part of the drug registration process and uses the information provided in the Pramipexole KDMF to evaluate the safety and efficacy of the drug.
After submitting a Pramipexole 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 Pramipexole API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Pramipexole suppliers with KDMF on PharmaCompass.
A Pramipexole CEP of the European Pharmacopoeia monograph is often referred to as a Pramipexole Certificate of Suitability (COS). The purpose of a Pramipexole CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Pramipexole EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Pramipexole to their clients by showing that a Pramipexole CEP has been issued for it. The manufacturer submits a Pramipexole CEP (COS) as part of the market authorization procedure, and it takes on the role of a Pramipexole CEP holder for the record. Additionally, the data presented in the Pramipexole CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Pramipexole DMF.
A Pramipexole CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Pramipexole 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 Pramipexole suppliers with CEP (COS) on PharmaCompass.
A Pramipexole written confirmation (Pramipexole WC) is an official document issued by a regulatory agency to a Pramipexole manufacturer, verifying that the manufacturing facility of a Pramipexole active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Pramipexole APIs or Pramipexole finished pharmaceutical products to another nation, regulatory agencies frequently require a Pramipexole WC (written confirmation) as part of the regulatory process.
click here to find a list of Pramipexole suppliers with Written Confirmation (WC) on PharmaCompass.
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 Pramipexole as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Pramipexole API and other APIs are published in this directory by the FDA.
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 Pramipexole 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.
The NDC directory also contains data on finished compounded human drug products that contain Pramipexole and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pramipexole NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Pramipexole suppliers with NDC on PharmaCompass.
Pramipexole 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 Pramipexole 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 Pramipexole GMP manufacturer or Pramipexole GMP API supplier for your needs.
A Pramipexole CoA (Certificate of Analysis) is a formal document that attests to Pramipexole's compliance with Pramipexole specifications and serves as a tool for batch-level quality control.
Pramipexole CoA mostly includes findings from lab analyses of a specific batch. For each Pramipexole 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.
Pramipexole may be tested according to a variety of international standards, such as European Pharmacopoeia (Pramipexole EP), Pramipexole JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pramipexole USP).
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