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Chemistry

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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


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","customerCountry":"MEXICO","quantity":"2.50","actualQuantity":"2.5","unit":"KGS","unitRateFc":"7920","totalValueFC":"19383.4","currency":"USD","unitRateINR":650341.59999999998,"date":"09-Aug-2024","totalValueINR":"1625854","totalValueInUsd":"19383.4","indian_port":"Hyderabad Air","hs_no":"29252990","bill_no":"3091347","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MEXICO","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"FLAT NO.404 TO 406,4TH FLOOR,VIJAY, HYDERABAD.AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723401000,"product":"DRUGS AND PHARMACEUTICALS HARMLESSMEDICINES PRAMIPEXOLE DIHYDROCHLORIDE USP + IN-HOUSE)CAS NO 191217-81-9","address":"304,ATLANTA ARCADE,","city":"MUMBAI MAHARASHTRA","supplier":"MACLEODS PHARMACEUTICALS LTD","supplierCountry":"INDIA","foreign_port":"ALGIERS","customer":"SPA EL KENDI INDUSTRIE DU MEDICAME","customerCountry":"ALGERIA","quantity":"2.50","actualQuantity":"2.5","unit":"KGS","unitRateFc":"13000","totalValueFC":"34454.9","currency":"EUR","unitRateINR":1156010,"date":"12-Aug-2024","totalValueINR":"2890025","totalValueInUsd":"34454.9","indian_port":"Bombay Air","hs_no":"29342000","bill_no":"3154667","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ALGERIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"304,ATLANTA ARCADE,, MUMBAI MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723573800,"product":"ACTIVE PHARMACEUTICALS INGREDIENT- (PHARMACEUTICALS RAW MATERIAL) PRODUCT PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE PH.EUR","address":"ALEMBIC ROAD","city":"GUJARAT","supplier":"ALEMBIC PHARMACEUTICALS LIMITED","supplierCountry":"INDIA","foreign_port":"BOGOT","customer":"TO","customerCountry":"COLOMBIA","quantity":"0.10","actualQuantity":"0.1","unit":"KGS","unitRateFc":"14991","totalValueFC":"1481.6","currency":"USD","unitRateINR":1242750,"date":"14-Aug-2024","totalValueINR":"124275","totalValueInUsd":"1481.6","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"3213761","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"COLOMBIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"ALEMBIC ROAD, GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725042600,"product":"PRAMIPEXOLE DIHYDROCHLORIDE (TAX INVOICENO:NL\/EXP24-25\/431 DT:28.08.2024)","address":"FLAT NO.404 TO 406,4TH FLOOR,VIJAY","city":"HYDERABAD.AP","supplier":"NOSCH LABS PVT. LTD.","supplierCountry":"INDIA","foreign_port":"BASLE","customer":"AIRPHARM PRATTELN - (BONDED WAREHOU","customerCountry":"SWITZERLAND","quantity":"4.00","actualQuantity":"4","unit":"KGS","unitRateFc":"7722","totalValueFC":"30567.5","currency":"USD","unitRateINR":640990.19999999995,"date":"31-Aug-2024","totalValueINR":"2563960.8","totalValueInUsd":"30567.5","indian_port":"Hyderabad Air","hs_no":"29252990","bill_no":"3628877","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"FLAT NO.404 TO 406,4TH FLOOR,VIJAY, HYDERABAD.AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725301800,"product":"ACTIVE PHARMACEUTICALS INGREDIENTS(PHARMACEUTICALS RAW MATERIAL) PRODUCT PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE-PH.EUR","address":"ALEMBIC ROAD","city":"GUJARAT","supplier":"ALEMBIC PHARMACEUTICALS LIMITED","supplierCountry":"INDIA","foreign_port":"ISTANBUL","customer":"TO THE ORDER OF","customerCountry":"TURKEY","quantity":"4.00","actualQuantity":"4","unit":"KGS","unitRateFc":"8500","totalValueFC":"33495.7","currency":"USD","unitRateINR":701745.22250000003,"date":"03-Sep-2024","totalValueINR":"2806980.89","totalValueInUsd":"33495.7","indian_port":"Ahmedabad Air","hs_no":"29349990","bill_no":"3724569","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":"Q3","strtotime":1725561000,"product":"PRAMIPEXOLE DIHYDROCHLORIDE USP","address":"7-2-A2, HETERO CORPORATE,","city":"HYDERABAD, TELANGANA","supplier":"HETERO DRUGS","supplierCountry":"INDIA","foreign_port":"CAIRO","customer":"EVA PHARMA","customerCountry":"EGYPT","quantity":"3.00","actualQuantity":"3","unit":"KGS","unitRateFc":"7000","totalValueFC":"20769.1","currency":"USD","unitRateINR":580159.33333333337,"date":"06-Sep-2024","totalValueINR":"1740478","totalValueInUsd":"20769.1","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"3810461","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"EGYPT","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"7-2-A2, HETERO CORPORATE,, HYDERABAD, TELANGANA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1726684200,"product":"PRAMIPEXOLE DIHYDROCHLORIDE (TAX INVOICENO:NL\/EXP24-25\/493 DT:18.09.2024)","address":"FLAT NO.404 TO 406,4TH FLOOR,VIJAY","city":"HYDERABAD.AP","supplier":"NOSCH LABS PVT. 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LTD.","supplierCountry":"INDIA","foreign_port":"HAMBURG - FUHLSBUETT","customer":"I CARGO INTERNATIONALE ","customerCountry":"GERMANY","quantity":"0.30","actualQuantity":"0.3","unit":"KGS","unitRateFc":"15840","totalValueFC":"4581","currency":"USD","unitRateINR":1279642.6666666667,"date":"25-Sep-2024","totalValueINR":"383892.8","totalValueInUsd":"4581","indian_port":"Hyderabad Air","hs_no":"29252990","bill_no":"4340003","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"FLAT NO.404 TO 406,4TH FLOOR,VIJAY, HYDERABAD.AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727202600,"product":"PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"BASLE","customer":"AIRPHARM","customerCountry":"SWITZERLAND","quantity":"1.50","actualQuantity":"1.5","unit":"KGS","unitRateFc":"7375.5","totalValueFC":"10833.9","currency":"USD","unitRateINR":605264.28666666674,"date":"25-Sep-2024","totalValueINR":"907896.43","totalValueInUsd":"10833.9","indian_port":"Hyderabad Air","hs_no":"29342000","bill_no":"4335161","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727289000,"product":"PRAMIPEXOLE DIHYDROCHLORIDE (EXPORT INVOICE NO:NL\/EXP24-25\/507 DT:21\/09\/2024)","address":"FLAT NO.404 TO 406,4TH FLOOR,VIJAY","city":"HYDERABAD.AP","supplier":"NOSCH LABS PVT. 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D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,","city":"TURKAPALLY-V SHAMIRPET HYDERABAD,TE","supplier":"USP","supplierCountry":"INDIA","foreign_port":"NA","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.0002","unit":"KGS","unitRateFc":"1260000","totalValueFC":"260","currency":"USD","unitRateINR":"97396350","date":"23-Oct-2021","totalValueINR":"19479.27","totalValueInUsd":"260","indian_port":"HYDERABAD AIR","hs_no":"29342000","bill_no":"5970296","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"P.NO. D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,"}]
04-Jan-2021
25-Oct-2024
KGS
overview
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country Total Quantity
(KGS)
Average Price
(USD/KGS)
Number of Transactions

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FDA Orange Book

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01

DR REDDYS

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Flag India
Digital Content Digital Content

RLD : No

TE Code : AB

PRAMIPEXOLE DIHYDROCHLORIDE

Brand Name : PRAMIPEXOLE DIHYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 0.375MG

Approval Date : 2015-08-07

Application Number : 203354

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Dr Reddy Company Banner

02

DR REDDYS

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Flag India
Digital Content Digital Content

RLD : No

TE Code : AB

PRAMIPEXOLE DIHYDROCHLORIDE

Brand Name : PRAMIPEXOLE DIHYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 0.75MG

Approval Date : 2015-08-07

Application Number : 203354

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Dr Reddy Company Banner

03

DR REDDYS

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Flag India
Digital Content Digital Content

RLD : No

TE Code : AB

PRAMIPEXOLE DIHYDROCHLORIDE

Brand Name : PRAMIPEXOLE DIHYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 1.5MG

Approval Date : 2015-08-07

Application Number : 203354

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Dr Reddy Company Banner

04

DR REDDYS

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Flag India
Digital Content Digital Content

RLD : No

TE Code : AB

PRAMIPEXOLE DIHYDROCHLORIDE

Brand Name : PRAMIPEXOLE DIHYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 3MG

Approval Date : 2015-08-07

Application Number : 203354

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Dr Reddy Company Banner

05

DR REDDYS

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Flag India
Digital Content Digital Content

RLD : No

TE Code : AB

PRAMIPEXOLE DIHYDROCHLORIDE

Brand Name : PRAMIPEXOLE DIHYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 4.5MG

Approval Date : 2015-08-07

Application Number : 203354

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Dr Reddy Company Banner

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Flag India
Digital Content Digital Content

RLD : No

TE Code : AB

PRAMIPEXOLE DIHYDROCHLORIDE

Brand Name : PRAMIPEXOLE DIHYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 0.125MG

Approval Date : 2014-06-03

Application Number : 202702

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Flag India
Digital Content Digital Content

RLD : No

TE Code : AB

PRAMIPEXOLE DIHYDROCHLORIDE

Brand Name : PRAMIPEXOLE DIHYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 0.25MG

Approval Date : 2014-06-03

Application Number : 202702

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

08

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Flag India
Digital Content Digital Content

RLD : No

TE Code : AB

PRAMIPEXOLE DIHYDROCHLORIDE

Brand Name : PRAMIPEXOLE DIHYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 0.5MG

Approval Date : 2014-06-03

Application Number : 202702

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

09

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Flag India
Digital Content Digital Content

RLD : No

TE Code : AB

PRAMIPEXOLE DIHYDROCHLORIDE

Brand Name : PRAMIPEXOLE DIHYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 0.75MG

Approval Date : 2014-06-03

Application Number : 202702

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

10

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Flag India
Digital Content Digital Content

RLD : No

TE Code : AB

PRAMIPEXOLE DIHYDROCHLORIDE

Brand Name : PRAMIPEXOLE DIHYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 1MG

Approval Date : 2014-06-03

Application Number : 202702

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science
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Europe

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01

Helvepharm AG

France
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Medlab Asia & Asia Health
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Pramipexole dihydrochloride monohydrate

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Helvepharm AG

France
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Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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Pramipexole dihydrochloride monohydrate

Brand Name : Pramipexol Zentiva

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Helvepharm AG

France
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Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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Pramipexole dihydrochloride monohydrate

Brand Name : Pramipexol Zentiva

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Helvepharm AG

France
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Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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Regulatory Info :

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Pramipexole dihydrochloride monohydrate

Brand Name : Pramipexol Zentiva

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Helvepharm AG

France
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Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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Pramipexole dihydrochloride monohydrate

Brand Name : Pramipexole ER Zentiva

Dosage Form : Ret Tabl

Dosage Strength : 0.375mg

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Helvepharm AG

France
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Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

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Pramipexole dihydrochloride monohydrate

Brand Name : Pramipexole ER Zentiva

Dosage Form : Ret Tabl

Dosage Strength : 0.75mg

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Helvepharm AG

France
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Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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Regulatory Info :

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Pramipexole dihydrochloride monohydrate

Brand Name : Pramipexole ER Zentiva

Dosage Form : Ret Tabl

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Regulatory Info :

Registration Country : Switzerland

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Helvepharm AG

France
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Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
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Regulatory Info :

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Pramipexole dihydrochloride monohydrate

Brand Name : Pramipexole ER Zentiva

Dosage Form : Ret Tabl

Dosage Strength : 1.5mg

Packaging :

Approval Date :

Application Number :

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Helvepharm AG

France
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Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
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Regulatory Info :

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Pramipexole dihydrochloride monohydrate

Brand Name : Pramipexole ER Zentiva

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Dosage Strength : 3mg

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Helvepharm AG

France
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Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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Pramipexole dihydrochloride monohydrate

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Dosage Strength : 4.5mg

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South Africa

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Pramipexole

Brand Name : PEXASP 0.25mg

Dosage Form : TAB

Dosage Strength : 0.25mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

02

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Medlab Asia & Asia Health
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Pramipexole

Brand Name : PEXASP 0.125mg

Dosage Form : TAB

Dosage Strength : 0.125mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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03

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Medlab Asia & Asia Health
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Pramipexole

Brand Name : PEXASP 1mg

Dosage Form : TAB

Dosage Strength : 1mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

04

Medlab Asia & Asia Health
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Medlab Asia & Asia Health
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Pramipexole

Brand Name : Pexola 0.25 mg

Dosage Form : TAB

Dosage Strength : 0.25mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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05

Medlab Asia & Asia Health
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Medlab Asia & Asia Health
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Pramipexole Dihydrochloride Monohydrate

Brand Name : Pexola ER 1,5 mg

Dosage Form : TAB

Dosage Strength : 1.5mg

Packaging : 30X1mg

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Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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06

Medlab Asia & Asia Health
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Pramipexole Dihydrochloride Monohydrate

Brand Name : Oxpola 1,0 mg

Dosage Form : TAB

Dosage Strength : 1mg

Packaging : 100X1mg

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Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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07

Medlab Asia & Asia Health
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Medlab Asia & Asia Health
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Pramipexole Dihydrochloride Monohydrate

Brand Name : Pazoram 0,125

Dosage Form : TAB

Dosage Strength : 0.125mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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08

Sandoz SA (Pty) Ltd

Switzerland
Medlab Asia & Asia Health
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Sandoz SA (Pty) Ltd

Switzerland
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Medlab Asia & Asia Health
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Pramipexole Dihydrochloride Monohydrate

Brand Name : Pramiola 0,125

Dosage Form : TAB

Dosage Strength : 500mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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09

Medlab Asia & Asia Health
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Medlab Asia & Asia Health
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PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

Brand Name : PRAMIPEXOLE ER 3 TEVA

Dosage Form : TAB

Dosage Strength : 3MG

Packaging : 30X1MG

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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10

Medlab Asia & Asia Health
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Pramipexole dihydrochloride monohydrate

Brand Name : Mylan Pramipexole 0.125 mg

Dosage Form : TAB

Dosage Strength : 0.125mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Pharmathen SA

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Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

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Regulatory Info : EU Approved

Registration Country : Greece

Pramipexole

Brand Name :

Dosage Form : Tablet

Dosage Strength : 0.088MG

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Application Number :

Regulatory Info : EU Approved

Registration Country : Greece

Pharmathen

01

Pharmathen SA

Greece
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Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

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Pramipexole

Dosage : Tablet

Dosage Strength : 0.088MG

Brand Name :

Approval Date :

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Registration Country : Greece

Pharmathen

02

Pharmathen SA

Greece
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Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

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Regulatory Info : EU Approved

Registration Country : Greece

Pramipexole

Brand Name :

Dosage Form : Tablet

Dosage Strength : 0.18MG

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Application Number :

Regulatory Info : EU Approved

Registration Country : Greece

Pharmathen

02

Pharmathen SA

Greece
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Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Flag Greece
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Packaging :

Regulatory Info : EU Approved

Pramipexole

Dosage : Tablet

Dosage Strength : 0.18MG

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Registration Country : Greece

Pharmathen

03

Pharmathen SA

Greece
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Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

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Regulatory Info : EU Approved

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Pramipexole

Brand Name :

Dosage Form : Tablet

Dosage Strength : 0.35MG

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Application Number :

Regulatory Info : EU Approved

Registration Country : Greece

Pharmathen

03

Pharmathen SA

Greece
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Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

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Packaging :

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Pramipexole

Dosage : Tablet

Dosage Strength : 0.35MG

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Approval Date :

Application Number :

Registration Country : Greece

Pharmathen

04

Pharmathen SA

Greece
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Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

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Regulatory Info : EU Approved

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Pramipexole

Brand Name :

Dosage Form : Tablet

Dosage Strength : 0.7MG

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Regulatory Info : EU Approved

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Pharmathen

04

Pharmathen SA

Greece
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Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

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Pramipexole

Dosage : Tablet

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Pharmathen SA

Greece
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Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

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Pramipexole

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Dosage Form : Tablet

Dosage Strength : 1.1MG

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Regulatory Info : EU Approved

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Pharmathen

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Pharmathen SA

Greece
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Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

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Pramipexole

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Pramipexole Dihydrochloride

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Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

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Dosage Strength : 0.5MG

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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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