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ACTIVE PHARMA INGREDIENTS

45 API Suppliers, 24 USDMF, 18 CEP/COS, 2 JDMF, 17 EU WC, 10 KDMF, 12 NDC API, 25 Listed Suppliers, $ API Reference Price

45 API Suppliers
24 USDMF
18 CEP/COS
2 JDMF
17 EU WC
10 KDMF
12 NDC API
25 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

6 Drugs in Development

6 Drugs in Development

INTERMEDIATES

9 Intermediates Suppliers

9 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

751 FDF Dossiers, 181 FDA Orange Book, 398 Europe, 33 Canada, 41 Australia, 29 South Africa, 69 Listed Dossiers

751 FDF Dossiers
181 FDA Orange Book
398 Europe
33 Canada
41 Australia
29 South Africa
69 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

drugProductComposition
TABLET;ORAL - 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

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relatedExcipients
2 Rochem International Inc
16 SPI Pharma
7 DKSH
1 Pharm-RX Chemical
4 Faran Shimi Pharmaceutical
6 Boai NKY Pharmaceuticals Ltd
11 Gangwal Healthcare
1 Nanjing Well Pharmaceutical
1 Pfanstiehl
1 ACG Worldwide
1 Aeon Procare
6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
10 BASF
16 Corel Pharma Chem
2 DFE Pharma
7 Gangwal Chemicals
5 Ideal Cures Pvt Ltd
3 Ingredion Pharma Solutions
18 Kerry
3 Kima Chemical
6 Lonza Capsugel
5 Lubrizol Life Science Health
11 Microlex e.U
2 Novo Excipients
2 Pharmatrans-Sanaq
4 Pluviaendo
2 Prachin Chemical
1 Qianhao Chemical (Hebei) Co., Ltd
1 Qualicaps
23 Roquette
7 Seppic
6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shanghai Welltone Material Technology Co., Ltd
1 Shijiazhuang Huaxu Pharmaceutical
9 Sigachi Industries
2 The Dow Chemical Company
2 Ulanqab Kema New Material
2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

64 Fillers, Diluents & Binders, 45 Coating Systems & Additives, 35 Thickeners and Stabilizers, 33 Direct Compression, 30 Controlled & Modified Release, 22 Taste Masking, 21 Solubilizers, 19 Co-Processed Excipients, 18 Granulation, 15 Chewable & Orodispersible Aids, 15 Lubricants & Glidants, 11 Disintegrants & Superdisintegrants, 9 Topical, 9 Film Formers & Plasticizers, 7 Parenteral, 7 API Stability Enhancers, 5 Emulsifying Agents, 5 Empty Capsules, 4 Coloring Agents, 4 Rheology Modifiers, 4 Vegetarian Capsules

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19 NEWS #PharmaBuzz

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19 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 290 Finished Drug Prices

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2 US Medicaid Prescriptions
290 Finished Drug Prices

MARKET PLACE

10 APIs

marketPlace
10 APIs

PATENTS & EXCLUSIVITIES

14 US Patents, 17 Health Canada Patents

patents
14 US Patents
17 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM , 3 USP , 17 Others

otherSolutions
3 EDQM
3 USP
17 Others

ANALYTICAL

3 BioAnalytical Methods

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3 BioAnalytical Methods

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 11,303

MARKET PLACE

API

FDF

9INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

751

FDF Dossiers

181

FDA Orange Book

398

Europe

Canada

Australia

South Africa

Listed Dossiers

6DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

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News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

35,556,781

Annual Reports (USD Million)

Finished Drug Prices

208 RELATED EXCIPIENT COMPANIES

382EXCIPIENTS BY APPLICATIONS

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

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 Formula	C₁₀H₂₁Cl₂N₃OS
Molecular Weight	302.3 g/mol
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 Å²
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

4 Drug and Medication Information

4.1 Drug Information

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

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

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

API SUPPLIERS

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Deccan Nutraceuticals Pvt. Ltd

India

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HRV Global Life Sciences

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Torrent Pharmaceuticals Limited

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Chr. Olesen Synthesis A.S

Denmark

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Wockhardt

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API Reference Price

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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,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1698345000,"product":"PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE (SAMPLE FOR TESTINGPURPOSE)","address":"B-4, FLAT.N0.103, APOORVA RESIDENCY","city":"HYDERABAD","supplier":"NOVAST LABORATORIES","supplierCountry":"CHINA","foreign_port":"NANTONG","customer":"LUCID LABORATORIES PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"10","unit":"GMS","unitRateFc":"10","totalValueFC":"122.5","currency":"USD","unitRateINR":"1019.9","date":"27-Oct-2023","totalValueINR":"10198.72","totalValueInUsd":"122.5","indian_port":"Hyderabad Air","hs_no":"29182990","bill_no":"8488695","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NANTONG","supplierAddress":"1 GUANGONG ROAD NANTONG FREE TRADEZONE NETDA NANTONG 226009 CHINASDNF CN","customerAddress":"B-4, FLAT.N0.103, APOORVA RESIDENCY"}]

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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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

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

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

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

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

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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ACTIVE PHARMA INGREDIENTS

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10 KDMF

12 NDC API

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$ API Reference Price

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41 Australia

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

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

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

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

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

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

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33 Direct Compression

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

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

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

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

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

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