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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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ACTIVE PHARMA INGREDIENTS

45 API Suppliers, 24 USDMF, 18 CEP/COS, 2 JDMF, 17 EU WC, 11 KDMF, 12 NDC API, 25 Listed Suppliers, $ API Reference Price

45 API Suppliers
24 USDMF
18 CEP/COS
2 JDMF
17 EU WC
11 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

780 FDF Dossiers, 181 FDA Orange Book, 398 Europe, 33 Canada, 70 Australia, 29 South Africa, 69 Listed Dossiers

780 FDF Dossiers
181 FDA Orange Book
398 Europe
33 Canada
70 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TABLET;ORAL - 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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TABLET;ORAL - 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**

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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 Rheology Modifiers, 4 Vegetarian Capsules, 4 Coloring Agents

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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

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10 APIs

PATENTS & EXCLUSIVITIES

14 US Patents, 17 Health Canada Patents

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14 US Patents
17 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM , 3 USP , 17 Others

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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

780

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

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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

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API Reference Price

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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 DIHCL MONOHYDRATE BP\/PH.EUR","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"CIPLA","supplierCountry":"INDIA","foreign_port":"ISTANBUL","customer":"TO THE ORDER OF...","customerCountry":"TURKEY","quantity":"5.90","actualQuantity":"5900","unit":"GMS","unitRateFc":"7","totalValueFC":"40819.8","currency":"USD","unitRateINR":580.32338983050852,"date":"31-Aug-2024","totalValueINR":"3423908","totalValueInUsd":"40819.8","indian_port":"Bombay Air","hs_no":"29342000","bill_no":"3642863","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"TURKEY","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"MUMBAI CENTRAL,, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727116200,"product":"PRAMIPEXOLE DIHCL MONOHYDRATE BP\/PH.EUR","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"CIPLA","supplierCountry":"INDIA","foreign_port":"MADRID","customer":"SUAN FARMA , S.A.U..","customerCountry":"SPAIN","quantity":"0.50","actualQuantity":"500","unit":"GMS","unitRateFc":"24","totalValueFC":"11789.4","currency":"USD","unitRateINR":1975.9259999999999,"date":"24-Sep-2024","totalValueINR":"987963","totalValueInUsd":"11789.4","indian_port":"Bombay Air","hs_no":"29342000","bill_no":"4285125","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"MUMBAI CENTRAL,, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727116200,"product":"PRAMIPEXOLE DIHCL MONOHYDRATE BP\/PH.EUR","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"CIPLA","supplierCountry":"INDIA","foreign_port":"MADRID","customer":"SUAN FARMA , S.A.U..","customerCountry":"SPAIN","quantity":"0.50","actualQuantity":"500","unit":"GMS","unitRateFc":"24","totalValueFC":"11789.4","currency":"USD","unitRateINR":1975.9259999999999,"date":"24-Sep-2024","totalValueINR":"987963","totalValueInUsd":"11789.4","indian_port":"Bombay Air","hs_no":"29342000","bill_no":"4292768","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"MUMBAI CENTRAL,, MUMBAI, MAHARASHTRA.","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. LTD.","supplierCountry":"INDIA","foreign_port":"BARCELONA","customer":"AIRPHARM","customerCountry":"SPAIN","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"9900","totalValueFC":"48917.3","currency":"USD","unitRateINR":819865.19999999995,"date":"26-Sep-2024","totalValueINR":"4099326","totalValueInUsd":"48917.3","indian_port":"Hyderabad Air","hs_no":"29252990","bill_no":"4368772","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","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":1727289000,"product":"ACTIVE PHARMACEUTICALS INGREDIENTS - (API)(PHARMACEUTICALS RAW MATERIAL)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":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"8500","totalValueFC":"41898.1","currency":"USD","unitRateINR":702221.85999999999,"date":"26-Sep-2024","totalValueINR":"3511109.3","totalValueInUsd":"41898.1","indian_port":"Ahmedabad Air","hs_no":"29349990","bill_no":"4360073","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":"Q4","strtotime":1729103400,"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":"35205.7","currency":"EUR","unitRateINR":1183285.8,"date":"17-Oct-2024","totalValueINR":"2958214.5","totalValueInUsd":"35205.7","indian_port":"Bombay Air","hs_no":"29342000","bill_no":"4897230","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":"Q4","strtotime":1730745000,"product":"PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"NEW YORK","customer":"SCIEGEN PHARMACEUTICAS INC","customerCountry":"UNITED STATES","quantity":"6.00","actualQuantity":"6","unit":"KGS","unitRateFc":"8500","totalValueFC":"50116.3","currency":"USD","unitRateINR":704870.16666666663,"date":"05-Nov-2024","totalValueINR":"4229221","totalValueInUsd":"50116.3","indian_port":"Hyderabad Air","hs_no":"29342000","bill_no":"5372338","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732905000,"product":"PRAMIPEXOLE DIHYDROCHLORIDE (EXPORT INVOICE NO:NL\/EXP24-25\/710 DT:30\/11\/2024)","address":"FLAT NO.404 TO 406,4TH FLOOR,VIJAY","city":"HYDERABAD.AP","supplier":"NOSCH LABS PVT. LTD.","supplierCountry":"INDIA","foreign_port":"BARCELONA","customer":"AIRPHARM","customerCountry":"SPAIN","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"9900","totalValueFC":"48987.4","currency":"USD","unitRateINR":826792,"date":"30-Nov-2024","totalValueINR":"4133960","totalValueInUsd":"48987.4","indian_port":"Hyderabad Air","hs_no":"29252990","bill_no":"6074141","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"FLAT NO.404 TO 406,4TH FLOOR,VIJAY, HYDERABAD.AP","customerAddress":""},{"dataSource":"API Import","activeIngredients":"PRAMIPEXOLE DIHYDROCHLORIDE","year":"2021","qtr":"Q1","strtotime":1609698600,"product":"PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE","address":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM","city":"","supplier":"WAVELENGTH PHARMACEUTICALS","supplierCountry":"ISRAEL","foreign_port":"TEL AVIV-YAFO","customer":"PAR PHARMACEUTICAL","customerCountry":"INDIA","quantity":"8.00","actualQuantity":"8","unit":"KGS","unitRateFc":"50000","totalValueFC":"407181.9","currency":"USD","unitRateINR":"3722500","date":"04-Jan-2021","totalValueINR":"29780000","totalValueInUsd":"407181.9","indian_port":"Indore-EPZ\/SEZ","hs_no":"29349990","bill_no":"1000032","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ISRAEL","selfForZScoreResived":"Pharma Grade","supplierPort":"TEL AVIV-YAFO","supplierAddress":"29 LEHI ST PO BOX 31 BNEI BRAK 51200 IL ISRAEL","customerAddress":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM"},{"dataSource":"API Import","activeIngredients":"PRAMIPEXOLE DIHYDROCHLORIDE","year":"2021","qtr":"Q1","strtotime":1615919400,"product":"PLACEBO FOR PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED RELEASE TABLETS (FOC) (FOR R&D PURPOSE ONLY)","address":"OLD NO.1\/63, NEW NO.1\/5B PUDUPAKKAMVILLAGE, VIA VANDALLUR","city":"KELAMBAKKAM ROAD, KELAMBAKKAM","supplier":"PAR PHARMACEUTICAL","supplierCountry":"UNITED STATES","foreign_port":"NEW YORK - JOHN F. K","customer":"PAR PHARMACEUTICAL","customerCountry":"INDIA","quantity":"0.07","actualQuantity":"70","unit":"GMS","unitRateFc":"50.8","totalValueFC":"4155.6","currency":"USD","unitRateINR":"4321.9","date":"17-Mar-2021","totalValueINR":"302532.56","totalValueInUsd":"4155.6","indian_port":"MADRAS AIR","hs_no":"29349990","bill_no":"3177268","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NEW YORK - JOHN F. K","supplierAddress":"","customerAddress":"OLD NO.1\/63, NEW NO.1\/5B PUDUPAKKAMVILLAGE, VIA VANDALLUR"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1634927400,"product":"PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE (QTY:1X200MG,VALUE:USD 252)(FOC)","address":"P.NO. 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":"2021","qtr":"Q4","strtotime":1634927400,"product":"PRAMIPEXOLE RELATED COMPOUND D (QTY:2X25MG,VALUE:USD 798\/EACH)(FOC)","address":"P.NO. 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":"0.00005","unit":"KGS","unitRateFc":"31920000","totalValueFC":"1646.8","currency":"USD","unitRateINR":"2467374400","date":"23-Oct-2021","totalValueINR":"123368.72","totalValueInUsd":"1646.8","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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Drugs in Development

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INTERMEDIATES SUPPLIERS

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FDF Dossiers

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FDA Orange Book

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Europe

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Canada

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Australia

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South Africa

01

Pharmacare Limited, Woodmead

South Africa

Biotech Showcase

Not Confirmed

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South Africa

Virtual Booth

Digital Content

Regulatory Info : Generic

Registration Country : South Africa

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

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

02

Pharmacare Limited, Woodmead

South Africa

Biotech Showcase

Not Confirmed

Contact Supplier

South Africa

Virtual Booth

Digital Content

Regulatory Info : Generic

Registration Country : South Africa

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

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

03

Pharmacare Limited, Woodmead

South Africa

Biotech Showcase

Not Confirmed

Contact Supplier

South Africa

Virtual Booth

Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Pramipexole

Brand Name : PEXASP 1mg

Dosage Form : TAB

Dosage Strength : 1mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

04

Ingelheim Pharmaceuticals (Pty) Ltd

Germany

Israel

Biotech Showcase

Not Confirmed

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Listed Dossiers

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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

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

Related Excipient Companies

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Excipients by Applications

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Fillers, Diluents & Binders

01

Rochem International Inc

U.S.A

Suppliers Night Expo

Attending

Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

Dosage Form : Tablet

Grade : Oral

Category : Fillers, Diluents & Binders, Taste Masking

Brand Name : Mannitol

Application : Fillers, Diluents & Binders, Taste Masking

Excipient Details : Mannitol is used as a filler, bulking agent and taste masking agent in ODT formulations such as tablets.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

02

SPI Pharma

U.S.A

Duphat

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Tablet

Grade : Oral

Category : Direct Compression, Fillers, Diluents & Binders, Taste Masking

Brand Name : Mannogem® XL Opal

Application : Direct Compression, Fillers, Diluents & Binders, Taste Masking

Excipient Details : Mannogem® XL Opal, directly compressible 160 µm spray-dried mannitol provides superior binding properties and tabletability.

Pharmacopoeia Ref : NA

Technical Specs : 160 µm Powder Mannitol

Ingredient(s) : Mannitol

03

SPI Pharma

U.S.A

Duphat

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

Category : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking

Brand Name : Pharmaburst 500

Application : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking

Excipient Details : Pharmaburst® 500 is a directly compressible pharmaceutical excipient used to create orally disintegrating tablets quickly and easily.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

04

DKSH

Switzerland

CPhI WW Frankfurt

Booth #8.0P66

DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

Dosage Form : Capsule, Granule / Pellet, Tablet

Grade : Oral

Category : Fillers, Diluents & Binders, Lubricants & Glidants

Brand Name : STEROTEX

Application : Fillers, Diluents & Binders, Lubricants & Glidants

Excipient Details : Sterotex is used as a lubricant in tablets, capsules, granules, and pellets and as a binder in controlled release matrix tablets.

Pharmacopoeia Ref : BP

Technical Specs : N/A

Ingredient(s) : Hydrogenated Cottonseed Oil Excipient

05

Faran Shimi Pharmaceutical

Iran

Duphat

Not Confirmed

Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

Dosage Form : Tablet

Grade : Oral

Category : Co-Processed Excipients

Brand Name : Mannitol

Application : Co-Processed Excipients

Excipient Details : Mannitol is a co-processed excipient with superior compactibility, lower disintegration time, and hygroscopicity.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

06

Faran Shimi Pharmaceutical

Iran

Duphat

Not Confirmed

Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

Dosage Form : Tablet

Grade : Oral

Category : Fillers, Diluents & Binders

Brand Name : Polyvinylpyrrolidone

Application : Fillers, Diluents & Binders

Excipient Details : Polyvinylpyrrolidone is used as a low viscosity wet binder in solid dosage forms such as tablets.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Polyvinylpyrrolidone

07

Boai NKY Pharmaceuticals Ltd

China

Duphat

Not Confirmed

Boai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.

Dosage Form : Capsule, Tablet

Grade : Oral (Pharma Grade)

Category : Fillers, Diluents & Binders

Brand Name : KoVidone® K25

Application : Fillers, Diluents & Binders

Excipient Details : KoVidone® K25 is used as a low viscosity wet binder in solid dosage forms such as capsules and tablets.

Pharmacopoeia Ref : USP/NF, EP, JP, KP, IP, BP

Technical Specs : NA

Ingredient(s) : Polyvinylpyrrolidone

08

Gangwal Healthcare

India

Duphat

Not Confirmed

Gangwal Healthcare is powered by innovation, driving health, wellness & healing.

Dosage Form : Capsule, Tablet

Grade : Oral

Category : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders

Brand Name : STARLOSE®

Application : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders

Excipient Details : STARLOSE is used as a diluent, binder, directly compressible (DC), and co-processed excipient in tablets and capsules.

Pharmacopoeia Ref : IP/EP/USP-NF/IH

Technical Specs : NA

Ingredient(s) : Lactose Monohydrate

09

Pfanstiehl

U.S.A

Duphat

Not Confirmed

Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

Dosage Form : Injectable / Parenteral, Tablet

Grade : Parenteral, Oral

Category : Fillers, Diluents & Binders, Parenteral, Thickeners and Stabilizers

Brand Name : D-Mannitol

Application : Fillers, Diluents & Binders, Parenteral, Thickeners and Stabilizers

Excipient Details : D-mannitol protects proteins from denaturation & degradation. It is also used as a stabilizer in liquid formulations & as a bulking agent in tablets.

Pharmacopoeia Ref : USP, NF, EP, JP, ChP

Technical Specs : N/A

Ingredient(s) : Mannitol

10

Faran Shimi Pharmaceutical

Iran

Duphat

Not Confirmed

Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

Dosage Form : Tablet

Grade : Oral

Category : Fillers, Diluents & Binders

Brand Name : Pregelatinized Corn Starch

Application : Fillers, Diluents & Binders

Excipient Details : Corn starch is used as a filler and binder in pharmaceutical oral solid dosage forms, including tablets.

Pharmacopoeia Ref : BP/USP

Technical Specs : NA

Ingredient(s) : Corn Starch, Pregelatinized

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Coating Systems & Additives

01

SPI Pharma

U.S.A

Duphat

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Tablet

Grade : Oral

Category : Coating Systems & Additives

Brand Name : ACTILLETS

Application : Coating Systems & Additives

Excipient Details : ACTILLETS™ are microcrystalline cellulose spheres used in advanced drug formulations as starter cores for drug layering and coating.

Pharmacopoeia Ref : NA

Technical Specs : Bulk density: 0.80

Ingredient(s) : Microcrystalline Cellulose

02

DKSH

Switzerland

CPhI WW Frankfurt

Booth #8.0P66

DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

Dosage Form : Capsule, Granule / Pellet, Tablet

Grade : Oral

Category : Coating Systems & Additives, Coloring Agents

Brand Name : Titanium dioxide PRETIOX AV01FG

Application : Coating Systems & Additives, Coloring Agents

Excipient Details : Titanium dioxide Pretiox AV01FG is used as a coloring and coating agent in oral solid dosage forms such as capsules, tablets, granules, and pellets.

Pharmacopoeia Ref : Fami-QS, Kosher, Halal, OHSAS ...

Technical Specs : Ti 59.95% and O 40.05%

Ingredient(s) : Titanium Dioxide

03

DKSH

Switzerland

CPhI WW Frankfurt

Booth #8.0P66

DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

Dosage Form : Capsule, Granule / Pellet, Tablet

Grade : Oral

Category : Coating Systems & Additives, Coloring Agents

Brand Name : Titanium dioxide PRETIOX AV01PhG

Application : Coating Systems & Additives, Coloring Agents

Excipient Details : Titanium dioxide Pretiox AV01PhG is used as a coating and coloring agent in oral solids such as tablets, capsules, granules, and pellets.

Pharmacopoeia Ref : N/A

Technical Specs : Ti 59.95% and O 40.05%

Ingredient(s) : Titanium Dioxide

Excipients Web Link

India

Duphat

Not Confirmed

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Thickeners and Stabilizers

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Finished Drug Prices

01

Brand Name : Pramipexol Zentiva

France

BIO Partnering at JPM

Not Confirmed

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

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France

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RX/OTC/DISCN : Class B

Helvepharm AG

Pramipexole Dihydrochloride

Dosage Form : Tabl

Dosage Strength : 0.25mg

Price Per Pack (Euro) : 11.99

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

Portfolio PDF

Product Web Link

02

Brand Name : Pramipexole Orion

Finland

BIO Partnering at JPM

Not Confirmed

Contact Supplier

Finland

Virtual Booth

Digital Content

RX/OTC/DISCN :

Orion Corporation Orion Pharma, Esp...

Pramipexole Dihydrochloride

Dosage Form : Antic-calc Tablet

Dosage Strength : 0,088 mg

Price Per Pack (Euro) : 9.581

Published in :

Country : Norway

RX/OTC/DISCN :

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Website

Corporate PDF

03

Brand Name : PRAMIPEXOLE THINKS

Japan

BIO Partnering at JPM

Not Confirmed

Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.

Contact Supplier

Japan

Virtual Booth

Digital Content

RX/OTC/DISCN :

TOWA PHARMACEUTICAL SPA

Pramipexole Dihydrochloride

Dosage Form : Extended Release Tablets

Dosage Strength : 0.26 mg

Price Per Pack (Euro) : 2.38

Published in :

Country : Italy

RX/OTC/DISCN :

Portfolio PDF

Product Web Link

04

Brand Name : Pramipexole ER Zentiva

France

BIO Partnering at JPM

Not Confirmed

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France

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RX/OTC/DISCN : Class B

Helvepharm AG

Pramipexole Dihydrochloride

Dosage Form : Ret Tabl

Dosage Strength : 0.375mg

Price Per Pack (Euro) : 5.27

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

Portfolio PDF

Product Web Link

05

Brand Name : Pramipexole ER Zentiva

France

BIO Partnering at JPM

Not Confirmed

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

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France

Virtual Booth

Digital Content

RX/OTC/DISCN : Class B

Helvepharm AG

Pramipexole Dihydrochloride

Dosage Form : Ret Tabl

Dosage Strength : 0.75mg

Price Per Pack (Euro) : 9.74

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

Portfolio PDF

Product Web Link

06

Brand Name : Pramipexole ER Zentiva

France

BIO Partnering at JPM

Not Confirmed

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

Contact Supplier

France

Virtual Booth

Digital Content

RX/OTC/DISCN : Class B

Helvepharm AG

Pramipexole Dihydrochloride

Dosage Form : Ret Tabl

Dosage Strength : 0.75mg

Price Per Pack (Euro) : 27.2

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

Portfolio PDF

Product Web Link

07

Brand Name : Pramipexole ER Zentiva

France

BIO Partnering at JPM

Not Confirmed

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

Contact Supplier

France

Virtual Booth

Digital Content

RX/OTC/DISCN : Class B

Helvepharm AG

Pramipexole Dihydrochloride

Dosage Form : Ret Tabl

Dosage Strength : 1.5mg

Price Per Pack (Euro) : 54.4

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

Portfolio PDF

Product Web Link

08

Brand Name : Pramipexole ER Zentiva

France

BIO Partnering at JPM

Not Confirmed

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

Contact Supplier

France

Virtual Booth

Digital Content

RX/OTC/DISCN : Class B

Helvepharm AG

Pramipexole Dihydrochloride

Dosage Form : Ret Tabl

Dosage Strength : 3mg

Price Per Pack (Euro) : 108.8

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

Portfolio PDF

Product Web Link

09

Brand Name : Pramipexole ER Zentiva

France

BIO Partnering at JPM

Not Confirmed

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

Contact Supplier

France

Virtual Booth

Digital Content

RX/OTC/DISCN : Class B

Helvepharm AG

Pramipexole Dihydrochloride

Dosage Form : Ret Tabl

Dosage Strength : 4.5mg

Price Per Pack (Euro) : 163.2

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

Portfolio PDF

Product Web Link

10

Brand Name : Pramipexol Zentiva

France

BIO Partnering at JPM

Not Confirmed

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

Contact Supplier

France

Virtual Booth

Digital Content

RX/OTC/DISCN : Class B

Helvepharm AG

Pramipexole Dihydrochloride

Dosage Form : Tab

Dosage Strength : 0.25mg

Price Per Pack (Euro) : 33.34

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

Portfolio PDF

Product Web Link

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ABOUT THIS PAGE

Pramipexole Dihydrochloride Manufacturers

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

Pramipexole Dihydrochloride Suppliers

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

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

Pramipexole Dihydrochloride USDMF

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

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

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

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

Pramipexole Dihydrochloride KDMF

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

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

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

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

Pramipexole Dihydrochloride CEP

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

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

Pramipexole Dihydrochloride WC

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

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

Pramipexole Dihydrochloride 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 Pramipexole Dihydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Pramipexole Dihydrochloride GMP

Pramipexole Dihydrochloride 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 Dihydrochloride 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 Dihydrochloride GMP manufacturer or Pramipexole Dihydrochloride GMP API supplier for your needs.

Pramipexole Dihydrochloride CoA

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

Pramipexole Dihydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Pramipexole Dihydrochloride 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 Dihydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Pramipexole Dihydrochloride EP), Pramipexole Dihydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pramipexole Dihydrochloride 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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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

45 API Suppliers

24 USDMF

18 CEP/COS

2 JDMF

17 EU WC

11 KDMF

12 NDC API

25 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

6 Drugs in Development

INTERMEDIATES

9 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

780 FDF Dossiers

181 FDA Orange Book

398 Europe

33 Canada

70 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**

RELATED EXCIPIENT COMPANIES

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

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9 Sigachi Industries

2 The Dow Chemical Company

2 Ulanqab Kema New Material

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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

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