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Chemistry

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Also known as: 70359-46-5, Alphagan, Brimonidine tartarate, Brimonidine l-tartrate, Lumify, Brimonidinne tartrate
Molecular Formula
C15H16BrN5O6
Molecular Weight
442.22  g/mol
InChI Key
QZHBYNSSDLTCRG-LREBCSMRSA-N
FDA UNII
4S9CL2DY2H

Brimonidine Tartrate
A quinoxaline derivative and ADRENERGIC ALHPA-2 RECEPTOR AGONIST that is used to manage INTRAOCULAR PRESSURE associated with OPEN-ANGLE GLAUCOMA and OCULAR HYPERTENSION.
1 2D Structure

Brimonidine Tartrate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
5-bromo-N-(4,5-dihydro-1H-imidazol-2-yl)quinoxalin-6-amine;(2R,3R)-2,3-dihydroxybutanedioic acid
2.1.2 InChI
InChI=1S/C11H10BrN5.C4H6O6/c12-9-7(17-11-15-5-6-16-11)1-2-8-10(9)14-4-3-13-8;5-1(3(7)8)2(6)4(9)10/h1-4H,5-6H2,(H2,15,16,17);1-2,5-6H,(H,7,8)(H,9,10)/t;1-,2-/m.1/s1
2.1.3 InChI Key
QZHBYNSSDLTCRG-LREBCSMRSA-N
2.1.4 Canonical SMILES
C1CN=C(N1)NC2=C(C3=NC=CN=C3C=C2)Br.C(C(C(=O)O)O)(C(=O)O)O
2.1.5 Isomeric SMILES
C1CN=C(N1)NC2=C(C3=NC=CN=C3C=C2)Br.[C@@H]([C@H](C(=O)O)O)(C(=O)O)O
2.2 Other Identifiers
2.2.1 UNII
4S9CL2DY2H
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 5-bromo-6-(2-imidazolin-2-ylamino)quinoxaline D-tartrate

2. 5-bromo-6-(imidazolidinylideneamino)quinoxaline

3. 5-bromo-6-(imidazolin-2-ylamino)quinoxaline

4. Agn 190342

5. Agn-190342

6. Agn190342

7. Alphagan

8. Alphagan P

9. Brimonidine

10. Brimonidine Purite

11. Brimonidine Tartrate (1:1)

12. Brimonidine Tartrate (1:1), (s-(r*,r*))-isomer

13. Brimonidine Tartrate, (r-(r*,r*))-isomer

14. Bromoxidine

15. Mirvaso

16. Ratio Brimonidine

17. Ratio-brimonidine

18. Sanrosa

19. Uk 14,304

20. Uk 14,304 18

21. Uk 14,304-18

22. Uk 14,30418

23. Uk 14,308

24. Uk 14304

25. Uk 14308

26. Uk-14,304-18

27. Uk-14,308

28. Uk-14304

29. Uk14,30418

30. Uk14,308

31. Uk14304

2.3.2 Depositor-Supplied Synonyms

1. 70359-46-5

2. Alphagan

3. Brimonidine Tartarate

4. Brimonidine L-tartrate

5. Lumify

6. Brimonidinne Tartrate

7. 5-bromo-n-(4,5-dihydro-1h-imidazol-2-yl)quinoxalin-6-amine (2r,3r)-2,3-dihydroxysuccinate

8. Mirvaso

9. 4s9cl2dy2h

10. Agn 190342-lf

11. Brimonidine D-tartarate

12. 5-bromo-n-(4,5-dihydro-1h-imidazol-2-yl)quinoxalin-6-amine;(2r,3r)-2,3-dihydroxybutanedioic Acid

13. Uk-14304-18

14. Qoliana

15. Agn-190342-lf

16. Bromoxidine Tartrate

17. (5-bromo-quinoxalin-6-yl)-(4,5-dihydro-1h-imidazol-2-yl)-amine L-tartrate

18. Brimonidine Purite

19. Brimonidine Tartrate [usan]

20. (2r,3r)-2,3-dihydroxybutanedioic Acid; 5-bromo-n-(4,5-dihydro-1h-imidazol-2-yl)quinoxalin-6-amine

21. 6-quinoxalinamine, 5-bromo-n-(4,5-dihydro-1h-imidazol-2-yl)-, (2r,3r)-2,3-dihydroxybutanedioate (1:1)

22. 6-quinoxalinamine, 5-bromo-n-(4,5-dihydro-1h-imidazol-2-yl)-, (r-(r*,r*))-2,3-dihydroxybutanedioate (1:1)

23. 59803-99-5

24. Ocu300

25. Unii-4s9cl2dy2h

26. Ocu-300

27. Agn-190342lf

28. Alphagan-p

29. Cd-07805

30. Agn 190342lf

31. Brimonidine Tartrate [usan:jan]

32. N-(5-bromoquinoxalin-6-yl)imidazolidin-2-imine;(2r,3r)-2,3-dihydroxybutanedioic Acid

33. Alphagan (tn)

34. 304 Tartrate

35. Uk-1430418

36. 5-bromo-n-

37. Uk14304 Tartrate

38. Agn190342 Tartrate

39. Uk 14304 (tartrate)

40. Agn190342 (tartrate)

41. Uk 14,304 (tartrate)

42. Schembl265607

43. Chembl1200389

44. Ex-a5415a

45. Hy-b0659a

46. Dtxsid70911371

47. Brimonidine Tartrate (jan/usan)

48. Brimonidine Tartrate [jan]

49. Hms3715p18

50. Act08633

51. Brimonidine D-tartrate [mi]

52. Brimonidine Tartrate [vandf]

53. Brimonidine Tartrate [mart.]

54. Mfcd07773072

55. Brimonidine Tartrate [usp-rs]

56. Brimonidine Tartrate [who-dd]

57. Akos016845265

58. Ccg-221278

59. Cs-4496

60. 5-bromo-n-(4,5-dihydro-1h-imidazol-2-yl)quinoxalin-6-amine(2r,3r)-2,3-dihydroxysuccinate

61. As-18083

62. Brimonidine Tartrate [orange Book]

63. Brimonidine Tartrate [ep Monograph]

64. Brimonidine Tartrate [usp Monograph]

65. Cd07805/47

66. Cd-07805/47

67. Combigan Component Brimonidine Tartrate

68. A19740

69. D02076

70. Simbrinza Component Brimonidine Tartrate

71. Brimonidine Tartrate Component Of Combigan

72. 359b465

73. Brimonidine Tartrate Component Of Simbrinza

74. (4,5-bihydro-1h-imidazol-2-yl)quinoxalin-6-amine L-tartrate

75. 5-bromo-n-(4,5-dihydro-1h-imidazol-2-yl) Quinoxalin-6-amine Tartrate

76. 109826-56-4

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 442.22 g/mol
Molecular Formula C15H16BrN5O6
Hydrogen Bond Donor Count6
Hydrogen Bond Acceptor Count9
Rotatable Bond Count5
Exact Mass441.02840 g/mol
Monoisotopic Mass441.02840 g/mol
Topological Polar Surface Area177 Ų
Heavy Atom Count27
Formal Charge0
Complexity442
Isotope Atom Count0
Defined Atom Stereocenter Count2
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameBrimonidine tartrate
Drug LabelBrimonidine Tartrate Ophthalmic Solution, 0.2% is a relatively selective alpha-2 adrenergic agonist for ophthalmic use. The chemical name of brimonidine tartrate is 5-bromo-6 (2-imidazolidinylideneamino) quinoxaline L-tartrate. It is a white to sligh...
Active IngredientBrimonidine tartrate
Dosage FormSolution/drops; Solution
Routeophthalmic; Ophthalmic
Strength0.2%; 0.1%
Market StatusTentative Approval; Prescription
CompanyApotex; Bausch And Lomb; Alcon Pharms; Sandoz; Akorn

2 of 2  
Drug NameBrimonidine tartrate
Drug LabelBrimonidine Tartrate Ophthalmic Solution, 0.2% is a relatively selective alpha-2 adrenergic agonist for ophthalmic use. The chemical name of brimonidine tartrate is 5-bromo-6 (2-imidazolidinylideneamino) quinoxaline L-tartrate. It is a white to sligh...
Active IngredientBrimonidine tartrate
Dosage FormSolution/drops; Solution
Routeophthalmic; Ophthalmic
Strength0.2%; 0.1%
Market StatusTentative Approval; Prescription
CompanyApotex; Bausch And Lomb; Alcon Pharms; Sandoz; Akorn

4.2 Drug Indication

Mirvaso is indicated for the symptomatic treatment of facial erythema of rosacea in adult patients.


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Adrenergic alpha-2 Receptor Agonists

Compounds that bind to and activate ADRENERGIC ALPHA-2 RECEPTORS. (See all compounds classified as Adrenergic alpha-2 Receptor Agonists.)


Antihypertensive Agents

Drugs used in the treatment of acute or chronic vascular HYPERTENSION regardless of pharmacological mechanism. Among the antihypertensive agents are DIURETICS; (especially DIURETICS, THIAZIDE); ADRENERGIC BETA-ANTAGONISTS; ADRENERGIC ALPHA-ANTAGONISTS; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; CALCIUM CHANNEL BLOCKERS; GANGLIONIC BLOCKERS; and VASODILATOR AGENTS. (See all compounds classified as Antihypertensive Agents.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
alpha-Adrenergic Agonist [EPC]; Adrenergic alpha-Agonists [MoA]
5.3 ATC Code

D11AX21


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06-Jan-2022
29-Sep-2025
KGS
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Quantity (KGS) & Unit rate (USD/KGS) over time

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API Imports and Exports

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Drugs in Development

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  • Development Update

Details:

Brimonidine Tartrate is a small molecule drug candidate, which is currently being evaluated in Phase IV clinical studies for the treatment of Glaucoma.


Lead Product(s): Brimonidine Tartrate,Inapplicable

Therapeutic Area: Ophthalmology Brand Name: Undisclosed

Study Phase: Phase IVProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 07, 2025

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01

Insight Eyecare Specialties, Inc

Country
arrow
AIChE Annual Meeting
Not Confirmed

Insight Eyecare Specialties, Inc

Country
arrow
AIChE Annual Meeting
Not Confirmed

Details : Brimonidine Tartrate is a small molecule drug candidate, which is currently being evaluated in Phase IV clinical studies for the treatment of Glaucoma.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

October 07, 2025

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  • Development Update

Details:

Brimonidine is a Other Small Molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Chemotherapy-induced Peripheral Nervous System Diseases.


Lead Product(s): Brimonidine Tartrate,Inapplicable

Therapeutic Area: Neurology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 24, 2025

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02

Tarian Pharma

Country
arrow
AIChE Annual Meeting
Not Confirmed

Tarian Pharma

Country
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AIChE Annual Meeting
Not Confirmed

Details : Brimonidine is a Other Small Molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Chemotherapy-induced Peripheral Nervous System Diseases.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

July 24, 2025

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Details:

Under the terms of the licensing agreement, Théa will commercialize LNZ100 (aceclidine HCl) for the treatment of presbyopia in Canada.


Lead Product(s): Aceclidine Hydrochloride,Brimonidine Tartrate

Therapeutic Area: Ophthalmology Brand Name: Vizz

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Laboratoires Thea

Deal Size: Undisclosed Upfront Cash: $70.0 million

Deal Type: Licensing Agreement July 07, 2025

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03

AIChE Annual Meeting
Not Confirmed
AIChE Annual Meeting
Not Confirmed

Details : Under the terms of the licensing agreement, Théa will commercialize LNZ100 (aceclidine HCl) for the treatment of presbyopia in Canada.

Product Name : Vizz

Product Type : Miscellaneous

Upfront Cash : $70.0 million

July 07, 2025

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Details:

Under the licensing agreement, Lotus will holds the rights of LNZ100 (Aceclidine HCl) in Korea, which is being evaluated for the treatment of Presbyopia.


Lead Product(s): Aceclidine Hydrochloride,Brimonidine Tartrate

Therapeutic Area: Ophthalmology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Lotus Pharmaceutical

Deal Size: $125.0 million Upfront Cash: Undisclosed

Deal Type: Licensing Agreement May 09, 2025

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04

AIChE Annual Meeting
Not Confirmed
AIChE Annual Meeting
Not Confirmed

Details : Under the licensing agreement, Lotus will holds the rights of LNZ100 (Aceclidine HCl) in Korea, which is being evaluated for the treatment of Presbyopia.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Undisclosed

May 09, 2025

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Details:

Brimonidine Tartrate is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Presbyopia.


Lead Product(s): Brimonidine Tartrate,Carbachol

Therapeutic Area: Ophthalmology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 29, 2025

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05

AIChE Annual Meeting
Not Confirmed
AIChE Annual Meeting
Not Confirmed

Details : Brimonidine Tartrate is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Presbyopia.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

April 29, 2025

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Details:

Brimochol PF is a fixed-dose combination of carbachol and brimonidine tartrate that improves near vision in presbyopia by reducing pupil size to create a "pinhole effect," enhancing depth of focus.


Lead Product(s): Brimonidine Tartrate,Carbachol

Therapeutic Area: Ophthalmology Brand Name: Brimochol PF

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 08, 2025

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06

Tenpoint Therapeutics

United Kingdom
arrow
AIChE Annual Meeting
Not Confirmed

Tenpoint Therapeutics

United Kingdom
arrow
AIChE Annual Meeting
Not Confirmed

Details : Brimochol PF is a fixed-dose combination of carbachol and brimonidine tartrate that improves near vision in presbyopia by reducing pupil size to create a "pinhole effect," enhancing depth of focus.

Product Name : Brimochol PF

Product Type : Miscellaneous

Upfront Cash : Inapplicable

April 08, 2025

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  • Development Update

Details:

Brinzolamide is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Glaucoma, Open-Angle.


Lead Product(s): Brinzolamide,Brimonidine Tartrate,Netarsudil,Latanoprost

Therapeutic Area: Ophthalmology Brand Name: Undisclosed

Study Phase: Phase IVProduct Type: Miscellaneous

Sponsor: Sengi

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 19, 2025

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07

Prairie Eye Center

Country
arrow
AIChE Annual Meeting
Not Confirmed

Prairie Eye Center

Country
arrow
AIChE Annual Meeting
Not Confirmed

Details : Brinzolamide is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Glaucoma, Open-Angle.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

March 19, 2025

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Details:

Brimonidine Tartrate is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Exanthema.


Lead Product(s): Brimonidine Tartrate,Inapplicable

Therapeutic Area: Dermatology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 10, 2025

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08

Tarian Pharma

France
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AIChE Annual Meeting
Not Confirmed

Tarian Pharma

France
arrow
AIChE Annual Meeting
Not Confirmed

Details : Brimonidine Tartrate is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Exanthema.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

February 10, 2025

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Details:

Brimochol PF is a fixed-dose combination of carbachol and brimonidine tartrate that improves near vision in presbyopia by reducing pupil size to create a "pinhole effect," enhancing depth of focus.


Lead Product(s): Carbachol,Brimonidine Tartrate

Therapeutic Area: Ophthalmology Brand Name: Brimochol PF

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 09, 2025

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09

Tenpoint Therapeutics

United Kingdom
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AIChE Annual Meeting
Not Confirmed

Tenpoint Therapeutics

United Kingdom
arrow
AIChE Annual Meeting
Not Confirmed

Details : Brimochol PF is a fixed-dose combination of carbachol and brimonidine tartrate that improves near vision in presbyopia by reducing pupil size to create a "pinhole effect," enhancing depth of focus.

Product Name : Brimochol PF

Product Type : Miscellaneous

Upfront Cash : Inapplicable

January 09, 2025

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Details:

The merger brings together a late-stage, potentially best-in-class, presbyopia-correcting eye drop, Brimochol PF, on track for NDA filing, with a promising pipeline of innovative therapeutics.


Lead Product(s): Carbachol,Brimonidine Tartrate

Therapeutic Area: Ophthalmology Brand Name: Brimochol PF

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Visus Therapeutics

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Merger December 12, 2024

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10

Tenpoint Therapeutics

United Kingdom
arrow
AIChE Annual Meeting
Not Confirmed

Tenpoint Therapeutics

United Kingdom
arrow
AIChE Annual Meeting
Not Confirmed

Details : The merger brings together a late-stage, potentially best-in-class, presbyopia-correcting eye drop, Brimochol PF, on track for NDA filing, with a promising pipeline of innovative therapeutics.

Product Name : Brimochol PF

Product Type : Miscellaneous

Upfront Cash : Undisclosed

December 12, 2024

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INTERMEDIATE SUPPLIERS

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01

Amara Labs

India
AIChE Annual Meeting
Not Confirmed
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Amara Labs

India
AIChE Annual Meeting
Not Confirmed
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CAS Number : 50358-63-9

End Use API : Brimonidine Tartrate

About The Company : Amara Labs Pvt Ltd is a WHO-GMP certified manufacturing company wholly owned by a team of technocrats with working experience of more than 20 years in Multi-Nat...

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02

AIChE Annual Meeting
Not Confirmed
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AIChE Annual Meeting
Not Confirmed
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CAS Number : 6298-37-9

End Use API : Brimonidine Tartrate

About The Company : Founded in 2005, Hangzhou Deli Chemical Co., Ltd. is a specialized manufacturing factory of APIs, pharmaceutical intermediates and other chemicals, with product...

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03

AIChE Annual Meeting
Not Confirmed
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AIChE Annual Meeting
Not Confirmed
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CAS Number : 50358-63-9

End Use API : Brimonidine Tartrate

About The Company : Founded in 2005, Hangzhou Deli Chemical Co., Ltd. is a specialized manufacturing factory of APIs, pharmaceutical intermediates and other chemicals, with product...

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04

AIChE Annual Meeting
Not Confirmed
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Not Confirmed
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CAS Number : CAS-59803-98-4

End Use API : Brimonidine Tartrate

About The Company : OM Pharmaceutical Industries is one of the established pharmaceutical company in India, which is engaged in manufacturing of Active Pharmaceutical Ingredients (...

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05

AIChE Annual Meeting
Not Confirmed
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AIChE Annual Meeting
Not Confirmed
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CAS Number : 6298-37-9

End Use API : Brimonidine Tartrate

About The Company : Eyougene was incubated in Fudan Chemical and has grown into a leader in the field of chemical research and development, now based in the dynamic Lingang area of...

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ABOUT THIS PAGE

Looking for 109826-56-4 / Brimonidine Tartrate API manufacturers, exporters & distributors?

Brimonidine Tartrate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Brimonidine Tartrate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Brimonidine Tartrate manufacturer or Brimonidine Tartrate supplier for your needs.

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

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

API | Excipient name

Brimonidine Tartrate

Synonyms

70359-46-5, Alphagan, Brimonidine tartarate, Brimonidine l-tartrate, Lumify, Brimonidinne tartrate

Cas Number

109826-56-4

Unique Ingredient Identifier (UNII)

4S9CL2DY2H

About Brimonidine Tartrate

A quinoxaline derivative and ADRENERGIC ALHPA-2 RECEPTOR AGONIST that is used to manage INTRAOCULAR PRESSURE associated with OPEN-ANGLE GLAUCOMA and OCULAR HYPERTENSION.

Brimonidine Tartrate Manufacturers

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

Brimonidine Tartrate Suppliers

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

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

Brimonidine Tartrate USDMF

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

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

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

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

Brimonidine Tartrate KDMF

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

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

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

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

Brimonidine Tartrate CEP

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

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

Brimonidine Tartrate WC

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

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

Brimonidine Tartrate 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 Brimonidine Tartrate as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Brimonidine Tartrate GMP

Brimonidine Tartrate 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 Brimonidine Tartrate 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 Brimonidine Tartrate GMP manufacturer or Brimonidine Tartrate GMP API supplier for your needs.

Brimonidine Tartrate CoA

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

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

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