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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


API Reference Price

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BARCELONA SPAIN","customerAddress":"236, OKHLA INDUSTRIAL AREA,PHASE."},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732213800,"product":"BRIMONIDINE TARTRATE (IMP LIC NO.SW\/OD\/11\/2024\/000007092 DT.12.11.24)","address":"208, OKHLA INDUSTRIAL ESTATE,,PHAS","city":"NEW DELHI,DELHI","supplier":"MEDICHEM S A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"MANKIND PHARMA LTD","customerCountry":"INDIA","quantity":"1.63","actualQuantity":"1.63","unit":"KGS","unitRateFc":"18000","totalValueFC":"29674.4","currency":"USD","unitRateINR":"1536300","date":"22-Nov-2024","totalValueINR":"2504169","totalValueInUsd":"29674.4","indian_port":"Delhi Air","hs_no":"29332990","bill_no":"6829006","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"FRUCTUOS GELBERT 6-8 08970 SANT JAON DESPL. 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OFFICE: NO. 16\/2,","city":"BANGALORE, KARNATAKA","supplier":"C SQUARED PHARMA LTD","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"SOMERSET THERAPEUTICS PRIVATE LTD","customerCountry":"INDIA","quantity":"12.00","actualQuantity":"12","unit":"KGS","unitRateFc":"8800","totalValueFC":"106666.4","currency":"USD","unitRateINR":"766480","date":"25-Jan-2025","totalValueINR":"9197760","totalValueInUsd":"106666.4","indian_port":"Bangalore Air","hs_no":"29332990","bill_no":"8000109","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"BRIDGE HOUSE UNIT 2 SKEHARD ROAD T1 2 H2TK CORK IRELAND (IRL) Dublin, , Ireland","customerAddress":"REGD. OFFICE: NO. 16\/2,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737743400,"product":"(FOC) - BRIMONIDINE TARTRATE - LL\/FP\/ABT-6 - A020761124 (FOC) - BRIMONIDINE TARTRATE - LL\/FP\/ABT-6 - A020761124","address":"REGD. OFFICE: NO. 16\/2,","city":"BANGALORE, KARNATAKA","supplier":"C SQUARED PHARMA LTD","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"SOMERSET THERAPEUTICS PRIVATE LTD","customerCountry":"INDIA","quantity":"12.00","actualQuantity":"12","unit":"KGS","unitRateFc":"8800","totalValueFC":"106666.4","currency":"USD","unitRateINR":"766480","date":"25-Jan-2025","totalValueINR":"9197760","totalValueInUsd":"106666.4","indian_port":"Bangalore Air","hs_no":"29332990","bill_no":"8000109","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"BRIDGE HOUSE UNIT 2 SKEHARD ROAD T1 2 H2TK CORK IRELAND (IRL) Dublin, , Ireland","customerAddress":"REGD. OFFICE: NO. 16\/2,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737743400,"product":"(FOC) - BRIMONIDINE TARTRATE - LL\/FP\/ABT-6 - A020771124 (FOC) - BRIMONIDINE TARTRATE - LL\/FP\/ABT-6 - A020771124","address":"REGD. OFFICE: NO. 16\/2,","city":"BANGALORE, KARNATAKA","supplier":"C SQUARED PHARMA LTD","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"SOMERSET THERAPEUTICS PRIVATE LTD","customerCountry":"INDIA","quantity":"7.00","actualQuantity":"7","unit":"KGS","unitRateFc":"8800","totalValueFC":"62222.1","currency":"USD","unitRateINR":"766480","date":"25-Jan-2025","totalValueINR":"5365360","totalValueInUsd":"62222.1","indian_port":"Bangalore Air","hs_no":"29332990","bill_no":"8000109","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"BRIDGE HOUSE UNIT 2 SKEHARD ROAD T1 2 H2TK CORK IRELAND (IRL) Dublin, , Ireland","customerAddress":"REGD. OFFICE: NO. 16\/2,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1739125800,"product":"BRIMONIDINE TARTRATE (QTY: 0.1KG, VALUE : USD 1100) BRIMONIDINE TARTRATE","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"C SQUARED PHARMA LTD","supplierCountry":"IRELAND","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"AUROBINDO PHARMA LTD","customerCountry":"INDIA","quantity":"0.10","actualQuantity":"0.1","unit":"KGS","unitRateFc":"13100","totalValueFC":"1331.6","currency":"USD","unitRateINR":"1158040","date":"10-Feb-2025","totalValueINR":"115804","totalValueInUsd":"1331.6","indian_port":"Hyderabad Air","hs_no":"29331999","bill_no":"8266215","productDescription":"API","marketType":"REGULATED MARKET","country":"IRELAND","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"BRIDGE HOUSE UNIT 2, SKEHARD ROAD, T12 H2TK CORK, IRELAND (IRL) SDNF Ireland","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1739125800,"product":"BRIMONIDINE TARTRATE (QTY: 0.3KG, VALUE : USD 3300) BRIMONIDINE TARTRATE","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"C SQUARED PHARMA LTD","supplierCountry":"IRELAND","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"AUROBINDO PHARMA LTD","customerCountry":"INDIA","quantity":"0.30","actualQuantity":"0.3","unit":"KGS","unitRateFc":"13100","totalValueFC":"3994.9","currency":"USD","unitRateINR":"1158040","date":"10-Feb-2025","totalValueINR":"347412","totalValueInUsd":"3994.9","indian_port":"Hyderabad Air","hs_no":"29331999","bill_no":"8266215","productDescription":"API","marketType":"REGULATED MARKET","country":"IRELAND","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"BRIDGE HOUSE UNIT 2, SKEHARD ROAD, T12 H2TK CORK, IRELAND (IRL) SDNF Ireland","customerAddress":"PLOT NO.2, MAITRIVIHAR,"}]
06-Jan-2022
30-May-2025
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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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