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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":"208, OKHLA INDUSTRIAL ESTATE,,PHAS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733509800,"product":"BRIMONIDINE TARTRATE USP BRIMONIDINE TARTRATE USP","address":"NARBAVI NO3 LAKSHMANAN STREET,,T.N","city":"CHENNAI,TAMIL NADU","supplier":"C-SQUARED PHARMA LTD","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"CAPLIN STERILES LIMITED","customerCountry":"INDIA","quantity":"0.22","actualQuantity":"0.22","unit":"KGS","unitRateFc":"12692.3","totalValueFC":"2814.7","currency":"USD","unitRateINR":"1087096.1","date":"07-Dec-2024","totalValueINR":"239161.15","totalValueInUsd":"2814.7","indian_port":"Madras Air","hs_no":"29332990","bill_no":"7107886","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"BRIDGE HOUSE UNIT 2 SKEHARD ROAD T12 H2TK CORK IE","customerAddress":"NARBAVI NO3 LAKSHMANAN STREET,,T.N"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733509800,"product":"BRIMONIDINE TARTRATE USP BRIMONIDINE TARTRATE USP","address":"NARBAVI NO3 LAKSHMANAN STREET,,T.N","city":"CHENNAI,TAMIL NADU","supplier":"C-SQUARED PHARMA LTD","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"CAPLIN STERILES LIMITED","customerCountry":"INDIA","quantity":"0.41","actualQuantity":"0.41","unit":"KGS","unitRateFc":"12692.3","totalValueFC":"5245.6","currency":"USD","unitRateINR":"1087096.1","date":"07-Dec-2024","totalValueINR":"445709.42","totalValueInUsd":"5245.6","indian_port":"Madras Air","hs_no":"29335990","bill_no":"7107886","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"BRIDGE HOUSE UNIT 2 SKEHARD ROAD T12 H2TK CORK IE","customerAddress":"NARBAVI NO3 LAKSHMANAN STREET,,T.N"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737743400,"product":"(FOC) - BRIMONIDINE TARTRATE - LL\/FP\/ABT-6 - A019881024 (FOC) - BRIMONIDINE TARTRATE - LL\/FP\/ABT-6 - A019881024","address":"REGD. OFFICE: NO. 16\/2,","city":"BANGALORE, KARNATAKA","supplier":"C-SQUARED PHARMA LIMITED","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"SOMERSET THERAPEUTICS PRIVATE LIMITED","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 - A019891024 (FOC) - BRIMONIDINE TARTRATE - LL\/FP\/ABT-6 - A019891024","address":"REGD. OFFICE: NO. 16\/2,","city":"BANGALORE, KARNATAKA","supplier":"C-SQUARED PHARMA LIMITED","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"SOMERSET THERAPEUTICS PRIVATE LIMITED","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 LIMITED","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"SOMERSET THERAPEUTICS PRIVATE LIMITED","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 - A020781124 (FOC) - BRIMONIDINE TARTRATE - LL\/FP\/ABT-6 - A020781124","address":"REGD. OFFICE: NO. 16\/2,","city":"BANGALORE, KARNATAKA","supplier":"C-SQUARED PHARMA LIMITED","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"SOMERSET THERAPEUTICS PRIVATE LIMITED","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: 0.3KG, VALUE : USD 3300) BRIMONIDINE TARTRATE","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"C-SQUARED PHARMA LIMITED","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,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741717800,"product":"IMP I (BRIMONIDINE)-LL\/FP\/IIB-6 BATCH NO.IRS\/HYD1\/ABT\/23\/33820MG (IMPURITY)IMP I (BRIMONIDINE)-LL\/FP\/IIB-6 BATCH NO.IRS\/HYD1\/ABT\/23\/338","address":"ACME PLAZA, ANDHERI KURLA ROAD,","city":"MUMBAI, MAHARASHTRA.","supplier":"C-SQUARED PHARMA LIMITED","supplierCountry":"INDIA","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.02","unit":"GMS","unitRateFc":"24184","totalValueFC":"490.3","currency":"USD","unitRateINR":"2123355","date":"12-Mar-2025","totalValueINR":"42467.1","totalValueInUsd":"490.3","indian_port":"Bombay Air","hs_no":"29332990","bill_no":"8843817","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"BRIDGE HOUSE UNIT 2 SKEHARD ROAD,T12 H2TK CORK IRELAND (IRL) IE","customerAddress":"ACME PLAZA, ANDHERI KURLA ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742322600,"product":"BRIMONIDINE TARTRATE USP BRIMONIDINE TARTRATE USP","address":"HETERO HOUSE,","city":"HYDERABAD, AP.","supplier":"C-SQUARED PHARMA LIMITED","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"ASPIRO PHARMA LIMITED","customerCountry":"INDIA","quantity":"0.09","actualQuantity":"0.09","unit":"KGS","unitRateFc":"14407.4","totalValueFC":"1314.4","currency":"USD","unitRateINR":"1264970.3","date":"19-Mar-2025","totalValueINR":"113847.33","totalValueInUsd":"1314.4","indian_port":"Hyderabad Air","hs_no":"29332990","bill_no":"8963444","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"BRIDDHE HOUSE UNIT 2 SKEHARD ROAD,T 12 H2TK CORK H2TK CORK, , Ireland SDNF Ireland","customerAddress":"HETERO HOUSE,"}]
06-Jan-2022
21-Apr-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.

SIMBRINZA Manufacturers

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

SIMBRINZA Suppliers

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

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

SIMBRINZA USDMF

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

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

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

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

SIMBRINZA KDMF

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

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

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

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

SIMBRINZA CEP

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

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

SIMBRINZA WC

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

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

SIMBRINZA 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 SIMBRINZA as an active pharmaceutical ingredient (API).

Finished drug products

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

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

SIMBRINZA GMP

SIMBRINZA 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 SIMBRINZA 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 SIMBRINZA GMP manufacturer or SIMBRINZA GMP API supplier for your needs.

SIMBRINZA CoA

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

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

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