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Chemistry

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Also known as: 91714-93-1, 120638-55-3, Bromfenac (sodium), Bronuck, Bromfenac sodium salt, Bromsite
Molecular Formula
C15H11BrNNaO3
Molecular Weight
356.15  g/mol
InChI Key
HZFGMQJYAFHESD-UHFFFAOYSA-M
FDA UNII
9X8YF771OU

Bromfenac Sodium
Bromfenac Sodium is the sodium salt form of bromfenac, a nonsteroidal anti-inflammatory drug (NSAID) with analgesic and anti-inflammatory activities. Upon ophthalmic administration, bromfenac binds to and inhibits the activity of cyclooxygenase II (COX II), an enzyme which converts arachidonic acid to cyclic endoperoxides, precursors of prostaglandins (PG). By inhibiting PG formation, bromfenac is able to inhibit PG-induced inflammation, thereby preventing vasodilation, leukocytosis, disruption of the blood-aqueous humor barrier, an increase in vascular permeability and an increase in intraocular pressure (IOP).
1 2D Structure

Bromfenac Sodium

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
sodium;2-[2-amino-3-(4-bromobenzoyl)phenyl]acetate
2.1.2 InChI
InChI=1S/C15H12BrNO3.Na/c16-11-6-4-9(5-7-11)15(20)12-3-1-2-10(14(12)17)8-13(18)19;/h1-7H,8,17H2,(H,18,19);/q;+1/p-1
2.1.3 InChI Key
HZFGMQJYAFHESD-UHFFFAOYSA-M
2.1.4 Canonical SMILES
C1=CC(=C(C(=C1)C(=O)C2=CC=C(C=C2)Br)N)CC(=O)[O-].[Na+]
2.2 Other Identifiers
2.2.1 UNII
9X8YF771OU
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Ahr-10282

2. Bromfenac

3. Duract

4. Isv-303

5. Sodium Bromfenac

6. Xibrom

2.3.2 Depositor-Supplied Synonyms

1. 91714-93-1

2. 120638-55-3

3. Bromfenac (sodium)

4. Bronuck

5. Bromfenac Sodium Salt

6. Bromsite

7. Bromfenac Sodium Anhydrous

8. Xibrom

9. Chebi:140536

10. Ahr 10282b

11. Bromfenac Monosodium Salt Sesquihydrate

12. Bromfenac (sodium Hydrate)

13. Benzeneacetic Acid, 2-amino-3-(4-bromobenzoyl)-, Monosodium Salt

14. Sodium;2-[2-amino-3-(4-bromobenzoyl)phenyl]acetate

15. 9x8yf771ou

16. Bromday

17. Prolensa

18. Sodium 2-(2-amino-3-(4-bromobenzoyl)phenyl)acetate

19. Ahr-10282b

20. Bromfenac Sodium Hydrate

21. Sodium 2-[2-amino-3-(4-bromobenzoyl)phenyl]acetate

22. 2-amino-3-(4-bromobenzoyl)benzeneacetic Acid Sodium Salt

23. Bromfenac Sodium Salt Sesquihydrate

24. Unii-9x8yf771ou

25. Sodium [2-amino-3-(4-bromobenzoyl)phenyl]acetate

26. Mfcd03701673

27. Benzeneacetic Acid, 2-amino-3-(4-bromobenzoyl)-, Sodium Salt (1:1)

28. Bromfenac Monosodium Salt

29. Chembl751

30. Schembl56644

31. Hy-b1888a

32. Dtxsid70273981

33. Bromfenac Sodium [who-dd]

34. Ahr 10282r

35. Hms3652d21

36. Hms3885l13

37. Amy22137

38. Bcp05811

39. Bromfenac Sodium, >=98% (hplc)

40. Ac-149

41. Bdbm50225143

42. S4248

43. Akos000280377

44. Bromfenac Monosodium Salt [mi]

45. Ac-9334

46. Ccg-268104

47. Sb17363

48. Bb164264

49. Cs-0014295

50. Ft-0602701

51. Ft-0660252

52. Sw219148-1

53. Sodium 2-amino-3-(4-bromobenzoyl) Phenylacetate

54. J-004372

55. Q-200752

56. Sodium2-(2-amino-3-(4-bromobenzoyl)phenyl)acetate

57. Q27225685

58. Sodium (-amino-3-(p-bromobenzoyl)phenyl)acetate

59. Sodium; [2-amino-3-(4-bromo-benzoyl)-phenyl]-acetate

60. Benzeneacetic Acid,2-amino-3-(4-bromobenzoyl)-,monosodium Salt

61. Ahr 10282b;ahr-10282; Ahr10282; Ahr 10282;sodium Bromfenac

2.4 Create Date
2008-02-05
3 Chemical and Physical Properties
Molecular Weight 356.15 g/mol
Molecular Formula C15H11BrNNaO3
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count4
Rotatable Bond Count4
Exact Mass354.98200 g/mol
Monoisotopic Mass354.98200 g/mol
Topological Polar Surface Area83.2 Ų
Heavy Atom Count21
Formal Charge0
Complexity372
Isotope Atom Count0
Defined Atom Stereocenter Count0
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 NameBromfenac sodium
Drug LabelBromfenac ophthalmic solution 0.09% is a sterile, topical, nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use. Each mL of bromfenac ophthalmic solution contains 1.035 mg bromfenac sodium (equivalent to 0.9 mg bromfenac free acid). Bromfen...
Active IngredientBromfenac sodium
Dosage FormSolution/drops
RouteOphthalmic
Strengtheq 0.09% acid
Market StatusPrescription
CompanyApotex; Hi-tech Pharmacal; Luitpold; Coastal Pharms

2 of 2  
Drug NameBromfenac sodium
Drug LabelBromfenac ophthalmic solution 0.09% is a sterile, topical, nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use. Each mL of bromfenac ophthalmic solution contains 1.035 mg bromfenac sodium (equivalent to 0.9 mg bromfenac free acid). Bromfen...
Active IngredientBromfenac sodium
Dosage FormSolution/drops
RouteOphthalmic
Strengtheq 0.09% acid
Market StatusPrescription
CompanyApotex; Hi-tech Pharmacal; Luitpold; Coastal Pharms

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Anti-Inflammatory Agents, Non-Steroidal

Anti-inflammatory agents that are non-steroidal in nature. In addition to anti-inflammatory actions, they have analgesic, antipyretic, and platelet-inhibitory actions. They act by blocking the synthesis of prostaglandins by inhibiting cyclooxygenase, which converts arachidonic acid to cyclic endoperoxides, precursors of prostaglandins. Inhibition of prostaglandin synthesis accounts for their analgesic, antipyretic, and platelet-inhibitory actions; other mechanisms may contribute to their anti-inflammatory effects. (See all compounds classified as Anti-Inflammatory Agents, Non-Steroidal.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Cyclooxygenase Inhibitors [MoA]; Nonsteroidal Anti-inflammatory Drug [EPC]; Anti-Inflammatory Agents, Non-Steroidal [CS]

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Bromfenac Sodium

Registration Number : 230MF10078

Registrant's Address : Na vlcinci 16/3 Klasterni Hradisko 77900 Olomouc Czech Republic

Initial Date of Registration : 2018-07-03

Latest Date of Registration : 2018-07-03

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Registration Number : 306MF10119

Registrant's Address : Na vlcinci 16/3 Klasterni Hradisko 77900 Olomouc Czech Republic

Initial Date of Registration : 2024-09-03

Latest Date of Registration : 2024-09-03

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Bromfenac sodium hydrate (for manufacturing purposes only)

Registration Number : 223MF10031

Registrant's Address : 207, Sujeong-ro, Jangan-myeon, Hwaseong-si, Gyeonggi-do, 18581, Republic of Korea

Initial Date of Registration : 2011-03-03

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About the Company : Farmak, A.S. is a privately held chemical and pharmaceutical company based in the Czech Republic. It specializes in researching, developing and producing active pharmaceutical ingr...

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TL\/WZ\/23\/004227)","address":"142-48 S.V.ROAD,","city":"MUMBAI, MAHARASHTRA","supplier":"ALP PHARM","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"FDC","customerCountry":"INDIA","quantity":"0.13","actualQuantity":"131","unit":"GMS","unitRateFc":"80","totalValueFC":"11602.7","currency":"USD","unitRateINR":"7396.3","date":"20-Apr-2024","totalValueINR":"968912","totalValueInUsd":"11602.7","indian_port":"Bombay Air","hs_no":"29189990","bill_no":"3114854","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Non-sterile","supplierPort":"BEIJING","supplierAddress":"12-2-620 JIA 69 FUSHI RD HAIDIANBEIJING 100049SDNF CHINA","customerAddress":"142-48 S.V.ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1718908200,"product":"BROMFENAC SODIUM SESQUIHYDRATE - BF123L010 BF124B020","address":"REGD. OFFICE: NO. 16\/2,","city":"BANGALORE, KARNATAKA","supplier":"YS LIFE SCIENCE ","supplierCountry":"KOREA, REPUBLIC OF","foreign_port":"SEOUL - INCHEON INT\\'","customer":"SOMERSET THERAPEUTICS LIMITED","customerCountry":"INDIA","quantity":"0.40","actualQuantity":"400","unit":"GMS","unitRateFc":"130","totalValueFC":"54113.1","currency":"USD","unitRateINR":"11293.3","date":"21-Jun-2024","totalValueINR":"4517326.77","totalValueInUsd":"54113.1","indian_port":"Bangalore Air","hs_no":"29332990","bill_no":"4117728","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"SEOUL - INCHEON INT\\'","supplierAddress":"207 SUJEONG-RO JANGAN-MYEON HWASEONG-SI GYEONGGI-DO 18581 Incheon IntlApt\/Seoul, , Korea, Republic of Korea, Republic of","customerAddress":"REGD. OFFICE: NO. 16\/2,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729535400,"product":"BROMFENAC SODIUM SESQUIHYDRATE","address":"HETERO HOUSE,","city":"HYDERABAD, AP.","supplier":"YS LIFE SCIENCE CO., LTD","supplierCountry":"KOREA, REPUBLIC OF","foreign_port":"SEOUL - INCHEON INT\\'","customer":"ASPIRO PHARMA","customerCountry":"INDIA","quantity":"0.25","actualQuantity":"250","unit":"GMS","unitRateFc":"150","totalValueFC":"37912.1","currency":"USD","unitRateINR":"12742.5","date":"22-Oct-2024","totalValueINR":"3185625","totalValueInUsd":"37912.1","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"6269289","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"SEOUL - INCHEON INT\\'","supplierAddress":"207 SUJEONG-RO,JANGAN-MYEON HWASEON G-SI GYEONGGI-DO 18581 HWASEONG, , Korea, Republic of Korea, Republic of","customerAddress":"HETERO HOUSE,"}]
09-Feb-2021
31-Mar-2025
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ABOUT THIS PAGE

Looking for 91714-93-1 / Bromfenac Sodium API manufacturers, exporters & distributors?

Bromfenac Sodium manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Bromfenac Sodium 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 Bromfenac Sodium manufacturer or Bromfenac Sodium supplier for your needs.

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

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

API | Excipient name

Bromfenac Sodium

Synonyms

91714-93-1, 120638-55-3, Bromfenac (sodium), Bronuck, Bromfenac sodium salt, Bromsite

Cas Number

91714-93-1

Unique Ingredient Identifier (UNII)

9X8YF771OU

About Bromfenac Sodium

Bromfenac Sodium is the sodium salt form of bromfenac, a nonsteroidal anti-inflammatory drug (NSAID) with analgesic and anti-inflammatory activities. Upon ophthalmic administration, bromfenac binds to and inhibits the activity of cyclooxygenase II (COX II), an enzyme which converts arachidonic acid to cyclic endoperoxides, precursors of prostaglandins (PG). By inhibiting PG formation, bromfenac is able to inhibit PG-induced inflammation, thereby preventing vasodilation, leukocytosis, disruption of the blood-aqueous humor barrier, an increase in vascular permeability and an increase in intraocular pressure (IOP).

Bromfenac Sodium Manufacturers

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

Bromfenac Sodium Suppliers

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

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

Bromfenac Sodium USDMF

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

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

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

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

Bromfenac Sodium WC

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

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

Bromfenac Sodium 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 Bromfenac Sodium as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Bromfenac Sodium GMP

Bromfenac Sodium 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 Bromfenac Sodium 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 Bromfenac Sodium GMP manufacturer or Bromfenac Sodium GMP API supplier for your needs.

Bromfenac Sodium CoA

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

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

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