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ACTIVE PHARMA INGREDIENTS

19 API Suppliers, 10 USDMF, 2 JDMF, 6 EU WC, 12 NDC API, 13 Listed Suppliers, $ API Reference Price

19 API Suppliers
10 USDMF
2 JDMF
6 EU WC
12 NDC API
13 Listed Suppliers
$ API Reference Price

INTERMEDIATES

2 Intermediates Suppliers

2 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

22 FDF Dossiers, 20 FDA Orange Book, 1 Europe, 1 Listed Dossiers

22 FDF Dossiers
20 FDA Orange Book
1 Europe
1 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 DKSH, 1 Jai Radhe Sales, 1 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 2 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 8 Actylis, 1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 12 BASF, 1 Curia, 1 Finar, 5 Gangwal Chemicals, 1 Lubrizol Life Science Health, 1 Microlex e.U, 2 Nanjing Bold Chemical, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 1 Pluviaendo, 6 Seppic, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Ulanqab Kema New Material

EXCIPIENTS BY APPLICATIONS

24 Solubilizers, 11 Fillers, Diluents & Binders, 11 Parenteral, 7 Direct Compression, 6 Granulation, 6 Topical, 6 Controlled & Modified Release, 6 Thickeners and Stabilizers, 4 Co-Processed Excipients, 3 Film Formers & Plasticizers, 3 Emulsifying Agents, 2 API Stability Enhancers, 2 Surfactant & Foaming Agents, 2 Lubricants & Glidants, 2 Disintegrants & Superdisintegrants, 1 Rheology Modifiers, 1 Chewable & Orodispersible Aids, 1 Coating Systems & Additives

excipientsByApplications
24 Solubilizers
11 Fillers, Diluents & Binders
11 Parenteral
7 Direct Compression
6 Granulation
6 Topical
6 Controlled & Modified Release
6 Thickeners and Stabilizers
4 Co-Processed Excipients
3 Film Formers & Plasticizers
3 Emulsifying Agents
2 API Stability Enhancers
2 Surfactant & Foaming Agents
2 Lubricants & Glidants
2 Disintegrants & Superdisintegrants
1 Rheology Modifiers
1 Chewable & Orodispersible Aids
1 Coating Systems & Additives

DIGITAL CONTENT

11 NEWS #PharmaBuzz

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11 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 1 Finished Drug Prices

globalSalesInformation
2 US Medicaid Prescriptions
1 Finished Drug Prices

MARKET PLACE

6 APIs

marketPlace
6 APIs

PATENTS & EXCLUSIVITIES

12 US Patents, 1 US Exclusivities

patents
12 US Patents
1 US Exclusivities

Farmak Bromfenac Sodium

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 45,729

MARKET PLACE

API

FDF

2INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

0 DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

13,157,422

Annual Reports (USD Million)

Finished Drug Prices

56 RELATED EXCIPIENT COMPANIES

98EXCIPIENTS BY APPLICATIONS

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 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 Formula	C₁₅H₁₁BrNNaO₃
Molecular Weight	356.15 g/mol
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	4
Rotatable Bond Count	4
Exact Mass	354.98200 g/mol
Monoisotopic Mass	354.98200 g/mol
Topological Polar Surface Area	83.2 Å²
Heavy Atom Count	21
Formal Charge	0
Complexity	372
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Bromfenac sodium
Drug Label	Bromfenac 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 Ingredient	Bromfenac sodium
Dosage Form	Solution/drops
Route	Ophthalmic
Strength	eq 0.09% acid
Market Status	Prescription
Company	Apotex; Hi-tech Pharmacal; Luitpold; Coastal Pharms

2 of 2
Drug Name	Bromfenac sodium
Drug Label	Bromfenac 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 Ingredient	Bromfenac sodium
Dosage Form	Solution/drops
Route	Ophthalmic
Strength	eq 0.09% acid
Market Status	Prescription
Company	Apotex; 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]

API SUPPLIERS

01

FARMAK, a.s

Czech Republic

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI India 2024

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Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.

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ChemWerth Inc

U.S.A

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03

LGM Pharma

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BioFlorida Conference

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Jai Radhe Sales

India

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CPhI India 2024

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Yonsung Fine Chemicals

South Korea

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06

Indoco Remedies Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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01

Farmak As

Czech Republic

CPhI India 2024

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Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.

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Bromfenac Sodium

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 38922

Submission : 2023-10-18

Status : Active

Type : II

02

Chemwerth Inc

U.S.A

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Bromfenac Sodium (sesquihydrate)

GDUFA

DMF Review : Complete

Rev. Date : 2013-10-17

Pay. Date : 2013-07-09

DMF Number : 24521

Submission : 2011-05-20

Status : Active

Type : II

03

Sterling Wisconsin Llc

U.S.A

Compamed

Not Confirmed

04

Alp Pharm Beijing Co Ltd

China

South Korea

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API Reference Price

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