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ACTIVE PHARMA INGREDIENTS

18 API Suppliers, 10 USDMF, 2 JDMF, 5 EU WC, 12 NDC API, 13 Listed Suppliers, $ API Reference Price

18 API Suppliers
10 USDMF
2 JDMF
5 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 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 2 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 8 Actylis, 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, 1 Ulanqab Kema New Material

EXCIPIENTS BY APPLICATIONS

23 Solubilizers, 11 Parenteral, 10 Fillers, Diluents & Binders, 6 Granulation, 6 Direct Compression, 6 Topical, 6 Controlled & Modified Release, 6 Thickeners and Stabilizers, 4 Co-Processed Excipients, 3 Emulsifying Agents, 3 Film Formers & Plasticizers, 2 Surfactant & Foaming Agents, 2 Lubricants & Glidants, 2 API Stability Enhancers, 1 Rheology Modifiers, 1 Chewable & Orodispersible Aids, 1 Coating Systems & Additives, 1 Disintegrants & Superdisintegrants

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

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

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Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

13,157,422

Annual Reports (USD Million)

Finished Drug Prices

53 RELATED EXCIPIENT COMPANIES

94EXCIPIENTS 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

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ChemWerth Inc

U.S.A

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LGM Pharma

U.S.A

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Jai Radhe Sales

India

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India

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Micro Labs Limited

India

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Listed Suppliers

01

FARMAK, a.s

Czech Republic

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Bromfenac Sodium

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...

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 ingredients (APIs), intermediates and specialized chemicals. The company primarily focuses on exporting its products, with the main markets being the EU, USA, India, Japan and Latin America. Additionally, Farmak offers contract manufacturing and custom synthesis services through its R&D department to support the clients.

02

ChemWerth Inc

U.S.A

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About the Company : Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs ...

Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs to regulated markets worldwide and has exclusive partnerships for new product development, compliance support and secure supply chain logistics. ChemWerth has access to over 500 APIs and more than 30 manufacturing facilities in the US, Europe, India and China. ChemWerth acts as a regulatory agent for over 25 FDA-approved facilities and sells more than 100 products. It has established its presence in 38 countries. In 2020, ChemWerth filed its 500th DMF with the FDA.

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LGM Pharma

U.S.A

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About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.

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Jai Radhe Sales

India

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About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...

Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete sourcing solutions for pharmaceutical products from India, including technical and regulatory assistance. It believes in providing its customers with high-quality products at reasonable prices. It has always endeavored to achieve global standards in the field of pharmaceuticals and has carved out a niche for itself through new methods based on current market needs. Today, it has established itself as a truly global company, with exports to almost every continent.

05

ALP Pharm

China

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06

Enaltec Labs Private Limited

India

Italy

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Viatris

U.S.A

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API Reference Price

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