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1. Ahr-10282
2. Bromfenac Sodium
3. Duract
4. Isv-303
5. Sodium Bromfenac
6. Xibrom
1. 91714-94-2
2. 2-(2-amino-3-(4-bromobenzoyl)phenyl)acetic Acid
3. Xibrom
4. Bromfenac [inn]
5. Bromfenaco
6. Bromfenacum
7. 2-[2-amino-3-(4-bromobenzoyl)phenyl]acetic Acid
8. Prolensa
9. 2-amino-3-(4-bromobenzoyl)benzeneacetic Acid
10. Bromday
11. Isv-303
12. [2-amino-3-(4-bromobenzoyl)phenyl]acetic Acid
13. Ahr-10282
14. Bromfenac (inn)
15. Yellox
16. 120638-55-3
17. Benzeneacetic Acid, 2-amino-3-(4-bromobenzoyl)-
18. Chebi:240107
19. Bromfenaco [spanish]
20. [2-amino-3-(4-bromo-benzoyl)-phenyl]-acetic Acid
21. Bromsite
22. 864p0921dw
23. 2-{2-amino-3-[(4-bromophenyl)carbonyl]phenyl}acetic Acid
24. Bromfenacum [latin]
25. Bromfenac Sodium Hydrate
26. Ahr-10282b
27. Sodium (2-amino-3-(4-bromobenzoyl)phenyl)acetate
28. Unii-864p0921dw
29. 4mjq
30. Ahr 10282
31. Bromfenac Acid
32. Bromfenac [mi]
33. Bromfenac [vandf]
34. Bromfenac [who-dd]
35. Chembl1077
36. Schembl34411
37. Mls004774052
38. Gtpl7131
39. {2-amino-3-[(4-bromophenyl)carbonyl]phenyl}acetic Acid
40. Dtxsid7040655
41. Hms3741c05
42. Hy-b1888
43. Vea63855
44. Zinc2570817
45. Bdbm50248104
46. Mfcd00864341
47. Akos015998697
48. Db00963
49. Gs-3830
50. Sb17362
51. Da-00968
52. Smr003500721
53. Cs-0013951
54. Ft-0710423
55. D07541
56. Benzeneacetic Acid,2-amino-3-(4-bromobenzoyl)-
57. 638b553
58. A844048
59. A906783
60. Sr-01000941476
61. J-519935
62. Q2487682
63. Sr-01000941476-2
64. Brd-k47679368-323-01-3
65. 2-[2-amino-3-(4-bromobenzoyl)phenyl]acetic Acid;2-(2-amino-3-(4-bromobenzoyl)phenyl)acetic Acid
66. 27r
| Molecular Weight | 334.16 g/mol |
|---|---|
| Molecular Formula | C15H12BrNO3 |
| XLogP3 | 3.3 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 4 |
| Rotatable Bond Count | 4 |
| Exact Mass | 333.00006 g/mol |
| Monoisotopic Mass | 333.00006 g/mol |
| Topological Polar Surface Area | 80.4 Ų |
| Heavy Atom Count | 20 |
| Formal Charge | 0 |
| Complexity | 366 |
| 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 | 1 |
| 1 of 4 | |
|---|---|
| Drug Name | Bromday |
| PubMed Health | Bromfenac (Into the eye) |
| Drug Classes | Anti-Inflammatory |
| Drug Label | Bromday (bromfenac ophthalmic solution) 0.09% is a sterile, topical, nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use. Each mL of Bromday contains 1.035 mg bromfenac sodium (equivalent to 0.9 mg bromfenac free acid). Bromfenac sodi... |
| Active Ingredient | Bromfenac sodium |
| Dosage Form | Solution/drops |
| Route | Ophthalmic |
| Strength | eq 0.09% acid |
| Market Status | Prescription |
| Company | Bausch And Lomb |
| 2 of 4 | |
|---|---|
| Drug Name | Prolensa |
| Drug Label | PROLENSA (bromfenac ophthalmic solution) 0.07% is a sterile, topical, nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use. Each mL of PROLENSA contains 0.805 mg bromfenac sodium sesquihydrate (equivalent to 0.7 mg bromfenac free acid). The... |
| Active Ingredient | Bromfenac sodium |
| Dosage Form | Solution/drops |
| Route | Ophthalmic |
| Strength | eq 0.07% acid |
| Market Status | Prescription |
| Company | Bausch And Lomb |
| 3 of 4 | |
|---|---|
| Drug Name | Bromday |
| PubMed Health | Bromfenac (Into the eye) |
| Drug Classes | Anti-Inflammatory |
| Drug Label | Bromday (bromfenac ophthalmic solution) 0.09% is a sterile, topical, nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use. Each mL of Bromday contains 1.035 mg bromfenac sodium (equivalent to 0.9 mg bromfenac free acid). Bromfenac sodi... |
| Active Ingredient | Bromfenac sodium |
| Dosage Form | Solution/drops |
| Route | Ophthalmic |
| Strength | eq 0.09% acid |
| Market Status | Prescription |
| Company | Bausch And Lomb |
| 4 of 4 | |
|---|---|
| Drug Name | Prolensa |
| Drug Label | PROLENSA (bromfenac ophthalmic solution) 0.07% is a sterile, topical, nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use. Each mL of PROLENSA contains 0.805 mg bromfenac sodium sesquihydrate (equivalent to 0.7 mg bromfenac free acid). The... |
| Active Ingredient | Bromfenac sodium |
| Dosage Form | Solution/drops |
| Route | Ophthalmic |
| Strength | eq 0.07% acid |
| Market Status | Prescription |
| Company | Bausch And Lomb |
For the treatment of postoperative inflammation in patients who have undergone cataract extraction.
FDA Label
Treatment of postoperative ocular inflammation following cataract extraction in adults.
Bromfenac ophthalmic solution is a sterile, topical, nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use.
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.)
S01BC11
S - Sensory organs
S01 - Ophthalmologicals
S01B - Antiinflammatory agents
S01BC - Antiinflammatory agents, non-steroids
S01BC11 - Bromfenac
Absorption
The plasma concentration of bromfenac following ocular administration in humans is unknown.
The mechanism of its action is thought to be due to its ability to block prostaglandin synthesis by inhibiting cyclooxygenase 1 and 2. Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed in animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilation, increased vascular permeability, leukocytosis, and increased intraocular pressure.
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GDUFA
DMF Review : Reviewed
Rev. Date : 2013-07-31
Pay. Date : 2013-07-18
DMF Number : 23704
Submission : 2010-04-12
Status : Active
Type : II
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USDMF
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-31
Pay. Date : 2013-07-18
DMF Number : 23704
Submission : 2010-04-12
Status : Active
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
NDC Package Code : 40016-004
Start Marketing Date : 2010-02-10
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
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About the Company : We provide quality products and services, consistently, reliably responsibly and continuously applying some of the world’s most difficult to handle chemical technologies. Synth...
About the Company : Varion Lifesciences provide an essential link in the Global Neutraceutical and Pharmaceutical Industry. It manufactures Specialty Neutraceutical Ingredients, Novel Plant Extracts, ...
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| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Drugs in Development
Details:
BromSite-Generic (bromfenac) acts by inhibiting Cox-1 and 2. It is indicated for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery.
Lead Product(s): Bromfenac
Therapeutic Area: Ophthalmology Brand Name: BromSite-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 14, 2024
Lead Product(s) : Bromfenac
Therapeutic Area : Ophthalmology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lupin Launches Bromfenac Ophthalmic Solution, 0.075% in US
Details : BromSite-Generic (bromfenac) acts by inhibiting Cox-1 and 2. It is indicated for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery.
Brand Name : BromSite-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
February 14, 2024
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATES SUPPLIERS
(4-Bromophenyl)(1H-indol-7-yl)methan
CAS Number : 91714-50-0
End Use API : Bromfenac
About The Company : Symphony Pharma Life Sciences Private Limited was established in 2008 by pharma industry experts with an excellent track record in the pharmaceutical industry. ...
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ABOUT THIS PAGE
A Bromfenac manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bromfenac, including repackagers and relabelers. The FDA regulates Bromfenac manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bromfenac 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bromfenac supplier is an individual or a company that provides Bromfenac active pharmaceutical ingredient (API) or Bromfenac finished formulations upon request. The Bromfenac suppliers may include Bromfenac API manufacturers, exporters, distributors and traders.
click here to find a list of Bromfenac suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bromfenac DMF (Drug Master File) is a document detailing the whole manufacturing process of Bromfenac active pharmaceutical ingredient (API) in detail. Different forms of Bromfenac DMFs exist exist since differing nations have different regulations, such as Bromfenac USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bromfenac DMF submitted to regulatory agencies in the US is known as a USDMF. Bromfenac USDMF includes data on Bromfenac's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bromfenac USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bromfenac suppliers with USDMF on PharmaCompass.
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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Bromfenac API and other APIs are published in this directory by the FDA.
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 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.
The NDC directory also contains data on finished compounded human drug products that contain Bromfenac and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Bromfenac NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Bromfenac suppliers with NDC on PharmaCompass.
Bromfenac 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 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 GMP manufacturer or Bromfenac GMP API supplier for your needs.
A Bromfenac CoA (Certificate of Analysis) is a formal document that attests to Bromfenac's compliance with Bromfenac specifications and serves as a tool for batch-level quality control.
Bromfenac CoA mostly includes findings from lab analyses of a specific batch. For each Bromfenac 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Bromfenac EP), Bromfenac JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bromfenac USP).
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