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Molecule

Bromfenac

Also known as bromfenac sodium
Available on requestOphthalmology
Presentations
9
Brands
2
Manufacturers
2
Available from stock
0

Bromfenac is a nonsteroidal anti-inflammatory drug indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. It is available as eye drops and ophthalmic solution. MedsAcross supplies Bromfenac for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Anti-Inflammatory Agents, Nonsteroidal Anti-inflammatory Drug, Cyclooxygenase Inhibitors
ATC classification
S01BC11 Bromfenac · Eye medicines, subgroup S01B, subgroup S01BC
US FDA first approval
24 March 2005
EU status
Authorised
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Ophthalmic
Dosage forms
Eye drops, Ophthalmic solution
Identifiers
UNII 864P0921DWRxCUI 19737CAS 91714-94-2DrugBank DB00963Q2487682

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

Bromfenac Ophthalmic Solution 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Bromfenac Ophthalmic Solution is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.

Source: US FDA prescribing information

How it works

Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) that has anti-inflammatory activity. The mechanism of its action is thought to be due to its ability to block prostaglandin synthesis by inhibiting cyclooxygenase (COX) 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.

Source: US FDA prescribing information

Dosing overview

Instill one drop into the affected eye once daily beginning 1 day prior to surgery, continued on the day of surgery, and through the first 14 days postsurgery.

Source: US FDA prescribing information

Warnings and precautions

Sulfite Allergic Reactions. Slow or Delayed Healing. Potential for Cross-Sensitivity. Increased Bleeding Time. Keratitis and Corneal Reactions

Source: US FDA prescribing information

Side effects

The most commonly reported adverse reactions in 3% to 8% of patients were anterior chamber inflammation, foreign body sensation, eye pain, photophobia, and blurred vision.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

9 presentations of Bromfenac, sorted by availability.

MedicineManufacturerRegisterAvailability
Bromfenac 0.7 mg/mL eye dropsOphthalmicGeneric name—US FDAAvailable on request
Bromfenac 0.9 mg/mL eye dropsOphthalmicGeneric name—US FDAAvailable on request
Bromfenac 0.805 mg/mL eye dropsOphthalmicGeneric name—US FDAAvailable on request
Bromfenac 1.035 mg/mL eye dropsOphthalmicGeneric name—US FDAAvailable on request
Prolensa 0.7 mg/mL eye dropsOphthalmicBausch & LombUS FDAAvailable on request
Bromfenac 0.75 mg/mL eye dropsOphthalmicGeneric name—US FDAAvailable on request
Bromfenac 0.76 mg/mL eye dropsOphthalmicGeneric name—US FDAAvailable on request
Bromfenac 0.9 mg/mL ophthalmic solutionOphthalmicGeneric name—US FDAAvailable on request
Bromsite 0.075% 0.76 mg/mL eye dropsOphthalmicSun Pharmaceutical IndustriesIndiaUS FDAAvailable on request

Brands by market

2 brand names across 1 markets.

Brand names by country

Manufacturers

Indian manufacturers are highlighted.

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 24 March 2005Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Bromfenac in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Bromfenac available for export from India?

Yes, on request. MedsAcross lists 9 presentations of Bromfenac and sources them for licensed hospitals, importers and physicians against valid import documents. Indian manufacturers include Sun Pharmaceutical Industries.

What brand names does Bromfenac have?

The catalogue lists 2 brand names for Bromfenac, including Bromsite 0.075%, Prolensa.

Is Bromfenac approved by the US FDA?

Yes. The US FDA first approved Bromfenac on 24 March 2005, according to Drugs@FDA.

Is Bromfenac authorised in the European Union?

Yes. Bromfenac has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Bromfenac need cold chain shipping?

No listed presentation of Bromfenac is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Bromfenac in?

Bromfenac is classified under ATC code S01BC11 (Bromfenac).

References

  1. bromfenac ophthalmic solution prescribing information (Bausch & Lomb Americas). U.S. National Library of Medicine, DailyMed. Retrieved 5 May 2026
  2. Yellox: European public assessment report (EPAR). European Medicines Agency. Retrieved 8 April 2026

Request Bromfenac for export supply

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