Medicine
Bromfenac 0.805 mg/mL eye drops
Bromfenac 0.805 mg/mL eye drops is a generic prescription medicine for ophthalmic use, made by 2 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 25°C (77°F), excursions permitted to 15 to 30°C (59 to 86°F).
Key facts
- Active ingredient (INN)
- Bromfenac
- Brand
- Sold under the generic name
- Strength
- 0.805 mg/mL
- Dosage form
- Eye drops
- Route
- Ophthalmic
- Packs
- 1 bottle
- Manufacturers
- Alembic PharmaceuticalsIndiaLupinIndia
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15 to 30°C (59 to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- S01BC11 Bromfenac
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 8 January 2024
- Identifiers
- RxCUI 1375917DailyMed set ID 26f3e5b3-a739-4b09-8046-e71ecb3a5a7b, f66f1436-daaa-412a-8822-c64866cfeada, f6911061-d00e-466d-b623-f81730f38f98NDC 68180-433, 46708-583, 62332-583Application ANDA206027, ANDA214340
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle in 1 carton / 3 mL in 1 bottle | 46708-583-03 | Alembic PharmaceuticalsIndia | 8 July 2024 |
| 1 bottle in 1 carton / 3 mL in 1 bottle | 62332-583-03 | Alembic PharmaceuticalsIndia | 8 July 2024 |
| 1 bottle, dropper in 1 carton / 3 mL in 1 bottle, dropper | 68180-433-02 | LupinIndia | 8 January 2024 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Bromfenac
Clinical summary
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
Read about BromfenacFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- bromfenac ophthalmic solution prescribing information (Bausch & Lomb Americas) · U.S. National Library of Medicine, DailyMed
- Yellox: European public assessment report (EPAR) · European Medicines Agency
Need Bromfenac 0.805 mg/mL eye drops for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.