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Ophthalmics

Bromfenac

Prolensa®

Bromfenac is an ophthalmic NSAID for postoperative ocular inflammation and pain following cataract surgery.

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Product Details

Dosage FormOphthalmic Solution
Strength0.07%, 0.09%
StorageStore at 15–25°C.
CategoryOphthalmics
AvailabilityAvailable for Transfer

Indication

Postoperative inflammation and pain after cataract surgery.

Mechanism of Action

Nonsteroidal anti-inflammatory drug that inhibits cyclooxygenase (COX) enzymes (primarily COX-2), reducing prostaglandin synthesis and decreasing inflammation and pain.

Technology Transfer Package

Each Burrard Pharmaceuticals technology transfer package for Bromfenac includes comprehensive documentation and support:

Master Formula

Complete formulation with manufacturing parameters, excipient specifications, and process controls.

Analytical Methods

Validated methods for assay, impurities, dissolution, and stability-indicating analysis.

CTD/eCTD Dossier

Market-ready regulatory dossier sections for a named territory, scoped per programme.

Stability Data

ICH-compliant stability studies (accelerated and long-term) with detailed protocols.

Manufacturing Protocols

Scale-up procedures, batch records, equipment specifications, and in-process controls.

Expert Support

Direct advisory access to formulation scientists and regulatory specialists throughout transfer.

Ready for Bromfenac Technology Transfer?

Scope and timing for the complete know-how package are confirmed in writing after a confidentiality agreement. Book a consultation to discuss your specific requirements.

Request a Programme Review Tech Transfer & CTD