What Is Nepafenac Ophthalmic?
Nepafenac is an NSAID prodrug that is rapidly deaminated by intraocular hydrolases to its active metabolite, amfenac, a potent inhibitor of both COX-1 and COX-2. This prodrug approach allows nepafenac to penetrate the cornea in its inactive form, minimizing ocular surface toxicity, and then be activated within the eye where anti-inflammatory activity is needed. The 0.3% formulation (Ilevro) enables once-daily dosing through enhanced intraocular drug levels. Burrard Pharmaceuticals offers complete technology transfer know-how packages for Nepafenac Ophthalmic manufacturing, including master batch formulas, manufacturing process parameters, stability data, and CTD/eCTD regulatory dossier templates.
Manufacturing Overview
Nepafenac Ophthalmic manufacturing requires GMP-compliant facilities with ophthalmic-grade cleanroom capabilities. The formulation process involves precise compounding, sterile filtration or aseptic processing, and quality control testing to ensure release specifications are met for intraocular or topical ophthalmic administration.
Key Manufacturing Challenges
- Suspension formulation with precise particle size distribution control
- Polymorphic form control of nepafenac affecting dissolution rate
- Shake-well formulation requiring resuspendability validation
- Preservative system compatibility with suspended drug particles
- Sterile manufacturing of ophthalmic suspension via aseptic processing
- Prodrug stability vs. premature conversion during manufacturing and storage
💡 Why Nepafenac Ophthalmic Is a Valuable Technology Transfer Opportunity
The prodrug mechanism of nepafenac provides a differentiated safety profile compared to direct-acting ophthalmic NSAIDs. With cataract surgery volumes growing globally and increasing use in diabetic macular edema, technology transfer for nepafenac addresses a substantial and expanding market.
What Is Included in the Technology Transfer Package
Master Batch Formula
Complete formula with API and excipient quantities, equipment specifications, and step-by-step manufacturing instructions with process flow charts.
Manufacturing Process
Detailed process description with critical process parameters, in-process controls, and validated acceptable ranges for scale-up.
Stability Data
Accelerated and long-term stability results under ICH conditions with degradation analysis and shelf-life projections.
CTD/eCTD Dossier
Pre-formatted regulatory templates for FDA, EMA, Health Canada, TGA, and PMDA submissions — ICH and PIC/S compliant.
Analytical Methods
Validated procedures for assay, impurity profiling, sterility, particulate matter, osmolality, pH, and complete release testing.
Expert Consultation
Direct access to Burrard's ophthalmic formulation scientists and regulatory specialists for hands-on technical guidance.
Regulatory Pathway
Burrard Pharmaceuticals provides CTD/eCTD dossier templates pre-formatted for submissions to FDA, EMA, Health Canada, TGA, and PMDA. All documentation complies with ICH guidelines and PIC/S standards. Our regulatory team can help adapt documentation for additional national authorities in your target markets.
Target Markets
Nepafenac Ophthalmic technology transfer is particularly suited for pharmaceutical manufacturers in regions with growing ophthalmic care infrastructure: Eastern Europe, Middle East, CIS countries, Latin America, Southeast Asia, and Africa — markets with increasing demand for affordable, locally produced ophthalmic treatments.
Why Choose Burrard Pharmaceuticals
- Established since 2005: Nearly two decades of CDMO experience from Vancouver, Canada.
- GMP-compliant know-how: All documentation meets FDA, EMA, Health Canada, TGA, PMDA, PIC/S, and WHO GMP standards.
- Complete integrated package: Master formula through regulatory dossier in one delivery.
- Fast delivery: 2–21 business days via our secure digital portal.
- Ongoing support: Expert consultation hours included, plus 24/7 technical support after transfer.
- 70+ molecule portfolio: Cross-therapeutic expertise from oncology to ophthalmics.