What Is Netarsudil & Latanoprost Ophthalmic?
Netarsudil and latanoprost ophthalmic solution is a fixed-dose combination that pairs the ROCK inhibitor netarsudil (0.02%) with the prostaglandin analog latanoprost (0.005%). This combination addresses IOP reduction through four complementary mechanisms: increased trabecular outflow (netarsudil), increased uveoscleral outflow (latanoprost), reduced aqueous production (netarsudil), and decreased episcleral venous pressure (netarsudil). Clinical trials demonstrated superior IOP lowering compared to either component alone. Burrard Pharmaceuticals offers complete technology transfer know-how packages for Netarsudil & Latanoprost Ophthalmic manufacturing, including master batch formulas, manufacturing process parameters, stability data, and CTD/eCTD regulatory dossier templates.
Manufacturing Overview
Netarsudil & Latanoprost 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
- Dual-API compatibility and co-stability in single formulation
- Different pH optima for each API requiring compromise formulation
- Differential degradation kinetics management over shelf life
- Preservative system effective for both components
- Sterile manufacturing with dual analytical release testing
- Regulatory complexity of fixed-dose combination dossier preparation
💡 Why Netarsudil & Latanoprost Ophthalmic Is a Valuable Technology Transfer Opportunity
Fixed-dose combinations improve patient compliance by reducing drop burden, a critical factor in glaucoma management where adherence directly impacts disease progression. The combination of two distinct mechanisms in one formulation commands premium pricing and growing market share.
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
Netarsudil & Latanoprost 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.