What Is Netarsudil Ophthalmic?
Netarsudil is a Rho kinase (ROCK) inhibitor and norepinephrine transporter (NET) inhibitor that reduces intraocular pressure through a unique triple mechanism: increasing trabecular meshwork outflow facility, reducing aqueous humor production, and decreasing episcleral venous pressure. This mechanism is distinct from and complementary to prostaglandin analogs, making it valuable as both monotherapy and adjunctive therapy for glaucoma. Burrard Pharmaceuticals offers complete technology transfer know-how packages for Netarsudil Ophthalmic manufacturing, including master batch formulas, manufacturing process parameters, stability data, and CTD/eCTD regulatory dossier templates.
Manufacturing Overview
Netarsudil 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
- Complex organic synthesis with aminoisoquinoline core structure
- Low-concentration formulation (0.02%) with precise potency control
- Chemical stability management of the ester prodrug linkage
- Sterile ophthalmic manufacturing with particulate matter control
- Preservative compatibility and antimicrobial effectiveness
- Light-sensitive formulation requiring amber container packaging
💡 Why Netarsudil Ophthalmic Is a Valuable Technology Transfer Opportunity
Netarsudil represents the first new mechanism of action for glaucoma in over 20 years. As the only approved ROCK inhibitor in many markets, early technology transfer positioning allows manufacturers to capitalize on growing physician adoption and combination therapy prescribing patterns.
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 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.