What Is Cyclosporine Ophthalmic?
Cyclosporine ophthalmic is a topical immunomodulator that increases tear production in patients whose tear production is suppressed due to ocular inflammation associated with dry eye disease. It works by inhibiting calcineurin in T-lymphocytes, reducing inflammatory cytokine production on the ocular surface. Available as an oil-in-water emulsion (Restasis 0.05%) and a nanomicellar aqueous solution (Cequa 0.09%), each requiring distinct formulation expertise. Burrard Pharmaceuticals offers complete technology transfer know-how packages for Cyclosporine Ophthalmic manufacturing, including master batch formulas, manufacturing process parameters, stability data, and CTD/eCTD regulatory dossier templates.
Manufacturing Overview
Cyclosporine 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
- Emulsion stability with cyclosporine's extreme hydrophobicity (logP ~3)
- Nanomicellar formulation technology for aqueous-based delivery
- Particle size distribution control critical for ocular tolerability
- Preservative-free multi-dose or single-unit packaging systems
- Sterilization method selection (terminal vs. aseptic) based on formulation type
- Drug substance polymorphism control affecting dissolution and bioavailability
💡 Why Cyclosporine Ophthalmic Is a Valuable Technology Transfer Opportunity
Cyclosporine ophthalmic has become the standard of care for moderate-to-severe dry eye disease. With Restasis losing exclusivity and the growing recognition of dry eye as a treatable condition, demand for affordable generic alternatives continues to grow globally.
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
Cyclosporine 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.