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Ophthalmics

Cyclosporine (Ophthalmic)

Restasis® / Cequa®

Ophthalmic cyclosporine is an immunomodulator that increases tear production in patients with dry eye disease associated with ocular inflammation.

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Product Details

Dosage FormOphthalmic Emulsion / Solution (Single-Use Vials)
Strength0.05% (Restasis); 0.09% (Cequa)
StorageStore at 15–25°C. Do not freeze.
CategoryOphthalmics
AvailabilityAvailable for Transfer

Indication

Dry eye disease (to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation).

Mechanism of Action

Calcineurin inhibitor that suppresses T-cell activation and reduces inflammatory cytokine production in the lacrimal gland, restoring tear production.

Technology Transfer Package

Each Burrard Pharmaceuticals technology transfer package for Cyclosporine (Ophthalmic) 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 Templates

Market-ready regulatory dossier templates — available through Burrard Intelligence subscription.

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 Cyclosporine (Ophthalmic) Technology Transfer?

Our team can deliver the complete know-how package within 2–21 business days. Book a consultation to discuss your specific requirements.

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