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Diabetes & GLP-1

Insulin Glargine

Lantus® / Toujeo®

Insulin Glargine is a long-acting insulin analog providing basal insulin coverage for approximately 24 hours with a relatively flat pharmacokinetic profile.

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Product Details

Dosage FormSC Injectable (Prefilled Pen / Vial)
Strength100 units/mL (Lantus); 300 units/mL (Toujeo)
StorageStore at 2–8°C. After first use, store at room temperature for up to 28 days (Lantus) or 56 days (Toujeo).
CategoryDiabetes & GLP-1
AvailabilityAvailable for Transfer

Indication

Type 1 diabetes mellitus; type 2 diabetes mellitus (basal insulin for glycemic control).

Mechanism of Action

Long-acting insulin analog that forms microprecipitates at injection site due to low solubility at physiological pH, providing slow, prolonged absorption and relatively flat 24-hour activity.

Technology Transfer Package

Each Burrard Pharmaceuticals technology transfer package for Insulin Glargine 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 Dossier

Market-ready regulatory dossier sections for a named territory, scoped per programme.

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 Insulin Glargine Technology Transfer?

Scope and timing for the complete know-how package are confirmed in writing after a confidentiality agreement. Book a consultation to discuss your specific requirements.

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