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Cardiovascular

Empagliflozin

Jardiance®

Empagliflozin is an SGLT2 inhibitor originally developed for diabetes, now with strong evidence for heart failure and renal protection.

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Product Details

Dosage FormOral Tablet (Film-Coated)
Strength10 mg, 25 mg
StorageStore at 25°C.
CategoryCardiovascular
AvailabilityAvailable for Transfer

Indication

Type 2 diabetes; heart failure (with or without diabetes); chronic kidney disease.

Mechanism of Action

Inhibits sodium-glucose co-transporter 2 (SGLT2) in the proximal renal tubule, reducing glucose reabsorption, promoting glycosuria, and providing cardio- and nephroprotective effects.

Technology Transfer Package

Each Burrard Pharmaceuticals technology transfer package for Empagliflozin 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 Empagliflozin 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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