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Diabetes & GLP-1

Sitagliptin

Januvia®

Sitagliptin is a DPP-4 inhibitor for type 2 diabetes. It increases active incretin levels, stimulating insulin release and reducing glucagon in a glucose-dependent manner.

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Product Details

Dosage FormOral Tablet (Film-Coated)
Strength25 mg, 50 mg, 100 mg
StorageStore at 20–25°C.
CategoryDiabetes & GLP-1
AvailabilityAvailable for Transfer

Indication

Type 2 diabetes mellitus (adjunct to diet and exercise, as monotherapy or in combination with metformin, sulfonylureas, or insulin).

Mechanism of Action

Selectively inhibits dipeptidyl peptidase-4 (DPP-4), preventing the degradation of incretin hormones GLP-1 and GIP. This increases insulin secretion and decreases glucagon in a glucose-dependent manner.

Technology Transfer Package

Each Burrard Pharmaceuticals technology transfer package for Sitagliptin 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 Sitagliptin 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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