Vildagliptin

Sinonimi: (2S)-1-{2-[(3-hydroxyadamantan-1-yl)amino]acetyl}pyrrolidine-2-carbonitrile, Galvus, Eucreas, LAF237, Vildagliptin

Vildagliptin is a potent, orally active dipeptidyl peptidase-4 (DPP-4) inhibitor used in the management of type 2 diabetes. It works by prolonging the action of incretin hormones, thereby enhancing insulin secretion and suppressing glucagon release in a glucose-dependent manner. The compound is widely recognized for its favorable safety profile and low risk of hypoglycemia when used as monotherapy or in combination with other antidiabetic agents.

First approved in Europe in 2007, Vildagliptin has since become a key component in fixed-dose combinations such as Galvus Met (with metformin). Its API is manufactured under strict cGMP conditions, and high-purity grades are available to support formulation development, clinical trials, and commercial production.

The product is typically supplied as a white to off-white crystalline powder with an assay of ≥99.0% (HPLC). It is freely soluble in water and common organic solvents, making it suitable for immediate-release and fixed-dose combination tablets.

Product Overview & Composition

Vildagliptin is a synthetic small-molecule API belonging to the gliptin class. Its chemical structure features a pyrrolidine-2-carbonitrile moiety linked to a hydroxyadamantyl aminoacetyl group. The active pharmaceutical ingredient is manufactured through a multi-step synthesis, followed by purification and micronization to meet pharmaceutical specifications. Each batch is tested for identity, purity, and residual solvents to ensure compliance with ICH guidelines.

Applications & Product Lines

• Type 2 diabetes treatment: Used as monotherapy or in combination with metformin, sulfonylureas, or insulin.
• Fixed-dose combinations: Co-formulated with metformin (e.g., Galvus Met) for improved glycemic control.
• Clinical research: Investigated in studies exploring beta-cell function and cardiovascular outcomes.
• Formulation development: Suitable for immediate-release tablets and orally disintegrating tablets.
• Generic drug manufacturing: High-purity API for generic equivalents of Galvus and Eucreas.

Quality Control Standards

Bulk Packaging & Supply

• Confezionamento: 25 kg net in fiber drum with double polyethylene bags, or as per customer request.
• MOQ: 1 kg for trial orders; 25 kg for commercial orders.
• Tempi di consegna: 3-5 business days (stock items)
• Documentazione: COA, MSDS, TDS, and cGMP declaration available upon request.

Frequently Asked Questions

What is the minimum order quantity (MOQ)?

We offer flexible MOQs: 1 kg for trial orders and 25 kg for commercial orders. Larger quantities can be negotiated.

What is the typical lead time?

For stock items, lead time is 3-5 business days. Custom synthesis or large-scale orders may take 3-5 business days.

Do you provide a Certificate of Analysis (COA) and samples?

Yes, a COA is available for every batch. Samples (typically 10–50 g) can be provided for evaluation, though shipping costs may apply.

Contact & Ordering Information

• Company: LyvBio Co., Ltd.
• Address: Room 5-0203, Courtyard 205, Lianhu District, Xi’an, Shaanxi, China
• Email: info@lyvbio.com
• Phone: +86-29-65816888

Learn more about our quality control and certifications, or send us your specification for a quotation.