Saxagliptin + Metformin (XR) tablets bulk supplier for pharma manufacturers

Saxagliptin + Metformin (Xr) Tablets Suppliers & Bulk Manufacturers

Available Forms: Tablets XR

Available Strengths: 2.5 mg/1000 mg, 5 mg/500 mg, 5 mg/1000 mg

Reference Brands: Kombiglyze XR®(EU & US)

Category: Diabetes

Saxagliptin + Metformin (XR) combines a DPP-4 inhibitor and a biguanide. Saxagliptin enhances incretin activity, boosting insulin and reducing glucagon. Metformin decreases hepatic glucose production. Together, they improve glycemic control with low hypoglycemia risk, weight neutrality, and convenient once-daily dosing—ideal for managing type 2 diabetes effectively.

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Product Description: Saxagliptin + Metformin extended-release tablets are approved for type 2 diabetes treatment in both the USA and EU. In the US, they are marketed as Kombiglyze XR®, approved via an NDA and regulated under 21 CFR, with mandatory labeling for lactic acidosis risk and heart failure. Compliance with GMP and post-marketing pharmacovigilance is essential. In the EU, the product is known as Komboglyze® and is authorized via the centralized procedure. It requires a CTD format, Risk Management Plan (RMP), PSURs, and full pharmacovigilance compliance. For regulatory support and sourcing, visit PharmaTradz.com.

Saxagliptin + Metformin (Xr) Tablets — third party manufacturing & bulk supply

Saxagliptin + Metformin (Xr) Tablets is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.

Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.

Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Saxagliptin + Metformin (Xr) Tablets is supplied as Tablets XR — an oral solid dosage form, so the indicative MOQ is 200,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Saxagliptin + Metformin (Xr) Tablets listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Saxagliptin + Metformin (XR) tablets is listed as Tablets XR in 2.5 mg/1000 mg, 5 mg/500 mg, 5 mg/1000 mg. Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

Saxagliptin + Metformin (XR) tablets is referenced against Kombiglyze XR®(EU & US). Reference brands are shown for identification only and remain the property of their respective trademark owners.