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.
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:
What to include when you enquire
- Destination market — determines which manufacturers hold the right site-level approvals
- First order quantity and estimated annual volume
- Whether you need a registration dossier or the product is already registered
- Packaging, labelling and language requirements
- Incoterms and required 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. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.
Request a quote for Saxagliptin + Metformin (Xr) Tablets →The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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