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
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. 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.
Frequently Asked Questions
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