Product/Composition:- | Saxagliptin + Metformin (XR) tablets |
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Strength:- | 2.5 mg/1000 mg, 5 mg/500 mg, 5 mg/1000 mg |
Form:- | Tablets XR |
Reference Brands:- | Kombiglyze XR®(EU & US) |
MOQ | As per the manufacturer batch size |
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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.
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.