Saxagliptin + Metformin (XR) tablets

Form: Tablets XR

Strength: 2.5 mg/1000 mg, 5 mg/500 mg, 5 mg/1000 mg

Reference Brands: Kombiglyze XR®(EU & US)

Category: Diabetes

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.