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) tablets is available in Tablets XR and strengths such as 2.5 mg/1000 mg, 5 mg/500 mg, 5 mg/1000 mg. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Saxagliptin + Metformin (XR) tablets is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.
| Technical Specifications & Supply Details | |
|---|---|
| Lead Time | 7 to 60 days (depending on batch size & schedule) |
| MOQ | As per manufacturer’s batch size |
| COA | Available with every batch |
| Regulatory Dossier / DMF | Available upon request |
| Export Documentation | FSC, COA, Manufacturing License, Product Permission |
| Standards | IP, BP, USP |
| Certifications | WHO-GMP, EU-GMP, USFDA (as applicable) |
Saxagliptin + Metformin (XR) tablets can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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.
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