Linagliptin + Metformin Ir & Xr Tablets Suppliers & Bulk Manufacturers
Available Forms: Tablets(IR & XR)
Available Strengths: 2.5 mg / 1000 mg, 2.5 mg / 850 mg, 2.5 mg / 500 mg
Reference Brands: Jentadueto® / Jentadueto XR®
Category:
Diabetes
Linagliptin boosts insulin and lowers glucagon via DPP-4 inhibition, while Metformin reduces liver glucose output and improves insulin sensitivity. Together, they offer effective glycemic control with low hypoglycemia risk, weight neutrality, and flexible IR/ER dosing—ideal for managing type 2 diabetes in monotherapy or combination therapy.
Linagliptin + Metformin IR & XR Tablets is available in Tablets(IR & XR)
and strengths such as 2.5 mg / 1000 mg, 2.5 mg / 850 mg, 2.5 mg / 500 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, Linagliptin + Metformin IR & 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) |
Linagliptin + Metformin IR & 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.
Product Description:
Linagliptin + Metformin (IR/ER) tablets are approved for type 2 diabetes management in both the USA and EU. In the USA, they are marketed as Jentadueto® (IR) and Jentadueto XR® (ER), approved via NDA under 21 CFR, with labeling for lactic acidosis and pancreatitis risks. GMP compliance and post-marketing surveillance are required. In the EU, the same formulations are marketed under Jentadueto®, authorized through the centralized procedure. Regulatory requirements include CTD submission, RMP, PSURs, and strict pharmacovigilance. For regulatory guidance, dossier support, or global B2B sourcing, visit PharmaTradz.com.
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