Linagliptin + Metformin IR & XR Tablets

Form: Tablets(IR & XR)

Strength: 2.5 mg / 1000 mg, 2.5 mg / 850 mg, 2.5 mg / 500 mg

Reference Brands: Jentadueto® / Jentadueto XR®

Category: Diabetes

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.