Product/Composition:- | Linagliptin + Metformin IR & XR Tablets |
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Strength:- | 2.5 mg / 1000 mg, 2.5 mg / 850 mg, 2.5 mg / 500 mg |
Form:- | Tablets(IR & XR) |
Reference Brands:- | Jentadueto® / Jentadueto XR® |
MOQ | As per the manufacturer batch size |
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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/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.