Product/Composition:- | Linagliptin Tablets |
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Strength:- | 5 mg |
Form:- | Tablets |
Reference Brands:- | Tradjenta®(EU & US) |
MOQ | As per the manufacturer batch size |
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Linagliptin is a DPP-4 inhibitor that increases incretin levels, enhancing insulin secretion and lowering glucagon in a glucose-dependent manner. Benefits include improved glycemic control, low hypoglycemia risk, once-daily dosing, and weight neutrality. Approved in both the USA and EU, it's suitable as monotherapy or in combination therapy.
Linagliptin tablets are approved for the treatment of type 2 diabetes in both the USA and EU. In the USA, they are marketed as Tradjenta®, approved via a New Drug Application (NDA) and regulated under 21 CFR, with labeling for risks like pancreatitis and joint pain. Manufacturers must ensure GMP compliance and implement post-marketing surveillance. In the EU, Linagliptin is authorized as Trajenta® via the centralized procedure, requiring CTD-format submission, a Risk Management Plan (RMP), PSURs, and full pharmacovigilance. For regulatory support, dossier preparation, or B2B sourcing, visit PharmaTradz.com.