Linagliptin Tablets

Form: Tablets

Strength: 5 mg

Reference Brands: Tradjenta®(EU & US)

Category: Diabetes

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.