Saxagliptin tablets

Form: Tablets

Strength: 2.5 mg, 5 mg

Reference Brands: Onglyza®(US & EU)

Category: Diabetes

Saxagliptin oral tablets, marketed as Onglyza®, are FDA-approved in the USA and EMA-authorized in the EU for managing type 2 diabetes. Also available in combination with metformin as Kombiglyze XR® (USA) and Komboglyze® (EU), these DPP-4 inhibitors require full compliance with GMP, pharmacovigilance, and post-marketing safety reporting. US regulations mandate NDA approval under 21 CFR, with heart failure warnings. In the EU, approval follows the centralized procedure with CTD submissions and Risk Management Plans (RMPs). For compliant sourcing, regulatory support, or B2B pharmaceutical trade, visit PharmaTradz.com – your trusted partner in global pharma solutions.