Insulin Glargine (Lantus) Injectable

Form: Vials/pens

Strength: U-100, U-300

Reference Brands: Lantus, Basaglar, Toujeo(US); Lantus, Toujeo(EU)

Category: Diabetes

nsulin Glargine (Lantus) is a long-acting basal insulin approved in the EU and US for managing diabetes. In the EU, it is regulated by the EMA, with Sanofi’s Lantus and Toujeo holding approved dossiers demonstrating safety and efficacy. In the US, the FDA approved Lantus and biosimilars like Basaglar, based on comprehensive clinical data and biosimilarity studies. Both regions require detailed dossiers and ongoing pharmacovigilance for post-marketing surveillance. For expert support with regulatory dossiers and compliance, visit PharmaTradz, your trusted partner in pharmaceutical regulatory services.