Regular Insulin (Human) Injectable

Form: Vials/pens

Strength: U-100 (100 units/mL)

Reference Brands: Humulin R, Novolin R, Admelog R(US); Actrapid, Humulin R, Monotard R(EU)

Category: Diabetes

Regulatory approval for Regular Insulin (Human) in the EU and US ensures safety, efficacy, and quality. In the EU, brands like Actrapid and Humulin R are approved by EMA, including biosimilars that enhance access. In the US, FDA-approved options include Humulin R, Novolin R, and biosimilars such as Admelog R. Both regions require comprehensive dossiers demonstrating biosimilarity, manufacturing standards, and post-marketing surveillance to maintain high-quality standards. For detailed information on regulatory processes, visit PharmaTradz, your trusted source for pharmaceutical dossier support and compliance solutions.