Product/Composition:- | Regular Insulin (Human) Injectable |
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Strength:- | U-100 (100 units/mL) |
Form:- | Vials/pens |
Reference Brands:- | Humulin R, Novolin R, Admelog R(US); Actrapid, Humulin R, Monotard R(EU) |
MOQ | As per the manufacturer batch size |
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Regular Insulin (Human) works by mimicking natural insulin to regulate blood glucose levels, reducing hyperglycemia in diabetics. Its benefits include rapid blood sugar control, predictable action, and widespread availability, making it essential for managing both type 1 and type 2 diabetes effectively.
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.