
Regular Insulin (Human) Injectable Suppliers & Bulk Manufacturers
Available Forms: Vials/pens
Available Strengths: U-100 (100 units/mL)
Reference Brands: Humulin R, Novolin R, Admelog R(US); Actrapid, Humulin R, Monotard R(EU)
Category: Diabetes
Regular Insulin (Human) Injectable is available in Vials/pens and strengths such as U-100 (100 units/mL). Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Regular Insulin (Human) Injectable is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.
Technical Specifications & Supply Details | |
---|---|
Lead Time | 7 to 60 days (depending on batch size & schedule) |
MOQ | As per manufacturer’s batch size |
COA | Available with every batch |
Regulatory Dossier / DMF | Available upon request |
Export Documentation | FSC, COA, Manufacturing License, Product Permission |
Standards | IP, BP, USP |
Certifications | WHO-GMP, EU-GMP, USFDA (as applicable) |
Regular Insulin (Human) Injectable can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Product Description: 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.
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