Regular Insulin (Human) Injectable bulk supplier for pharma manufacturers

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.

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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.

Frequently Asked Questions

Yes, Regular Insulin (Human) Injectable is available with DMF and other regulatory documents such as COA and MSDS. These can be provided upon request for qualified buyers.

Absolutely. Sample requests are accepted for formulation trials and quality checks. Please submit an enquiry to initiate the process.

Our manufacturing partners are GMP-certified and comply with ISO and WHO standards, ensuring global quality benchmarks.

Lead times vary based on quantity and destination, but most orders are fulfilled within 1–3 weeks. Express shipping options are available.

Yes, Regular Insulin (Human) Injectable is exported to over 30 countries across Asia, Africa, Europe, and Latin America. We support documentation for customs and regulatory clearance.

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