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Insulin Glargine (Lantus) injectable bulk supplier for pharma manufacturers

Insulin Glargine (Lantus) Injectable U-100, U-300 Suppliers & Bulk Manufacturers

Available Forms: Vials/pens

Available Strengths: U-100, U-300

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

Category: Diabetes

Insulin Glargine (Lantus) provides a steady, long-lasting release of insulin, mimicking natural basal insulin to regulate blood sugar levels throughout the day. Its benefits include consistent glucose control, reduced risk of hypoglycemia, and improved insulin adherence, making it effective for managing both type 1 and type 2 diabetes.

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📘 Sourcing Guide

Product Description:

Insulin 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.

Insulin Glargine (Lantus) Injectable — third party manufacturing & bulk supply

Insulin Glargine (Lantus) Injectable U-100, U-300 is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.
Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.
Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

What to include when you enquire

  • Destination market — determines which manufacturers hold the right site-level approvals
  • First order quantity and estimated annual volume
  • Whether you need a registration dossier or the product is already registered
  • Packaging, labelling and language requirements
  • Incoterms and required shelf life

Manufacturers of Insulin Glargine (Lantus) Injectable listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.

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Frequently Asked Questions

Insulin Glargine is a synthetic human insulin analogue produced by recombinant DNA technology using Escherichia coli or Saccharomyces cerevisiae (yeast) cells. The amino acid sequence is modified to provide prolonged, consistent insulin release after injection.

The main trade name of Insulin Glargine is Lantus®.

Other marketed brand names include

The original manufacturer of Lantus® is Sanofi-Aventis.

Other companies manufacturing biosimilar versions include

The generic name is Insulin Glargine.

The brand name is Lantus® (by Sanofi).

Common biosimilar brand names:

Lantus® is manufactured by Sanofi-Aventis at multiple global facilities, including sites in Frankfurt (Germany), Paris (France), and India (Sanofi India Ltd., Goa).

Biosimilars are also manufactured in the

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