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omalizumab‑igec bulk supplier for pharma manufacturers

Omalizumab‑Igec 75 mg/0.5 mL and 150 mg/mL Suppliers & Bulk Manufacturers

Available Forms: Pre filled syringe

Available Strengths: 75 mg/0.5 mL and 150 mg/mL

Reference Brands: Xolair, Omlyclo - a Biosimilar to Xolair

Category: Biosimilars

Omlyclo, a biosimilar to Xolair (omalizumab), blocks immunoglobulin E (IgE), reducing allergic reactions and inflammation. It effectively treats asthma, chronic idiopathic urticaria, and other allergies. Benefits include similar efficacy, lower costs, increased access, and improved allergy management when used under medical supervision.

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Product Description:

Omlyclo, a biosimilar to Xolair (omalizumab), is regulated in the EU and US, supported by dossiers demonstrating biosimilarity, safety, efficacy, and manufacturing quality compliant with GMP and MDR standards. In the US, FDA approval involves extensive comparability data, clinical validation, and safety assessments. In the EU, CE marking certifies conformity with MDR. These biosimilars undergo validation, stability testing, and audits, with detailed documentation including biosimilarity data, clinical trial results, safety profiles, and manufacturing practices.

Omalizumab‑Igec — third party manufacturing & bulk supply

Omalizumab‑Igec 75 mg/0.5 mL and 150 mg/mL 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

Indicative minimum order quantity

Omalizumab‑Igec is supplied as Pre filled syringe — an injectable dosage form, so the indicative MOQ is 50,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Omalizumab‑Igec 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

omalizumab‑igec is listed as Pre filled syringe in 75 mg/0.5 mL and 150 mg/mL. Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

omalizumab‑igec is referenced against Xolair, Omlyclo - a Biosimilar to Xolair. Reference brands are shown for identification only and remain the property of their respective trademark owners.

omalizumab‑igec is catalogued under Biosimilars on PharmaTradz. Related products within the same category are listed at the foot of this page.

Submit an RFQ stating your destination market, required quantity and whether you need stock supply, third party manufacturing or dossier licensing. Matched suppliers respond with pricing, MOQ and lead times.

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