At 2â8 Â°C in the original carton, protected from light.

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

Omalizumab-igec (Omlyclo) is the first biosimilar of omalizumab (Xolair), an anti-IgE antibody for severe allergic asthma, chronic spontaneous urticaria, nasal polyps and food allergy. It is given by injection every two or four weeks in 75 mg and 150 mg pre-filled syringes, stored at 2–8 °C. Ask PharmaTradz for a quote; we confirm the manufacturer, registration documents and lead time for your country.

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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.

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.

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Usually answered within 48 hours, with matched manufacturers, indicative prices and document status.

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