Omalizumab‑Igec 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

omalizumab‑igec is available in Pre filled syringe and strengths such as 75 mg/0.5 mL and 150 mg/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, omalizumab‑igec is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

omalizumab‑igec 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.

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. For licensing procedures, approved dossiers, and regulatory updates, visit Pharmatradz. Ensuring regulatory compliance guarantees access to affordable, high-quality biosimilar therapies for allergy and asthma management worldwide.