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
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.
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.
|
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) |
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.
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