Xolair (omalizumab): refrigerated anti-IgE injection for allergic asthma, urticaria and nasal polyps, supplied to importers and tender desks
M Care Exports supplies Xolair (omalizumab), the anti-IgE monoclonal antibody, to hospital pharmacies, ministry of health tender desks and licensed importers in the GCC, Africa and the UK. It is a refrigerated subcutaneous biologic. M Care is a merchant exporter, so we source the originator product and, where your regulator allows it, the Omlyclo biosimilar, and we quote per destination.
Omalizumab exporter and bulk supplier from India.
I'm looking for Xolair, or a partner who can supply it across a tender. That is how most enquiries open. Tell us the presentation (150 mg lyophilised vial, or 75 mg, 150 mg or 300 mg prefilled syringe), the quantity per delivery, and whether your regulator registers the originator, the biosimilar or both. We confirm the route, the documents your authority asks for and the refrigerated lane before we quote. Because Xolair is a biologic with a boxed anaphylaxis warning and a supervised start, we agree dispatch frequency and shelf-life at arrival up front.
Source
WHO-GMP-certified Indian manufacturing line, named on every quote.
Minimum order
No blanket MOQ. Set by the source manufacturer's minimum batch-release quantity for the strength and pack ordered.
Pricing
On request. Indicative FOB or CIF quote, formal proforma on confirmation.
Incoterms
EXW, FOB, CIF, CIP or DAP.
Payment
Letter of credit (sight or usance) and telegraphic transfer.
Documentation
WHO-GMP certificate of the source line, product-specific CoPP, batch CoA, method of analysis, Free Sale Certificate, Certificate of Origin, CTD or eCTD dossier. On request.
Shelf-life
Minimum remaining shelf-life agreed per order and confirmed on the proforma.
Response
Availability and CoPP status within two working days; pre-alert documents before dispatch.
Anti-IgE monoclonal antibody, sourced and documented for export.
Omalizumab is a recombinant humanised anti-IgE antibody given by subcutaneous injection. The US label (DailyMed, Genentech) lists four indications: moderate to severe persistent asthma from 6 years of age, add-on maintenance for chronic rhinosinusitis with nasal polyps in adults, IgE-mediated food allergy from 1 year of age to reduce reactions after accidental exposure, and chronic spontaneous urticaria from 12 years of age in patients still symptomatic on H1 antihistamines. The EU authorisation (Novartis Europharm, granted 25 October 2005) covers allergic asthma, nasal polyps and chronic spontaneous urticaria. US presentations are a 150 mg lyophilised powder vial, plus 75 mg/0.5 mL, 150 mg/mL and 300 mg/2 mL prefilled syringes and autoinjectors. The EU page lists a vial and a prefilled syringe. Urticaria dosing is 150 mg or 300 mg every 4 weeks on the US label, independent of IgE level and body weight.
Active ingredient
Omalizumab. Anti-IgE monoclonal antibody.
Forms and strengths
150 mg lyophilised powder single-dose vial; 75 mg/0.5 mL prefilled syringe; 150 mg/mL prefilled syringe; 300 mg/2 mL prefilled syringe.
Indications
Omalizumab is a recombinant humanised anti-IgE monoclonal antibody for allergic asthma, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria and, on the US label, IgE-mediated food allergy. Supplied as Xolair and as the Omlyclo biosimilar where registered.
Administration
Subcutaneous. Powder for solution for injection (vial) and solution for injection (prefilled syringe or autoinjector).
Documentation
Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.
Hospital pharmacies, licensed importers and tender desks across our export markets.
India is our origin. We do not sell into the Indian market.
Buyers are hospital pharmacies serving allergy, respiratory and dermatology clinics, ministry of health and hospital tender desks, and licensed importers and distributors who hold the registration or work under an import permit. We hear two phrases most: I'm looking for omalizumab for a named formulary, and we need a partner for ongoing supply of a refrigerated biologic. Destination regulators differ on whether the originator, the biosimilar or both are registered, so we ask for that first.
GCC registration routes
Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.
UK unlicensed routes
Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.
Tender desks
Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.
Dossier support
CTD documentation from the sourcing manufacturer, compiled for your regulator's format.
What the dispensing pharmacist checks on omalizumab.
Xolair carries a boxed warning for anaphylaxis. The US label says it can occur after the first dose or more than a year into treatment, that therapy should start in a healthcare setting with observation afterwards, and that patients must be taught the warning signs. Home use is a prescriber decision: the label sets criteria including no prior anaphylaxis to Xolair, at least three supervised doses without hypersensitivity, and the ability to recognise and treat anaphylaxis and to inject correctly. The prefilled syringe may be self-administered from 12 years under adult supervision, with a caregiver injecting children aged 1 to 11. The autoinjector is for ages 12 and over. Food allergy dosing runs from 75 mg to 600 mg every 2 or 4 weeks and is set from pre-treatment serum IgE and body weight, so pack-size planning differs from urticaria, where the 150 mg or 300 mg every 4 weeks dose ignores both. Syringes and autoinjectors are stored at 2 to 8 degrees C in the carton, protected from direct sunlight, never frozen. Total time out of the refrigerator must not exceed 2 days, and product left above 25 degrees C is not to be used.
The documentation pack a regulator actually asks for.
For the importer's regulator we provide batch certificates of analysis, the originator's or manufacturer's regulatory documentation as the destination requires, and temperature records for each shipment. Xolair is a biologic, so the 2 to 8 degrees C chain matters at every handover. The US label states the 150 mg vial ships at controlled ambient temperature (up to 30 degrees C) and is then stored refrigerated in its carton, while syringes and autoinjectors tolerate no more than 2 days in total out of the refrigerator. We validate the lane against these limits and give you the logger data on arrival. On the brand question, the EU lists Omlyclo (Celltrion Healthcare Hungary, authorised 16 May 2024) as a biosimilar of Xolair, in a prefilled syringe, and DailyMed carries an Omlyclo (omalizumab-igec) label from Celltrion USA. Registration status in Gulf and African markets varies, so we do not assume it. We confirm it on the destination regulator's register before quoting.
CoA and MoA, per batch
Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.
CoPP, WHO-GMP, MFG licence
Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.
CTD Module 3
Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.
Pack insert, labels, artwork
Destination-language patient information and labelling to the local regulator's standard, locked before shipment.
Pharmacovigilance
A named PV contact arranged in the destination market where the registration requires one.
Adjacent lines procurement desks order alongside omalizumab.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Form and strength, pack preference, destination market and indicative volume for omalizumab.
- We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
- Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
- Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
- After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Omalizumab supply, the specific questions.
What is the Xolair price for an importer or tender?
We do not publish a Xolair price, because the landed cost depends on facts that change by order. These are originator or biosimilar, the presentation and strength, the quantity per delivery, the destination's registration route, the refrigerated lane and the Incoterms. A 150 mg vial and a 300 mg prefilled syringe are not priced alike. M Care Exports quotes per destination once you send the presentation, volume, country and whether your authority requires a registered product or accepts a named-patient or tender import.
Do you supply Xolair 150 mg injection, and in which presentations?
Yes, we quote Xolair 150 mg. The US label lists a 150 mg lyophilised powder vial for reconstitution and a 150 mg/mL prefilled syringe or autoinjector, alongside 75 mg/0.5 mL and 300 mg/2 mL prefilled formats. The EU page for Xolair lists a powder and solvent vial and a prefilled syringe. Tell us which presentation your regulator and clinic use, because they are not interchangeable at pharmacy level.
What is the Xolair dose for chronic urticaria?
On the US label, chronic spontaneous urticaria is treated with 150 mg or 300 mg subcutaneously every 4 weeks, and the dose does not depend on IgE level or body weight. The indication is adults and adolescents aged 12 and over who remain symptomatic despite H1 antihistamines. In the EU it is an add-on to H1 antihistamines from age 12. The prescriber sets the dose, so procurement should plan for both 150 mg and 300 mg packs.
Is Xolair approved for food allergy, and can you supply it for that use?
On the US label, Xolair is indicated for IgE-mediated food allergy from 1 year of age, to reduce allergic reactions, including anaphylaxis, after accidental exposure, and it is used with food allergen avoidance. The EU page we checked lists asthma, nasal polyps and urticaria only. Food allergy dosing is 75 mg to 600 mg every 2 or 4 weeks, set from serum IgE and body weight. We supply the product, and your local label decides which indications apply.
Is there a generic or biosimilar of Xolair?
There is no small-molecule generic, because Xolair is a monoclonal antibody. The EU authorised Omlyclo from Celltrion Healthcare Hungary on 16 May 2024 as a biosimilar of Xolair, and DailyMed carries an Omlyclo (omalizumab-igec) label for the US. We have not confirmed an Indian-market omalizumab generic from a regulator page, so we quote the originator and the registered biosimilar where your authority accepts it.
How is Xolair stored and shipped, and where do I find the FDA label?
The FDA label is on DailyMed under Genentech. Syringes and autoinjectors are stored at 2 to 8 degrees C in the carton, away from direct sunlight, and must not be frozen. Total time out of the refrigerator may not exceed 2 days, and product left above 25 degrees C is not used. The 150 mg vial ships at up to 30 degrees C and is then stored refrigerated. We ship in validated refrigerated packs with loggers and agree arrival shelf-life before dispatch.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-11-07.
This page is sourcing information for licensed importers, hospital procurement and tender desks. It is not medical, pharmaceutical or prescribing advice, and it is not a substitute for the approved product information of the line on your order. See our full disclaimer.
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