Nucala (mepolizumab) is an anti-IL-5 antibody for severe eosinophilic asthma, nasal polyps, eosinophilic COPD, EGPA and hypereosinophilic syndrome, supplied as a 100 mg vial, a 100 mg pen or syringe and a 40 mg paediatric syringe, given every 4 weeks.
M Care Exports supplies Nucala (mepolizumab), marketed by GSK, to hospital pharmacies, respiratory and rheumatology units, importers and tender desks in the GCC, Africa and the UK. If you are looking for the 100 mg vial, the 100 mg pre-filled pen or syringe, or the 40 mg syringe for children aged 6 to 11, send the destination, the presentation and the quantity, and we quote per destination.
Mepolizumab exporter and bulk supplier from India.
"We need a partner for Nucala" is a typical enquiry from a hospital respiratory pharmacy or a tender desk. M Care Exports is a merchant-exporter: we quote against your specification and confirm which presentations your destination registers. Nucala is not one line but four: a 100 mg lyophilised powder in a single-dose vial that a healthcare professional reconstitutes, a 100 mg/mL pre-filled autoinjector (pen), a 100 mg/mL pre-filled syringe and a 40 mg/0.4 mL pre-filled syringe. The vial is stored below 25 °C. The pen and both syringes are refrigerated at 2 to 8 °C. The quote therefore turns on which presentation you need, the cold-chain packing for the refrigerated lines, the registration route in the destination, the quantity and Incoterms. Dose also changes the unit count: 100 mg is one unit, while the 300 mg dose for EGPA or HES in the US label is three separate 100 mg injections.
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.
Interleukin-5 (IL-5) antagonist monoclonal antibody, sourced and documented for export.
Nucala is an interleukin-5 (IL-5) antagonist monoclonal antibody (IgG1 kappa) given by subcutaneous injection every 4 weeks. The US label (GlaxoSmithKline LLC, revised May 2025) lists add-on maintenance treatment of severe asthma with an eosinophilic phenotype in patients aged 6 years and older, chronic rhinosinusitis with nasal polyps in adults aged 18 and older, inadequately controlled COPD with an eosinophilic phenotype in adults (added in the May 2025 revision), eosinophilic granulomatosis with polyangiitis (EGPA) in adults, and hypereosinophilic syndrome (HES) in patients aged 12 and older. US label doses are 100 mg every 4 weeks for severe asthma (40 mg for ages 6 to 11), nasal polyps and COPD, and 300 mg every 4 weeks for EGPA and HES. The EU SmPC lists the same five areas, with EGPA as an add-on treatment from age 6 and HES as an add-on treatment in adults. The EU marketing authorisation is held by GlaxoSmithKline Trading Services Limited and was first granted on 2 December 2015. The emc SmPC for the UK pre-filled pen, held by GlaxoSmithKline UK Limited, also lists COPD.
Active ingredient
Mepolizumab. Interleukin-5 (IL-5) antagonist monoclonal antibody.
Forms and strengths
100 mg lyophilised powder single-dose vial; 100 mg/mL single-dose pre-filled autoinjector (pen); 100 mg/mL single-dose pre-filled syringe; 40 mg/0.4 mL single-dose pre-filled syringe.
Indications
Humanised IgG1 kappa monoclonal antibody produced in Chinese hamster ovary cells that binds interleukin-5 and lowers eosinophils, used in severe eosinophilic asthma, CRSwNP, eosinophilic COPD, EGPA and HES.
Administration
Subcutaneous. Powder for solution for injection (vial) and solution for injection (pre-filled pen and pre-filled syringe).
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 pharmacists in respiratory, rheumatology and haematology units, MoH and hospital tender desks, and licensed importers and distributors in the GCC, Africa and the UK. Typical enquiries read "I'm looking for Nucala 100 mg pens for a respiratory clinic" or "We need a partner for mepolizumab for a tender". Each destination has its own route to registration or import, for example the Emirates Drug Establishment (EDE) in the UAE, NAFDAC in Nigeria and the MHRA in the UK. For a biologic, whether the destination has registered Nucala or needs a named-patient or unlicensed import depends on the regulator, and M Care Exports confirms the route per enquiry before quoting.
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 mepolizumab.
Order by presentation, because the vial and the pen or syringe are handled differently. The vial is reconstituted by a healthcare professional with 1.2 mL of Sterile Water for Injection to give 100 mg/mL. The US label says to swirl gently and not to shake, and the EU SmPC states the reconstituted solution is stable for 8 hours below 30 °C. Pens and syringes are refrigerated at 2 to 8 °C, protected from light, never frozen or shaken. An unopened carton may sit outside the fridge for up to 7 days at up to 30 °C, and the product must be given within 8 hours of opening the carton. The 100 mg pen and syringe are for ages 12 and over, so children aged 6 to 11 use the 40 mg syringe or the vial. Dose maths matters: the 300 mg dose for EGPA and HES is three 100 mg injections at least 5 cm apart. The label warns of hypersensitivity reactions, herpes zoster and helminth infection, and says to treat pre-existing helminth infection before starting.
The documentation pack a regulator actually asks for.
Nucala is a mixed-storage biologic. The US label and EU SmPC store the lyophilised vial below 25 °C, not frozen, in the carton away from light, and the EU SmPC gives the powder a 4-year shelf life. The pen and pre-filled syringes need 2 to 8 °C, with the 7-day room-temperature allowance at up to 30 °C for an unopened pack and a 3-year shelf life in the EU SmPC. Refrigerated lines are packed for 2 to 8 °C transit and timed to the receiving site. The emc page for the UK vial presentation is marked discontinued, so we state the status of each presentation before quoting. M Care Exports is a merchant-exporter, not the manufacturer. Documentation covers batch certificates of analysis and export documents, and we support destination-aligned dossiers where a regulator asks.
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 mepolizumab.
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 mepolizumab.
- 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.
Mepolizumab supply, the specific questions.
What sets the price of Nucala injection for an importer?
M Care Exports does not publish a price for Nucala. The landed price for an importer depends on the presentation (100 mg vial, 100 mg pen, 100 mg syringe or 40 mg syringe), the quantity, the destination's registration route, the cold chain needed for pens and syringes, and the Incoterms. We quote per destination once we have the presentation, the quantity and the country.
Is Nucala approved for COPD?
Yes, as an add-on maintenance indication in adults. The US label covers add-on maintenance treatment of adults with inadequately controlled COPD and an eosinophilic phenotype, at 100 mg subcutaneously every 4 weeks, and states it is not for relief of acute bronchospasm. The EU SmPC lists adults with uncontrolled COPD characterised by raised blood eosinophils, and the UK emc SmPC lists adults with uncontrolled COPD of an eosinophilic phenotype, in both cases on a combination of an inhaled corticosteroid, a long-acting beta2-agonist and a long-acting muscarinic antagonist. Other destinations follow their own regulator's labelling.
What does Nucala 100 mg mean, and which presentations come in 100 mg?
Three presentations carry 100 mg: a single-dose vial of lyophilised powder that a healthcare professional reconstitutes to 100 mg/mL, a 100 mg/mL pre-filled autoinjector and a 100 mg/mL pre-filled syringe. The US label dose of 100 mg every 4 weeks covers severe asthma in ages 12 and over, nasal polyps and COPD. The pen and 100 mg syringe are for ages 12 and over only. A separate 40 mg/0.4 mL syringe exists for children aged 6 to 11 with severe asthma.
What should I check when I am looking for Nucala injection for a hospital tender?
Decide the presentation first. The vial is stored below 25 °C and is reconstituted by a healthcare professional. The pen and syringes need 2 to 8 °C and allow up to 7 days at up to 30 °C in the unopened pack. Then list the indications you will treat, because the 300 mg dose for EGPA and HES is three injections. M Care Exports confirms registration status per destination before quoting.
How does Nucala compare with Xolair and Dupixent?
They are different products with different targets, indication lists, doses and dosing intervals. Nucala blocks IL-5 and is dosed every 4 weeks, per its label. For the other two, see the label facts on our omalizumab and dupilumab pages. We do not recommend one product over another. Selection is a prescriber decision, and we supply whichever your tender specifies.
Is there a generic or biosimilar of Nucala?
We found no biosimilar or generic of mepolizumab in the regulator pages we reviewed for the US, EU and UK, where Nucala is the GSK product. Mepolizumab is a biologic, so the term is biosimilar. Availability changes, so M Care Exports confirms the current position for the US, EU and UK, and for your destination, when you send an enquiry.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-11-08.
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.
Send the specifics. You'll have a price inside one working day.
Form and strength, destination market and indicative volume. The Mumbai desk replies within one working day, including when the honest answer is that the route is not viable yet.