Dupixent (dupilumab) remains patent-protected in its major markets, so hospital and tender buyers are sourcing licensed originator stock, not a generic, through verified cold-chain channels.
Dupixent (dupilumab) is Sanofi and Regeneron's IL-4/IL-13 receptor blocker, licensed for moderate-to-severe atopic dermatitis, asthma and several other indications. M Care sources Dupixent pre-filled pens and syringes through licensed Indian distribution channels as a merchant exporter, not a manufacturer, and moves cold-chain-validated shipments into GCC, African and other served markets on a quote basis.
Dupilumab exporter and bulk supplier from India.
For MoH tenders, NGO procurement frameworks and hospital group contracts, M Care coordinates bulk Dupixent supply through licensed Indian channels, with cold-chain-validated lanes, batch-specific certificates of analysis and CTD/eCTD-format documentation assembled to match each destination regulator's import dossier requirements. Volumes, lead times and lane options are confirmed against the buyer's specific tender or purchase order; we do not publish list pricing.
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-4 receptor alpha antagonist (IL-4/IL-13 pathway blocker), human monoclonal antibody (IgG4), sourced and documented for export.
Dupilumab is a human monoclonal antibody that blocks the shared alpha subunit of the interleukin-4 and interleukin-13 receptors, interrupting the type 2 (Th2) inflammatory signalling that drives several atopic and eosinophilic conditions. It is not a biosimilar target molecule at this stage; Dupixent is the only licensed brand in this class carrying its current label breadth.
FDA-labelled indications include moderate-to-severe atopic dermatitis (from 6 months of age), add-on maintenance therapy for eosinophilic or oral-corticosteroid-dependent asthma (from 6 years), chronic rhinosinusitis with nasal polyps (12 years and older), eosinophilic oesophagitis (1 year and older, at least 15 kg), prurigo nodularis, chronic obstructive pulmonary disease with an eosinophilic phenotype, chronic spontaneous urticaria (2 years and older), bullous pemphigoid, and allergic fungal rhinosinusitis (6 years and older, with a history of sino-nasal surgery). Destination-country labelling may authorise a narrower or wider set; buyers should confirm against the local SmPC for their market.
Dupixent is supplied as a sterile solution for injection in single-dose pre-filled pens and pre-filled syringes, at 300 mg/2 mL (150 mg/mL) and 200 mg/1.14 mL (175 mg/mL) strengths. It is a refrigerated biologic, stored at 2 to 8 degrees C, and must not be frozen or shaken.
Active ingredient
dupilumab. Interleukin-4 receptor alpha antagonist (IL-4/IL-13 pathway blocker), human monoclonal antibody (IgG4).
Forms and strengths
300 mg/2 mL (150 mg/mL); 200 mg/1.14 mL (175 mg/mL).
Indications
Dupixent (dupilumab) blocks IL-4/IL-13 signalling and is licensed for moderate-to-severe atopic dermatitis, eosinophilic or OCS-dependent asthma, chronic rhinosinusitis with nasal polyps, eosinophilic oesophagitis, prurigo nodularis, COPD with an eosinophilic phenotype, chronic spontaneous urticaria, bullous pemphigoid and allergic fungal rhinosinusitis, per current FDA labelling.
Administration
subcutaneous. Solution for injection in single-dose pre-filled pen or 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 for Dupixent through M Care are typically hospital and specialist dermatology or respiratory pharmacies, NHS trust and private hospital group buyers, GCC and African MoH tender desks stocking biologics for dermatology and severe asthma programmes, and licensed importers and wholesalers who hold the relevant national distribution authorisation for their market. Because dupilumab is a self-administered biologic in many treatment settings, retail pharmacy chains with cold-chain-capable dispensing also enquire directly.
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 dupilumab.
Adult and adolescent dosing for most indications is a 600 mg loading dose (two 300 mg injections at separate sites) followed by 300 mg every other week; the eosinophilic oesophagitis and paediatric atopic dermatitis regimens are weight-banded and age-banded, so confirm the destination label's dosing table rather than defaulting to the adult schedule. Injection sites should be rotated and the thigh, abdomen (except the 5 cm around the navel) or upper arm used.
Pre-filled pens are labelled for patients 2 years and older; pre-filled syringes cover the full approved age range down to 6 months, so paediatric and low-body-weight patients require the syringe presentation, not the pen. Before injection, the pen or syringe should be removed from the refrigerator and left to reach room temperature out of direct sunlight before use, allowing at least 45 minutes for the 300 mg presentation or at least 30 minutes for the 200 mg presentation; do not warm it any other way.
Once removed from the refrigerator, unused Dupixent must be used within 14 days or discarded; it should never be returned to the fridge or frozen after that room-temperature window starts, so dispensing counts and patient counselling need to account for that 14-day ceiling if a dose is delayed. The product must not be shaken.
Injection-site reactions (erythema, swelling) and conjunctivitis are the most frequently reported adverse events across the atopic dermatitis and asthma trial populations; hypersensitivity reactions, though uncommon, warrant the same anaphylaxis-preparedness protocol used for other subcutaneous biologics. There is no licensed biosimilar to substitute against: any Dupixent supply chain is an originator-brand chain, so batch traceability back to a Sanofi/Regeneron-authorised source is the relevant quality check, not brand-versus-biosimilar equivalence.
The documentation pack a regulator actually asks for.
Dupixent moves through M Care's supply chain as a cold-chain biologic: 2 to 8 degrees C validated packaging and lane monitoring from the Indian distribution point through to destination, with temperature-excursion logging available against each shipment and batch-specific certificates of analysis matched to the pre-filled pen or syringe lot supplied. Import documentation is assembled in CTD/eCTD-compatible format to support each destination regulator's registration or named-patient import route, whether that is MHRA (Medicines and Healthcare products Regulatory Agency, UK) market authorisation recognition, SFDA (Saudi Food and Drug Administration) or MOHAP (UAE Ministry of Health and Prevention) registration pathways, or NAFDAC (Nigeria) and PPB (Pharmacy and Poisons Board, Kenya) import permits.
Dupilumab remains patent-protected and has no FDA-licensed or EMA-authorised biosimilar on the market, so every legitimate supply route for Dupixent is an originator-brand channel. M Care sources it through licensed Indian distribution channels of the originator, consistent with how it handles other patent-protected brands, and does not manufacture or hold WHO-GMP or WHO-PQ status itself; export documentation reflects the CDSCO (Central Drugs Standard Control Organization, India) licensing basis under which the shipment leaves India.
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 dupilumab.
Adalimumab
Another allergy & immunology line ordered on the same formularies.
Etanercept
Another allergy & immunology line ordered on the same formularies.
Infliximab
Another allergy & immunology line ordered on the same formularies.
All allergy & immunology
The full category listing for procurement desks.
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 dupilumab.
- 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.
Dupilumab supply, the specific questions.
Is there a generic or biosimilar version of Dupixent (dupilumab)?
No. Dupilumab is still patent-protected in the major markets M Care serves, and no biosimilar has been licensed by the FDA or authorised by the EMA to date. Every Dupixent supply route currently on the market is an originator-brand channel.
Can M Care supply Dupixent to my country?
M Care sources Dupixent through licensed Indian distribution channels and exports on a quote-by-quote basis once the shipment's regulatory and import basis for your destination market is confirmed. Tell us the destination country and buyer type (hospital, MoH tender, importer) and we will confirm the applicable route.
How is Dupixent cold chain managed during export?
Dupixent is a biologic that must be stored at 2 to 8 degrees C and must not be frozen. M Care ships it on cold-chain-validated lanes with temperature monitoring, and documentation includes batch-specific certificates of analysis so the receiving pharmacy can verify the chain on arrival.
What is the difference between the Dupixent pre-filled pen and pre-filled syringe?
Both are available in the same 300 mg/2 mL or 200 mg/1.14 mL strengths. The pen is licensed for patients aged 2 years and older; the pre-filled syringe covers the full approved age range down to 6 months, so paediatric and lower-body-weight patients require the syringe.
What indications is Dupixent licensed for?
The FDA label covers moderate-to-severe atopic dermatitis, add-on maintenance for eosinophilic or oral-corticosteroid-dependent asthma, chronic rhinosinusitis with nasal polyps, eosinophilic oesophagitis, prurigo nodularis, COPD with an eosinophilic phenotype, chronic spontaneous urticaria, bullous pemphigoid and allergic fungal rhinosinusitis. Confirm the exact indications and age bands against the SmPC or label for your destination market, as approved use can vary by country.
Does M Care manufacture Dupixent or hold WHO-GMP status for it?
No. M Care is a merchant exporter. We source Dupixent through licensed Indian distribution channels of the originator and export under our CDSCO export licensure; we do not manufacture the product and do not hold WHO-GMP or WHO-PQ status ourselves.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-08-28.
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.