Daratumumab carries two documented laboratory interference effects, blood bank compatibility testing and the myeloma patient's own M-protein monitoring, that a receiving hospital must plan for before the first infusion.
Daratumumab is one of the few oncology biologics where the drug itself interferes with two separate lab tests: it produces a false positive blood compatibility screen in the transfusion service, and its IgG kappa structure can be mistaken for the patient's own myeloma protein on response-monitoring assays. M Care Exports supplies daratumumab, marketed as Darzalex and equivalent presentations, sourced from WHO-GMP certified Indian manufacturers, to regulatory affairs teams, hospital procurement and licensed importers across the UK, EU, Gulf, Africa, Latin America, Southeast Asia and CIS markets, quoted to the buyer's own registered label and destination file.
Daratumumab exporter and bulk supplier from India.
Daratumumab moves as a cold chain biologic: single-dose glass vials of concentrate for infusion, shipped and stored at 2 to 8 degrees Celsius, protected from light, never frozen, with continuous temperature logging from the Indian dispatch point through to destination customs clearance. M Care prepares the shipment against the buyer's own import documentation requirements: certificate of pharmaceutical product, certificate of analysis per batch, cold chain validation report with data logger printouts, and packing list cross-referenced to the destination country's biologics import checklist. Because daratumumab is a monoclonal antibody biologic rather than a small-molecule generic, importers in several destination markets require a distinct biologics import permit or named-patient authorisation separate from standard pharmaceutical registration, and the tender or import file should be built around the specific brand and batch quoted rather than the molecule alone. Freight is arranged on validated cold chain lanes with insulated packaging rated for the transit duration, and documentation is issued per shipment against the buyer's own registered label and destination regulatory file, confirmed against enquiry-specific requirements rather than a standing template.
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-CD38 monoclonal antibody, oncology immunotherapy, sourced and documented for export.
Daratumumab is unusual among oncology biologics in carrying two separate, well-documented laboratory interference effects that a receiving hospital's own lab teams, not just the treating oncologist, must plan around before the first dose. It binds CD38 on red blood cells and causes a false positive indirect antiglobulin (indirect Coombs) test that can persist up to six months after the last infusion, masking detection of minor-antigen alloantibodies unless the blood bank is told in advance and uses treated reagent cells or genotyping. Separately, because daratumumab is itself an IgG kappa monoclonal antibody, it can appear on the same serum protein electrophoresis and immunofixation assays used to track the patient's own multiple myeloma M-protein, complicating a complete-response determination unless a daratumumab-specific reflex assay is used. Daratumumab targets CD38 on malignant plasma cells via complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity and phagocytosis, and is indicated across newly diagnosed and relapsed or refractory multiple myeloma regimens, typically alongside lenalidomide, bortezomib or dexamethasone combinations.
Active ingredient
Daratumumab (human IgG1 kappa monoclonal antibody targeting CD38). Anti-CD38 monoclonal antibody, oncology immunotherapy.
Forms and strengths
100 mg per 5 mL vial (20 mg/mL); 400 mg per 20 mL vial (20 mg/mL).
Indications
Daratumumab is a human IgG1 kappa monoclonal antibody that binds CD38 on malignant plasma cells, inducing tumour cell lysis through complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity and phagocytosis. Reference brand Darzalex (Janssen) is approved across newly diagnosed and relapsed or refractory multiple myeloma regimens in combination with lenalidomide, bortezomib or melphalan-based protocols, and as monotherapy in later lines. A separate co-formulated presentation combining daratumumab with hyaluronidase for subcutaneous administration is also marketed under a distinct brand name and is a different product line from the intravenous vials referenced here.
Administration
Intravenous infusion. Concentrate for solution for infusion, single-dose vial.
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.
Daratumumab is ordered by hospital oncology pharmacy procurement, regional tender desks and licensed pharmaceutical importers responsible for stocking multiple myeloma biologic regimens, across the UK, EU, Gulf and GCC, African, Latin American, Southeast Asian and CIS markets. Buyers are typically regulatory affairs or procurement staff filing a specific brand and batch against their own national drug registration or a named-patient or hospital exemption route where the product is not yet locally registered, rather than retail pharmacy channels. Given the cold chain and biologic-specific import requirements, enquiries usually come from teams that already handle other monoclonal antibody oncology products and need the certificate of pharmaceutical product, batch certificate of analysis and cold chain validation pack alongside the commercial quote. India is the country of manufacture and export origin only; it is not a served market for this listing.
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 daratumumab.
A reviewing pharmacist checks two label-specific interference points before daratumumab reaches the ward. First, the drug binds CD38 on reagent and donor red blood cells, producing a pan-agglutination pattern that reads as a false positive indirect antiglobulin test for up to six months post-dose, so the transfusion service needs advance notice, a pre-treatment type and screen, and either DTT-treated reagent cells or extended red cell phenotyping or genotyping to rule out genuine alloantibodies before any future transfusion. Second, because daratumumab is itself an IgG kappa antibody, it co-migrates with endogenous M-protein on serum protein electrophoresis and immunofixation, which can mask a true complete response or falsely suggest persistent disease in IgG kappa myeloma patients; a daratumumab-specific reflex immunofixation assay resolves the ambiguity where it matters for staging decisions. Standard oncology biologic checks also apply: infusion-related reaction premedication, baseline and on-treatment neutrophil and platelet counts, and confirmation of CD38 expression status where relevant to the regimen. None of this substitutes for the approved label's full warnings and precautions section.
The documentation pack a regulator actually asks for.
Daratumumab export documentation is built around its status as a biologic monoclonal antibody rather than a conventional small-molecule generic. Each shipment is supported by a certificate of pharmaceutical product, a batch-specific certificate of analysis covering identity, purity and potency, and a cold chain validation report with continuous temperature logging from dispatch to destination, since the product must be maintained at 2 to 8 degrees Celsius and protected from light throughout transit. M Care's own credentials, ISO 9001:2015 quality management and a CDSCO export licence, cover the trade of finished pharmaceutical products out of India; the underlying manufacturing is carried out at WHO-GMP certified Indian sites and the certificate of analysis traces to that site's batch release. As a biologic, daratumumab does not have generic equivalents in the way small-molecule drugs do. As of 2026 no daratumumab biosimilar holds full marketing approval in the US or EU, with biosimilar candidates at earlier regulatory stages in other markets, so buyers evaluating a biosimilar route should confirm current approval status in their specific destination country at enquiry rather than assuming uniform availability. Several destination markets also route monoclonal antibody biologics through a distinct import or named-patient authorisation pathway separate from standard pharmaceutical registration, which the buyer's own regulatory team should confirm applies to their specific filing.
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.
What a buyer should know before this line enters a formulary.
We publish the awkward facts alongside the useful ones. A supplier who omits them is not saving you work, only deferring it.
Not for patient-directed dosing use; content is for regulatory, procurement and clinical-pharmacy reference only.
Daratumumab causes a false positive indirect antiglobulin (indirect Coombs) test that can persist up to six months post-dose; blood banks must be notified before any transfusion.
Daratumumab is itself an IgG kappa monoclonal antibody and can interfere with serum protein electrophoresis and immunofixation used to monitor the patient's own M-protein and determine complete response.
Daratumumab carries a recognised risk of infusion-related reactions, most common with the first infusion, requiring premedication and monitoring per the approved label.
Neutropenia and thrombocytopenia are recognised on-treatment risks requiring blood count monitoring.
Cold chain product: store and transport at 2 to 8 degrees Celsius, protect from light, never freeze.
Adjacent lines procurement desks order alongside daratumumab.
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 daratumumab.
- 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.
Daratumumab supply, the specific questions.
Why does daratumumab interfere with blood bank compatibility testing?
Daratumumab binds CD38 expressed at low levels on reagent red blood cells, producing a pan-reactive false positive indirect antiglobulin (indirect Coombs) test that can persist up to six months after the last infusion. ABO and Rh typing are unaffected, but detection of minor-antigen alloantibodies is masked unless the transfusion service is notified in advance and uses DTT-treated cells or extended phenotyping.
Does daratumumab affect monitoring of the patient's own myeloma response?
Yes. Daratumumab is itself an IgG kappa monoclonal antibody and can appear on serum protein electrophoresis and immunofixation assays used to track the patient's endogenous M-protein, which can obscure determination of complete response in some IgG kappa myeloma patients. A daratumumab-specific reflex immunofixation assay distinguishes the drug from residual disease protein where interference is suspected.
Does M Care hold WHO-GMP or WHO-PQ certification directly?
No. M Care Exports is a merchant-exporter, not a manufacturer, and does not hold WHO-GMP or WHO-PQ certification itself. Daratumumab is sourced from WHO-GMP certified Indian manufacturing and packing sites, and M Care's own credentials are ISO 9001:2015 quality management and a CDSCO export licence covering the trade of finished pharmaceutical products out of India.
Can M Care supply the reference brand Darzalex or a biosimilar of daratumumab?
M Care can source the branded reference product Darzalex and, where regulatory approval exists in the destination market, biosimilar daratumumab presentations, quoted to the buyer's own registered label and destination file. As a biologic monoclonal antibody, daratumumab does not have generic equivalents in the way small-molecule drugs do. As of 2026 no daratumumab biosimilar holds full marketing approval in the US or EU, though biosimilar candidates are approved in some other markets and remain in clinical development elsewhere, so biosimilar availability should be confirmed against the specific destination country and current regulatory status at enquiry.
What documentation should a tender desk request for a daratumumab import file?
A daratumumab import file typically needs a certificate of pharmaceutical product, batch-specific certificate of analysis, cold chain validation report with continuous temperature data logging, and confirmation of the brand and manufacturing site quoted, since daratumumab is a biologic and several destination markets treat monoclonal antibody imports under a separate registration or named-patient pathway from standard small-molecule generics.
Is daratumumab available as an intravenous or a subcutaneous product, and does that change what should be quoted?
Both administration routes exist on the global market as distinct branded products, an intravenous concentrate dosed by body weight and a separate hyaluronidase co-formulated subcutaneous injection dosed as a fixed amount regardless of weight. These are different presentations with different vial content, so buyers should specify which route and brand they need rather than assuming interchangeability.
What premedication and monitoring does daratumumab require that affects how it is used clinically?
Daratumumab carries a recognised risk of infusion-related reactions, most frequent with the first infusion, along with neutropenia and thrombocytopenia. Regimens include corticosteroid, antihistamine and antipyretic premedication and post-infusion monitoring per the approved label. This is stated here for regulatory and clinical-pharmacy awareness, not as dosing guidance.
Does daratumumab require cold chain shipping, and how is that validated for export?
Yes. Daratumumab vials must be stored and transported at 2 to 8 degrees Celsius, protected from light and never frozen. Export shipments are dispatched with continuous temperature data logging and accompanied by a cold chain validation report and batch-specific certificate of analysis, consistent with how any monoclonal antibody biologic is documented for cross-border pharmaceutical trade.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-08-22.
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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