Infliximab is the chimeric anti-TNF antibody confined to hospital IV infusion, and the molecule behind Europe's first monoclonal antibody biosimilar approval in 2013.
Infliximab reaches every anti-TNF indication, rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis, but only as a hospital intravenous infusion, never a self-injected pen. Its chimeric structure, roughly a quarter murine protein on a human antibody framework, was also the structure that carried the first monoclonal antibody biosimilar through EMA approval in 2013, a precedent every biosimilar antibody dossier since has followed. M Care Exports sources both the branded originator and biosimilar lines from WHO-GMP certified Indian manufacturers for regulated markets outside India.
Also marketed as Remicade, Inflectra and Renflexis.
Infliximab exporter and bulk supplier from India.
Infliximab ships as a lyophilized powder in single-use 100mg vials, reconstituted and diluted only at the point of infusion, so cold chain integrity from origin to hospital pharmacy is the documentation buyers scrutinise most: temperature logging for the full transit, cold chain validation reports and vial-level batch numbers matched to the certificate of analysis. Export documentation is built around the destination's biologics import requirements, covering the manufacturer's product licence, batch release certificate, stability data supporting the storage claim, and, for biosimilar lines, the comparability dossier referenced in the buyer's own registration. M Care Exports prepares this pack against the buyer's registered specification and destination regulatory requirement; availability of a specific brand or batch is confirmed at enquiry.
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-TNF-alpha monoclonal antibody (chimeric IgG1 biologic), sourced and documented for export.
Infliximab is the only major anti-TNF biologic built as a chimeric antibody, roughly a quarter mouse protein fused to a human IgG1 framework, and the only one confined to hospital intravenous infusion rather than self-administered subcutaneous injection. That chimeric structure carries the class's highest immunogenicity risk, which is why infliximab is routinely co-prescribed with methotrexate or another immunomodulator to suppress anti-drug antibody formation. Approved for rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis, it carries boxed warnings for serious infection and for hepatosplenic T-cell lymphoma in young males on combination immunosuppressive therapy. The same molecule was also the first monoclonal antibody biosimilar approved in Europe, when the EMA authorised CT-P13 in 2013, a decision that shaped every biosimilar antibody filing in the EU and other Western-regulated markets since.
Active ingredient
Infliximab. Anti-TNF-alpha monoclonal antibody (chimeric IgG1 biologic).
Forms and strengths
100 mg.
Indications
Infliximab is a chimeric (part-murine, part-human) IgG1 monoclonal antibody that binds and neutralises tumour necrosis factor-alpha. It is approved for rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis, and is administered exclusively as a hospital or infusion centre intravenous infusion, typically over about two hours, under an induction and maintenance dosing schedule that is confirmed to the specific indication.
Administration
Intravenous infusion. Lyophilized powder for reconstitution and intravenous infusion.
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 pharmacy departments and infusion centres, oncology and rheumatology tender desks at public procurement agencies, and licensed pharmaceutical importers and distributors who hold the destination market authorisation or are preparing a biosimilar or parallel-import filing. Demand comes from UK and EU hospital groups, Gulf and GCC government tenders, African ministry of health procurement, Latin American public and private hospital networks, Southeast Asian distributors and CIS importers. Because infliximab is infusion-only and never dispensed through retail pharmacy, enquiries come almost exclusively from institutional buyers rather than individual pharmacies, and most ask for both the branded originator and a biosimilar alternative to compare against their formulary and tender specification.
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 infliximab.
A reviewing pharmacist checks TB and hepatitis B status before initiation, since both boxed warnings for serious infection are screened for, not just labelled. Because infliximab is chimeric rather than humanized, anti-drug antibody formation is more likely than with adalimumab or golimumab, so a therapeutic drug monitoring pathway (trough level plus antibody titre) is standard practice at loss of response, and concomitant methotrexate or azathioprine is checked as the usual mitigation, alongside the hepatosplenic T-cell lymphoma signal tied to that combination in young male IBD patients. Infusion-reaction premedication protocols and the 0, 2, 6 week induction schedule are confirmed against the specific indication, since rheumatoid arthritis and inflammatory bowel disease dosing differ. For a biosimilar line, the pharmacist checks the destination market's interchangeability and switching rules against the buyer's own registration, since these vary by regulator and are not decided by M Care.
The documentation pack a regulator actually asks for.
The documentation pack is assembled to the buyer's destination requirement and typically includes the manufacturer's WHO-GMP certificate, product licence and batch manufacturing and release records, a certificate of analysis for the specific batch offered, and stability data supporting the labelled cold chain storage condition. For biosimilar lines, this extends to the comparability and biosimilarity study summary the buyer's own regulatory filing will reference, since destination interchangeability rules differ by market and are the buyer's determination, not M Care's. Given that infliximab reaches the patient only through a hospital or infusion centre, tender submissions are also matched against the procuring authority's own specification format rather than a generic dossier. M Care Exports itself holds ISO 9001:2015 certification and a CDSCO export licence; it is a merchant-exporter and does not hold, and has never claimed, WHO-GMP or WHO-PQ certification, which sits with the manufacturer whose product is being supplied.
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.
Boxed warning: serious infections including tuberculosis reactivation, invasive fungal infections, bacterial and viral infections; screen for latent TB and hepatitis B before starting therapy.
Boxed warning: malignancy, including hepatosplenic T-cell lymphoma, a rare and often fatal cancer reported predominantly in adolescent and young adult males with Crohn's disease or ulcerative colitis on concomitant azathioprine or 6-mercaptopurine.
Administered only as a hospital or infusion centre intravenous infusion under medical supervision; not for self-administration.
Chimeric (part-murine) structure carries a higher immunogenicity risk than humanized or fully human anti-TNF biologics; anti-drug antibody formation can cause infusion reactions and loss of response.
Biosimilar interchangeability status and reference-product exclusivity vary by destination market; buyer must confirm the applicable local regulatory route before filing.
M Care Exports is a merchant-exporter (ISO 9001:2015, CDSCO export licence) and does not hold WHO-GMP or WHO-PQ certification itself; those certifications sit with the manufacturer.
Adjacent lines procurement desks order alongside infliximab.
Etanercept
Another allergy & immunology line ordered on the same formularies.
Levocetirizine
Another allergy & immunology line ordered on the same formularies.
Mycophenolate
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 infliximab.
- 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.
Infliximab supply, the specific questions.
Does M Care hold WHO-GMP or WHO-PQ certification directly?
No. M Care Exports is a merchant-exporter, holding ISO 9001:2015 certification and a CDSCO export licence in its own name. WHO-GMP and WHO-PQ certification are held by the manufacturer of the specific infliximab product supplied, whether the branded originator or a biosimilar line, and that manufacturer's certificate is included in the documentation pack for every enquiry.
Why is infliximab given only as a hospital infusion rather than a self-injected pen like other anti-TNF biologics?
Infliximab is formulated as a lyophilized powder reconstituted and diluted immediately before use, then delivered intravenously over roughly two hours under clinical supervision, because its chimeric structure carries a meaningful infusion-reaction risk that needs monitoring. Etanercept and adalimumab are humanized or fully human proteins stable enough for a subcutaneous pen; infliximab's formulation and immunogenicity profile were never developed for self-administration.
What is the difference between infliximab and biosimilars such as CT-P13 (Remsima, Inflectra)?
CT-P13 was approved by the EMA in 2013 as the first monoclonal antibody biosimilar authorised in Europe, matching the originator's amino acid sequence and demonstrating comparable efficacy, safety and immunogenicity in head-to-head studies (Korea's regulator had approved the same molecule a year earlier, in 2012). Biosimilar and originator lines are prescribed for the same approved indications; interchangeability and substitution rules differ by destination regulator, so buyers confirm the applicable rule for their own market.
What does the hepatosplenic T-cell lymphoma boxed warning mean for a buyer?
It is a rare but often fatal T-cell lymphoma reported mostly in adolescent and young adult males with Crohn's disease or ulcerative colitis who were also taking azathioprine or 6-mercaptopurine alongside a TNF blocker. It is a labelled risk that shapes clinical prescribing decisions, not a supply restriction, and buyers sourcing infliximab for IBD indications should ensure their own clinical teams are aware of it.
Can M Care supply both the branded originator (Remicade) and biosimilar infliximab?
Yes. As a merchant-exporter, M Care sources both branded and biosimilar infliximab lines from WHO-GMP certified Indian manufacturers, matched to the buyer's registered specification and destination market authorisation. Which specific brand or biosimilar is available for a given enquiry depends on the manufacturer's current supply position, confirmed directly with the buyer rather than published on the page.
What documentation does M Care provide to support a biosimilar infliximab tender submission?
The pack is built to the buyer's destination requirement and typically includes the manufacturer's WHO-GMP certificate, product licence, batch manufacturing and release records, a batch-specific certificate of analysis, stability data supporting the cold chain claim, and, for biosimilar lines, the comparability study summary referenced in the buyer's own regulatory filing.
Does infliximab's chimeric, part-murine structure affect how it needs to be monitored clinically?
Yes. The murine component increases the likelihood of anti-drug antibody formation compared with humanized or fully human anti-TNF biologics, which is why infliximab is routinely co-prescribed with methotrexate or another immunomodulator and why trough level and antibody testing are standard practice when a patient loses response. This is a clinical monitoring consideration for the prescriber, not a constraint on supply.
What markets and buyer types does M Care Exports supply infliximab to?
Hospital pharmacy departments, infusion centres, and rheumatology, gastroenterology and oncology tender desks across the UK, EU, Gulf and GCC, Africa, Latin America, Southeast Asia and CIS, along with licensed importers and distributors preparing a destination market filing. India is the country of manufacture only and is not a served market for this listing.
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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