Irinotecan injection (Camptosar, Campto) is a 20 mg/mL topoisomerase I inhibitor concentrate in 40 mg, 100 mg and 300 mg vials for hospital and tender buyers.
M Care Exports supplies irinotecan injection to hospital oncology pharmacies, importers and tender desks in the GCC, Africa and the UK, both regulator-registered originator brands such as Camptosar and Campto and Indian-made lines. If you are looking for irinotecan 100 mg or 40 mg vials, send the destination, the strength and the quantity, and we quote per destination.
Irinotecan exporter and bulk supplier from India.
"We need a partner for irinotecan injection" is a typical oncology tender or hospital pharmacy enquiry. M Care is a merchant-exporter: we quote against your specification and confirm which line your destination's registration route accepts. Irinotecan is a cytotoxic concentrate with no cold chain on the US or UK labels we read, which keeps freight simpler than for biologicals, but it is a hazardous drug and needs cytotoxic-compliant handling at the receiving end. We supply originator or regulator-registered brands such as Camptosar and Campto, and Indian-made lines such as Irinotel, Irnocam and Iritero for destinations whose registration accepts them. The quote turns on strength, pack, quantity, the registration route in the destination and the source line. Buyers who build the full regimen usually ask about oxaliplatin, 5-fluorouracil, capecitabine and bevacizumab in the same enquiry, and each is quoted as its own line.
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.
Topoisomerase I inhibitor cytotoxic, sourced and documented for export.
Irinotecan is a topoisomerase I inhibitor cytotoxic. The UK SmPC for Campto (Pfizer Limited) describes a concentrate for solution for infusion at 20 mg/mL irinotecan hydrochloride trihydrate, in single amber Onco-Tain glass vials of 2 mL (40 mg), 5 mL (100 mg) and 15 mL (300 mg), noting that not all pack sizes may be marketed. The US Camptosar label lists the same three vial sizes as single-dose vials, in Cytosafe polypropylene or Onco-Tain glass packaging. The UK indications are advanced colorectal cancer as monotherapy after failure of a 5-fluorouracil regimen, with 5-fluorouracil and folinic acid in patients with no prior chemotherapy for advanced disease, with cetuximab in EGFR-expressing, RAS wild-type metastatic colorectal cancer, with 5-fluorouracil, folinic acid and bevacizumab as first-line treatment, and with capecitabine with or without bevacizumab as first-line treatment. The US label (revised 6/2024) lists first-line metastatic colon or rectal carcinoma with 5-fluorouracil and leucovorin, and metastatic disease that has recurred or progressed after initial fluorouracil-based therapy. Both the US and UK texts carry strong warnings for diarrhoea and myelosuppression, and the US label has a boxed warning for them. Onivyde is a different, liposomal product with its own label and its own pancreatic indication.
Active ingredient
Irinotecan hydrochloride trihydrate. Topoisomerase I inhibitor cytotoxic.
Forms and strengths
40 mg/2 mL single-dose vial (20 mg/mL); 100 mg/5 mL single-dose vial (20 mg/mL); 300 mg/15 mL single-dose vial (20 mg/mL).
Indications
Irinotecan, a topoisomerase I inhibitor concentrate for metastatic colorectal cancer. Sold as Camptosar in the US and Campto in the UK, and supplied to GCC, African and UK buyers as originator or regulator-registered brands and Indian-made lines.
Administration
Intravenous. Concentrate for solution for infusion (single-dose vials, 20 mg/mL).
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 oncology pharmacists, MoH and hospital tender desks, and licensed importers and distributors in the GCC, Africa and the UK. Typical enquiries read "I'm looking for irinotecan 100 mg injection for a hospital tender" or "We need a partner for irinotecan vials for a ministry of health 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, and we align the offer with that route before quoting. We supply both originator or regulator-registered brands and Indian-made lines. Examples from our own catalogue are Irinotel (40 mg and 100 mg), Irnocam (100 mg) and Iritero (40 mg and 100 mg). We do not claim any of these Indian-made lines is registered in a given destination, and we say which line is which before you commit.
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 irinotecan.
Read the dose against the regimen. The UK SmPC gives 350 mg/m² every 3 weeks as monotherapy (200 mg/m² if bilirubin is 1.5 to 3 times the upper limit, no treatment above 3 times) and 180 mg/m² every 2 weeks with 5-fluorouracil and folinic acid. The US label also lists weekly regimens, such as 125 mg/m² on days 1, 8, 15 and 22. Expect two diarrhoea syndromes. For early cholinergic diarrhoea the SmPC gives atropine 0.25 mg subcutaneously unless contraindicated. Late diarrhoea, after 24 hours, is managed with high-dose loperamide (4 mg, then 2 mg every 2 hours) and fluids, and the SmPC says not to give loperamide prophylactically. Weekly full blood counts are recommended, and febrile neutropenia needs urgent IV antibiotics. Both texts say to consider a reduced starting dose in UGT1A1 *28 or *6 homozygous patients. Irinotecan must not start sooner than 1 hour after cetuximab ends. Each vial contains sorbitol (E420). The SmPC advises preparing diluted solution close to use.
The documentation pack a regulator actually asks for.
Irinotecan concentrate is a room-temperature product. The UK SmPC says store below 25 °C in the original package to protect from light, with shelf life of 24 months for the 40 mg/2 mL vial and 36 months for the 100 mg/5 mL and 300 mg/15 mL vials. The US label says store at 15 to 30 °C, protect from freezing and light, and keep in the carton until use. Both treat irinotecan as a cytotoxic or hazardous drug, with gloves, immediate washing after skin contact and special disposal procedures. The UK marketing authorisation holder for Campto is Pfizer Limited, with the first UK authorisation dated 5 May 1995. The US Camptosar label shows Pharmacia & Upjohn Company LLC as labeler. Several other irinotecan hydrochloride injections are listed on DailyMed, and the UK emc also lists other irinotecan products such as a Sun Pharmaceutical Industries Europe 1.5 mg/mL ready-to-use infusion bag. M Care documentation covers batch certificates of analysis, export documents and destination-aligned dossier support where the regulator requires it. We state the source and quality status of each line before quoting, and make no claim for M Care itself beyond merchant-exporter documentation.
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 irinotecan.
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 irinotecan.
- 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.
Irinotecan supply, the specific questions.
What sets the landed price of irinotecan or Camptosar for an importer?
We do not publish prices. The landed cost of irinotecan depends on whether you want an originator or regulator-registered brand such as Camptosar or Campto, or an Indian-made line, plus the strength (40 mg, 100 mg or 300 mg vial), pack, quantity, the registration route in your destination and Incoterms. Irinotecan needs no cold chain on the US and UK labels we read, so freight is simpler than for refrigerated products. M Care Exports quotes per destination once you send the strength, volume and country.
What is the brand name of irinotecan, and which versions can you supply?
The originator brand is Camptosar in the US (DailyMed lists Pharmacia & Upjohn Company LLC as labeler) and Campto in the UK (Pfizer Limited is the marketing authorisation holder on the emc). Other irinotecan hydrochloride injections are listed under the generic name on DailyMed, and the UK emc lists other irinotecan products. M Care supplies both originator or regulator-registered brands and Indian-made lines, for example Irinotel, Irnocam and Iritero, for destinations whose registration accepts them. We do not claim these Indian-made lines are registered in any destination.
What is the irinotecan package insert or SmPC, and what vial sizes does it list?
The package insert for Camptosar is the US prescribing label, revised 6/2024 on Pfizer's labelling site. For the UK, the Campto SmPC is on the emc. Both describe a 20 mg/mL concentrate in single vials of 40 mg/2 mL, 100 mg/5 mL and 300 mg/15 mL. The UK text says not all pack sizes may be marketed, so confirm the exact line your destination registers. We send the label and the batch documents with the quote, and an Indian-made line carries its own manufacturer insert.
What are the main side effects of irinotecan chemotherapy?
The US label carries a boxed warning for diarrhoea and myelosuppression. Late diarrhoea can be life threatening, and severe neutropenia can occur, so the UK SmPC recommends weekly blood counts. The SmPC also describes early cholinergic diarrhoea, and it notes a higher risk of severe neutropenia and diarrhoea in UGT1A1 poor metabolisers. The UK SmPC contraindications include chronic inflammatory bowel disease or bowel obstruction, bilirubin above 3 times the upper limit, severe bone marrow failure and breastfeeding. Prescribers decide treatment, and a procurement desk should keep the full label to hand.
What is irinotecan used for, and which regimens does the label list?
Irinotecan is licensed for advanced or metastatic colorectal cancer. The UK SmPC lists monotherapy after failure of a 5-fluorouracil regimen, and combinations with 5-fluorouracil and folinic acid, with cetuximab in EGFR-expressing RAS wild-type disease, with 5-fluorouracil, folinic acid and bevacizumab, and with capecitabine with or without bevacizumab. The US label lists first-line use with 5-fluorouracil and leucovorin, and use after progression on fluorouracil-based therapy. Companion lines such as oxaliplatin and bevacizumab are quoted separately.
Is irinotecan liposome (Onivyde) the same as irinotecan injection?
No. Onivyde is a pegylated liposomal product with its own label. The EMA lists Les Laboratoires Servier as marketing authorisation holder (authorised 14 October 2016) for metastatic adenocarcinoma of the pancreas. The UK emc text describes a 4.3 mg/mL dispersion, a different concentration from the 20 mg/mL Camptosar and Campto concentrate. It states Onivyde is not equivalent to non-liposomal irinotecan formulations and should not be interchanged. Tell us which product you need, and we quote it as a separate line.
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.