Opdivo (nivolumab) is a PD-1 checkpoint inhibitor with no licensed generic or biosimilar in any major market, so tender desks are sourcing the originator biologic through validated cold-chain lanes, not a lower-cost copy.
Opdivo (nivolumab) is Bristol Myers Squibb's PD-1 immune checkpoint inhibitor, supplied across a wide range of solid tumours and Hodgkin lymphoma indications. M Care sources Opdivo through licensed Indian distribution channels as a merchant exporter, not a manufacturer, and dispatches on cold-chain validated lanes to hospital and MoH oncology tenders across Africa, the GCC and other served markets.
Nivolumab exporter and bulk supplier from India.
For MoH oncology tenders and hospital group contracts, M Care quotes Opdivo by pack size and lane, drawing on licensed Indian distribution channels rather than a single fixed source. Every consignment moves on a cold-chain validated route with temperature logging from dispatch to delivery, and we build the CTD-format documentation pack a tender desk needs for registration or import clearance before quoting a volume or timeline.
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.
PD-1 immune checkpoint inhibitor (human IgG4 monoclonal antibody), sourced and documented for export.
Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1 on T cells, restoring an anti-tumour immune response by preventing PD-L1/PD-L2 engagement. It belongs to the PD-1 immune checkpoint inhibitor class, alongside pembrolizumab.
FDA-licensed indications span melanoma, non-small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of the head and neck, urothelial carcinoma, MSI-H/dMMR colorectal cancer, hepatocellular carcinoma, oesophageal and gastric/gastro-oesophageal junction cancer, as monotherapy or combined with ipilimumab or chemotherapy in specific settings. Destination-country labelling varies, and M Care refers tender desks to the locally approved indication set alongside the FDA/EMA reference dossier.
Opdivo is supplied as a solution for intravenous infusion in single-dose vials, at 40 mg/4 mL, 100 mg/10 mL, 120 mg/12 mL and 240 mg/24 mL (10 mg/mL). Vials are stored at 2-8C, protected from light in the original carton, and must never be frozen or shaken.
Active ingredient
nivolumab. PD-1 immune checkpoint inhibitor (human IgG4 monoclonal antibody).
Forms and strengths
40 mg/4 mL; 100 mg/10 mL; 120 mg/12 mL; 240 mg/24 mL.
Indications
Human IgG4 monoclonal antibody blocking PD-1 to restore T-cell anti-tumour activity, licensed across multiple solid tumour types and classical Hodgkin lymphoma per FDA and EMA labelling.
Administration
intravenous infusion. Solution for intravenous infusion in single-dose vials.
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.
Hospital oncology pharmacy departments, NHS trust and private hospital group buyers, MoH cancer-programme tender desks across the GCC and Africa, and licensed oncology wholesalers and importers who need a documented, cold-chain-verified route to Opdivo rather than a spot-market parcel.
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 nivolumab.
Opdivo has two approved flat-dose monotherapy schedules: 240 mg by IV infusion over 30 minutes every 2 weeks, or 480 mg over 60 minutes every 4 weeks. In combination regimens (with ipilimumab, or with chemotherapy in specific tumour types), the label specifies different doses and a 3-week or other interval, so match the schedule to the exact indication and combination on the order, not a generic 'nivolumab dose'.
Cold chain is the operational constraint that matters most for a tender desk. Vials must stay at 2-8C from dispatch to point of use and never be frozen or shaken; even brief warming or agitation is a discard event, not a documentation problem to paper over. Once diluted for infusion, the prepared solution is stable for no more than 8 hours at room temperature and room light, or up to 7 days under refrigeration protected from light, counted from time of preparation to end of infusion, so pharmacy scheduling has to work backwards from that window.
Infusion-related reactions are managed by severity rather than pre-empted: nivolumab does not carry a routine premedication requirement the way some older monoclonal antibodies do. Grade 1-2 reactions are typically managed by interrupting or slowing the infusion; Grade 3-4 reactions require discontinuation. The bigger monitoring burden is immune-mediated toxicity, pneumonitis, colitis, hepatitis, endocrinopathies (thyroid, adrenal, pituitary), nephritis and skin reactions, which can present weeks after the last dose and are managed with corticosteroids and, for endocrinopathies, hormone replacement per the label's management algorithms.
There is no FDA-licensed biosimilar to nivolumab at present, so hospital pharmacy formularies are working with the originator product only; there is no substitution decision to make.
The documentation pack a regulator actually asks for.
As a temperature-sensitive biologic, Opdivo moves through M Care's cold-chain validated lanes with continuous temperature logging from the Indian dispatch point through to arrival, and the CTD-format dossier we prepare covers batch release documentation, cold-chain transit records and the manufacturer's certificate of analysis, so a tender desk or importer has what it needs for registration or customs clearance. M Care holds CDSCO export licensure as an Indian merchant exporter; we do not hold WHO-GMP or WHO-PQ certification ourselves; those sit with the originator manufacturer, and we supply Opdivo through licensed Indian distribution channels, not our own manufacturing.
Opdivo remains an originator biologic with no FDA-licensed biosimilar version on the market, so the regulatory position for a buyer is straightforward: this is a single, well-documented product line, and the compliance question is about import licensing and cold-chain integrity in the destination market rather than choosing between originator and biosimilar.
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 nivolumab.
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 nivolumab.
- 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.
Nivolumab supply, the specific questions.
Does a generic or biosimilar version of Opdivo (nivolumab) exist?
No. Nivolumab remains under patent protection and there is no FDA-licensed biosimilar on the market. Buyers sourcing nivolumab today are sourcing the Bristol Myers Squibb originator product, Opdivo, through licensed distribution channels.
Can M Care supply Opdivo to our market?
Yes. M Care sources Opdivo through licensed Indian distribution channels and exports on a quote basis to served markets, subject to the destination country's own import and marketing-authorisation requirements. Tell us the destination and required volume and we will confirm the registration and licensing route.
How is Opdivo shipped and stored to protect the cold chain?
Opdivo vials require continuous storage at 2-8C, protected from light, and must never be frozen or shaken. M Care dispatches on cold-chain validated lanes with temperature logging for the full transit, and provides the shipment's temperature record alongside the documentation pack.
What indications is Opdivo licensed for?
Opdivo carries FDA and EMA licences across a range of solid tumours and classical Hodgkin lymphoma, including melanoma, non-small cell lung cancer, renal cell carcinoma, urothelial carcinoma, MSI-H/dMMR colorectal cancer, hepatocellular carcinoma, and oesophageal and gastric cancers, as monotherapy or in combination regimens. The exact licensed indication set depends on destination-country labelling, and we can share the relevant reference label alongside a quote.
What dosing schedules does Opdivo use?
The two flat-dose monotherapy schedules are 240 mg IV every 2 weeks and 480 mg IV every 4 weeks. Combination regimens with ipilimumab or chemotherapy use different doses and intervals depending on the tumour type, so hospital pharmacy should confirm the schedule against the specific indication on the order.
What documentation does M Care provide for a tender submission?
We prepare a CTD-format dossier covering manufacturer batch release data, certificate of analysis and cold-chain transit records, built for the destination market's registration or import-clearance requirements ahead of quoting volume or timeline.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-08-26.
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.