WHO-GMP sourced EU-GMP partners ISO 9001:2015 49+ export markets Since 2003

Navelbine (vinorelbine), a vinca alkaloid dosed both as a strictly intravenous injection and as an oral soft capsule for non-small cell lung cancer and advanced breast cancer, is available from M Care as the originator brand or a licensed generic line, quoted against your tender specification.

M Care Exports supplies Navelbine (vinorelbine), originated by Pierre Fabre, a semi-synthetic vinca alkaloid that arrests tumour cell division by binding tubulin, licensed for first-line non-small cell lung cancer and for advanced breast cancer that has relapsed after anthracycline therapy. As a merchant exporter M Care sources the originator brand and licensed generic vinorelbine, injection and oral capsule alike, through Indian distribution and manufacturing channels and dispatches on quote, not from our own manufacturing.

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WHO-GMP sourcing CDSCO licensed exporter EU-GMP capable partners Cold-chain validated (2–8°C & −25°C) CTD / eCTD dossier-ready ISO 9001:2015
Bulk supply and export terms

Vinorelbine exporter and bulk supplier from India.

For hospital oncology pharmacy, wholesaler and MoH tender orders, M Care quotes vinorelbine as the 10 mg per 1 mL and 50 mg per 5 mL single-dose injection vials or, where a destination market's formulary calls for it, the 20 mg, 30 mg and 80 mg oral soft capsules, against buyer specification, originator Navelbine or a licensed generic line, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because both presentations move under 2 to 8 degrees C cold chain, we confirm the buyer's onward storage capacity and dispatch frequency before quoting, then align CTD/eCTD or country-specific dossier paperwork to the destination regulator's requirements. Vinorelbine's global supply base has tightened in recent years, so tender desks specifying it are often working against a live availability gap rather than a routine restock.

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.

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At a glance

Semi-synthetic vinca alkaloid; microtubule-inhibitor cytotoxic, sourced and documented for export.

Vinorelbine is a semi-synthetic vinca alkaloid, derived from the periwinkle plant, that binds tubulin and blocks microtubule assembly, arresting tumour cells in mitosis. Unlike most vinca alkaloids it is dosed both intravenously, as a strictly IV-only injection, and orally, as a soft capsule, giving prescribers a route choice that most cytotoxics do not offer. FDA-labelled indications cover first-line treatment of unresectable, advanced non-small cell lung cancer, either as a single agent or in combination with cisplatin; the UK and EU-licensed Navelbine capsule additionally covers adjuvant treatment of resected NSCLC with platinum-based chemotherapy, and advanced or metastatic breast cancer that has relapsed or is resistant to an anthracycline-containing regimen. It carries a boxed warning for severe myelosuppression, and, separately, its EU label states intrathecal administration may be fatal, so current safe-handling practice for vinca alkaloids dispenses the diluted drug in an IV infusion bag rather than a syringe, to avoid it being confused with an intrathecal medicine.

Active ingredient

Vinorelbine tartrate. Semi-synthetic vinca alkaloid; microtubule-inhibitor cytotoxic.

Forms and strengths

10 mg/1ml vial, 10mg/ml concentrate for solution for infusion; 50 mg/5ml vial, 10mg/ml concentrate for solution for infusion; 20 mg soft capsule; 30 mg soft capsule; 80 mg soft capsule.

Indications

Vinorelbine is a semi-synthetic vinca alkaloid that binds tubulin to block microtubule assembly, arresting tumour cells in mitosis, indicated for non-small cell lung cancer and, in oral form, advanced breast cancer. Supplied from Indian channels as originator Navelbine or licensed generic injection and capsules to regulated and semi-regulated export markets.

Administration

Intravenous, Oral. Concentrate for solution for infusion and soft capsule.

Documentation

Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.

Who we supply

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 vinorelbine are hospital oncology pharmacists running NSCLC and breast-cancer regimens who need the injection, oral capsule, or both stocked for route flexibility, national and regional MoH tender desks running lung-cancer treatment protocols, licensed pharmaceutical wholesalers and importers stocking oncology ranges, and NGO or cancer-programme procurement working in markets where generic vinorelbine registration is already in place.

GCC registration routes

Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.

MoH registration, GCC →

UK unlicensed routes

Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.

MHRA Specials →

Tender desks

Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.

Tender response →

Dossier support

CTD documentation from the sourcing manufacturer, compiled for your regulator's format.

Dossier preparation →

Pharmacist's note

What the dispensing pharmacist checks on vinorelbine.

Vinorelbine dosing is BSA-based and route-dependent: 25 to 30 mg/m2 IV once weekly, against 60 mg/m2 oral once weekly for the first three doses, stepping to 80 mg/m2 if neutrophil counts allow, so a switch between injection and capsule is not a simple unit conversion and needs a fresh prescription. The injection is for intravenous use only; extravasation causes severe local irritation, tissue necrosis and thrombophlebitis, so infusion should run through a free-flowing line with immediate cessation and standard extravasation management, including hyaluronidase and dry heat, if it occurs. Vinorelbine's EU label states intrathecal administration may be fatal, so it should be diluted and dispensed only in an IV infusion bag, never a syringe, to guard against misadministration. Both injection and capsule are cold-chain products, stored at 2 to 8 degrees C and protected from light, and oral capsules must be swallowed whole with food, never chewed, crushed or re-dosed after early vomiting. Close pre-dose haematological monitoring is mandatory given the myelosuppression boxed warning.

Regulatory & quality

The documentation pack a regulator actually asks for.

Vinorelbine injection and the oral soft capsule both require validated 2 to 8 degrees C cold-chain logistics, light protection and on-arrival temperature-excursion records, distinct from ambient-stored oral oncology tablets. Vinorelbine sits on the WHO Essential Medicines List for Children (EMLc) complementary list, section 8.2.1 cytotoxic medicines, restricted to the intravenous 10 mg per mL, 1 mL and 5 mL vial presentations for intravenous use only; the 80 mg oral capsule entry was reviewed and removed from the EMLc in the WHO's 2023 update in favour of the parenteral form, so buyers citing WHO-EML/EMLc status for vinorelbine should reference the injection, not the capsule. On brand-versus-generic, vinorelbine is off-patent, and licensed generic vinorelbine injection is separately approved and marketed in the US, UK and EU alongside Pierre Fabre's originator Navelbine, so the two are interchangeable on a standard bioequivalence basis for the injectable form. Global supply of vinorelbine injection has tightened in recent years, so lead-time confirmation before a tender quote is prudent. M Care does not manufacture vinorelbine itself and holds no WHO-GMP or WHO-PQ certification in its own name; every batch exported carries its manufacturing partner's own certification.

The paperwork above is the molecule-specific part; the general pathway a destination regulator expects is set out in our licensed import route guide.

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.

How the enquiry works

Molecule · strength · volume · destination. One working day to a quote.

  1. Send us the specifics. Form and strength, pack preference, destination market and indicative volume for vinorelbine.
  2. We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
  3. Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
  4. Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
  5. After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Frequently asked

Vinorelbine supply, the specific questions.

Is Navelbine the same medicine as vinorelbine?

Yes. Vinorelbine is the non-proprietary name and Navelbine is Pierre Fabre's originator brand. Licensed generic vinorelbine injection is separately approved and marketed in the US, UK and EU, so buyers can specify either the brand or a generic line against a tender.

What is vinorelbine licensed to treat?

In the US, first-line treatment of unresectable, advanced non-small cell lung cancer, alone or with cisplatin. The UK and EU-licensed oral capsule additionally covers adjuvant treatment of resected NSCLC with platinum-based chemotherapy, and advanced or metastatic breast cancer that has relapsed or is resistant to anthracycline therapy. Check destination-country labelling for the exact indication set.

Does vinorelbine come as a tablet as well as an injection?

It comes as a soft capsule, not a tablet, in 20 mg, 30 mg and 80 mg strengths, alongside the 10 mg per 1 mL and 50 mg per 5 mL injection vials. The oral and IV doses are not interchangeable milligram-for-milligram; each has its own weekly BSA-based regimen.

Why does vinorelbine need cold-chain shipping?

Both the injection and the oral capsule are stored at 2 to 8 degrees C and protected from light, per the manufacturer label, so vinorelbine moves on M Care's validated cold-chain lanes rather than standard ambient logistics, with temperature logging in transit and an on-arrival excursion check.

Is vinorelbine on the WHO Essential Medicines List?

Yes, on the WHO Essential Medicines List for Children (EMLc) complementary list, restricted to the intravenous 10 mg per mL vial presentations for intravenous use only. The earlier 80 mg oral capsule listing was removed from the EMLc in 2023 in favour of the injectable form, so WHO-EML/EMLc status applies to the injection, not the capsule.

Can M Care supply vinorelbine for our tender or hospital order?

Yes. Tell us your formulation (injection or capsule), strength, pack requirement, brand-or-generic preference and destination market, and we quote Navelbine or a licensed generic vinorelbine line against your specification, drawn from licensed WHO-GMP manufacturer lines on the M Care roster.

Sources and review

Who stands behind this page, and where its statements come from.

Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-19.

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.

Vinorelbine enquiry

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