Voriconazole Exporter and Supplier: Tablets, Oral Suspension and IV Infusion
You are sourcing a triazole that a haematology ward cannot run out of mid-course, and one that has to arrive in the right form for the patient in front of the clinician. M Care Exports has traded pharmaceuticals out of India since 2003, and we supply voriconazole across all four presentations: 50mg and 200mg film-coated tablets, powder for oral suspension reconstituting to 40mg/mL, and 200mg powder for solution for infusion. We buy from CDSCO-licensed manufacturing lines, consolidate the strengths and forms you actually need into a single shipment, and obtain the manufacturer's dossier paperwork so you can register or clear it.
Why voriconazole is a four-format order, not a single line item
Most antifungals you can order as one strength and be done. Voriconazole rarely works that way. A patient may start on the 200mg IV vial in intensive care, step down to 200mg tablets once oral intake is tolerated, move to 50mg tablets for dose titration after a trough level comes back high, and a paediatric or nasogastric case needs the 40mg/mL suspension instead. A buyer who orders only the 200mg tablet finds three of those four situations uncovered. We are a merchant-exporter and a wholesaler, not a manufacturer, and that is precisely the point here: we are not tied to one plant's product list, so we can assemble all four presentations of voriconazole against one purchase order and one set of shipping documents.
All four presentations under one PO
50mg and 200mg tablets, 40mg/mL oral suspension and the 200mg IV vial ship together on a single invoice and packing list, rather than as four separate imports from four different sources.
Order quantity set by the batch, not by us
Minimum order is set by the source manufacturer's batch-release minimum for the presentation you pick, and the IV vial and the suspension usually carry different minimums to the tablets. Tell us the split you need and we will confirm the real floor before you commit.
Pricing quoted per enquiry
We do not publish voriconazole pricing. Cost moves with the source line, the pack configuration, the batch, and your Incoterm, so we quote against your actual requirement rather than against a number that would be stale by the time you read it.
Shelf life declared before dispatch, not after
Voriconazole often moves against tenders with a hard remaining-shelf-life clause. We confirm the batch expiry in writing before the goods leave, so you are not arguing about a two-thirds rule after the container has landed.
Voriconazole at a glance for procurement
Active ingredient
Voriconazole, a second-generation triazole antifungal. ATC code J02AC03, within J02AC (triazole and tetrazole derivatives) under antimycotics for systemic use. WHO defined daily dose is 0.4g for both oral and parenteral routes.
Presentations stocked
Film-coated tablets at 50mg and 200mg, powder for oral suspension reconstituting to 40mg/mL, and 200mg powder for solution for infusion. Reference brands include the originator Vfend and Indian brands such as Vorizol 200mg Tablet, named here purely as buyer-reference context.
Regulatory class
Prescription-only in essentially every market we ship to, and hospital-restricted in many. Voriconazole appears on the WHO Model List of Essential Medicines (complementary list, antifungal medicines). Tablets came off patent in 2011 and the injectable followed in 2012, so multiple Indian lines now produce it. AWaRe classification does not apply, as AWaRe covers antibacterials only.
Clinical position
IDSA and joint ESCMID-ECMM-ERS guidance recommend voriconazole for primary treatment of invasive aspergillosis at the highest grading. Guidance published from 2016 onward places isavuconazole at a comparable evidence level, so both now appear as first-line options rather than voriconazole alone.
Handling and storage
Tablets and unreconstituted vials are ambient-stable and do not need cold chain, which keeps freight straightforward. The reconstituted oral suspension carries a defined in-use period. Storage conditions are per the source manufacturer's approved labelling and we pass those through unchanged.
Reconstitution note for the IV form
The 200mg infusion vial is a powder requiring reconstitution and further dilution before use. Its solubilising excipient is sulfobutylether beta-cyclodextrin (SBECD), which is directly relevant to which patients receive the IV rather than the oral form.
The wards that actually consume this molecule
Voriconazole demand does not come from general pharmacy. It concentrates in a small number of departments that treat profoundly immunocompromised patients, which means the buyers we deal with on this line look different to the ones ordering broad-spectrum orals.
Haematology and oncology procurement
Neutropenic patients through induction chemotherapy are the core invasive-aspergillosis population. These buyers order to a treatment protocol and need continuity across a course measured in weeks, so a stockout mid-therapy is the failure mode they are guarding against.
Transplant centre pharmacy
Solid organ and stem cell transplant units carry standing antifungal requirements, and EU labelling includes prophylaxis in high-risk allogeneic stem cell transplant recipients. They typically want the IV and oral forms held together, because their patients move between the two as gut function recovers.
Hospital and government tender buyers
Ministries and central medical stores tender voriconazole as part of an essential antifungal basket. These orders turn on document completeness and remaining shelf life, not on price alone, which is where most of our work on this line actually goes.
Importers and distributors building an antifungal range
Distributors who already carry fluconazole find voriconazole is the natural next step up the ladder, because it covers moulds that fluconazole does not. We supply the full presentation set so the range does not have gaps.
Intensive care and pulmonology units
Invasive pulmonary aspergillosis in critically ill patients, including post-viral cases, is a recognised demand driver, and these units pull the IV vial first.
Safety and handling facts your regulatory reviewer will ask about
Voriconazole carries a safety profile that a distributor should understand before quoting it, because several of its warnings drive real labelling and registration consequences. Hepatotoxicity is the headline: liver function is monitored at baseline and during therapy per the approved labelling, and abnormalities can force discontinuation. Visual disturbances, including photopsia, altered colour perception and blurring, are common enough to be expected rather than exceptional, and are generally transient and reversible on stopping. The drug prolongs the QT interval. It is also a potent perpetrator and victim of CYP2C19, CYP2C9 and CYP3A4 interactions, and CYP2C19 polymorphism produces wide between-patient exposure variation, which is why therapeutic drug monitoring of trough concentrations is widely recommended. Labelling contraindicates co-administration with several CYP3A4 substrates that prolong QT (including terfenadine, astemizole, cisapride, pimozide and quinidine) and with strong inducers such as rifampicin and carbamazepine. Note that US labelling carries no boxed warning for voriconazole, which reviewers sometimes ask about. None of this is dosing instruction, and nothing on this page is medical advice: it is reference context so you can anticipate what a tender's clinical annex or an importing regulator will expect to see reflected in the approved labelling you submit.
Two points deserve particular attention. First, phototoxicity is not a minor cosmetic warning on this molecule. Long-term voriconazole exposure is associated with cutaneous squamous cell carcinoma, and in November 2024 the IARC Monographs programme (Volume 137) classified voriconazole as Group 1, carcinogenic to humans, on the basis of sufficient evidence for squamous cell carcinoma of the skin in humans, with strong mechanistic evidence in combination with ultraviolet radiation. Prescribing information in most markets already reflects photoprotection advice and dermatological surveillance for prolonged therapy. Related to the same long-course population, labelling also warns of fluorosis and periostitis reported during long-term therapy, with discontinuation advised where skeletal pain and compatible radiologic findings appear. Buyers registering the product should expect both to be live points in labelling review rather than formalities.
Second, the intravenous form deserves a specific note. The 200mg infusion vial is solubilised with SBECD, a cyclodextrin excipient cleared by glomerular filtration, and it accumulates where creatinine clearance falls below roughly 50mL/min. Oral voriconazole itself needs no dose adjustment for renal impairment, so the labelled consequence is that the oral forms are generally preferred over IV in renally impaired patients unless a benefit-risk assessment justifies the IV, rather than the dose being changed. Infusion-related reactions are also documented for the IV form. That is exactly why we advise stocking the tablets and the suspension alongside the vial instead of relying on IV supply alone. Prescribing decisions rest with the treating clinician against the approved labelling.
"Written for professional buyers and importers, not as medical advice. Prescribing decisions sit with the treating clinician and the approved label in your market.
Documents we compile for your voriconazole filing
Let us be exact about our role, because it matters when you are filing. M Care Exports is an Indian merchant-exporter and wholesaler. We do not manufacture voriconazole and we do not hold WHO-GMP, WHO-PQ or EU-GMP: those approvals belong to the manufacturing site, and we source from WHO-GMP-listed lines. Our own credential is ISO 9001:2015, covering how we run the trading and quality-assurance side. What we do for you is obtain and assemble the manufacturer's documentation and work through the submission with you.
CTD dossier compiled alongside you
We obtain the source manufacturer's dossier modules for the voriconazole presentation you are registering and work through the compilation with your regulatory consultant or in-house team, rather than handing over a folder and stepping back.
CoPP and free sale certification
Certificate of Pharmaceutical Product in WHO format, plus free sale certification where your regulator requires it, obtained against the manufacturing site holding the Indian approval for the presentation.
Batch-specific quality paperwork
Certificate of Analysis against the declared pharmacopoeial specification for the actual dispatched batch, the manufacturing site's GMP certificate, and batch manufacturing and expiry declaration.
Stability and shelf-life data
Zone-appropriate stability data from the manufacturer, which matters for the reconstituted oral suspension in-use period and for tenders that impose a remaining-shelf-life threshold at the port of entry.
Shipping and clearance set
Commercial invoice, packing list, certificate of origin, bill of lading or airway bill, and any legalisation or embassy attestation your market imposes. We flag which of these your specific destination needs before you order, not after.
Molecules buyers source alongside Voriconazole.
Fluconazole
The other triazole in our range, and the one voriconazole is usually stepped up from: fluconazole covers Candida but not the moulds, so most buyers carry both.
Amphotericin B
The polyene alternative for invasive mould infection, often the salvage or second-line option where a triazole fails or cannot be tolerated.
Meropenem
A carbapenem rather than an antifungal, but it sits on the same neutropenic-fever protocols, so hospital buyers frequently order it on the same PO.
How ordering works.
- Send the presentation split, not just the molecule name. Tell us how much of each form you need across 50mg tablets, 200mg tablets, 40mg/mL suspension and the 200mg IV vial, plus your destination market and whether this is a tender, a registration batch or replenishment stock. The split changes which source lines can serve you.
- We come back with sourcing, pricing and the real minimum. You get a quote per presentation, the source manufacturer's batch-release minimum for each, indicative lead time, and a clear statement of which documents your market will require. If a presentation you asked for cannot be sourced sensibly, we say so at this stage.
- Documents assembled and confirmed before dispatch. CoA, CoPP, the site GMP certificate, stability data and the shipping set are put together and shared with you for review. Batch expiry is confirmed in writing so any shelf-life clause is settled before goods move.
- Consolidated dispatch and tracking through to landing. All four presentations move as one consignment on the Incoterm we agreed, ambient rather than cold chain, and we stay on the shipment through clearance rather than closing the file at the port of loading.
Voriconazole supply, the specific questions.
Is voriconazole still first-line for invasive aspergillosis, or has isavuconazole replaced it?
It has not been replaced, but it is no longer alone. IDSA and the joint ESCMID-ECMM-ERS guidance recommend voriconazole for primary treatment of invasive aspergillosis at the highest grading, and guidance published from 2016 onward places isavuconazole at a comparable evidence level, either alongside voriconazole or as an alternative to it. Trial data showed isavuconazole non-inferior on 42-day all-cause mortality with fewer drug-related adverse events, which is what earned it that position. In practical procurement terms, voriconazole remains a preferred first-line agent, it is on the WHO Model List of Essential Medicines, and it is off-patent with a broad Indian manufacturing base. We would not encourage a buyer to drop it from a formulary on the strength of the isavuconazole data.
Does the IARC Group 1 carcinogen classification affect whether we can register or supply voriconazole?
It has not removed voriconazole from any market we ship to, and it should not be read as a withdrawal signal. In November 2024 the IARC Monographs programme (Volume 137) classified voriconazole as Group 1, carcinogenic to humans, based on sufficient human evidence for squamous cell carcinoma of the skin associated with prolonged therapy, with strong mechanistic evidence in combination with ultraviolet radiation. IARC assesses hazard, not the risk-benefit balance of treating a life-threatening mould infection, and the phototoxicity and skin-malignancy signal was already reflected in prescribing information before the classification. What it does change is reviewer attention: expect a registration reviewer to look closely at how photoprotection and dermatological surveillance appear in your proposed labelling. We supply the source manufacturer's approved labelling as it stands and will not alter safety text to smooth a submission.
Our renal unit was told to avoid IV voriconazole. Should we order the vial at all?
Order it, but do not order it alone. The caution is about the excipient rather than the drug: the 200mg infusion vial is solubilised with SBECD, a renally cleared cyclodextrin that accumulates where creatinine clearance falls below roughly 50mL/min. Voriconazole itself does not require a dose adjustment in renal impairment, so the labelled position is to give the oral form in these patients unless a benefit-risk assessment justifies the IV, rather than to reduce the IV dose. That is a supply question as much as a clinical one, because it only works if the tablets or the 40mg/mL suspension are physically on the shelf. This is a common reason we advise buyers on this molecule to stock the vial, the 200mg tablet and the suspension together. Prescribing decisions rest with the treating clinician against the approved labelling, and nothing here is medical advice.
Why would we stock the 50mg tablet when the 200mg covers standard therapy?
Because voriconazole exposure varies widely between patients, and the 50mg tablet is the titration tool. Metabolism runs mainly through CYP2C19, which is polymorphic, so poor metabolisers and extensive metabolisers on an identical dose can land at very different trough concentrations. Therapeutic drug monitoring of trough levels is widely recommended for exactly this reason, and when a level comes back outside the target range the dose is adjusted against the approved labelling. Without the 50mg strength, a unit doing TDM properly has less granular ability to act on the result. Stocking only the 200mg tablet tends to leave that gap open.
Does voriconazole need cold chain, and what about the oral suspension once reconstituted?
No cold chain is needed for the forms as shipped. The film-coated tablets and the unreconstituted 200mg vial are ambient-stable per the source manufacturer's approved storage conditions, which keeps freight cost and validation burden low compared with a biologic or a cold-chain antifungal. The oral suspension is the one to plan for: it ships as a powder and is reconstituted at the point of use to 40mg/mL, after which it carries a defined in-use period stated on the approved labelling. If you are supplying a paediatric or nasogastric-feeding population, factor that in-use window into how you size and phase the order, since a large single drop of suspension is not necessarily a saving.
Do you hold WHO-GMP or WHO prequalification for voriconazole?
No, and any supplier telling you otherwise about themselves is worth a second look. M Care Exports is a merchant-exporter and wholesaler, not a manufacturer, so GMP and prequalification approvals are held by the manufacturing site, not by us. What we can say honestly is that we supply voriconazole from WHO-GMP-listed manufacturing lines and pass through that site's GMP certification with the consignment. Our own credential is ISO 9001:2015, which covers our trading, sourcing and documentation processes. If your tender requires a specific site approval, tell us at enquiry stage and we will confirm what the available source lines actually hold before you build your bid around it.
What is the minimum order quantity, and can you quote a price?
There is no single figure for either, and we would rather say that than invent one. Minimum order is set by the source manufacturer's batch-release minimum for the specific presentation, and the four voriconazole forms do not share a minimum: the IV vial and the oral suspension typically carry different floors to the tablets. Pricing is quoted on request, because it moves with the source line, pack configuration, batch and your chosen Incoterm. Send us the presentation split and destination market and you will get real numbers against your actual requirement, along with the minimum for each form.
Tell us your voriconazole presentation split
Send the quantities you need across 50mg tablets, 200mg tablets, 40mg/mL oral suspension and 200mg IV vials, plus your destination market and whether this is tender, registration or replenishment stock. We come back with sourcing, price on request, the source manufacturer's real batch minimum for each form, and the document list your regulator will ask for. Trading from India since 2003, ISO 9001:2015.