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Voriconazole | CAS No: 137234-62-9 | GMP-certified suppliers
A medication that treats invasive aspergillosis, candidemia, esophageal candidiasis, and other serious fungal infections, supporting reliable management of opportunistic disease in high‑risk patients.
Therapeutic categories
Primary indications
- For the treatment of esophageal candidiasis, cadidemia, invasive pulmonary aspergillosis, and serious fungal infections caused by <i>Scedosporium apiospermum</i> and <i>Fusarium</i> spp
Product Snapshot
- Voriconazole is an azole antifungal available as oral solid forms and parenteral/IV injectable formulations
- It is used for invasive fungal infections including candidemia, esophageal candidiasis, invasive pulmonary aspergillosis, and infections due to Scedosporium apiospermum and Fusarium species
- It is approved in major regulated markets including the US, EU, and Canada
Clinical Overview
The compound exerts fungistatic activity. Its pharmacologic effect is driven by high‑affinity binding to fungal CYP51 (14‑alpha sterol demethylase), which blocks the demethylation of lanosterol in the ergosterol biosynthesis pathway. Depletion of ergosterol disrupts membrane function and suppresses fungal proliferation, enabling host immune clearance. This mechanism provides activity against Aspergillus spp., Candida spp., and some pathogens with reduced susceptibility to earlier triazoles.
Voriconazole exhibits nonlinear pharmacokinetics due to saturable metabolism. It is extensively metabolized in the liver, involving CYP2C19 as a primary pathway, with contributions from CYP2C9 and CYP3A4. As both a substrate and inhibitor of these enzymes, it presents clinically relevant potential for drug–drug interactions. Systemic exposure varies with genetic polymorphisms in CYP2C19.
Common safety considerations include hepatotoxicity, visual disturbances, photosensitivity reactions, and risk of QTc prolongation. Monitoring of hepatic function and evaluation of coadministered agents that affect CYP2C19, CYP2C9, or CYP3A pathways are routinely required. Severe cutaneous adverse reactions have been reported, particularly with prolonged exposure.
Voriconazole is supplied globally in oral and intravenous forms, with Vfend being the originator brand. In API procurement, key quality considerations include control of stereochemical integrity, compliance with ICH impurity limits, and verification of polymorphic form. Reliable suppliers should demonstrate validated manufacturing processes, robust stability data, and regulatory documentation suitable for international submissions.
Identification & chemistry
| Generic name | Voriconazole |
|---|---|
| Molecule type | Small molecule |
| CAS | 137234-62-9 |
| UNII | JFU09I87TR |
| DrugBank ID | DB00582 |
Pharmacology
| Summary | Voriconazole is a triazole antifungal that inhibits fungal 14‑alpha sterol demethylase (CYP51), blocking ergosterol synthesis and disrupting cell membrane function. This action produces fungistatic activity against a broad range of pathogenic fungi, including Aspergillus and Candida species. Its pharmacology is characterized by growth inhibition of susceptible organisms and known risks of hepatotoxicity and photosensitivity. |
|---|---|
| Mechanism of action | Voriconazole is used to treat fungal infections caused by a variety of organisms but including _Aspergillus spp._ and _Candida spp_. Voriconazole is a triazole antifungal exhibiting fungistatic activity against fungal pathogens.Like other triazoles, voriconazole binds to 14-alpha sterol demethylase, also known as CYP51, and inhibits the demethylation of lanosterol as part of the ergosterol synthesis pathway in yeast and other fungi. The lack of sufficient ergosterol disrupts fungal cell membrane function and limits fungal cell growth. With fungal growth limited, the host's immune system is able to clear the invading organism. |
| Pharmacodynamics | Voriconazole is a fungistatic triazole antifungal used to treat infections by inhibiting fungal growth.It is known to cause hepatotoxic and photosensitivity reactions in some patients. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Cytochrome P450 51 | Yeast | antagonist, inhibitor |
ADME / PK
| Absorption | The oral bioavailability is estimated to be 96% in healthy adults. Population pharmacokinetic studies report a reduced bioavailability pediatric patients with a mean of 61.8% (range 44.6–64.5%) thought to be due to differences in first-pass metabolism or due to differences in diet . Of note, transplant patients also have reduced bioavailability but this is known to increase with time after transplantation and may be due in part to gastrointestinal upset from surgery and some transplant medications. Tmax is 1-2 hours with oral administration. When administered with a high-fat meal Cmax decreases by 34% and AUC by 24%. pH does not have an effect on absorption of voriconazole. Differences in Cmax and AUC have been observed between healthy adult males and females with Cmax increasing by 83% and AUC by 113% although this has not been observed to significantly impact medication safety profiles. |
|---|---|
| Half-life | Voriconazole follows non-linear kinetics and has a terminal half-life of elimination which is dose-dependent. |
| Protein binding | Voriconazole is 58% bound to plasma proteins . |
| Metabolism | Voriconazole undergoes extensive hepatic metabolism through cytochrome enzymes CYP2C9, CYP2C19, and CYP3A4. CYP2C19 mediates N-oxidation with an apparent Km of 14 μM and an apparent Vmax of 0.22 nmol/min/nmol CYP2C19.Voriconazole N-oxide is the major circulating metabolite, accounting for 72% of radiolabeled metabolites found.CYP3A4 contributes to N-oxidation with a Km of 16 μM and Vmax of 0.05 nmol/min/nmol CYP3A4 as well as 4-hydroxylation with a Km of 11 μM and a Vmax of 0.10 nmol/min/nmol CYP3A4.CYP3A5 and CYP3A7 provide minor contributions to N-oxidation and 4-hydroxylation. The N-oxide and 4-hydroxylated metabolites undergo glucuronidation and are excreted through the urine with other minor glucuronidated metabolites. |
| Route of elimination | Voriconazole is eliminated via hepatic metabolism with less than 2% of the dose excreted unchanged in the urine. |
| Volume of distribution | The estimated volume of distribution of voriconazole is 4.6 L/kg . Population pharmacokinetic studies estimate the median volume of distribution to be 77.6 L with the central compartment estimated at 1.07 L/kg Voriconazole is known to achieve therapeutic concentrations in many tissues including the brain, lungs, liver, spleen, kidneys, and heart. |
| Clearance | The clearance of voriconazole is estimated to be a mean of 5.25-7 L/h in healthy adults for the linear portion of the drug's kinetics. |
Formulation & handling
- Oral formulations require attention to food effects; administer on an empty stomach to avoid reduced absorption.
- Low aqueous solubility necessitates solubilizing excipients for oral products and reconstitution considerations for IV powders.
- Solid small‑molecule API is typically supplied as lyophilized powder for injection, requiring protection from moisture and controlled reconstitution conditions to maintain stability.
Regulatory status
| Lifecycle | The active ingredient is in a mature market phase, with all listed US and Canadian patents expiring between 2009 and 2018. With products already marketed in Canada, the US, and the EU, the API is positioned in a post‑exclusivity environment characterized by established generic availability. |
|---|
| Markets | Canada, US, EU |
|---|
Supply Chain
| Supply chain summary | Voriconazole is produced by an originator manufacturer along with at least one additional API supplier, with several third‑party organizations handling packaging for distribution. Branded and non‑branded products are present across the US, EU, and Canada, indicating broad global availability. With key US and Canadian patents expiring between 2009 and 2018, the market conditions support existing and ongoing generic competition. |
|---|
Safety
| Toxicity | Symptoms of overdose include photophobia and possible QTc prolongation.In case of overdose, supportive care and ECG monitoring are recommended. Activated charcoal may aid in the removal of unabsorbed drug. Voriconazole is cleared by hemodialysis at a rate of 121 mL/min which may be helpful in removing absorbed drug. Carcinogenicity studies found hepatocellular adenomas in female rats at doses of 50 mg/kg and hepatocellular carcinomas found in male rats at doses of 6 and 50 mg/kg. These doses are equivalent to 0.2 and 1.6 times the recommended maintenance dose (RMD). Studies in mice detected hepatocellular carcinomas in males at doses of 100 mg/kg or 1.4 times the RMD. Hepatocellular adenomas were detected in both male and female mice. |
|---|
- Overexposure has been associated with photophobia and QTc interval prolongation
- ECG changes should be considered relevant for analytical and handling controls
- Carcinogenicity signals observed in rodent studies include hepatocellular adenomas and carcinomas at exposures near or modestly above human maintenance‑dose equivalents
Voriconazole is a type of Antimycotics
Antimycotics, a subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs), are essential in the treatment of various fungal infections. These powerful medications target and eliminate harmful fungi that can cause infections in humans.
Antimycotics are classified into two main types: systemic and topical. Systemic antimycotics are administered orally or intravenously and work by circulating throughout the body, treating systemic fungal infections that affect internal organs or spread throughout the bloodstream. On the other hand, topical antimycotics are applied externally to treat localized fungal infections such as athlete's foot or yeast infections.
The efficacy of antimycotics lies in their ability to disrupt fungal cell membranes, inhibit the synthesis of fungal DNA or proteins, or interfere with essential metabolic processes specific to fungi. This targeted action minimizes damage to human cells, making these medications relatively safe for patients.
Commonly prescribed antimycotics include azoles, polyenes, allylamines, and echinocandins. Azoles inhibit the synthesis of ergosterol, a vital component of fungal cell membranes, while polyenes bind to ergosterol, resulting in the formation of pores that lead to cell death. Allylamines disrupt the synthesis of ergosterol and inhibit the activity of squalene epoxidase, an enzyme involved in ergosterol production. Echinocandins target the synthesis of β-(1,3)-D-glucan, an essential component of the fungal cell wall.
Antimycotics play a crucial role in the management of fungal infections, offering relief to patients and aiding in their recovery. As with any medication, it is important to follow healthcare professionals' guidance regarding dosage, duration of treatment, and potential side effects to ensure optimal therapeutic outcomes.
Voriconazole (Antimycotics), classified under Antifungals
Antifungals are a vital category of pharmaceutical active pharmaceutical ingredients (APIs) designed to combat fungal infections. These medications are developed to target and eliminate fungi, including yeasts and molds, which can cause a range of diseases in humans and animals.
Antifungals work by interfering with specific components or processes essential for fungal growth and reproduction. They may inhibit the synthesis of fungal cell walls or disrupt the production of ergosterol, a crucial component of fungal cell membranes. By targeting these key mechanisms, antifungal APIs effectively hinder the growth and spread of fungal infections.
The diversity within the antifungal category is reflected in the various classes of antifungal APIs available. Azoles, polyenes, echinocandins, and allylamines are common classes of antifungals. Each class exhibits unique mechanisms of action and targets specific types of fungi. This diversity enables healthcare professionals to tailor treatment plans to the specific fungal infection, optimizing therapeutic outcomes.
Antifungal APIs find application in various pharmaceutical formulations, including oral medications, topical creams, ointments, and intravenous solutions. They are crucial for the treatment of common fungal infections like athlete's foot, ringworm, vaginal yeast infections, and oral thrush. Additionally, antifungals play a crucial role in managing serious systemic fungal infections that can pose significant health risks, especially in immunocompromised individuals.
Overall, antifungal APIs are indispensable tools in the fight against fungal infections, offering effective treatment options and improving the quality of life for patients suffering from these conditions. With ongoing research and development, the antifungal category continues to evolve, providing innovative solutions to combat the ever-changing landscape of fungal pathogens.
Voriconazole API manufacturers & distributors
Compare qualified Voriconazole API suppliers worldwide. We currently have 23 companies offering Voriconazole API, with manufacturing taking place in 7 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Arshine Pharmaceutical Co... | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, MSDS, USDMF | 176 products |
| Chromo Labs. | Producer | India | India | CEP, CoA, USDMF, WC | 11 products |
| Cipla | Producer | India | India | CoA, GMP, WC | 164 products |
| Dalian Wista Pharma Co Lt... | Producer | China | China | CoA | 16 products |
| Dongkook Pharma | Producer | South Korea | South Korea | CEP, CoA, JDMF | 6 products |
| Dr. Reddy's | Producer | India | India | BSE/TSE, CEP, CoA, FDA, GMP, MSDS, USDMF, WC | 170 products |
| Flavine | Distributor | Germany | Unknown | CoA | 83 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Hetero Labs | Producer | India | India | CoA, GMP, USDMF, WC | 90 products |
| Kleem Pharmaceuticals | Producer | India | India | CoA | 22 products |
| Lee Pharma | Producer | India | India | CEP, CoA, FDA, GMP, ISO9001, WHO-GMP | 21 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Medichem | Producer | Spain | Malta | CoA, GMP | 39 products |
| MSN Labs. | Producer | India | India | CEP, CoA, FDA, GMP, JDMF, USDMF, WC | 119 products |
| Mylan | Producer | India | India | CEP, CoA, USDMF, WC | 201 products |
| Pharmacia & Upjohn | Producer | United States | Ireland | CoA, GMP | 30 products |
| Senova Technology Co., Lt... | Producer | China | China | CoA, GMP, ISO9001, USDMF | 157 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, USDMF, WC | 757 products |
| Sun Pharma | Producer | India | India | CEP, CoA, WC | 219 products |
| Tresinde Biotech | Producer | India | India | CoA, GMP | 50 products |
| Yangtze River Pharmaceuti... | Producer | China | China | CoA, GMP, ISO14001 | 34 products |
| Zhuhai Rundu | Producer | China | China | CoA, WC | 11 products |
When sending a request, specify which Voriconazole API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Voriconazole API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
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Technical
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