Suppliers and packagers for voriconazole

voriconazole

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal Pharms	VORICONAZOLE	voriconazole	FOR SUSPENSION;ORAL	205034	ANDA	Amneal Pharmaceuticals LLC	65162-913-22	75 mL in 1 BOTTLE (65162-913-22)	2013-11-29
Hetero Labs Ltd V	VORICONAZOLE	voriconazole	FOR SUSPENSION;ORAL	211598	ANDA	Camber Pharmaceuticals, Inc.	31722-266-31	1 BOTTLE in 1 CARTON (31722-266-31) / 75 mL in 1 BOTTLE	2025-08-08
Novel Labs Inc	VORICONAZOLE	voriconazole	FOR SUSPENSION;ORAL	206799	ANDA	Novel Laboratories, Inc.	40032-038-60	1 BOTTLE in 1 CARTON (40032-038-60) / 75 mL in 1 BOTTLE (40032-038-00)	2016-06-01
Novel Labs Inc	VORICONAZOLE	voriconazole	FOR SUSPENSION;ORAL	206799	ANDA	Lupin Pharmaceuticals,Inc.	43386-038-60	1 BOTTLE in 1 CARTON (43386-038-60) / 75 mL in 1 BOTTLE	2016-06-01
Zhejiang Poly Pharm	VORICONAZOLE	voriconazole	FOR SUSPENSION;ORAL	216805	ANDA	Slate Run Pharmaceuticals, LLC	70436-230-39	1 BOTTLE in 1 CARTON (70436-230-39) / 75 mL in 1 BOTTLE	2024-03-01
Zhejiang Poly Pharm	VORICONAZOLE	voriconazole	FOR SUSPENSION;ORAL	216805	ANDA	Zhejiang Poly Pharm Co., Ltd.	72673-111-30	1 BOTTLE in 1 CARTON (72673-111-30) / 75 mL in 1 BOTTLE	2025-04-11
Aspiro	VORICONAZOLE	voriconazole	POWDER;INTRAVENOUS	218533	ANDA	Camber Pharmaceuticals, Inc.	31722-224-31	1 VIAL, SINGLE-DOSE in 1 CARTON (31722-224-31) / 20 mL in 1 VIAL, SINGLE-DOSE	2024-04-03

Global Suppliers of Voriconazole

Last updated: February 19, 2026

Voriconazole is a broad-spectrum antifungal medication used primarily for invasive fungal infections. It is marketed under various brand names, including Vfend by Pfizer. Multiple suppliers globally manufacture or distribute voriconazole, with key manufacturers and authorized distributors operating across different regions.

Major Pharmaceutical Companies Producing Voriconazole

Company	Manufacturing Status	Regions Covered	Notable Brands
Pfizer, Inc.	Original developer and patent holder	Global (primarily North America, Europe, Asia)	Vfend, Vfend Intravenous
Hikma Pharmaceuticals	Generic producer	Middle East, Europe, selected Asia-Pacific	Voriconazole Hikma, Voriconazole Hospira (via licensing)
Sandoz (Novartis)	Generic manufacturer	Europe, North America	Voriconazole Sandoz
Mylan (Now Viatris)	Generic producer	North America, Europe, Asia-Pacific	Voriconazole Mylan
Sun Pharmaceutical Ltd	Generic producer	India, Asia-Pacific	Voriconazole Sun Pharma

Contract Manufacturers and Distributors

• Several Contract Manufacturing Organizations (CMOs) provide outsourcing services for drug production. These include:

  • WuXi AppTec: Offers formulation and manufacturing services for voriconazole.
  • Fisher BioServices: Supplies research and clinical-grade voriconazole.
  • Biocon: Produces active pharmaceutical ingredients (APIs) and finished formulations for designated markets.

• Distribution channels are often managed through regional distributors with licensed rights, especially for generic formulations.

Regulatory Approvals and Market Presence

• Voriconazole is approved by the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and other authorities.
• Pfizer holds original patents; generic manufacturers relied on patent expirations to gain market space.
• Patent expiry varies by region: the main patent expired in the US in 2014, enabling generics elsewhere from 2015 onward.

Supply Chain Considerations

• The active pharmaceutical ingredient (API) production is centralized in regions with strong chemical manufacturing sectors: China and India.
• Finished dosages are assembled globally, with regional suppliers focusing on filling, packaging, and distribution.
• Supply chain disruptions have occurred due to COVID-19 impacts, affecting availability and pricing in certain markets.

Summary of Key Suppliers by Region

Region	Key Suppliers	Market Dynamics
North America	Pfizer, Sandoz, Mylan, Sun Pharma	Dominated by Pfizer; generic competition pressures
Europe	Sandoz, Mylan, Pfizer	Presence of multiple generics; market price reductions
Asia-Pacific	Sun Pharma, Mylan, local regional suppliers	High API production; growing generic market
Middle East	Hikma Pharmaceuticals	Main generic provider in multiple Middle Eastern markets
Global	Contract manufacturers like WuXi, FwyrBio	Outsource API and formulation manufacturing

Conclusion

Voriconazole's supply chain involves multiple global players, including original patent holders like Pfizer, generics manufacturers such as Hikma, Sandoz, and Mylan, alongside contract manufacturers supporting regional needs. Patent expiration opened the market for generics, increasing supply but also amplifying competition. Regional distribution networks and manufacturing capacities largely shape the availability and pricing dynamics.

---

Key Takeaways

• Original production by Pfizer; multiple generic suppliers active post-patent expiry.
• API manufacturing concentrated in China and India.
• Market presence varies by region, with significant generic competition.
• Supply chain stability affected by geopolitical and pandemic-related disruptions.

FAQs

1. Who are the leading patent holders for voriconazole?
   Pfizer holds the original patent and primary manufacturing rights.

2. When did generic versions of voriconazole become available?
   Patent expiration in the US occurred in 2014, enabling generics from 2015 onward.

3. What regions have the most voriconazole manufacturers?
   Asia (China and India) dominate API production; Europe and North America contain most finished-dose manufacturing.

4. Are there regional differences in voriconazole supply?
   Yes; some regions rely more on regional generic suppliers, while others depend on imports from major global manufacturers.

5. How has the COVID-19 pandemic impacted voriconazole supplies?
   It caused supply chain disruptions, affecting availability and causing price fluctuations in certain markets.

---

References

1. Pfizer Inc. (2022). Vfend (Voriconazole) prescribing information.
2. European Medicines Agency. (2015). Voriconazole marketing authorization.
3. U.S. Food and Drug Administration. (2014). Approval letter for Vfend.
4. GlobalData Healthcare. (2022). Market analysis report on antifungal drugs.
5. IMS Health. (2022). Pharmaceutical market supply chain report.