Suppliers and packagers for NOXAFIL

NOXAFIL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Merck Sharp Dohme	NOXAFIL	posaconazole	SOLUTION;INTRAVENOUS	205596	NDA	Merck Sharp & Dohme LLC	0085-4331-01	1 VIAL, GLASS in 1 CARTON (0085-4331-01) / 16.7 mL in 1 VIAL, GLASS	2014-03-13
Schering	NOXAFIL	posaconazole	SUSPENSION;ORAL	022003	NDA	Merck Sharp & Dohme LLC	0085-1328-01	1 BOTTLE, GLASS in 1 CARTON (0085-1328-01) / 105 mL in 1 BOTTLE, GLASS	2006-09-15
Schering	NOXAFIL	posaconazole	SUSPENSION;ORAL	022003	NDA AUTHORIZED GENERIC	ENDO USA, Inc.	0254-1016-36	1 BOTTLE, GLASS in 1 CARTON (0254-1016-36) / 105 mL in 1 BOTTLE, GLASS	2023-03-29

Suppliers for the Pharmaceutical Drug: NOXAFIL

Last updated: July 27, 2025

Introduction

Noxafil (posaconazole) is a broad-spectrum triazole antifungal agent prescribed for the prophylaxis and treatment of invasive fungal infections, including aspergillosis and mucormycosis. Its importance in clinical settings has heightened the demand for reliable suppliers capable of providing high-quality posaconazole. Navigating the diverse landscape of pharmaceutical suppliers is critical for healthcare providers, distributors, and manufacturers aiming to ensure drug availability, quality, and regulatory compliance.

This in-depth analysis delineates the key suppliers of Noxafil, explores their geographical distribution, manufacturing capabilities, regulatory statuses, and strategic positioning within the global pharmaceutical supply chain. The review aims to aid stakeholders in identifying stable and compliant sources for this vital antifungal therapy.

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Global Manufacturing Landscape of Noxafil (Posaconazole)

The supply of Noxafil hinges on a limited number of global manufacturers authorized to produce the active pharmaceutical ingredient (API) and finished dosage forms. The major players are predominantly located in Europe, North America, and Asia, reflecting the innovations and regulatory environments conducive to antifungal drug production.

Primary Suppliers of Posaconazole API and Finished Products

1. Pfizer Inc.

Overview:
Pfizer is the original innovator and exclusive manufacturer of Noxafil (posaconazole) in both its oral suspension and delayed-release tablet formulations. The company holds the patent and regulatory approvals, positioning it as the primary supplier globally.

Manufacturing Capabilities:
Pfizer’s production facilities are equipped with state-of-the-art technology licensed under stringent good manufacturing practice (GMP) standards. Its manufacturing plants in the United States and Europe ensure continuous supply, supported by robust quality assurance protocols.

Regulatory Status:
Pfizer’s Noxafil is approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other major regulatory bodies. The company maintains an extensive compliance framework, assuring high-quality standards.

Market Position:
As the proprietary source, Pfizer's supply chain is integral to global procurement strategies. Its extensive distribution network guarantees consistent availability across regions that adhere to regulatory approvals.

2. Zhejiang Huahai Pharmaceutical Co., Ltd. (China)

Overview:
Zhejiang Huahai is among the prominent Chinese manufacturers producing generic versions of posaconazole. Their API manufacturing facilities are approved by the China Food and Drug Administration (CFDA) and some international agencies.

Manufacturing Capabilities:
Huahai's facilities employ advanced chemical synthesis processes, meeting international GMP standards. Their capacity covers both API production and finished formulations, enabling domestic and export markets.

Regulatory Status:
While Chinese regulatory approval for domestic markets is robust, international approval for their API and formulations varies. The company has sought WHO prequalification and CE marking, expanding its export potential.

Supply Chain Impact:
Due to their competitive pricing and increasing regulatory acceptance, Huahai's products are increasingly utilized globally, especially in emerging markets.

3. Dr. Reddy’s Laboratories (India)

Overview:
Dr. Reddy’s, a leading Indian pharmaceutical company, manufactures generic posaconazole, primarily focusing on APIs and finished forms for domestic use and export.

Manufacturing Capabilities:
The company operates multiple GMP-certified facilities in India and has invested significantly in R&D to improve synthetic processes and optimize yields.

Regulatory Status:
Dr. Reddy’s API and formulations have obtained regulatory approvals in multiple countries, including the US, Europe, and emerging markets. Their adherence to quality standards enhances credibility.

Market Position:
Their strategic focus on affordability and wide licensing agreements makes Dr. Reddy’s a notable alternative supplier for generic Noxafil.

4. Other Notable Suppliers

• Sino Biopharmaceutical Ltd. (Hong Kong/China): Engaged in producing generic antifungals, including posaconazole, with regulatory filings underway.
• Glenmark Pharmaceuticals (India): Developing generic formulations, with some regional approvals.
• Fresenius Kabi (Germany): Limited distribution of antifungals; potential collaborative sourcing.

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Key Considerations in Supplier Selection

Regulatory Compliance:
Manufacturers must hold valid GMP certifications and have clear drug registration statuses in target markets. Approval by the FDA, EMA, or WHO prequalification enhances credibility.

Quality Assurance:
Consistent API purity, stability, and bioequivalence are critical. Suppliers should have rigorous QA/QC measures verified via audits and third-party assessments.

Supply Stability:
Long-term partnerships are preferable with suppliers demonstrating production capacity elasticity, reliable delivery schedules, and contingency planning.

Pricing Dynamics:
While generic suppliers often offer lower prices, quality and regulatory risk considerations influence procurement decisions.

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Challenges in the Noxafil Supply Chain

• Regulatory Divergence: Variability in international approvals can complicate supplier vetting.
• Manufacturing Limitations: API synthesis is complex, requiring sophisticated technology and expertise, limiting the number of capable producers.
• Supply Disruptions: Factors such as global disruptions (e.g., COVID-19 pandemic) and geopolitical issues can impair supply continuity.
• Patent and Intellectual Property Landscapes: Original patent protections and licensing obligations influence supplier rights and availability.

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Emerging Trends and Future Outlook

• Expansion of Generic Manufacturing: Increasing approvals of generic posaconazole from firms in China, India, and other emerging markets will diversify supply sources.
• Regulatory Harmonization: Efforts toward mutual recognition and international standards could facilitate broader supplier approval and ease of procurement.
• Supply Chain Transparency: Digital tracking and serialization are being adopted to ensure authenticity and prevent counterfeit products.
• Manufacturing Innovation: Enhancements in synthetic processes and biopharmaceutical manufacturing could augment capacity and quality control.

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Key Takeaways

• Pfizer remains the primary supplier of Noxafil worldwide, holding original patent rights and regulatory approvals.
• Several generic manufacturers, including Zhejiang Huahai (China) and Dr. Reddy’s (India), offer alternative sources, driven by regional demands and pricing considerations.
• Regulatory compliance, quality assurance, and supply stability are paramount in supplier evaluation.
• The global supply chain faces challenges from regulatory divergence, manufacturing complexity, and geopolitical factors.
• The future landscape predicts increased diversification with more players, driven by global demand and evolving regulatory environments.

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FAQs

Q1. Are generic versions of Noxafil as effective and safe as the original?
Yes. Generic posaconazole formulations approved by regulatory authorities undergo rigorous bioequivalence and quality testing, ensuring comparable safety and efficacy to branded Noxafil.

Q2. How can healthcare providers verify the authenticity and quality of supplier products?
Providers should source from approved suppliers with valid GMP certifications, proper registration, and verification through official regulatory databases. Audit reports and batch testing further ensure product integrity.

Q3. What factors influence the choice between branded and generic Noxafil?
Cost, regulatory status, supply reliability, and institutional policies typically guide this decision. Branded drugs often have a proven track record, while generics offer cost advantages and increasing regulatory acceptance.

Q4. How do geopolitical issues impact the supply of Noxafil?
Trade tensions, export restrictions, and manufacturing disruptions caused by geopolitical conflicts can impede supply chains, necessitating diversified sourcing strategies.

Q5. Is there a risk of counterfeit Noxafil products in the supply chain?
While measures such as serialization and certification reduce risk, counterfeit products remain a concern, especially in markets with weak regulation. Sourcing from reputable suppliers and verifying authentic documentation are critical.

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Sources

[1] Pfizer Inc. Noxafil (posaconazole) product information.
[2] WHO Prequalification Programme - Antibiotics and Antifungals.
[3] Zhejiang Huahai Pharmaceuticals - Regulatory approvals and manufacturing capabilities.
[4] Dr. Reddy’s Laboratories - API and formulation approvals.
[5] Global pharmaceutical supply chain analyses, 2023.