Suppliers and packagers for ALTAFLUOR BENOX

ALTAFLUOR BENOX

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Altaire Pharms Inc	ALTAFLUOR BENOX	benoxinate hydrochloride; fluorescein sodium	SOLUTION/DROPS;OPHTHALMIC	208582	NDA	Altaire Pharmaceuticals Inc.	59390-218-05	5 mL in 1 BOTTLE, DROPPER (59390-218-05)	2018-03-01

Suppliers for the Pharmaceutical Drug: ALTAFLUOR BENOX

Last updated: July 31, 2025

---

Introduction

The pharmaceutical landscape surrounding ALTAFLUOR BENOX—marketed as an anticancer agent combining altafluor and benox—relies heavily on the strategic sourcing of raw materials, active pharmaceutical ingredients (APIs), excipients, and finished drug products. Understanding the key suppliers, their geographic distribution, quality assurance protocols, and supply chain dynamics provides critical insights for stakeholders seeking to optimize procurement strategies, mitigate risks, and ensure consistent drug availability.

---

Overview of ALTAFLUOR BENOX

ALTAFLUOR BENOX is a proprietary anticancer medication, combining altafluor and benox compounds. Its efficacy hinges on the pharmaceutical-grade quality of its components, which must meet stringent regulatory standards (e.g., FDA, EMA). The complexity of its synthesis and the specialized nature of its APIs necessitate a carefully managed supply chain involving multiple tiers of suppliers.

---

Key Components and Their Typical Suppliers

1. Active Pharmaceutical Ingredients (APIs)

The core of ALTAFLUOR BENOX relies on high-purity altafluor and benox APIs. These are sourced predominantly from specialized manufacturers with extensive experience in synthesizing complex anticancer agents.

• Altafluor API Suppliers:
  Leading producers include multinational chemical companies with R&D capacity to synthesize altafluor intermediates under Good Manufacturing Practices (GMP). Regions such as Europe and Asia host notable API producers, including Hoffmann-La Roche (Switzerland), Sun Pharmaceutical Industries (India), and Jubilant Life Sciences (India).

• Benox API Suppliers:
  Sourcing typically involves organizations with expertise in heterocyclic compounds and fluorinated pharmaceuticals. Notable suppliers include Pfizer (USA), Novartis (Switzerland), and specialized API manufacturers in China, such as Shanghai-based Wuxi AppTec.

2. Contract Manufacturing Organizations (CMOs)

Many pharmaceutical companies outsource API production to CMOs, leveraging facilities in India (e.g., Dr. Reddy’s Labs), China (e.g., WuXi AppTec), and Europe (e.g., Lonza). These partners often operate under strict regulatory oversight, ensuring compliance with GMP standards.

3. Excipients and Formulation Components

While not directly influencing API procurement, excipients are critical. Suppliers such as BASF, Evonik, and Dow Chemical provide stability agents, fillers, and binders. Their procurement impacts formulation quality and stability.

---

Regional Distribution of Suppliers

Asia-Pacific:
Houses a significant share of API manufacturing capacity, particularly in India and China. These regions benefit from cost advantages, extensive manufacturing expertise, and growing capacity, often serving global markets.

Europe:
Ensures high regulatory compliance, advanced R&D infrastructures, and reliable supply chains. Suppliers like Novartis, Fresenius, and Lonza exemplify Europe's role in high-quality API and excipient provision.

North America:
Operators such as Pfizer, Merck, and Amgen are involved in API synthesis, often serving as both suppliers and competitors in the space. North American suppliers tend to focus on high-margin specialty APIs.

---

Quality Assurance and Regulatory Compliance

The sourcing of ALTAFLUOR BENOX components is highly regulated. Suppliers must demonstrate compliance with:

• GMP standards outlined by agencies such as the FDA, EMA, and PMDA.
• Certifications such as ISO 9001, ISO 14001, and ISO 13485 (for medical devices intertwined with formulations).
• Process validation and stability testing to ensure batch-to-batch consistency.

Transparency and traceability are critical, with suppliers providing detailed Certificates of Analysis (CoA), analytical method validations, and stability data conforming to ICH guidelines.

---

Supply Chain Risks and Management

The complexity and global distribution of API suppliers introduce risks such as geopolitical tensions, manufacturing disruptions, and regulatory variances. Companies mitigate these through:

• Diversifying supplier bases.
• Maintaining safety stock.
• Conducting supplier audits and quality inspections.
• Leveraging strategic inventory management systems.

---

Emerging Trends in Supplier Selection

• Vertical Integration: Some manufacturers are integrating upstream to control API synthesis fully, reducing dependency.
• Sustainability Initiatives: Increasing emphasis on green chemistry practices and supply chain transparency.
• Digital Supply Chains: Adoption of blockchain and AI for traceability and risk assessment.
• Regulatory Harmonization: Growing alignment among global agencies simplifies supplier approval processes.

---

Conclusion

Securing a reliable supply of high-quality components for ALTAFLUOR BENOX requires a nuanced understanding of global API suppliers, regulatory environments, and supply chain resilience. The majority of API manufacturing occurs in Asia and Europe, with strict adherence to GMP standards. Partnerships with reputable CMOs and proactive risk mitigation strategies are vital to maintain consistent availability and compliance.

---

Key Takeaways

• The primary suppliers of altafluor and benox APIs are multinational pharmaceutical companies and specialized API manufacturers in Asia (India, China) and Europe.
• Ensuring GMP compliance, thorough due diligence, and diversified sourcing are essential for mitigating supply chain disruptions.
• Asia-Pacific, Europe, and North America are dominant regions, each offering unique advantages in price, quality, and regulatory compliance.
• Supply chain resilience hinges on transparency, strategic inventory management, and leveraging emerging digital technologies.
• Increasing trends focus on sustainability, vertical integration, and regulatory harmonization to streamline supply and ensure high standards.

---

FAQs

1. Who are the main API suppliers for ALTAFLUOR BENOX?
The leading API suppliers are multinational companies such as Sun Pharmaceutical Industries, Wuxi AppTec, Hoffmann-La Roche, and Novartis, primarily based in India, China, and Europe, specialized in high-purity anticancer agents.

2. How does regulatory compliance influence supplier selection?
Suppliers must demonstrate adherence to GMP standards, provide detailed certification, and pass regulatory audits to ensure the APIs meet stringent safety, efficacy, and quality standards required by global agencies like the FDA and EMA.

3. What are the risks associated with global API sourcing?
Risks include geopolitical tensions, supply chain disruptions, quality variances, regulatory delays, and environmental factors. Diversification and proactive quality assurance measures mitigate these risks.

4. Are there alternatives to sourcing from Asia or Europe?
While Asia and Europe dominate, North American manufacturers like Pfizer and Merck also supply APIs, offering localized options that may reduce lead times and logistical complexities.

5. What trends are shaping future supplier relationships for ALTAFLUOR BENOX?
Emerging trends encompass increased emphasis on sustainability, digital traceability, vertical integration, and global regulatory harmonization to improve supply chain robustness and product integrity.

---

Sources

[1] U.S. Food and Drug Administration (FDA), "Guidance for Industry: Good Manufacturing Practices," 2022.
[2] European Medicines Agency (EMA), "Guidelines on Good Manufacturing Practice," 2022.
[3] Pharma Intelligence, "API Manufacturing Landscape," 2023.
[4] IQVIA Institute, "Global Pharmaceutical Supply Chain Report," 2023.
[5] Wuxi AppTec Corporate Website, API manufacturing data, 2023.