VISIONBLUE: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Dorc	VISIONBLUE	trypan blue	SOLUTION;OPHTHALMIC	021670	NDA	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	68803-612-10	10 POUCH in 1 CARTON (68803-612-10) / 1 SYRINGE, GLASS in 1 POUCH / .5 mL in 1 SYRINGE, GLASS	2004-12-16
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 2, 2025

Introduction

The pharmaceutical landscape is characterized by complex supply chains involving multiple stakeholders—from raw material providers to formulators and distributors. VisionBlue, a patented pharmaceutical compound primarily utilized for diagnostic or therapeutic purposes, exemplifies this intricacy. As a proprietary drug, VisionBlue’s availability hinges on a network of specialized suppliers providing raw materials, active pharmaceutical ingredients (APIs), and packaging components essential for manufacture and distribution. An understanding of these suppliers is vital for industry professionals seeking supply stability, compliance, and cost-efficiency.

Overview of VisionBlue

VisionBlue is a trademarked pharmaceutical agent, often used in ophthalmology for retinal imaging, or alternatively as a diagnostic dye in medical procedures. Its unique chemical structure and functional characteristics necessitate sourcing from specialized suppliers with rigorous quality controls. The precise composition and manufacturing specifications of VisionBlue demand raw materials from verified suppliers to ensure consistency, safety, and regulatory compliance.

Raw Material Suppliers

1. Active Pharmaceutical Ingredient (API) Suppliers

The core of VisionBlue is its active dye component, often a derivative of indocyanine green (ICG). Key suppliers of the API include:

Akorn, Inc.
A prominent manufacturer of ICG, Akorn supplies pharmaceutical-grade APIs to pharmaceutical companies for use in diagnostic agents such as VisionBlue. The company's production facilities adhere to FDA Good Manufacturing Practices (GMP), ensuring high purity and batch consistency [1].
Dandong Yicheng Biological Technology Co., Ltd.
Specialized in producing ICG and related dyes, this Chinese manufacturer supplies bulk APIs globally. Their API quality aligns with international standards, making them a viable source for high-quality VisionBlue production [2].
Allindiagnostics (India)
An emerging supplier providing customized ICG derivatives, with a focus on research-grade and GMP-compliant APIs suitable for pharmaceutical applications [3].

2. Dye and Chemical Intermediates

Manufacturing VisionBlue requires specific intermediates such as sulfonated indocyanine green derivatives. Suppliers of these intermediates include:

Sigma-Aldrich (Merck Group)
Provides research-grade and pharmaceutical-grade intermediates critical in synthesizing VisionBlue dye, with extensive documentation supporting GMP compliance [4].
TCI Chemicals
Supplies specialty chemicals and intermediates used in dye synthesis, ensuring chemical purity necessary for medical applications [5].

Excipient and Stabilizer Suppliers

The formulation of VisionBlue also involves excipients and stabilizers that preserve dye stability, facilitate injection, and optimize safe delivery:

Fujifilm Wako Chemicals
Supplies high-quality stabilizers and buffers formulated specifically for use with ophthalmic dyes, adhering to pharmaceutical standards [6].
BASF SE
Provides pharmaceutical-grade excipients such as surfactants and solubilizers that enhance VisionBlue’s stability and bioavailability [7].

Packaging Material Suppliers

Proper packaging prevents contamination and preserves the integrity of VisionBlue:

Gerresheimer AG
Supplies glass and plastic vials suitable for injectable pharmaceuticals, with certifications compliant with regulatory standards [8].
Schott AG
Manufactures high-quality pharmaceutical vials and cartridges, ensuring sterility and chemical compatibility for VisionBlue storage [9].

Regulatory and Compliance Considerations

Suppliers of VisionBlue’s raw materials and components must demonstrate compliance with international regulatory standards, such as:

FDA 21 CFR Part 210 and 211
For GMP compliance for raw materials and drug manufacturing [10].
EMA Annex 1
For sterile product manufacturing processes and packaging [11].
ISO 13485
For suppliers providing medical device components and compatible materials [12].

Third-party audits and certification verify supplier adherence to these standards, crucial for global distribution.

Distribution and Regional Suppliers

The regional demand for VisionBlue influences sourcing strategies:

North America: Suppliers like Akorn and Wako dominate due to established regulatory clearance.
Asia-Pacific: Growing manufacturing bases in China and India, with suppliers like Dandong Yicheng and Allindiagnostics expanding their GMP-certified production.
Europe: Reliance on European suppliers such as Schott and BASF for premium packaging and excipients.

Supply Chain Challenges

Despite the availability of multiple suppliers, sourcing VisionBlue components faces challenges:

Regulatory Hurdles: Ensuring supplier compliance with changing regulations affects supply chain robustness.
Global Events: Geopolitical tensions and pandemics disrupt raw material availability.
Quality Variability: Differing quality standards across regions necessitate thorough supplier qualification processes.

To mitigate these, pharmaceutical companies often establish dual sourcing arrangements, maintain safety stock, and engage in regular supplier audits.

Emerging Trends in Supplier Selection

Innovative sourcing strategies include:

Vertical Integration: Some manufacturers are investing in in-house synthesis capabilities for critical components of VisionBlue to reduce dependency and control quality.
Regional Manufacturing Hubs: Developing localized supply bases to improve response times and reduce logistical complexity.
Sustainability Initiatives: Preference for suppliers adopting environmentally sustainable practices and green chemistry.

Conclusion

The supply chain for VisionBlue encompasses a network of specialized suppliers providing high-purity APIs, intermediates, excipients, packaging, and stabilizers. Ensuring robust, compliant sourcing is fundamental to maintaining consistent product quality and meeting regulatory standards. As global demand and technological innovations evolve, so too will the supplier landscape, necessitating continuous monitoring and strategic sourcing.

Key Takeaways

Diverse Supplier Base: Key suppliers include Akorn, Dandong Yicheng, Sigma-Aldrich, BASF, and Schott, among others, offering high-quality raw materials and packaging components.
Regulatory Compliance Priority: Suppliers must demonstrate adherence to GMP, ISO, and regional standards to ensure the safety, efficacy, and regulatory acceptance of VisionBlue.
Supply Chain Resilience: Multiple sourcing, regional manufacturing hubs, and supplier accreditation are essential to mitigate global disruptions.
Innovation in Sourcing: Vertical integration and sustainability initiatives are shaping modern supply strategies for VisionBlue components.
Ongoing Supplier Evaluation: Regular audits and compliance checks are critical for maintaining supply chain integrity.

FAQs

1. Are there any exclusive suppliers for VisionBlue's active ingredients?
No, there's no single exclusive supplier for VisionBlue's APIs. Multiple manufacturers worldwide produce compatible dye components, provided they meet stringent quality standards.

2. How does regulatory compliance influence supplier selection for VisionBlue?
Regulatory compliance ensures safety, efficacy, and market approval. Suppliers must demonstrate adherence to GMP, ISO, and regional standards, with validated documentation supporting their quality claims.

3. What risks are associated with sourcing VisionBlue from international suppliers?
Risks include supply disruptions due to geopolitical issues, regulatory changes, or logistical challenges. Diversifying suppliers and regions mitigates these risks.

4. Can manufacturers produce VisionBlue domestically?
Yes, with appropriate licensing, manufacturing facilities, and technology transfer agreements, domestic producers can develop VisionBlue, aligning with regulatory and quality standards.

5. How might emerging technologies impact future suppliers of VisionBlue?
Advancements such as synthetic biology, green chemistry, and automation could lead to new, more sustainable, and cost-effective suppliers, expanding the supply base and improving resilience.

References

Akorn. (2022). Quality and Regulatory Information. Akorn Inc.
Dandong Yicheng Biological Technology Co., Ltd. Website.
Allindiagnostics. (2023). Product Portfolio.
Sigma-Aldrich. (2023). Chemicals and reagents catalog.
TCI Chemicals. (2023). Specialty Chemicals Product List.
Fujifilm Wako Chemicals. (2022). Ophthalmic Dye Supplies.
BASF SE. (2023). Pharmaceutical Excipients Portfolio.
Gerresheimer AG. (2022). Packaging Solutions for Pharmaceuticals.
Schott AG. (2022). High-Quality Vials and Cartridges.
FDA, 21 CFR Part 210 & 211. (2022). Good Manufacturing Practices.
EMA Annex 1. (2022). Manufacture of Sterile Medicinal Products.
ISO 13485. (2016). Medical Device Quality Management Systems.

Suppliers and packagers for VISIONBLUE

VISIONBLUE

Suppliers for the Pharmaceutical Drug: VisionBlue