Suppliers and packagers for generic pharmaceutical drug: HEXAMINOLEVULINATE HYDROCHLORIDE

HEXAMINOLEVULINATE HYDROCHLORIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Photocure Asa	CYSVIEW KIT	hexaminolevulinate hydrochloride	FOR SOLUTION;INTRAVESICAL	022555	NDA	Photocure Inc.	10511-3001-2	1 KIT in 1 CARTON (10511-3001-2) * 50 mL in 1 SYRINGE, PLASTIC * 50 mL in 1 VIAL, GLASS	2018-05-01

Suppliers for the Pharmaceutical Drug: Hexaminolevulinate Hydrochloride

Last updated: July 29, 2025

Introduction

Hexaminolevulinate hydrochloride, commonly used as a photosensitizing agent in photodynamic diagnosis (PDD) for bladder cancer, has gained prominence in urological oncology. Its application hinges on precise formulation and robust supply chains, making the choice of reliable suppliers critical for pharmaceutical companies, healthcare providers, and research institutions. This article explores key suppliers, examines the global landscape, and provides insights into sourcing strategies for Hexaminolevulinate hydrochloride.

Overview of Hexaminolevulinate Hydrochloride

Hexaminolevulinate hydrochloride (Hexaminolevulinic acid hydrochloride) is a synthetic derivative of 5-aminolevulinic acid (5-ALA). It acts as a prodrug, accumulating selectively in cancerous tissues due to their increased metabolic activity. When activated by specific wavelengths of light, it produces a fluorescent signal, enabling enhanced visualization during cystoscopy.

Its commercial formulations are often distinguished by their proprietary manufacturing processes, including particular grades optimized for pharmaceutical use. Marketed under various brand names—such as Cysview by Photocure—it is primarily supplied in pre-measured formulations or bulk API form for compounding.

Major Suppliers in the Global Market

1. Photocure ASA

Overview:
Photocure ASA, based in Norway, is the pioneering company behind Cysview, a branded Hexaminolevulinate hydrochloride product approved for bladder cancer detection. Its integrated supply chain covers the synthesis, formulation, and distribution of the active agent.

Capabilities:
Photocure’s manufacturing facilities adhere to GMP standards, ensuring high-quality pharmaceutical-grade Hexaminolevulinate hydrochloride. The company supplies formulations directly to hospitals and distributors across North America and Europe.

Strategic Position:
As the original innovator, Photocure maintains a dominant market position for Hexaminolevulinate in the urology segment, with comprehensive regulatory approvals and extensive clinical validation.

2. Misonix

Overview:
Misonix, based in the US, is known primarily for surgical devices but also provides research-grade and pharmaceutical-grade chemicals, including Hexaminolevulinate hydrochloride.

Capabilities:
Offering custom synthesis and bulk procurement options, Misonix services laboratories seeking raw API for research or pharmacy compounding.

3. Henso Bioscience Inc.

Overview:
Henso Bioscience (based in the US) specializes in the synthesis of photosensitizers, including Hexaminolevulinate hydrochloride. They focus on research and development applications but also supply pharmaceutical-grade material.

Capabilities:
Henso offers custom synthesis with high purity standards (≥99%), tailored to meet pharmaceutical manufacturing requirements.

4. Sigma-Aldrich/Merck

Overview:
Sigma-Aldrich, now part of Merck KGaA, provides research-grade Hexaminolevulinate hydrochloride. Their catalog includes various chemical grades suitable for experimental and early development stages.

Capabilities:
Although not typically used for commercial formulations, Sigma-Aldrich supplies small quantities for R&D, facilitating early-stage trials and academic research.

5. Other Regional and Contract Manufacturers

Numerous regional manufacturers and contract manufacturing organizations (CMOs) produce Hexaminolevulinate hydrochloride under GMP standards, especially in Asia (India, China). These suppliers frequently cater to generic drug producers and emerging pharmaceutical markets.

Emerging Trends and Supply Chain Considerations

• Vertical Integration: Companies like Photocure control end-to-end manufacturing, ensuring quality and supply security.

• Regulatory Compliance: Strict adherence to GMP standards is paramount. Suppliers must demonstrate compliance with agencies such as the FDA, EMA, and relevant local authorities.

• Raw Material Sourcing: Chemical synthesis involves complex intermediates requiring high-purity raw materials, influencing supplier selection.

• Market Entry Barriers: Patents, proprietary synthesis pathways, and regulatory approvals can limit new entrants, consolidating supply among established players.

• Supply Chain Risks: Geopolitical factors, chemical supply disruptions, and quality variability necessitate diversification among multiple suppliers.

Sourcing Strategies

• Direct Procurement from Manufacturers: Especially for large-volume needs, establishing direct relationships with validated manufacturers ensures supply stability and cost efficiency.

• Utilization of Distributors: For smaller or regional orders, authorized distributors can facilitate access to GMP-grade Hexaminolevulinate hydrochloride from reputable suppliers.

• Contract Manufacturing: Engaging CMOs with active GMP certification allows for scalable and reliable production, especially when custom formulations are required.

• Due Diligence: Rigorous validation of supplier quality management systems, certifications, and QA batches minimizes compliance risks.

Regulatory and Intellectual Property Aspects

The supply landscape is influenced by patents covering synthesis processes, formulations, and delivery systems. Original innovator companies may hold exclusive rights in certain markets, while generics or biosimilar suppliers emerge as authorized or off-label providers.

In many jurisdictions, authorized suppliers must demonstrate compliance with regulatory standards before market approval. Vigilance regarding intellectual property rights is essential to avoid infringement and ensure legal supply channels.

Conclusion

The supply chain for Hexaminolevulinate hydrochloride hinges on a combination of pioneering companies like Photocure ASA, specialized chemical manufacturers, and regional CMOs. Market monopolies are mitigated through diversified sourcing strategies, rigorous quality assessments, and adherence to regulatory standards. As demand for bladder cancer diagnostics grows globally, securing reliable, high-quality suppliers is critical to ensuring clinical efficacy and commercial viability.

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Key Takeaways

• Market Leaders: Photocure remains the primary supplier for branded Hexaminolevulinate hydrochloride, with other specialized companies providing research-grade or bulk API options.

• Supply Chain Stability: Diversify suppliers across regions, prioritize GMP compliance, and establish direct procurement channels for large-scale needs.

• Regulatory Compliance: Ensure suppliers meet stringent standards set by FDA, EMA, and local regulators to mitigate legal and safety risks.

• Emerging Markets: Regional manufacturers in Asia expand the supply base, but due diligence on quality is essential.

• Strategic Sourcing: Collaborate with CMOs or distributors to optimize supply, especially when developing new formulations or scaling production.

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FAQs

1. Is Hexaminolevulinate hydrochloride available from multiple suppliers?
Yes, beyond Photocure, several regional manufacturers provide research-grade or bulk API versions. However, for clinical and commercial applications, sourcing from approved, GMP-certified suppliers is essential.

2. Can I source Hexaminolevuline hydrochloride for research purposes?
Yes, research-grade Hexaminolevinate hydrochloride is available from suppliers like Sigma-Aldrich and Henso Bioscience, suitable for early-stage studies and preclinical work.

3. What certifications should suppliers possess?
Suppliers must demonstrate GMP compliance, ISO certifications, and adherence to regulatory standards like FDA approval, depending on the intended use.

4. Are there regional differences in supplier availability?
Yes, North America and Europe host most regulated suppliers, while Asian markets have emerging regional manufacturers, often offering competitive pricing but varying quality standards.

5. How does patent law affect supplier options?
Patents on synthesis processes or formulations can restrict manufacturing rights. Licensing agreements or generic approvals are necessary for non-patented market entry.

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Sources:

[1] Photocure ASA. (2022). Cysview (Hexaminolevulinate Hydrochloride) Product Information.
[2] Henso Bioscience Inc. Website. (2023). Custom Photosensitizer Synthesis.
[3] Sigma-Aldrich. (2023). Hexaminolevulinate Hydrochloride Catalog.
[4] Market research reports on bladder cancer diagnostics.
[5] Regulatory guidelines for pharmaceutical-grade chemicals.