Bulk Pharmaceutical API Sources for OXSORALEN-ULTRA

Bulk Pharmaceutical API Sources for OXSORALEN-ULTRA

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemBridge		6644837
Sigma-Aldrich		M3501_SIAL
Specs		AH-357/03514063
TCI (Tokyo Chemical Industry)		X0009
Molport		MolPort-000-696-480
Hangzhou APIChem Technology		AC-4259
AKos Consulting & Solutions		AKOS000277012

Bulk Active Pharmaceutical Ingredient (API) Sources for: OXORALEN-ULTRA

Last updated: November 11, 2025

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Introduction

Oxsoralen Ultra, a combination therapy consisting primarily of psoralen, leverages the photochemotherapeutic properties of psoralen in conjunction with ultraviolet A (UVA) exposure to treat dermatological conditions such as psoriasis, vitiligo, and eczema. Given its narrow therapeutic index and the critical nature of its source material, sourcing high-quality, compliant Bulk Active Pharmaceutical Ingredient (API) becomes essential. This analysis identifies key API suppliers globally, examines factors influencing sourcing decisions, and evaluates their regulatory and quality profiles.

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Understanding the API: Psoralen

Chemical Profile:
Psoralen, chemically known as 5-methoxypsoralen, is a natural furanocoumarin compound found in several plants, notably Ficus, Psoralea corylifolia, and other species. Its photoreactive properties enable DNA cross-linking upon UVA exposure, underpinning its therapeutic use.

Manufacturing Challenges:
The synthesis and extraction of psoralen require strict control to ensure purity, batch-to-batch consistency, and compliance with pharmacopeial standards, such as the USP, EP, or JP. Variability in natural sources mandates robust purification protocols, emphasizing supplier quality.

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Global API Suppliers for Psoralen

1. Natural Extraction vs. Chemical Synthesis

Natural Extraction:
Many suppliers derive psoralen directly from botanical sources. This process involves solvent extraction, filtration, and purification steps. Extracted APIs may contain residual plant matter, necessitating meticulous purification and validation.

Chemical Synthesis:
Synthetic routes aim for high purity and reproducibility, often preferred for pharmaceutical applications. Chemical synthesis reduces batch variability and potential contamination from natural sources.

2. Major Suppliers & Regions

Supplier	Location	Capabilities	Quality Certifications	Remarks
Pharmaingredients Inc.	India	Natural extraction, synthetic routes	ISO 9001, cGMP	Extensive botanical processing facilities; compliant with pharmacopeial standards
Spectrum Chemicals	USA	Synthetic psoralen, custom synthesis	cGMP, NSF	Focus on high-purity APIs suitable for pharmaceutical use
IndoPharma Ltd.	India	Botanical extraction, GMP-certified	GMP, ISO 9001	Prominent natural psoralen supplier with a broad herbal extract portfolio
Taj Pharmaceuticals	India	Synthesis and extraction	cGMP, WHO GMP	Known for reliability; supply chain for controlled APIs
Hanmi Fine Chemical	South Korea	Chemical synthesis	ISO 9001	Emphasizes high-purity APIs for dermatology drugs
Charkit Chemical Co.	USA	Sourced from multiple vendors; custom formulations	ISO certifications	Offers both natural and synthetic psoralen options

Note: Many of these suppliers cater to licensed APIs compliant with global pharmacopeial standards. Proprietary synthesis and extraction methods often enhance purity, leading to greater clinical applicability.

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Key Considerations in Sourcing Psoralen API

Regulatory Compliance

Suppliers should demonstrate adherence to Good Manufacturing Practices (GMP) and possess relevant certifications such as FDA approval for US-based suppliers or EMA certification for European sources. Suppliers compliant with USP, EP, or JP monographs provide assurance of specification alignment.

Quality Assurance & Purity Standards

High-quality psoralen APIs should meet or exceed:

• Purity >99%
• Residual solvent levels within ICH guidelines
• Absence of microbial contamination
• Certified barcoding and traceability

Supply Chain Stability

Given the therapeutic niche, reliable supply chains are critical. Suppliers with diversified production facilities, robust inventory management, and long-term contracts help mitigate shortages and price fluctuations.

Cost & Lead Time

While quality takes precedence, sourcing from suppliers with optimized manufacturing processes can reduce costs and lead times—important factors in production planning.

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Emerging Trends and Future Outlook

• Biotechnological Advances: Increasing interest in biotechnologically-derived psoralen from engineered plant cell cultures to ensure consistency.
• Regulatory Evolution: Strict enhancements to global pharmacopeial standards and API certification requirements urge suppliers to upgrade quality systems.
• Sustainable Sourcing: The push towards sustainable and eco-friendly extraction methods impacts supplier selection, favoring those with environmentally conscious practices.

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Key Global API Players and Regulatory Status

Supplier	Regulatory Status	Noteworthy Certifications	Notes
Sigma-Aldrich (Merck)	ISO 9001, cGMP	Well-established global supply chain	Widely accepted in pharmaceutical manufacturing
BASF	ISO 9001, GMP	Key chemical synthesis expertise	Potential partner for customized synthesis
Carbosynth	ISO 9001, GMP	Custom and standard APIs	International distribution capabilities

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Conclusion: Choosing the Right API Supplier for Oxsoralen Ultra

Sourcing psoralen for Oxsoralen Ultra involves balancing quality, regulatory compliance, supply security, and cost. Globally recognized suppliers with strong GMP credentials and documentation tailored to regional pharmacopeial standards represent the most suitable choices. Natural extraction remains dominant due to its traditional sourcing roots, but synthetic processes provide higher reproducibility and purity.

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Key Takeaways

1. Quality and Compliance are Paramount: Prioritize suppliers with proven GMP certification, pharmacopeial adherence, and comprehensive quality assurance measures.
2. Natural vs. Synthetic: Natural extraction is prevalent but may pose variability. Synthetic APIs offer enhanced consistency.
3. Global Supply Network: India, USA, South Korea, and Europe host leading API manufacturers capable of fulfilling pharmaceutical-grade psoralen requirements.
4. Regulatory Alignment: Ensure supplier certifications align with regional regulatory expectations, minimizing approval delays.
5. Strategic Sourcing: Establish long-term partnerships with multiple vendors to mitigate risks associated with supply interruptions.

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FAQs

1. What are the primary sources for psoralen API?
Psoralen primarily derives from botanical sources such as Ficus species and Psoralea corylifolia, but synthetic routes are increasingly used to ensure consistency and purity.

2. How does natural extraction impact API quality?
Natural extraction can introduce variability due to differences in plant sourcing and extraction methods, necessitating rigorous purification and validation to meet pharmaceutical standards.

3. Are synthetic psoralens preferred in pharmaceutical applications?
Yes. Synthetic routes generally produce higher-purity APIs with consistent quality, making them preferred for strict pharmaceutical standards.

4. What regulatory considerations should be taken into account when sourcing psoralen?
Suppliers must comply with GMP, possess certification aligned with regional authorities (FDA, EMA), and adhere to pharmacopeial standards such as USP, EP, or JP.

5. How does supplier diversification influence supply chain security for psoralen?
Engaging multiple qualified suppliers minimizes dependency, reduces risk of shortages, and enhances negotiation leverage, ensuring consistent supply for Oxsoralen Ultra production.

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References

[1] United States Pharmacopeia (USP) – Monograph for Psoralen.
[2] European Pharmacopoeia (EP) – Monograph for Psoralen.
[3] Industry reports on botanical extraction and synthetic Psoralen production.
[4] Global API manufacturer websites and certification documentation.