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Suppliers and packagers for METHOXSALEN
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METHOXSALEN
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Onesource Specialty | METHOXSALEN | methoxsalen | CAPSULE;ORAL | 202687 | ANDA | Strides Pharma Science Limited | 64380-752-16 | 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, GLASS (64380-752-16) | 2016-12-08 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Methoxsalen
Introduction
Methoxsalen, a naturally occurring psoralen compound, plays a vital role in the treatment of skin conditions such as psoriasis, vitiligo, and eczema. It functions as a photoactive agent that enhances skin lightening and controls abnormal keratinocyte proliferation when combined with ultraviolet A (UVA) radiation. The complexity of methoxsalen’s manufacturing, its regulatory environment, and market dynamics make identifying reliable suppliers essential for pharmaceutical companies, healthcare providers, and research institutions. This analysis reviews prominent suppliers globally, evaluates their market positions, and explores factors influencing the supply landscape for methoxsalen.
Regulatory Landscape and Market Overview
Methoxsalen is classified as an authorized medicinal product in many jurisdictions, with specific approval processes governed by bodies such as the Food and Drug Administration (FDA) in the U.S., the European Medicines Agency (EMA), and counterpart agencies globally. Its supply chain is characterized by stringent quality standards, including Good Manufacturing Practice (GMP) compliance, to ensure safety and efficacy. As a compound with limited synthesis pathways, the majority of the supply is concentrated within a few specialized chemical and pharmaceutical manufacturers.
Market demand predominantly stems from dermatology clinics, phototherapy centers, and compounding pharmacies. While the global market for methoxsalen remains niche compared to blockbuster drugs, its strategic importance grows, especially with increasing emphasis on personalized medicine and phototherapy.
Major Suppliers of Methoxsalen
1. Sigma-Aldrich (a subsidiary of Merck KGaA)
- Overview: Sigma-Aldrich, renowned for its extensive catalog of research chemicals and pharmaceutical intermediates, supplies pharmaceutical-grade methoxsalen (also known as 8-methoxypsoralen).
- Product Profile: Their methoxsalen is characterized by high purity (typically ≥98%), supplied in bulk quantities suitable for clinical or research use.
- Regulatory Compliance: All products adhere to GMP standards, with detailed certificates of analysis (CoA).
- Market Position: As one of the largest chemical suppliers globally, Sigma-Aldrich's supply chain is reliable, with global distribution capabilities.
2. TCI Chemicals
- Overview: Tokyo Chemical Industry (TCI) specializes in the production of research chemicals and pharmaceutical intermediates.
- Product Profile: TCI offers methoxsalen in analytical and research-grade qualities, with flexible packaging options.
- Regulatory Compliance: TCI maintains rigorous GMP practices and regulatory documentation.
- Market Position: TCI commands significant presence in Asia and supplies internationally through various distributors.
3. Toronto Research Chemicals (TRC)
- Overview: TRC provides specialized chemical compounds for research and development, including methoxsalen.
- Product Profile: Their offerings feature high-purity methoxsalen suitable for pharmacological studies, with certificates of analysis indicating compliance with regulatory standards.
- Unique Selling Proposition: TRC emphasizes rapid delivery and custom quantities for research institutions.
4. Toronto Chemical Company and Others
- Overview: Several regional specialty chemical manufacturers and distributors, especially in Europe and Asia, offer pharmaceutical-grade methoxsalen.
- Key Points: Suppliers such as Alfa Aesar (a division of Thermo Fisher Scientific) also distribute psoralen derivatives, including methoxsalen.
Emerging and Niche Suppliers
Recent years have seen the rise of boutique chemical manufacturers and contract manufacturing organizations (CMOs) focusing on specific intermediates like methoxsalen, driven by the increasing demand for phototherapy and personalized dermatological treatments. These entities often operate under strict GMP conditions to meet pharmaceutical standards.
Challenges in the Supply Chain
- Limited Production Sites: Only a handful of manufacturers produce pharmaceutical-grade methoxsalen, resulting in supply vulnerability and potential price fluctuations.
- Regulatory Variability: Differences in regional approval processes may limit the ability of some suppliers to export globally.
- Quality Assurance: Ensuring consistent GMP compliance and lot-to-lot uniformity remains critical, especially for clinical applications.
- Raw Material Availability: The synthesis of methoxsalen depends on the availability of psoralen precursors derived from natural sources or chemical synthesis, influencing supply stability.
Key Factors Influencing Supplier Selection
- Regulatory Standards Compliance: Suppliers must demonstrate GMP compliance, validated quality control (QC) procedures, and complete regulatory documentation.
- Purity and Quality Certifications: Certificates of analysis (CoA), batch records, and stability data are essential for pharmaceutical applications.
- Supply Chain Reliability: Consistent quantity availability, lead times, and distribution network robustness are priorities.
- Cost and Pricing Structures: Competitive pricing while maintaining quality standards is critical, especially for large-scale procurement.
- Innovation and Customization: Suppliers capable of offering tailored formulations or derivatives provide strategic advantages.
Future Trends and Opportunities
The increasing utilization of phototherapy — including in personalized medicine approaches — is expected to sustain or enhance demand for methoxsalen. Additionally, advancements in synthesis techniques and process optimization could expand production capacities and diversify the supplier base. Regulatory harmonization, especially in emerging markets, may also facilitate broader access to pharmaceutical-grade methoxsalen.
Key Takeaways
- The core global suppliers of pharmaceutical-grade methoxsalen include Sigma-Aldrich, TCI Chemicals, and Toronto Research Chemicals, distinguished by their adherence to GMP standards and broad distribution networks.
- Supply chain stability is concentrated within a limited number of manufacturers, underscoring the importance of strategic supplier qualification.
- Regional regulatory variations and raw material sourcing influence the global availability and pricing of methoxsalen.
- Future growth hinges on technological innovations, regulatory harmonization, and increasing demand from dermatological therapies.
- Due diligence in quality assurance, compliance, and logistical capability remains essential for organizations sourcing methoxsalen.
FAQs
Q1: What are the primary regulatory considerations when sourcing methoxsalen?
A: Ensuring the supplier complies with GMP standards and possesses appropriate regulatory documentation, including certificates of analysis and batch validation, is crucial for safety and legal distribution, especially in regulated markets like the US and Europe.
Q2: Are generic formulations of methoxsalen available?
A: Yes, several suppliers offer generic or non-branded methoxsalen products formulated for clinical, research, or compounded use, provided they meet regulatory quality standards.
Q3: How does supply chain disruption affect methoxsalen procurement?
A: Given the limited number of producers, disruptions such as raw material shortages, manufacturing issues, or regulatory delays can significantly impact availability and pricing.
Q4: What emerging markets show promise for methoxsalen supply?
A: Countries with expanding dermatology and phototherapy infrastructure, such as China, India, and Brazil, are increasingly sourcing methoxsalen, either directly from foreign suppliers or through regional producers.
Q5: What key qualities should I look for when selecting a methoxsalen supplier?
A: High purity, GMP compliance, reliable delivery timelines, comprehensive regulatory documentation, and responsive customer service.
References
[1] Sigma-Aldrich Catalog. (2023). Available at: [Sigma-Aldrich official website].
[2] TCI Chemicals. (2023). Product specifications and certifications. Available at: [TCI official website].
[3] Toronto Research Chemicals. (2023). Product datasheets. Available at: [TRC official website].
[4] International Pharmaceutical Regulators Forum. (2022). Good Manufacturing Practice guidelines.
[5] MarketWatch. (2022). Global Dermatology Market Forecast.
Note: This overview reflects the current landscape as of early 2023. The supply environment for methoxsalen may evolve with technological advances and regulatory shifts.
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