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Suppliers and packagers for sorilux
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sorilux
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Mayne Pharma | SORILUX | calcipotriene | AEROSOL, FOAM;TOPICAL | 022563 | NDA | Mayne Pharma | 51862-376-12 | 1 CAN in 1 CARTON (51862-376-12) / 120 g in 1 CAN | 2017-04-11 |
| Mayne Pharma | SORILUX | calcipotriene | AEROSOL, FOAM;TOPICAL | 022563 | NDA | Mayne Pharma | 51862-512-60 | 1 CAN in 1 CARTON (51862-512-60) / 60 g in 1 CAN | 2021-02-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ppliers for the Pharmaceutical Drug: SORILUX
Introduction
Sorilux, branded as a topical foam or cream, contains calcipotriol, a vitamin D3 analogue used primarily to treat psoriasis. Marketed by LEO Pharma, Sorilux has gained prominence as a topical therapy for mild to moderate plaque psoriasis. The complex supply chain for Sorilux involves manufacturers, raw material providers, distributors, and regional authorized suppliers. Understanding these supply channels is essential for industry stakeholders, healthcare providers, and procurement organizations aiming to ensure product availability, maintain quality standards, and navigate regulatory landscapes. This report provides a comprehensive overview of current and potential suppliers involved in the production and distribution of Sorilux.
1. Manufacturing of Sorilux
a. Original Manufacturer: LEO Pharma
LEO Pharma, a global pharmaceutical company headquartered in Denmark, is the exclusive developer and manufacturer of Sorilux. The company specializes in dermatology and critical care, with extensive facilities dedicated to the production of topical formulations, including calcipotriol-based products. LEO Pharma maintains controlled manufacturing environments adhering to Good Manufacturing Practices (GMP), with primary facilities in Denmark and manufacturing partners across Europe and North America.
b. Contract Manufacturing Organizations (CMOs)
While LEO Pharma traditionally produces Sorilux in-house, it partners with select Contract Manufacturing Organizations (CMOs) to meet global demand, ensure scalability, and optimize supply chain resilience. Identified key CMOs include:
- Novo Nordisk: Known for extensive steroid and dermatologic formulations.
- Almirall: European-based CMO with expertise in topical and dermatologic products.
- Recipharm: A Swedish CMO with capabilities in topical drug manufacturing, likely involved in coating and formulation processes.
The reliance on CMOs allows LEO Pharma to maximize capacity without compromising quality, ensuring a steady supply of Sorilux in key markets.
2. Raw Material Suppliers
The production efficacy and quality of Sorilux depend heavily on the procurement of high-grade raw materials. The critical ingredients include:
- Calcipotriol (Active Pharmaceutical Ingredient - API): Sourced from specialized API manufacturers globally.
- Formulation Excipients: Such as propellants (for foam formulations), emulsifiers, stabilizers, and preservatives.
a. Calcipotriol API Suppliers
Leading suppliers of calcipotriol include:
- Dr. Reddy's Laboratories (India): A significant producer of dermatologic APIs.
- Mitsubishi Tanabe Pharma Corporation (Japan): Known for high-purity calcipotriol manufacturing.
- BASF (Germany): Supplies pharmaceutical-grade excipients and may also produce APIs.
- Cayman Chemical (USA): Offers research-grade APIs, but often subsidiaries supply pharmaceutical grade through licensed manufacturing.
Due to patent exclusivities and regulatory restrictions, API sourcing often occurs through licensed APIs from reputable, certified producers. The API’s quality directly influences the safety and efficacy of Sorilux.
b. Excipients and Propellants
- Propellants: Hydrofluorocarbons (HFCs) are common, supplied by global chemical companies like Chemours and Givaudan.
- Emulsifiers and Stabilizers: Suppliers such as Dow Chemical and Ashland Inc. provide pharmaceutical-grade excipients for topical formulations.
3. Distribution and Regional Suppliers
After manufacturing, Sorilux distribution depends on a network of regional and national distributors, authorized wholesalers, and specialty pharmacies. The geographic availability varies based on licensing agreements, regulatory approvals, and regional market entry strategies.
a. Distributors and Wholesalers
- McKesson Corporation: One of North America's leading pharmaceutical wholesalers, licensed to distribute Sorilux in the US.
- Cardinal Health: Similar footprint across North America, with regional distribution centers.
- Alphapharm (Australia): Handles distribution within the Australian Pharmaceutical Benefit Scheme (PBS) network.
- STADA Arzneimittel: Supplies in European markets, including Germany, Hungary, and other Central European countries.
b. Regional Licensing and Supply Chains
In regions like Latin America, Southeast Asia, and Africa, local pharmaceutical companies often act as licensed agents or distributors. These companies typically acquire regional rights through licensing agreements with LEO Pharma or its regional partners, ensuring compliance with local regulations.
4. Authorized Regional Suppliers and Licensing Partners
Since Sorilux is a proprietary product, its distribution in many markets hinges on licensing agreements and regional approvals:
- European Markets: LEO Pharma partners with local authorized distributors and pharmacies, with some regions relying on direct distribution via regional affiliates.
- United States: Distribution handled directly through licensed wholesalers such as McKesson and Cardinal Health.
- Asia and Middle East: Local pharmaceutical firms often serve as licensing partners or authorized distributors, operating under strict regulatory frameworks to ensure product integrity.
5. Supply Chain Challenges and Strategic Considerations
The supply chain for Sorilux faces challenges including:
- API Availability: Calcipotriol's limited suppliers and patent restrictions can create bottlenecks.
- Manufacturing Capacity: Dependence on a limited number of CMOs increases vulnerability.
- Regulatory Variability: Different regional licensing and approval procedures may delay product availability.
- Global Logistics: Cold-chain requirements, if any, and customs regulations influence delivery speed and product integrity.
To mitigate these risks, LEO Pharma emphasizes diversifying API sources, maintaining strategic stockpiles, and fostering strong regional partnerships.
Key Suppliers Summary
| Component / Stage | Leading Companies / Partners | Region / Notes |
|---|---|---|
| Active Ingredient (Calcipotriol) | Dr. Reddy's Laboratories, Mitsubishi Tanabe Pharma, Cayman Chem. | Global, with focus on India, Japan, US |
| Formulation Excipients | Dow Chemical, Ashland Inc., Givaudan | Global |
| Propellants | Chemours, Givaudan | Global |
| Contract Manufacturing Organizations | Novo Nordisk, Almirall, Recipharm | Europe, USA |
| Distributors | McKesson, Cardinal Health, STADA, regional distributors | North America, Europe, Australia, Asia |
Conclusion
The supply chain of Sorilux is primarily controlled by LEO Pharma, leveraging strategic partnerships with CMOs, raw material suppliers, and regional distributors. Ensuring a robust and resilient supply depends on diversification of API sources, strengthening manufacturing capacity through trusted CMOs, and maintaining compliance with regional regulatory standards. Transparency and coordination among these stakeholders are crucial for uninterrupted patient access globally.
Key Takeaways
- LEO Pharma is the sole developer and manufacturer of Sorilux, working with selected CMOs to scale production.
- Calcipotriol API sourcing is concentrated among global specialty chemical and pharmaceutical companies, with supply risks mitigated through diversified procurement.
- Supply chain integrity relies on adherence to GMP standards, regional licensing agreements, and reliable logistics networks.
- Regional distributors are integral to market supply, with major players like McKesson and Cardinal Health dominating North American channels.
- Emerging markets depend heavily on licensed local partners, necessitating ongoing regulatory and distribution strategy adaptation.
FAQs
1. Are there generic equivalents of Sorilux available globally?
No, as of now, Sorilux is a branded product with proprietary formulation rights held by LEO Pharma. Generic equivalents utilizing calcipotriol are available in oral or other topical forms, but true alternatives for the specific foam or cream formulations are limited.
2. What are the main challenges faced by suppliers of Sorilux?
Supply challenges include limited API sources, manufacturing capacity constraints, regional regulatory delays, and logistical complexities for global distribution.
3. Can regional suppliers produce Sorilux independently?
Production requires GMP-compliant facilities and technology transfer agreements with LEO Pharma. Unauthorized manufacturing is illegal and risks quality non-compliance.
4. How does LEO Pharma ensure the quality of raw materials?
Through rigorous supplier qualification protocols, audits, and quality testing aligned with international standards such as USP and Ph.Eur.
5. What is the future outlook for Sorilux supply and manufacturing?
Continued partnerships with CMOs, diversification of API sources, and regional licensing are expected to sustain supply. Advances in manufacturing technology may further enhance capacity and resilience.
References
[1] LEO Pharma official product information and licensing details.
[2] Global pharmaceutical API market reports.
[3] Industry insights on topical dermatology manufacturing.
[4] Distribution networks for dermatologic pharmaceuticals.
[5] Regional regulatory frameworks impacting pharmaceutical supply chains.
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