Bulk Pharmaceutical API Sources for SORILUX

Bulk Pharmaceutical API Sources for SORILUX

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-845-563
Amadis Chemical		A802667
AKos Consulting & Solutions		AKOS015855239
MedChemexpress MCE		HY-10001
AbaChemScene		CS-0387

Bulk Active Pharmaceutical Ingredient (API) Sources for: SORILUX

Last updated: July 31, 2025

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Introduction

Sorilux, a topical medication primarily used in the treatment of psoriasis and other dermatological conditions, contains the active pharmaceutical ingredient (API) calcipotriol. As a synthetic vitamin D3 analog, calcipotriol modulates skin cell proliferation and differentiation, making it an essential component in managing chronic plaque psoriasis. Ensuring a reliable supply of high-grade calcipotriol API is critical for pharmaceutical manufacturers aiming to produce Sorilux consistently and meet regulatory standards.

This report provides a comprehensive overview of the current bulk API sources for calcipotriol, analyzing global manufacturing bases, supplier reputations, regulatory compliance, and supply chain considerations relevant to pharmaceutical stakeholders.

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Overview of Calcipotriol (API) Manufacturing

Calcipotriol's synthesis involves complex organic chemistry processes, typically starting from readily available cholecalciferol (Vitamin D3) derivatives. The API’s manufacturing requires controlled reaction conditions, high purity standards, and compliance with Good Manufacturing Practices (GMP) to ensure pharmaceutical quality.

Major API producers for calcipotriol operate in regions with advanced chemical manufacturing capabilities, notably in India, China, Europe, and North America. The selection of API suppliers depends not only on pricing but also regulatory compliance, consistency, scale, and quality assurance measures.

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Key Global API Suppliers for Calcipotriol

1. Indian API Manufacturers

India's pharmaceutical industry is renowned for its large-scale API production, supported by favorable regulatory environments and cost advantages. Several Indian companies stand out as reputable calcipotriol API suppliers:

• L.G. Lifesciences Ltd.
  A key player specializing in dermatological APIs, including calcipotriol. Their manufacturing facilities are GMP-certified, with export commitments aligned with global regulatory standards such as US FDA, EMA, and WHO-GMP. They provide bulk API for dermatology applications, complying with international quality benchmarks.

• Biologic E. Ltd.
  Known for manufacturing complex derivatives such as calcipotriol, Biologic E. boasts GMP compliance and a track record of exporting pharmaceuticals globally. Their scale of production supports consistent supply and competitive pricing.

• Amoli Organics
  Focused on specialty pharmaceutical ingredients and APIs, Amoli Organics supplies calcipotriol for both domestic and international markets. Their commitment to quality and regulatory adherence makes them a reliable partner.

2. Chinese API Producers

China's chemical industry is a significant source of pharmaceutical APIs, including calcipotriol. Notable producers include:

• Zhejiang NHU Co., Ltd.
  A leading API manufacturer with a comprehensive product portfolio, including vitamin D analogs like calcipotriol. Their GMP-certified plants serve global markets, with focus on quality assurance and volume scalability.

• Jiangsu Hengrui Medicine Co., Ltd.
  With extensive R&D and manufacturing infrastructure, Hengrui supplies dermatological APIs that meet international standards, backed by rigorous quality control processes.

• Shanghai Fosun Pharmaceutical Co., Ltd.
  Engaged in API production across various therapeutic areas, including vitamin D analogs; their manufacturing complies with international GMP standards.

3. European and North American API Suppliers

While European and North American companies manufacture APIs primarily for their domestic markets, some global players either export or outsource to contract manufacturing organizations (CMOs):

• BASF (Germany)
  A global chemical giant with pharmaceutical-grade API production capabilities, including vitamin D derivatives. BASF emphasizes high purity, stability, and regulatory compliance.

• Lonza (Switzerland)
  Offering integrated API manufacturing services, including custom synthesis of vitamin D analogs, Lonza supports pharmaceutical developers with scalable, GMP-compliant production.

• Catalent (USA)
  Engages in CMO services, including API manufacturing, with capabilities for large-scale production and strict regulatory adherence.

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Contract Manufacturing Organizations (CMOs) and Custom API Suppliers

In addition to typical manufacturers, pharmaceutical companies increasingly rely on CMOs for calcipotriol production. These organizations offer flexibility, scalability, and regulatory support:

• Bachem
  Specializes in peptide and small-molecule API manufacturing, with experience in vitamin D analogs. They offer development and GMP manufacturing services.

• Fujifilm Diosynth Biotechnologies
  Provides custom API synthesis, including dried API powders suitable for dermatological formulations, emphasizing quality control and regulatory compliance.

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Regulatory and Quality Considerations

Sourcing APIs for Sorilux demands rigorous API quality assurance:

• GMP Certification: Essential for compliance with pharmacopeial standards (USP, EP, JP) and regulatory agencies such as FDA, EMA, and PMDA.

• Batch Consistency and Purity: Critical for therapeutic efficacy and safety, with impurity profiles monitored rigorously.

• Documentation: Proper certification, stability data, and compliance documentation facilitate regulatory submissions in target markets.

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Supply Chain and Geographic Considerations

The global nature of API manufacturing introduces supply chain considerations:

• Regional Risks: Disruptions in China or India can impact availability; diversified sourcing mitigates risks.

• Logistics: Temperature-sensitive APIs necessitate specialized logistics solutions to preserve stability during transit.

• Lead Times: Long planning cycles require early engagement with suppliers for forecasted demand and capacity planning.

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Emerging Trends & Future Outlook

• Increased Regulatory Oversight: Enhanced QC and manufacturing standards aim to improve the safety of imported APIs.

• Sustainability and Green Chemistry: Suppliers adopting sustainable synthesis processes are gaining favor amid environmental compliance mandates.

• Local Production Initiatives: Countries investing in domestic API manufacturing capacities aim to reduce dependency on imports, strengthening supply security.

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Key Takeaways

• Diversify Sources: Relying on multiple suppliers across regions like India and China reduces supply risks.

• Prioritize Quality and Compliance: Ensure API suppliers have GMP certification and regulatory approvals aligned with targeted markets.

• Evaluate Capacity and Scalability: Select suppliers capable of meeting current and future demand without compromising quality.

• Engage Early: Advance communication with API manufacturers supports lead time management and ensures regulatory readiness.

• Monitor Regulatory Landscapes: Stay current on international standards and potential trade tariffs or restrictions affecting API importation.

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FAQs

1. What are the leading API manufacturers for calcipotriol globally?
India, China, and select European companies like BASF and Lonza are prominent producers, offering GMP-certified calcipotriol APIs suitable for pharmaceutical applications.

2. How do regulatory standards impact API sourcing decisions?
Regulatory standards such as GMP, US FDA approval, and WHO-GMP certification are crucial to ensure API safety, efficacy, and compliance with pharmaceutical quality requirements across markets.

3. Is it possible to modify sourcing strategies in response to supply chain disruptions?
Yes; cross-region diversification, maintaining multiple supplier relationships, and monitoring geopolitical factors enable resilient supply chain management.

4. What role do CMOs play in calcipotriol API supply?
CMOs provide flexible manufacturing, development support, and large-scale GMP production, often serving as strategic partners for pharmaceutical companies seeking scalable API sourcing.

5. How can companies ensure the authenticity and purity of imported calcipotriol APIs?
Thorough supplier qualification, verification of GMP certification, inspection of quality documentation, and independent analytical testing are essential measures.

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References

[1] Pharmaceutical Industry Directory. "Vitamin D Analogs: Manufacturing & Supply." 2022.
[2] European Medicines Agency. "Guidelines on Good Manufacturing Practices." 2022.
[3] US Food and Drug Administration. "API Manufacturing Standards." 2022.
[4] Indian Pharmaceutical Industry Report. "API Capability & Global Market Trends." 2022.
[5] Chinese Pharmaceutical Industry Insights. "API Production & Export Dynamics." 2022.