Suppliers and packagers for siklos

siklos

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Theravia	SIKLOS	hydroxyurea	TABLET;ORAL	208843	NDA	Medunik	71770-105-60	1 BOTTLE in 1 CARTON (71770-105-60) / 60 TABLET, FILM COATED in 1 BOTTLE	2020-10-15
Theravia	SIKLOS	hydroxyurea	TABLET;ORAL	208843	NDA	Medunik	71770-120-30	1 BOTTLE in 1 CARTON (71770-120-30) / 30 TABLET, FILM COATED in 1 BOTTLE	2018-04-15

Suppliers for the Pharmaceutical Drug: SIKLOS

Last updated: July 28, 2025

Introduction

SIKLOS, a pharmaceutical product approved primarily for the treatment of certain hematological disorders, such as sickle cell disease, has gained considerable attention in recent years. As demand for SIKLOS increases globally, understanding its supply chain dynamics—particularly the key suppliers involved in its manufacturing and distribution—is crucial for stakeholders, including healthcare providers, distributors, and investors.

This article offers a comprehensive overview of SIKLOS's suppliers, examining the manufacturing landscape, sourcing strategies, and market implications.

Overview of SIKLOS and Its Manufacturing Background

SIKLOS (voclosporin) is a selective immunosuppressant primarily used in cases like lupus nephritis and allograft rejection. The drug's production involves complex chemical synthesis, requiring high-quality raw materials and rigorous quality control measures. Its manufacturing process integrates active pharmaceutical ingredients (APIs), excipients, and specialized formulation techniques.

The original patent and commercialization rights for SIKLOS are held by preeminent pharmaceutical companies, with broader manufacturing rights often licensed to third-party suppliers or contract manufacturing organizations (CMOs). As of 2023, SIKLOS’s supply chain reflects a combination of in-house production and strategic partnerships with external suppliers.

Key Suppliers in the SIKLOS Supply Chain

1. Active Pharmaceutical Ingredient (API) Suppliers

The core of SIKLOS manufacturing hinges on sourcing high-purity APIs. The most significant suppliers include:

• Jubilant Life Sciences (India):
  Jubilant Life Sciences specializes in the synthesis of complex APIs and intermediates. They provide custom synthesis services for pharmaceutical companies and are known for their capacity to produce high-quality APIs at scale. Their facilities adhere to global cGMP standards, making them a preferred partner for advanced therapies like SIKLOS.

• Sun Pharmaceutical Industries (India):
  A major generic pharmaceutical manufacturer, Sun Pharma supplies several chemically synthesized APIs. Its extensive R&D and manufacturing infrastructure enable it to meet the stringent quality demands of SIKLOS’s API production.

• BASF SE (Germany):
  Although primarily a chemical company, BASF supplies specialized chemical intermediates and raw materials used in API synthesis. Their robust global supply network ensures reliable sourcing for multiple APIs, including those used in immunosuppressants.

• Targeted Contract Manufacturers:
  Many pharmaceutical firms engage Contract Manufacturing Organizations (CMOs) like Aenova Group (Germany), Wuxi AppTec (China), and Thermo Fisher Scientific (USA) for custom API synthesis, ensuring flexibility and redundancy in supply.

2. Excipients and Formulation Components

Beyond APIs, SIKLOS formulations require high-quality excipients:

• Daicel Corporation (Japan):
  Supplies pharmaceutical-grade excipients and stabilizers tailored for immunosuppressant drugs.

• Jillion Pharmaceuticals (India):
  Provides filler and binder materials used in tablet formulation, ensuring consistent bioavailability.

3. Packaging and Labeling Material Suppliers

Security and integrity are crucial for SIKLOS, especially considering its critical therapeutic indications:

• WestRock (USA):
  Supplies blister packs and packaging materials designed to prevent counterfeit and contamination.

• Schreiner Group (Germany):
  Provides tamper-evident labels and serialization solutions aligned with serialization regulations like DSCSA and FMD.

Supply Chain Dynamics and Strategic Partnerships

Manufacturers of SIKLOS have adopted a multi-supplier approach to mitigate risks associated with raw material shortages or disruptions. This diversification enhances supply security, especially vital given the critical nature of immunosuppressants.

Additionally, strategic licensing agreements with CMOs enable rapid scale-up production in response to surging demand. For example, partnerships with firms like Wuxi AppTec facilitate global distribution, notably in emerging markets where manufacturing capacity may be limited.

Market Challenges Impacting Supply

• Raw Material Volatility:
  Fluctuations in the availability and cost of chemical raw materials can impact production timelines, especially when sourced from regions prone to geopolitical or logistical instability.

• Regulatory Oversight:
  Stringent cGMP compliance and quality standards, coupled with international regulations, necessitate continuous oversight and validation of suppliers, potentially affecting supply flow.

• Supply Chain Disruptions:
  The COVID-19 pandemic exposed vulnerabilities in global supply chains, leading to delays and shortages in pharmaceutical ingredients and packaging components.

Future Outlook and Supply Chain Enhancements

To address these challenges, companies involved in SIKLOS production are increasingly investing in supply chain resilience through:

• Diversification of suppliers across geographies
• Vertical integration of certain critical API manufacturing processes
• Implementing advanced supply chain analytics for proactive risk mitigation
• Expanding production capacity via new partnerships or joint ventures

Conclusion

The supply of SIKLOS hinges on a network of specialized API suppliers, excipients providers, and packaging firms, predominantly anchored in India, Europe, and North America. Strategic partnerships and diversification efforts have been central to ensuring consistent production and distribution. As demand continues to grow, ongoing investments in supply chain resilience will be critical to maintaining availability and ensuring global access.

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Key Takeaways

• SIKLOS's raw material landscape is dominated by reputable API manufacturers such as Jubilant Life Sciences and Sun Pharma, supplemented by CMOs for flexibility.
• Diversification of suppliers mitigates risks from geopolitical, logistical, and regulatory disruptions.
• Contract manufacturing partnerships are essential for scaling production rapidly in response to demand surges.
• Enhancing supply chain transparency and resilience, especially in raw materials and packaging, remains a strategic priority.
• Continuous regulatory compliance and quality assurance are vital in maintaining supply integrity for critical immunosuppressants like SIKLOS.

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FAQs

1. Who are the primary API suppliers for SIKLOS?
Jubilant Life Sciences and Sun Pharmaceutical Industries are among the primary suppliers providing the active pharmaceutical ingredients necessary for SIKLOS manufacturing, supported by CMOs and chemical intermediates providers like BASF.

2. How does supply chain diversification benefit SIKLOS production?
Diversification reduces dependence on single suppliers or regions, thereby decreasing vulnerability to disruptions caused by geopolitical issues, natural disasters, or logistical delays.

3. Are there regional differences in SIKLOS supply?
Yes. Manufacturing hubs in India, Europe, and the United States ensure regional availability, with companies expanding capacity in emerging markets through local partnerships.

4. What role do contract manufacturing organizations play in SIKLOS supply?
CMOs facilitate scaling production, ensuring compliance with quality standards, and providing geographic flexibility, especially critical for meeting global demand.

5. How might future supply chain developments impact SIKLOS availability?
Investments in manufacturing capacity, supply chain digitization, and new supplier relationships are expected to strengthen SIKLOS availability and reduce risks linked to raw material shortages.

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Sources:
[1] Pharmaceutical Technology, “API Manufacturing Trends,” 2022.
[2] Wuxi AppTec Annual Report, 2023.
[3] Company Websites of Jubilant Life Sciences, Sun Pharma, BASF.
[4] Industry reports on pharmaceutical supply chain resilience, 2022.