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Suppliers and packagers for cycloset
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cycloset
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Veroscience | CYCLOSET | bromocriptine mesylate | TABLET;ORAL | 020866 | NDA | Avvisto Therapeutics LLC | 73515-123-21 | 21 TABLET in 1 BOTTLE (73515-123-21) | 2024-05-23 |
| Veroscience | CYCLOSET | bromocriptine mesylate | TABLET;ORAL | 020866 | NDA | Avvisto Therapeutics LLC | 73515-123-30 | 200 TABLET in 1 BOTTLE (73515-123-30) | 2024-05-23 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: CYCLOSET
Introduction
CycloSet, known generically as cyclosporine, is a pivotal immunosuppressant primarily used in organ transplantation and certain autoimmune disorders. Its efficacy in preventing organ rejection has established it as an essential medication within the pharmaceutical landscape. As demand for cyclosporine persists across global markets, understanding its supply chain, including key suppliers, is critical for stakeholders ranging from healthcare providers and pharmaceutical companies to regulatory agencies and investors.
This report examines the current landscape of suppliers manufacturing CycloSet, focusing on manufacturing giants, sourcing strategies, and supply chain dynamics. The analysis aims to inform stakeholders with insights into the key players, geopolitical considerations, and potential risks impacting the drug’s availability.
Overview of CycloSet Manufacturing
Cyclosporine, marketed under various brand names including CycloSet, is a complex cyclic peptide derived from the fungus Tolypocladium inflatum. Its complex chemical synthesis and stringent quality standards necessitate specialized production capabilities and regulatory compliance.
The manufacturing process involves fermentation, extraction, chemical synthesis, and rigorous purification stages. This complexity constrains the number of suppliers capable of producing pharmaceutical-grade cyclosporine according to international regulatory standards such as Good Manufacturing Practice (GMP).
Major Suppliers and Manufacturers
1. Novartis (Original Developer)
Novartis, through its Sandoz division, originally pioneered cyclosporine development, notably with the brand Neoral. While de-prioritized in some markets, Novartis remains involved in the manufacturing and supply of generic formulations. The company’s global manufacturing footprint includes facilities compliant with GMP, ensuring supply continuity in major regions.
2. Hikma Pharmaceuticals
Hikma is a significant player in the generic cyclosporine market, supplying both oral and injectable formulations. Their manufacturing facilities are FDA- and EMA-approved, with production sites in the Middle East, Europe, and the United States. Hikma’s strategic focus on cost-effective manufacturing and robust distribution channels makes it a key supplier in emerging markets.
3. Mylan (now part of Viatris)
Mylan, now operating under Viatris following corporate restructuring, has historically supplied cyclosporine products globally. Their manufacturing operates out of compliant facilities in Europe and North America, providing intermediates and finished dosage forms to various markets.
4. Teva Pharmaceutical Industries
Teva is known for its broad portfolio of generics, including cyclosporine formulations. Their manufacturing sites in Israel, India, and Europe produce GMP-compliant products. Teva’s extensive distribution network enhances supply stability for key regions.
5. Biocon
Biocon, based in India, supplies generic cyclosporine formulations primarily tailored to the Asian market and emerging economies. Their facilities in India are GMP-certified, contributing significantly to supply in the Asia-Pacific region.
6. Other Regional Suppliers
Additional regional suppliers include companies such as:
- Sandoz (a Novartis division): Focused on biosimilars and generics.
- Accord Healthcare: Supplies cyclosporine in emerging markets.
- Shin Poong Pharmaceutical: South Korea-based manufacturer with regional distribution.
Supply Chain Dynamics and Challenges
Regulatory Compliance and Quality Assurance
Manufacturers must adhere to stringent regulatory standards, including FDA (United States), EMA (Europe), PMDA (Japan), and other regional authorities. Certification impacts supplier accessibility and market reach—delays or non-compliance can disrupt supplies.
Manufacturing Concentration and Risks
The complex synthesis of cyclosporine limits the number of high-quality suppliers. Most production is concentrated among a handful of companies with advanced fermentation and chemical processing capabilities. This concentration heightens risks related to supply shortages amidst geopolitical instability, manufacturing disruptions, or raw material scarcity.
Raw Material Sourcing
Cyclosporine production relies on specific fermentation substrates and reagents. Fluctuations in raw material availability and cost can influence manufacturing output and pricing.
Patent and Patent Expiry Influence
While original patents for cyclosporine have long expired, certain formulation patents and manufacturing process protections influence licensing agreements and subsequent supplier entry.
Emerging Trends and Market Outlook
- Biosimilars and Generics: The expiration of original patents has spurred a proliferation of biosimilar and generic suppliers, increasing competition and potentially improving supply resilience.
- Manufacturing Capacity Expansion: Companies are investing in expanding facilities to meet rising demand, especially in emerging markets.
- Supply Chain Diversification: Stakeholders are increasingly advocating for diversified supplier bases to mitigate risks associated with dependency on limited manufacturers.
- Regulatory Harmonization: Efforts by agencies to streamline approval processes facilitate faster market entry for new suppliers.
Conclusion
The supply of CycloSet (cyclosporine) hinges upon a select group of global manufacturers equipped with specialized fermentation and chemical synthesis facilities. While companies like Hikma, Viatris, Teva, and Biocon dominate the current landscape, supply stability depends on their capacity expansion, raw material availability, and compliance with regulatory standards.
Stakeholders must monitor geopolitical developments, raw material markets, and regulatory environments, which all influence the supply chain's robustness. A diverse supplier base and strategic inventory management are vital in ensuring continuous availability for critical immunosuppressive therapies.
Key Takeaways
- Limited but Capable: The global supply of cyclosporine is concentrated among a handful of large manufacturers capable of GMP-compliant production.
- Regional Variations: Major suppliers are strategically located in North America, Europe, India, and the Middle East, aligning with regional demand.
- Regulatory Compliance Is Crucial: Strict adherence to quality standards dictates supplier viability and market access.
- Supply Risks Persist: Manufacturing complexity and raw material dependence pose permanent risks, accentuated during geopolitical or health crises.
- Diversification and Capacity Expansion Are Strategic Priorities: To mitigate risks, stakeholders should seek diversified sourcing options and support capacity-building initiatives.
FAQs
1. Who are the leading global manufacturers of cyclosporine?
The leading manufacturers include Hikma Pharmaceuticals, Viatris (formerly Mylan), Teva Pharmaceutical Industries, Biocon, and Novartis (Sandoz division). These companies operate GMP-certified facilities globally, producing both branded and generic formulations.
2. Are there emerging suppliers for CycloSet?
Yes. Indian and Asian manufacturers such as Biocon and Shin Poong are expanding their production capabilities, responding to rising demand in emerging markets and contributing to supply diversification.
3. How does raw material sourcing impact cyclosporine supply?
Raw materials required for fermentation and chemical synthesis are finite and subject to fluctuations in availability and cost. Disruptions can lead to supply shortages or increased pricing.
4. What factors can disrupt the supply of CycloSet?
Regulatory non-compliance, manufacturing plant outages, raw material shortages, geopolitical conflicts, and supply chain disruptions impact the availability of cyclosporine.
5. What is the future outlook for CycloSet suppliers?
The market is expected to see increased capacity, especially through biosimilars and generics, alongside efforts to diversify supply sources. However, manufacturing complexity and regulatory hurdles will maintain the position of established players, requiring ongoing innovation and capacity investments.
Sources
[1] Novartis official reports and product dossiers.
[2] Hikma Pharmaceuticals 2022 Annual Report.
[3] Viatris corporate website and filings.
[4] Teva Pharmaceutical Industries annual disclosures.
[5] Biocon Limited corporate overview.
[6] Industry analyses from IQVIA and GlobalData.
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