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Suppliers and packagers for cystadane
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cystadane
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Recordati Rare | CYSTADANE | betaine | FOR SOLUTION;ORAL | 020576 | NDA | Recordati Rare Diseases | 52276-400-01 | 180 g in 1 BOTTLE (52276-400-01) | 1996-10-25 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Cystadane
Overview of Cystadane
Cystadane (betaine anhydrous) is a pharmaceutical compound primarily used to treat homocystinuria—a rare genetic disorder characterized by elevated homocysteine levels, which increases the risk of thromboembolism and other complications. Cystadane acts as a methyl donor, helping to reduce homocysteine concentrations in affected patients. It is manufactured by Horizon Therapeutics, a global leader in specialty pharmaceuticals.
Understanding the supply chain and key suppliers of Cystadane is vital for stakeholders—including healthcare providers, distributors, and investors—looking to secure consistent access or evaluate market dynamics. This report delves into the primary suppliers, manufacturing partnerships, distribution channels, and competitive landscape surrounding Cystadane.
Manufacturers and Sourcing of Cystadane
Primary Manufacturing by Horizon Therapeutics
Horizon Therapeutics is the sole manufacturer of Cystadane, holding exclusive rights to production and distribution worldwide. Their manufacturing facility is located in the United States, where they produce pharmaceutical-grade betaine anhydrous following strict Good Manufacturing Practice (GMP) standards. As an innovator in cystic fibrosis treatments and rare disease therapies, Horizon maintains control over its supply chain for Cystadane, ensuring quality and regulatory compliance.
Supply Chain and Raw Material Sources
The primary raw material for Cystadane is betaine, a naturally occurring compound found in sugar beets, spinach, and other plant sources. Horizon sources betaine anhydrous through a network of chemical suppliers specializing in high-purity betaine production. The raw material undergoes purification and stabilization processes before formulation into pharmaceutical-grade Cystadane.
Key raw material suppliers include:
- Sigma-Aldrich (Merck): Supplies laboratory-grade betaine, which is further processed under GMP standards for pharmaceutical use.
- Wacker Chemie AG: A major global chemical supplier offering betaine raw materials suitable for pharmaceutical applications.
- Hayashibara Co., Ltd.: Provides high-purity betaine derived from sugar beets, with a focus on pharmaceutical-grade quality.
Note: These suppliers primarily serve as raw material providers to Horizon or contracted manufacturing organizations (CMOs) specializing in drug formulation.
Distribution and Supply Channels
Direct Distribution by Horizon Therapeutics
Horizon maintains an extensive distribution network, supplying Cystadane through licensed distribution partners in various regions. This centralized approach ensures product integrity and regulatory compliance. The company’s distribution channels include:
- Regional Authorized Distributors: Certified regional distributors who supply hospitals, clinics, and pharmacies.
- Specialty Pharmacies: Serving patients with rare diseases, with direct access to Horizon’s products.
Partnerships and Licensing Agreements
Horizon has established licensing agreements with regional distributors and local pharmaceutical companies to extend the drug’s reach globally. For example, in Europe, Horizon collaborates with local distributors who handle importation and regulatory approval in respective markets.
Market-specific Supply Dynamics
- In North America, the product is predominantly supplied directly through Horizon’s network.
- In Europe and Asia, licensing agreements and local partnerships facilitate distribution.
- Certain emerging markets rely on regional importers due to regulatory complexities, affecting supply chain resilience.
Market Supply Challenges and Opportunities
Supply Security and Patent Status
Although Horizon is the exclusive producer, supply chain risks include raw material disruptions, manufacturing capacity limitations, and regulatory delays. The patent exclusivity and market exclusivity periods influence the market dynamics—patent protections typically restrict competition until expiration.
Potential for Generic Entry
Post-patent expiration, generic manufacturers may seek to produce Version of betaine for cystinuria, potentially increasing market competition. However, as of 2023, no generic versions have been approved or marketed, partly due to the specialized manufacturing process and regulatory hurdles.
Emerging Alternatives and Formulations
Research into alternative methylation therapies or biosimilar versions could diversify supply sources in the future, aiming to lower costs or improve access. Such innovations could alter the current supplier landscape, pending regulatory approval.
Key Suppliers Summary
| Entity | Type | Role | Region | Notes |
|---|---|---|---|---|
| Horizon Therapeutics | Manufacturer | Sole producer of Cystadane | Global | Exclusive rights worldwide |
| Sigma-Aldrich (Merck) | Raw material supplier | Betain raw material | Global | Pharmaceutical-grade betaine |
| Wacker Chemie AG | Raw material supplier | Betaine raw material | Global | Chemical purity compliance |
| Hayashibara Co., Ltd. | Raw material supplier | Plant-derived betaine | Japan, Asia | High purity and quality |
Regulatory and Licensing Landscape
Horizon’s production and distribution are supported by regulatory approvals from key agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and other health authorities. The licensing agreements with regional distributors ensure compliance with each jurisdiction’s standards, affecting supply security.
The regulatory environment also influences potential entry of generics, which requires rigorous approval processes including bioequivalence studies and manufacturing audits.
Conclusion
Cystadane’s supply chain hinges predominantly on Horizon Therapeutics’ manufacturing capabilities and their global distribution network. Raw materials, notably betaine, are sourced from specialized chemical suppliers globally, emphasizing quality and purity. While Horizon’s exclusive rights secure current supply, potential challenges include raw material disruptions, regulatory hurdles, and patent expirations that could introduce competition.
For stakeholders, monitoring Horizon’s manufacturing commitments, raw material sourcing stability, and ongoing regulatory developments remains essential for ensuring reliable Cystadane supply.
Key Takeaways
- Horizon Therapeutics is the sole manufacturer and distributor of Cystadane, controlling the entire supply chain.
- Raw materials for Cystadane, mainly betaine, are supplied by chemical companies like Sigma-Aldrich, Wacker Chemie, and Hayashibara.
- Distribution is managed through regional licensing agreements, with supply security closely linked to Horizon’s manufacturing capacity.
- Patent protections currently prevent generic competition, but this may change upon patent expiry.
- Supply challenges include raw material availability, manufacturing capacity, and regulatory complexities, which stakeholders must monitor.
FAQs
1. Who are the primary suppliers of raw betaine used in Cystadane production?
Major raw betaine suppliers include Sigma-Aldrich (Merck), Wacker Chemie, and Hayashibara, providing pharmaceutical-grade betaine globally.
2. Is Cystadane available from multiple manufacturers?
No, Horizon Therapeutics is the exclusive manufacturer worldwide, holding patents and licenses that prevent other companies from producing generic versions.
3. How does Horizon ensure the quality of Cystadane?
Horizon enforces strict GMP standards during manufacturing and sources high-purity raw betaine, complemented by regulatory oversight from agencies like the FDA and EMA.
4. What potential threats could impact the supply of Cystadane?
Raw material disruptions, manufacturing capacity limitations, regulatory delays, and patent expirations pose risks to ongoing supply.
5. Are there any emerging competitors or alternative therapies for homocystinuria?
Currently, no direct alternatives are approved; however, ongoing research into methylation therapies and biosimilars could challenge Horizon’s monopoly in the future.
Sources:
[1] Horizon Therapeutics Official Website
[2] U.S. FDA Drug Database
[3] European Medicines Agency (EMA) Approval Data
[4] Industry Reports on Betaine Raw Material Suppliers
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