Suppliers and packagers for RYTARY

RYTARY

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Impax	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312	NDA	Amneal Pharmaceuticals LLC	64896-661-01	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-661-01)	2015-01-12
Impax	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312	NDA	Amneal Pharmaceuticals LLC	64896-661-09	25 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-661-09)	2015-01-12
Impax	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312	NDA	Amneal Pharmaceuticals LLC	64896-661-43	240 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-661-43)	2015-01-12

Suppliers for the Pharmaceutical Drug: RYTARY

Last updated: July 29, 2025

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Introduction

RYTARY (carbidopa-levodopa) extended-release capsules are a critical treatment for Parkinson's disease, providing sustained symptom management. As a complex pharmaceutical product, its supply chain encompasses multiple manufacturers, raw material suppliers, and distribution channels. Understanding the suppliers involved in RYTARY's production ecosystem offers insights into its availability, manufacturing reliability, and strategic risks for stakeholders—from healthcare providers to investors.

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Manufacturers of RYTARY

Jazz Pharmaceuticals: The Original Manufacturer

Jazz Pharmaceuticals, Inc. is the sole original developer and manufacturer of RYTARY. The drug received FDA approval in 2016 specifically as an extended-release formulation of carbidopa-levodopa for Parkinson’s disease. Jazz’s integrated manufacturing facility located in the United States oversees the production, quality control, and distribution of RYTARY. As an innovator with proprietary formulation technology, Jazz holds the essential intellectual property rights and manufacturing licenses governing RYTARY.

Contract Manufacturing and Licensing

While Jazz Pharmaceuticals maintains the core manufacturing process, there is a growing reliance on contract manufacturing organizations (CMOs) for active pharmaceutical ingredients (APIs) and finished product production. Contract manufacturing is a common strategy to optimize capacity, reduce costs, and mitigate risks associated with supply chain disruptions. Jazz may collaborate with CMOs globally, notably in regions with robust pharmaceutical manufacturing infrastructure such as India, China, and Europe, although specific contractual arrangements are generally confidential.

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Suppliers for Core Components

Active Pharmaceutical Ingredients (APIs):

• Levodopa API Suppliers:
  Levodopa, the primary active ingredient in RYTARY, is synthesized from chemical precursors sourced globally. Major suppliers include pharmaceutical-grade API manufacturers based in India, China, and Europe. Companies such as Sun Pharmaceutical Industries, Dr. Reddy’s Laboratories, and Sanofi are known to produce levodopa for export. Their manufacturing processes adhere to international GMP standards, ensuring compliance with regulatory requirements.

• Carbidopa API Suppliers:
  Carbidopa, used alongside levodopa, is similarly sourced from established API manufacturers in India and Europe. These suppliers often produce both APIs under strict quality controls, with validation and stability data aligning with FDA and EMA standards.

Excipients and Formulation Components

• Suppliers of excipients (e.g., fillers, binders, coatings) for RYTARY capsules are typically global commodity and specialty chemical companies such as BASF, Ashland, and U.S.-based suppliers. These excipients must meet pharmacopeial standards and are subject to rigorous quality assessments.

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Formulation and Packaging Suppliers

• Capsule Shell Manufacturers:
  The capsule shells used in RYTARY are supplied by multinational pharmaceutical packaging companies such as Capsugel (a Lonza company) or Catalent. These companies specialize in gelatin or hydroxypropyl methylcellulose (HPMC) capsules, compliant with pharmacopeial standards and tailored for extended-release formulations.

• Packaging Suppliers:
  Final packaging, including blisters and cartons, is provided by specialized packaging firms with capabilities in high-barrier, tamper-evident packaging designed to protect the integrity of the drug during transport and storage.

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Distribution and Supply Chain Dynamics

Distribution Channels

Jazz Pharmaceuticals distributes RYTARY through a global network of wholesalers, specialty pharmacies, and hospitals. Distributors such as McKesson, Cardinal Health, and AmerisourceBergen are key players in the US, ensuring efficient supply chain flow. Internationally, distribution partnerships are tailored to each market’s regulatory and logistical requirements.

Supply Chain Risks and Challenges

Supply chain disruptions can impact RYTARY availability. Dependence on international API suppliers exposes manufacturing to geopolitical risks, regulatory shifts, and quality control issues. Recent global events, including the COVID-19 pandemic, highlighted vulnerabilities in pharmaceutical supply chains, prompting some manufacturers to reassess sourcing strategies.

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Regulatory and Compliance Considerations

Suppliers and manufacturers must adhere to stringent regulatory standards set by the FDA, EMA, and other agencies. Compliance with Good Manufacturing Practices (GMP) ensures product quality and safety. Jazz Pharmaceuticals conducts regular audits and inspections, and any supplier involved in API or formulation component production must undergo periodic validation.

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Emerging Trends in RYTARY’s Supply Ecosystem

• Localization of API Production: To reduce reliance on international suppliers, Jazz may explore increasing API manufacturing capacity domestically or within strategic regions to mitigate geopolitical and transportation risks.
• Supply Chain Digitization: Adoption of blockchain and IoT enhances traceability, quality assurance, and inventory management.
• Sustainability Initiatives: Suppliers are increasingly adopting environmentally sustainable practices, aligning with global regulations and corporate responsibility frameworks.

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Conclusion

The supply ecosystem for RYTARY hinges on a diversified network of API manufacturers, formulation component suppliers, contract manufacturers, and distribution partners. While Jazz Pharmaceuticals remains the core producer, an extensive web of international suppliers ensures the drug's availability. Continuous monitoring of geopolitical dynamics, regulatory changes, and manufacturing quality remain essential for maintaining a resilient supply chain.

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Key Takeaways

• Jazz Pharmaceuticals is the primary manufacturer of RYTARY, leveraging both proprietary facilities and strategic partnerships with CMOs.
• Core raw materials—levodopa and carbidopa APIs—are sourced predominantly from India, China, and Europe, under strict GMP compliance.
• Suppliers of excipients, capsule shells, and packaging materials are global, with major firms like Capsugel and Catalent playing pivotal roles.
• Supply chain resilience depends on diversification of suppliers, local manufacturing initiatives, and technology adoption.
• Ongoing regulatory compliance and quality assurance are essential to sustain RYTARY's supply and uphold therapeutic standards.

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FAQs

1. Who are the main manufacturers of RYTARY?
Jazz Pharmaceuticals is the exclusive developer and primary manufacturer of RYTARY, overseeing formulation, manufacturing, and distribution.

2. Where are the active pharmaceutical ingredients for RYTARY sourced?
Levodopa and carbidopa APIs are primarily sourced from reputable manufacturers in India, China, and Europe, meeting international GMP standards.

3. Are there any contract manufacturing organizations involved in RYTARY's supply chain?
Yes, jazzy Pharmaceuticals collaborates with CMOs globally for manufacturing segments, especially API production and finished drug manufacturing.

4. What are potential risks to the RYTARY supply chain?
Risks include geopolitical tensions, regulatory changes, pandemic disruptions, and supply dependencies on foreign APIs and excipients.

5. How is the supply chain for RYTARY evolving?
Recent trends favor local API manufacturing, supply chain digitization, and sustainability efforts to enhance resilience and compliance.

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Sources:

1. FDA Drug Approvals. FDA.gov
2. Jazz Pharmaceuticals Official Website. Jazzpharma.com
3. API Manufacturers. Reports and disclosures from Sun Pharmaceutical, Dr. Reddy’s Labs, and Sanofi.
4. Pharmaceutical Packaging and Excipients Suppliers. Company websites of Capsugel and Catalent.