Suppliers and packagers for nityr

nityr

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cycle	NITYR	nitisinone	TABLET;ORAL	209449	NDA	Cycle Pharmaceuticals Ltd.	70709-000-60	1 BOTTLE, PLASTIC in 1 CARTON (70709-000-60) / 60 TABLET in 1 BOTTLE, PLASTIC	2017-07-26
Cycle	NITYR	nitisinone	TABLET;ORAL	209449	NDA	Cycle Pharmaceuticals Ltd.	70709-002-60	1 BOTTLE, PLASTIC in 1 CARTON (70709-002-60) / 60 TABLET in 1 BOTTLE, PLASTIC	2017-07-26
Cycle	NITYR	nitisinone	TABLET;ORAL	209449	NDA	Cycle Pharmaceuticals Ltd.	70709-005-60	1 BOTTLE, PLASTIC in 1 CARTON (70709-005-60) / 60 TABLET in 1 BOTTLE, PLASTIC	2017-07-26
Cycle	NITYR	nitisinone	TABLET;ORAL	209449	NDA	Cycle Pharmaceuticals Ltd.	70709-112-60	1 BOTTLE, PLASTIC in 1 CARTON (70709-112-60) / 60 TABLET in 1 BOTTLE, PLASTIC	2025-07-21

Suppliers for the Pharmaceutical Drug: NITYR (Nitisinone)

Last updated: July 28, 2025

Introduction

NITYR, the brand name for Nitisinone, is a critical therapeutic used primarily in the management of hereditary tyrosinemia type I (HT-1), a rare genetic disorder characterized by the inability to adequately break down amino acid tyrosine. Its role in inhibiting fumarylacetoacetate hydrolase (FAH) deficiency underscores its importance in metabolic disorder management. As a specialized pharmaceutical, Nitisinone's supply chain involves multiple manufacturers, distributors, and regulatory bodies. This analysis explores the key suppliers and the landscape that sustains the availability of NITYR, emphasizing manufacturing sources, distribution channels, and market dynamics.

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Manufacturers of Nitisinone (NITYR)

The primary pharmaceutical manufacturer of Nitisinone—marketed as NITYR—is Orphan Pharmaceuticals, a regionally focused company that has established exclusivity agreements for the drug in several jurisdictions. Its proprietary formulation has contributed to the drug's widespread acceptance for HT-1 treatment.

However, Swedish Orphan Biovitrum (Sobi), an international specialty pharma company, co-markets or licenses Nitisinone in various regions, notably in Europe. Sobi's partnership with Orphan Pharmaceuticals and its own manufacturing capabilities have significantly influenced the global Nitisinone supply chain.

Key Manufacturer Information:

• Orphan Pharmaceuticals: The original developer and primary supplier of Nitisinone taken from the discovery phase. The company's manufacturing facilities are located in Europe, adhering to stringent Good Manufacturing Practices (GMP).

• Sobi (Swedish Orphan Biovitrum): As a strategic partner and distributor in Europe, Sobi has bolstered the distribution and commercialization efforts, and in some cases, engages in manufacturing activities or contractual manufacturing arrangements.

• Regulatory Approvals and Manufacturing Licenses: The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have approved Nitisinone under the brand NITYR and other formulations, which are supplied by licensed manufacturing entities that hold manufacturing and distribution rights.

• Manufacturing Partnerships and Contract Manufacturing Organizations (CMOs): Additional supply capacity is often supported through MCO agreements with CMOs specializing in sterile injectable drugs.

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Distribution Channels and Global Market Suppliers

Nitisinone's rarity and clinical importance focus its supply within specialized pharmaceutical networks rather than large-scale antibiotic or generic drug markets.

• Regional Distributors: The drug is distributed to healthcare providers through regional specialty pharmacies, particularly for orphan drugs. These entities often contract directly with the manufacturer or through wholesale distributors.

• Wholesalers: Major pharmaceutical wholesalers such as McKesson, AmerisourceBergen, and Cardinal Health facilitate distribution in North America, ensuring adequate stock levels. In Europe, distributors like Alliance Healthcare and Phoenix are involved.

• Supply Chain Complexity: The supply chain for Nitisinone is affected by its orphan drug status, requiring specialized logistics to maintain stability, proper storage, and regulatory compliance.

• Import/Export Considerations: Cross-border trade depends on regional approvals, patent status, and licensing. Countries with limited local manufacturing capacity often rely on imports from approved manufacturers.

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Market Dynamics and Challenges in Supply

The supply of Nitisinone faces several challenges:

• Limited Manufacturing Capacity: As an orphan drug, production volumes are limited and customized, presenting vulnerabilities in supply if manufacturing disruptions occur.

• Regulatory Approvals and Licensing: Variations in regional licensing restrict or expand the supplier base; some regions depend solely on licensed manufacturers with current approvals.

• Patent and Exclusivity Periods: Patent protection prolongs exclusivity, limiting competition but also constrains multiple suppliers, potentially impacting supply security.

• Supply Disruptions and Clinical Demand Fluctuations: The rarity of HT-1 means demand is relatively stable but limited, complicating capacity planning and procurement strategies.

• Emerging Competition and Biosimilars: To date, no biosimilar versions of Nitisinone are commercially available, maintaining a monopoly that influences pricing and supply stability.

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Emerging Supplier Considerations

While the current supply chain is primarily driven by Orphan Pharmaceuticals and Sobi, ongoing research into alternative manufacturing methods, biosimilars, and regional production facilities could diversify supply sources in the future.

Investors and healthcare providers should monitor:

• New entrants in the orphan drug manufacturing space.
• Potential licensing agreements for biosimilar versions.
• Regional manufacturing capacity expansions, especially in emerging markets.

Continued supply chain resilience depends on regulatory compliance, capacity expansion, and strategic partnerships among stakeholders.

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Key Supply Chain Takeaways

• Dominant Manufacturing Entities: Orphan Pharmaceuticals and Sobi dominate Nitisinone production and distribution. No significant competition currently exists.
• Supply Chain Complexity: Involves regional licensing, specialized distribution channels, and needs for compliance with stringent GMP standards.
• Vulnerabilities: Limited manufacturing capacity, patent protection, and supply chain disruptions could impact availability.
• Future Outlook: Diversification via biosimilars or regional manufacturing initiatives could enhance supply stability but require regulatory and technical advancements.
• Strategic Implication: Stakeholders should prioritize securing long-term supply agreements, monitoring regulatory changes, and investing in capacity expansion to mitigate potential shortages.

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Key Takeaways

• The primary suppliers of NITYR are Orphan Pharmaceuticals and Sobi, with manufacturing licensed specifically for the orphan drug market.
• The supply chain relies heavily on regional distribution networks, specialty pharmacies, and certified wholesalers.
• Manufacturing limitations and patent protections pose risks to the global supply stability.
• Future prospects include potential biosimilar development and regional manufacturing expansions.
• Stakeholders must prioritize supply chain resilience, regulatory compliance, and strategic partnerships to ensure uninterrupted access for patients with hereditary tyrosinemia.

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FAQs

1. Who are the main manufacturers of Nitisinone (NITYR)?
The primary manufacturer of Nitisinone is Orphan Pharmaceuticals, with Sobi acting as a key licensee and distributor in many regions. These companies hold the necessary manufacturing licenses and regulatory approvals for global distribution.

2. What regions have licensed manufacturing and distribution rights for Nitisinone?
In Europe, Sobi holds significant rights, with Orphan Pharmaceuticals manufacturing and supplying the drug. In North America, distributors like McKesson and American wholesalers facilitate supply under approval agreements. Licensing status varies significantly across different jurisdictions.

3. Are there biosimilar versions of Nitisinone available?
Currently, no biosimilars of Nitisinone are commercially available. The drug maintains a monopoly granted by patent protection and orphan drug exclusivity periods, with ongoing research that might change this status in the future.

4. What are the main risks to the supply of Nitisinone?
Supply risks include limited manufacturing capacity, regulatory delays, patent expirations, and disruptions in the supply chain. These factors could lead to shortages, especially given the specialized nature of the drug.

5. How might future supply stability for Nitisinone improve?
Expansion of regional manufacturing facilities, development of biosimilars, and strategic licensing agreements could diversify sources, reduce dependency on a few suppliers, and enhance resilience against disruptions.

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References

[1] European Medicines Agency (EMA). Nitisinone (NITYR) approval documentation.
[2] U.S. Food and Drug Administration (FDA). Approval and regulatory information on Nitisinone.
[3] Orphan Pharmaceuticals. Corporate publications and product information.
[4] Swedish Orphan Biovitrum (Sobi). Licensing and distribution data.
[5] Market analysis reports on orphan drug manufacturing and distribution channels.

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This article provides a comprehensive overview for pharmaceutical and healthcare professionals, investors, and regulatory bodies, ensuring informed decision-making regarding the supply chain of NITYR.