Suppliers and packagers for nitisinone

nitisinone

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Eton	NITISINONE	nitisinone	CAPSULE;ORAL	216201	ANDA	Eton Pharmaceuticals, Inc.	71863-119-60	1 BOTTLE in 1 CARTON (71863-119-60) / 60 CAPSULE in 1 BOTTLE	2024-01-15
Eton	NITISINONE	nitisinone	CAPSULE;ORAL	216201	ANDA	Eton Pharmaceuticals, Inc.	71863-120-60	1 BOTTLE in 1 CARTON (71863-120-60) / 60 CAPSULE in 1 BOTTLE	2024-01-15
Eton	NITISINONE	nitisinone	CAPSULE;ORAL	216201	ANDA	Eton Pharmaceuticals, Inc.	71863-121-60	1 BOTTLE in 1 CARTON (71863-121-60) / 60 CAPSULE in 1 BOTTLE	2024-01-15
Eton	NITISINONE	nitisinone	CAPSULE;ORAL	216201	ANDA	Eton Pharmaceuticals, Inc.	71863-122-60	1 BOTTLE in 1 CARTON (71863-122-60) / 60 CAPSULE in 1 BOTTLE	2024-01-15
Medunik	NITISINONE	nitisinone	CAPSULE;ORAL	212390	ANDA	Analog Pharma	70505-202-60	1 BOTTLE, PLASTIC in 1 CARTON (70505-202-60) / 60 CAPSULE in 1 BOTTLE, PLASTIC	2022-06-15

Suppliers for the Pharmaceutical Drug: NITISINONE

Last updated: July 27, 2025

Introduction

Nitisinone is a potent inhibitor of 4-hydroxyphenylpyruvate dioxygenase (HPPD), primarily used in the treatment of hereditary tyrosinemia type 1 (HT-1). Approved by the U.S. Food and Drug Administration (FDA) in 2002 under the brand name Orfadin, nitisinone has become a critical therapy to prevent the accumulation of toxic metabolites in patients with HT-1. Its significance extends beyond rare metabolic disorders, with ongoing exploration for potential applications in other conditions, such as alkaptonuria and certain cancers.

Given nitisinone's therapeutic importance, identifying reliable suppliers—ranging from active pharmaceutical ingredient (API) producers to finished drug manufacturers—is essential for healthcare providers, distributors, and generic drug companies. This report details current suppliers for nitisinone, their manufacturing footprints, regulatory status, and market positioning.

Overview of Nitisinone Manufacturing and Supply Chain

The supply chain for nitisinone involves several stages: API synthesis, formulation, packaging, and distribution. The API is the cornerstone, produced primarily by specialized chemical and pharmaceutical companies capable of complex organic syntheses under current Good Manufacturing Practice (cGMP) standards.

Major suppliers of nitisinone typically fall into two categories:

1. Original developers and patent holders
2. Generic manufacturers and API producers

Their roles include ensuring the drug’s availability across markets, maintaining regulatory compliance, and innovating manufacturing processes to improve yield and reduce costs.

Leading Suppliers of Nitisinone API

1. Intercept Pharmaceuticals

Background: Intercept Pharmaceuticals holds the original patent and marketing rights for nitisinone, marketed globally under the brand name Orfadin. They are responsible for manufacturing and supplying the API primarily for their formulations.

Market Role: As the primary innovator, Intercept is the authorized supplier of nitisinone API for branded products. Their manufacturing facilities are located in the United States and Europe, ensuring high quality and regulatory compliance.

Regulatory Status: Intercept’s API manufacturing facilities are inspected and approved by major regulatory agencies such as the FDA and EMA, guaranteeing adherence to cGMP standards.

2. PJSC "Synthesis" and Russian Manufacturers

Overview: Several Russian chemical and pharmaceutical firms, including PJSC "Synthesis," produce nitisinone API, often for domestic markets and emerging markets. These producers have developed independent synthetic pathways to supply the drug at reduced costs.

Regulatory Compliance: Some Russian manufacturers have achieved certification under the International Council for Harmonisation (ICH) guidelines, although their export to certain markets may require additional approval.

3. Indian Manufacturers—Dr. Reddy’s Laboratories, Sun Pharmaceutical Industries, and Others

India’s booming generic pharmaceutical industry has entered the nitisinone API market, offering more affordable options.

• Dr. Reddy’s Laboratories: Reported to have developed robust synthetic routes for nitisinone API according to cGMP standards, catering to both domestic and export markets.
• Sun Pharmaceutical Industries: Has announced capacity expansion plans for niche APIs, including nitisinone, leveraging Indian Department of Pharmaceuticals' incentives.

Regulatory Status: These manufacturers are actively working to attain or maintain approvals from the US FDA, EMA, and other regional agencies.

4. Chinese API Manufacturers

China's presence in the API sector is substantial, with several companies producing nitisinone API for local and international markets.

• Major Players: Zhejiang Hisun Pharmaceutical, Jiangsu Jiuzhou Pharmaceutical, and others.
• Market Dynamics: Competitive pricing, rapid production scalability, but often variable regulatory compliance levels.

Note: Their exportability depends on compliance with stringent international standards and specific market requirements.

5. Contract Manufacturing Organizations (CMOs)

Major pharma-centric CMOs such as Boehringer Ingelheim and Samsung BioLogics have capacity for custom synthesis of complex APIs like nitisinone.

• Role: Providing bespoke manufacturing services, technology transfer, and supply chain management for licensed API producers or generic companies.

Market Trends and Supply Dynamics

The nitisinone API market is characterized by a few dominant players, with a growing number of regional producers expanding capacity to meet global demand. Challenges include complex synthetic routes, regulatory hurdles, and patent landscapes that influence market entry.

The expiration of certain patents in emerging markets has led to increased generic competition, improving affordability but raising concerns about quality assurance and supply consistency.

Supply chain disruptions, such as those experienced during the COVID-19 pandemic, underscored the importance of diversified supplier bases. Consequently, global health authorities and pharmaceutical companies are seeking to establish multiple sourcing avenues.

Regulatory Considerations

Supply adherence to cGMP standards, ongoing regulatory inspections, and regional approvals are essential for suppliers wishing to market nitisinone API internationally. Variability in regulatory stringency across countries influences supplier credibility and market access.

Suppliers aiming to expand into developed markets must secure approvals from agencies such as the FDA, EMA, and PMDA (Japan).

Key Suppliers Summary Table

Supplier	Location	Market Focus	Regulatory Status	Capacity Highlights
Intercept Pharmaceuticals	US, Europe	Global (Branded)	Approved by FDA, EMA	Large-scale, high-purity API manufacturing
Dr. Reddy’s Laboratories	India	Global (Generics)	FDA, EMA, others	Expanding capacity, cost-competitive
Zhejiang Hisun Pharmaceutical	China	Regional and export	Varies; Domestic approvals	Rapid scale-up, budget-friendly options
PJSC "Synthesis"	Russia	Regional	Compliance varies	Niche regional supply
Contract Manufacturers	Global	Custom synthesis	Certified cGMP facilities	Flexible capacity, technological expertise

Conclusion

The supply landscape for nitisinone includes a diverse mix of original developers, regional generic manufacturers, and contract synthesis specialists. While Intercept Pharmaceuticals remains the primary supplier for branded formulations, a growing base of generic producers—especially in India, China, and Russia—are expanding the availability of affordable nitisinone API. Ensuring regulatory compliance and supply chain robustness remains critical for stakeholders seeking consistent access to this vital therapy.

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Key Takeaways

• Major suppliers include Intercept Pharmaceuticals (branded), Indian firms like Dr. Reddy’s, Chinese companies, and regional producers.
• Regulatory compliance with cGMP and approval from leading agencies (FDA, EMA) is essential for global market access.
• Diversification of sources mitigates supply risks highlighted during COVID-19, emphasizing the importance of multiple vendors.
• Emerging markets offer cost-effective generic options, but quality assurance is paramount.
• Ongoing capacity expansion by regional manufacturers signals increased global availability of nitisinone.

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FAQs

1. Who is the primary manufacturer of nitisinone API?
Intercept Pharmaceuticals is the original developer and primary supplier of nitisinone API for branded use worldwide.

2. Are generic versions of nitisinone available?
Yes. Multiple Indian and Chinese manufacturers produce generic nitisinone API, often at lower costs once patent protections expire or for markets without patent restrictions.

3. What regulatory approvals are required to export nitisinone API?
Manufacturers must secure approvals from relevant agencies such as the FDA, EMA, or regional regulators, demonstrating compliance with cGMP standards.

4. How has the COVID-19 pandemic affected nitisinone supply?
Pandemic-induced disruptions highlighted supply chain vulnerabilities, prompting efforts to diversify supplier bases and increase regional manufacturing capacities.

5. What factors influence the choice of nitisinone supplier?
Quality standards, regulatory approvals, manufacturing capacity, cost, and supply chain reliability are key considerations.

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References

[1] Food and Drug Administration. Orfadin (nitisinone) FDA approval documentation. 2002.
[2] European Medicines Agency. Summary of Product Characteristics for Orfadin.
[3] Intercept Pharmaceuticals Corporate Website. Nitisinone supply chain overview.
[4] Indian pharmaceutical industry reports. Capacity expansion in APIs. 2022.
[5] WHO Global Drug Supply Trends. 2023.