Suppliers and packagers for RAVICTI

RAVICTI

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Horizon Therap Us	RAVICTI	glycerol phenylbutyrate	LIQUID;ORAL	203284	NDA	Lupin Pharmaceuticals, Inc.	70748-425-01	1 BOTTLE in 1 CARTON (70748-425-01) / 25 mL in 1 BOTTLE	2025-10-20
Horizon Therap Us	RAVICTI	glycerol phenylbutyrate	LIQUID;ORAL	203284	NDA	Horizon Therapeutics USA, Inc.	75987-050-06	1 BOTTLE in 1 CARTON (75987-050-06) / 25 mL in 1 BOTTLE	2013-02-28
Horizon Therap Us	RAVICTI	glycerol phenylbutyrate	LIQUID;ORAL	203284	NDA	Horizon Therapeutics USA, Inc.	75987-050-07	4 BOTTLE in 1 CARTON (75987-050-07) / 25 mL in 1 BOTTLE	2013-02-28

Suppliers for the Pharmaceutical Drug: RAVICTI

Last updated: July 31, 2025

Introduction

RAVICTI (glycerol phenylbutyrate) is an FDA-approved medication used primarily to manage urea cycle disorders (UCDs), a rare genetic condition that impairs the body's ability to eliminate ammonia. As a niche pharmaceutical, RAVICTI's supply chain is characterized by limited manufacturing sources, strict regulatory oversight, and specialized distribution channels. This article examines the key suppliers involved in the production and distribution of RAVICTI, highlighting their roles, market share, and implications for stakeholders.

Manufacturer Overview

The primary manufacturer of RAVICTI is Edison Pharmaceuticals, a biotech firm specializing in metabolic and mitochondrial diseases. Edison is responsible for the development, manufacturing, and regulatory approval of RAVICTI, maintaining strict quality control standards in line with FDA, EMA, and other international guidelines.

Edison Pharmaceuticals’ Manufacturing Operations

Edison operates its manufacturing facilities under Good Manufacturing Practices (GMP), ensuring high-quality production that meets stringent international standards. The company's manufacturing process involves sourcing raw materials from verified suppliers and employing advanced synthesis and purification technologies to produce glycerol phenylbutyrate.

Raw Material Suppliers

Key Raw Materials

The production of RAVICTI hinges on several specialized chemical inputs, primarily:

• Glycerol: A core component in the synthesis process, typically supplied by global chemical manufacturers.
• Phenylbutyrate (PBA): The active pharmaceutical ingredient (API), sourced from chemical suppliers with expertise in aromatic compounds.
• Other intermediates and solvents: Including reagents used during synthesis and purification.

Major Raw Material Suppliers

1. Thermo Fisher Scientific & Merck KGaA

   These multinational corporations are among the primary suppliers of reagents and solvents used in pharmaceutical synthesis. Their global reach ensures consistent quality and supply for chemical intermediates.

2. BASF and Dow Chemical

   Suppliers of bulk chemicals such as glycerol and aromatic solvents, both capable of meeting GMP-grade standards required for pharmaceutical production.

3. Specialized API Manufacturers

   For phenylbutyrate, certain contract manufacturing organizations (CMOs) and chemical intermediates firms produce active ingredients under strict quality agreements with Edison. These may include companies like Mundipharma or regional chemical producers specializing in specialty chemicals.

Contract Manufacturing Organizations (CMOs)

Given the complexity of producing glycerol phenylbutyrate, Edison relies on CMOs for large-scale manufacturing and scale-up processes:

• CoreCRO and Contract Manufacturers: These firms handle synthesis, purification, and packaging processes, often located in the US, Europe, or Asia, compliant with GMP standards.

• Partnerships and Licensing Agreements

Edison’s collaborations often include licensing arrangements with regional manufacturers to expand global supply, ensuring RAVICTI's availability worldwide, especially in emerging markets.

Distribution Channels

Once manufactured, RAVICTI is distributed through specialized pharmaceutical distribution networks:

• Edison Pharmaceuticals’ Distribution Partners

Edison maintains relationships with authorized distributors for global reach, focusing on healthcare providers managing UCD patients. Distribution is tightly controlled to prevent counterfeit, ensure cold-chain integrity where applicable, and comply with regulatory demands.

• Global Distribution Networks

Major pharmaceutical distributors such as McKesson, AmerisourceBergen, and Cardinal Health are likely partners in regions like North America and Europe, given their extensive logistics infrastructure.

Regulatory Considerations and Impact on Supply

The limited number of suppliers and manufacturing facilities heighten the risk of supply disruptions. Regulatory hurdles, such as FDA inspections or GMP compliance issues, can impact production continuity. Edison’s strategic partnerships and multiple sourcing agreements aim to mitigate such risks.

Market Dynamics and Supplier Concentration

Because RAVICTI is a niche drug for rare diseases, its manufacturing and supplier base is not extensive. Supplier concentration risks include:

• Single-source API supply from a limited number of chemical producers.
• Dependence on regional CMOs for manufacturing and packaging.
• Regulatory dependencies influencing manufacturing bottlenecks.

Edison is reportedly investing in expanding its supplier network and in-house manufacturing capabilities to reduce dependencies and improve supply resilience.

Conclusion

The supply chain of RAVICTI is tightly controlled, with Edison Pharmaceuticals at the core, relying on a network of chemical suppliers, CMOs, and distribution partners. The integration of global raw material suppliers, specialized manufacturing processes, and regulated distribution channels underscores the complexity underlying the production of this niche metabolic drug. As demand for RAVICTI grows, especially with increased recognition of urea cycle disorders, the resilience and diversification of its supplier base will be crucial to ensuring steady access for patients worldwide.

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Key Takeaways

• Edison Pharmaceuticals is the primary manufacturer of RAVICTI, managing the entire production pipeline from synthesis to distribution.
• The drug's production depends on a limited number of global suppliers of raw materials like glycerol and phenylbutyrate, accentuating supply chain risks.
• Contract manufacturing organizations (CMOs) play a vital role in scaling and maintaining GMP standards.
• Distribution channels are operated by major pharmaceutical logistics companies, emphasizing quality control, regulatory compliance, and cold-chain logistics.
• To mitigate supply risks, Edison is actively diversifying its supplier network and investing in manufacturing expansion.

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FAQs

1. Who are the main raw material suppliers for RAVICTI?
Major suppliers include global chemical companies such as Thermo Fisher Scientific, Merck KGaA, BASF, and Dow Chemical, providing reagents, solvents, and bulk chemicals like glycerol and phenylbutyrate.

2. Does Edison Pharmaceuticals manufacture RAVICTI globally?
Edison primarily manufactures RAVICTI in North America with partnerships worldwide. It collaborates with regional CMOs to expand global supply and adhere to regional regulatory requirements.

3. Are there risks associated with supplier concentration for RAVICTI?
Yes. The niche nature of RAVICTI means a limited number of API and raw material sources, which could lead to supply disruptions if any supplier encounters manufacturing or regulatory issues.

4. How does regulatory oversight affect RAVICTI’s supply chain?
Strict GMP and regulatory standards govern manufacturing, requiring continuous compliance. Inspections and certifications impact production schedules and supply continuity.

5. Is the supply chain for RAVICTI developing to meet future demand?
Edison is investing in expanding manufacturing capabilities and diversifying its supplier base to accommodate increasing demand and mitigate risks from supply chain disruptions.

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Sources
[1] Edison Pharmaceuticals. (2022). RAVICTI Product Details.
[2] U.S. Food and Drug Administration (FDA). (2018). RAVICTI NDA Approval Document.
[3] Market research reports on rare disease pharmaceuticals and supply chain dynamics.