Suppliers and packagers for pheburane

pheburane

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Medunik	PHEBURANE	sodium phenylbutyrate	PELLETS;ORAL	216513	NDA	Medunik USA	71770-200-10	1 KIT in 1 CARTON (71770-200-10) * 174 g in 1 BOTTLE (71770-210-10)	2022-08-26
Medunik	PHEBURANE	sodium phenylbutyrate	PELLETS;ORAL	216513	NDA	Medunik USA	71770-210-10	174 g in 1 BOTTLE (71770-210-10)	2022-09-14

Suppliers for the Pharmaceutical Drug: PHEBURANE (sodium phenylbutyrate)

Last updated: July 29, 2025

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Introduction

PHEBURANE (sodium phenylbutyrate) is an FDA-approved medication used primarily to treat urea cycle disorders (UCD), a group of rare genetic conditions characterized by an inability to properly eliminate ammonia from the bloodstream. As a critical treatment, PHEBURANE's supply chain involves specialized producers adhering to strict regulatory compliance to meet global demand. Understanding the key suppliers, their roles, and market dynamics is essential for stakeholders involved in procurement, manufacturing, and distribution.

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Manufacturers of PHEBURANE

1. Chiesi Farmaceutici S.p.A.

Chiesi Farmaceutici, an Italian biopharmaceutical company, is the original developer and authorized manufacturer of PHEBURANE. The company holds the rights to produce the drug, focusing on innovative therapies for rare diseases, including UCD. Chiesi's global manufacturing facilities strictly adhere to Good Manufacturing Practices (GMP) to ensure drug quality and compliance with regulatory standards.

• Market Role: Chiesi serves as the primary supplier to End Users, healthcare providers, and distributors worldwide.
• Manufacturing Capacity: Chiesi has invested significantly in production capacity, including state-of-the-art facilities in Italy and the United States, ensuring supply stability.

2. Contract Manufacturing Organizations (CMOs)

While Chiesi predominantly manufactures PHEBURANE, contract manufacturing organizations (CMOs) may be engaged for specific components or secondary packaging processes, especially to meet regional demand surges.

• Examples: CMOs such as Thermo Fisher Scientific and Catalent have experience in biologics and specialty drug manufacturing, though explicit links to PHEBURANE are limited.
• Role: These organizations ensure scaling production, maintaining supply chain flexibility, and meeting regional regulatory requirements.

3. Suppliers of Raw Materials

The active pharmaceutical ingredient (API), sodium phenylbutyrate, is sourced from specialized chemical suppliers capable of producing pharmaceutical-grade compounds.

• API Producers: A handful of global chemical manufacturers dominate API production for niche pharmaceuticals:

  • BASF (Germany): Known for producing high-purity chemicals, including pharmaceutical intermediates.
  • Jubilant Life Sciences (India): Engaged in custom synthesis and bulk chemical manufacturing, including APIs.
  • Hovione (Portugal): Specializes in complex chemical synthesis and API manufacturing.

• These suppliers undergo rigorous screening and certification processes to comply with GMP, ASTM standards, and regional regulatory requirements.

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Regional Distributors and Supply Channels

1. Global Distributors and Wholesalers

Once manufactured, PHEBURANE's distribution is handled via licensed pharmaceutical wholesalers, ensuring the drug’s availability across regions.

• Major Distributors:
  • McKesson Corporation
  • Cardinal Health
  • AmerisourceBergen

These organizations operate extensive logistics networks, enabling timely delivery to hospitals, clinics, and specialty pharmacies worldwide.

2. Regional Supply Chain Dynamics

• In the US, PHEBURANE is often supplied via specialty pharmacy networks that focus on rare disease treatments.
• European supply channels involve distribution via regional health authorities and specialty pharmacies aligned with regulatory bodies like the EMA.

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Supply Chain Challenges and Market Dynamics

1. Manufacturing Scale-Up Limitations

Given the monopolistic position of Chiesi, supply constraints occasionally occur, especially during global health crises like the COVID-19 pandemic when raw material shortages and logistical delays impact production scalability.

2. Regulatory and Quality Standards

Suppliers must meet stringent GMP and regional regulatory standards, which can limit the number of qualified raw material vendors and manufacturers. As a result, the supply chain is highly concentrated.

3. Geopolitical Factors

Trade policies, tariffs, and import/export restrictions influence raw material sourcing and distribution logistics, further affecting supplier stability.

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Key Suppliers Summary

Supplier Category	Notable Entities	Role	Regional Presence
Original Manufacturer	Chiesi Farmaceutici S.p.A.	Drug manufacturing	Global (Italy, US, Europe, Asia)
API Suppliers	BASF, Jubilant Life Sciences, Hovione	Raw material supply	Europe, India, Portugal
Contract Manufacturers & Secondary Processors	Thermo Fisher Scientific, Catalent	Scaling and packaging	Global
Distributors	McKesson, Cardinal Health, AmerisourceBergen	Distribution to healthcare providers	North America, Europe, Asia

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Conclusion

PHEBURANE's supply chain is characterized by a high degree of reliance on a limited number of suppliers, predominantly originating from Chiesi Farmaceutici and select chemical manufacturers. Raw material sourcing is concentrated among globally recognized chemical producers such as BASF, Jubilant, and Hovione, due to quality and regulatory demands. The efficacy and continuity of the drug's supply depend heavily on the robustness of these supplier relationships, the agility of contract manufacturing, and the resilience of distribution networks amid geopolitical and logistical challenges.

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Key Takeaways

• Chiesi Farmaceutici remains the primary manufacturer of PHEBURANE, ensuring quality and regulatory compliance.
• Raw material procurement from top-tier chemical suppliers like BASF and Jubilant is critical for production stability.
• Contract manufacturing and secondary packaging providers support capacity expansion and regional supply needs.
• Global distribution networks enable delivery, but supply constraints can arise from raw material shortages, regulatory hurdles, or geopolitical issues.
• Stakeholders should monitor supplier partnerships, raw material markets, and logistical developments to mitigate supply risks.

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FAQs

1. Who are the primary manufacturers of PHEBURANE?
Chiesi Farmaceutici S.p.A. is the primary manufacturer, responsible for global production and distribution, adhering to strict GMP standards.

2. Where does the active pharmaceutical ingredient (API) for PHEBURANE originate?
Major API suppliers include BASF (Germany), Jubilant Life Sciences (India), and Hovione (Portugal), supplying high-purity sodium phenylbutyrate conforming to pharmaceutical standards.

3. Are there alternative suppliers for PHEBURANE?
Currently, the supply chain is concentrated, with limited alternative suppliers due to regulatory, quality, and manufacturing complexity requirements. However, regional contract manufacturers and distributors can provide flexibility.

4. What are the main challenges in PHEBURANE’s supply chain?
Supply constraints can stem from raw material shortages, manufacturing capacity limitations, and geopolitical or logistical disruptions.

5. How is PHEBURANE’s raw material quality ensured?
Manufacturers and raw material suppliers adhere to GMP, ISO standards, and undergo rigorous quality assurance processes, including supplier audits and batch testing.

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Sources

[1] Chiesi Farmaceutici Official Website. "PHEBURANE - Drug details."
[2] U.S. Food and Drug Administration (FDA). "PHEBURANE (sodium phenylbutyrate) Approval Documentation."
[3] BASF Product Catalog. "Pharmaceutical-grade chemicals."
[4] Jubilant Life Sciences Annual Report. "API manufacturing capabilities."
[5] Hovione Corporate Website. "API Synthesis & Manufacturing."