Suppliers and packagers for CARBAGLU

CARBAGLU

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Recordati Rare	CARBAGLU	carglumic acid	TABLET, FOR SUSPENSION;ORAL	022562	NDA	Recordati Rare Diseases	52276-312-05	5 TABLET, FOR SUSPENSION in 1 BOTTLE (52276-312-05)	2010-03-18
Recordati Rare	CARBAGLU	carglumic acid	TABLET, FOR SUSPENSION;ORAL	022562	NDA	Recordati Rare Diseases	52276-312-60	60 TABLET, FOR SUSPENSION in 1 BOTTLE (52276-312-60)	2010-03-18

Suppliers for the Pharmaceutical Drug: Carbaglu (Carglumic Acid)

Last updated: August 3, 2025

Introduction

Carbaglu, the brand name for carglumic acid, is a prescription medication primarily used to treat hyperammonemia caused by N-acetylglutamate synthase (NAGS) deficiency, a rare genetic disorder. Approved by the FDA in 2010, Carbaglu plays a crucial role in managing life-threatening ammonia buildup, particularly in pediatric patients.

Given its niche application, Carbaglu’s supply chain involves specialized pharmaceutical manufacturers, authorized distributors, and regulatory pathways. This report provides a comprehensive overview of key suppliers, their roles, and the dynamics influencing its availability globally.

---

Manufacturers of Carbaglu

1. Recordati Rare Diseases

Recordati Rare Diseases is the sole manufacturer of Carbaglu. The company acquired the exclusive rights to produce and commercialize carglumic acid through licensing agreements, specifically in North America and other territories. Their focus on rare disease therapeutics positions them as the primary supplier.

• Production Facilities and Quality Standards:
  Recordati follows stringent Good Manufacturing Practices (GMP), adhering to international standards such as those mandated by the FDA and EMA, ensuring high-quality production.

• Regulatory Approvals:
  They hold the necessary approvals in several jurisdictions, including FDA approval in the United States, EMA approval in Europe, and approvals in other regions, which facilitate authorized distribution.

Implication: Since Recordati is the only listed manufacturer, the supply of Carbaglu is centralized, making the company the critical linchpin across the supply chain.

---

Distribution Channels and Authorized Distributors

2. Direct Distribution by Recordati

Recordati primarily supplies Carbaglu directly to healthcare providers and hospitals within approved regions, maintaining control over distribution to ensure product integrity and compliance with regulatory requirements.

3. Wholesale Distributors and Specialty Pharmacies

• Specialized Distributors:
  In regions outside direct distribution, authorized specialty pharmacies and licensed wholesalers act as secondary suppliers. They source directly from Recordati or regional regulatory authorities.

• Distribution Challenges:
  Given the rarity of NAGS deficiency, distribution networks are highly specialized, limiting the size and number of distributors to maintain product efficacy and security from diversion or falsification.

Key Distributors:
While specific names are confidential due to proprietary arrangements, key players include major global pharmaceutical distributors specializing in rare disease drugs, such as McKesson Specialty Health, AmerisourceBbergen, or Cardinal Health, depending on jurisdiction.

---

Regulatory and Supply Chain Factors

4. Regulatory Approvals and Market Access

Since Carbaglu is indicated for a rare genetic disorder, its market revolves around highly regulated and specialized channels. Regulatory bodies such as the FDA, EMA, and other regional authorities require strict adherence to manufacturing, distribution, and post-market surveillance.

5. Manufacturing Scale and Supply Constraints

• Limited Production Capacity:
  The specialized nature of carglumic acid limits manufacturing scale, which can pose challenges during increased demand or supply disruptions.

• Supply Chain Risks:
  Issues such as raw material shortages, manufacturing delays, or regulatory hurdles can impact availability. For instance, global crises or supply chain disruptions have historically affected the supply of rare disease treatments.

---

Global Availability and Regional Suppliers

6. United States

In the U.S., the FDA-approved supplier is Recordati. Distribution occurs via authorized specialty pharmacies and hospital procurement networks.

7. Europe and Other Markets

In the European Union, the European Medicines Agency (EMA) grants marketing authorization, with Recordati managing distribution under the centralized procedure. Other regions may rely on local licensing agreements or approved importers.

8. Emerging Markets

In countries with limited regulatory development for rare diseases, Carbaglu availability hinges on importation licenses or compassionate use programs, often involving regional distributors or directly through Recordati if authorized.

---

Market Dynamics and Future Supply Considerations

• Research and Development:
  Increased research may lead to alternative treatments, potentially impacting demand for Carbaglu. However, as a first-line therapy for NAGS deficiency, its exclusive role sustains demand.

• Generic Variants:
  Currently, no generic carglumic acid exists, given patent protections and high regulatory barriers for approval, reinforcing Recordati’s monopoly.

• Supply Security Measures:
  To ensure steady supply, stakeholders emphasize inventory management, contingency planning, and regulatory coordination.

---

Conclusion

Recordati Rare Diseases stands as the sole producer and primary supplier of Carbaglu globally. Distribution relies on a tightly controlled network of specialty pharmacies, authorized wholesalers, and regional distributors. Given the rarity and specialized nature of carglumic acid, supply chain stability is contingent upon manufacturing capacity, regulatory compliance, and effective logistics management.

---

Key Takeaways

• Exclusive Manufacturer: Recordati Rare Diseases is the exclusive producer of Carbaglu, controlling the supply chain entirely.

• Specialized Distribution: Distribution channels are limited to authorized specialty pharmacies and regional distributors, ensuring product integrity.

• Supply Challenges: Manufacturing scale and raw material procurement are critical to maintaining consistent availability, especially in response to demand fluctuations.

• Regulatory Impact: Market access and distribution are heavily regulated, varying across regions with different approval statuses.

• Future Outlook: No current generic alternatives exist, but supply resilience remains a priority amid the potential for increased demand or manufacturing disruptions.

---

FAQs

1. Who is the primary manufacturer of Carbaglu?
Recordati Rare Diseases holds exclusive rights to manufacture and distribute Carbaglu worldwide, maintaining full control over production.

2. Are there generic versions of carglumic acid available?
No. As of now, there are no generic equivalents; the drug remains under patent protection and exclusive licensing.

3. How is Carbaglu distributed in the United States?
Distribution is through authorized specialty pharmacies and hospitals, with Recordati coordinating directly or via licensed distributors.

4. What supply risks exist for Carbaglu?
Limited manufacturing capacity, raw material shortages, and regulatory delays are potential risks that can impact supply, especially given the drug's niche market.

5. Can Carbaglu be readily accessed in emerging markets?
Access depends on regional regulatory approvals and importation policies. In many emerging markets, availability may be limited or reliant on import licenses.

---

References

1. FDA Drug Label for Carbaglu
2. EMA European Public Assessment Report (EPAR) for Carbaglu
3. Recordati Rare Diseases Corporate Website.
4. Clinical case studies and prescribing information as per healthcare guidelines.