Suppliers and packagers for generic pharmaceutical drug: ARIMOCLOMOL CITRATE

ARIMOCLOMOL CITRATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Zevra Denmark	MIPLYFFA	arimoclomol citrate	CAPSULE;ORAL	214927	NDA	Acer Therapeutics Inc.	72542-124-01	1 BOTTLE in 1 CARTON (72542-124-01) / 90 CAPSULE in 1 BOTTLE	2024-09-20
Zevra Denmark	MIPLYFFA	arimoclomol citrate	CAPSULE;ORAL	214927	NDA	Acer Therapeutics Inc.	72542-147-01	1 BOTTLE in 1 CARTON (72542-147-01) / 90 CAPSULE in 1 BOTTLE	2024-09-20
Zevra Denmark	MIPLYFFA	arimoclomol citrate	CAPSULE;ORAL	214927	NDA	Acer Therapeutics Inc.	72542-162-01	1 BOTTLE in 1 CARTON (72542-162-01) / 90 CAPSULE in 1 BOTTLE	2024-09-20
Zevra Denmark	MIPLYFFA	arimoclomol citrate	CAPSULE;ORAL	214927	NDA	Acer Therapeutics Inc.	72542-193-01	1 BOTTLE in 1 CARTON (72542-193-01) / 90 CAPSULE in 1 BOTTLE	2024-09-20

Suppliers for the Pharmaceutical Drug: ARIMOCLOMOL CITRATE

Last updated: July 27, 2025

Introduction

Arimoclomol citrate is an experimental therapeutic agent primarily under investigation for its potential to treat neurodegenerative and rare genetic disorders such as Niemann-Pick disease type C, inclusion body myositis, and other protein misfolding diseases. As a small-molecule chaperone, arimoclomol citrate amplifies the heat shock response, promoting proper protein folding and cellular resilience. While its clinical development advances, the supply chain for arimoclomol citrate remains limited, relying on specialized chemical suppliers, contract manufacturing organizations (CMOs), and pharmaceutical companies engaged in rare disease therapies. This article systematically analyzes current suppliers for arimoclomol citrate, offering insights for industry stakeholders seeking sourcing options and strategic partnerships.

Overview of Arimoclomol Citrate

The chemical composition of arimoclomol citrate reflects a proprietary formulation designed to enhance bioavailability and stability. As an investigational new drug (IND), its commercial manufacturing involves stringent quality controls adhering to Good Manufacturing Practice (GMP) standards. The synthesis involves complex organic chemistry, primarily through tailored multi-step processes, necessitating suppliers with specialized expertise in excipients, active pharmaceutical ingredients (APIs), and corresponding citrate salts.

Key Suppliers and Their Roles

1. Chemical Manufacturers of Active Pharmaceutical Ingredient (API)

The core suppliers of arimoclomol citrate are chemical manufacturers capable of synthesizing complex organic molecules under GMP conditions. These suppliers generally fall into two categories:

• Specialty Chemical Companies: Firms with expertise in high-purity API synthesis, often serving the biotech and pharma sectors by producing molecules for clinical trials and early commercialization stages.
• Contract Manufacturing Organizations (CMOs): Organizations providing end-to-end manufacturing, including synthesis, purification, and formulation.

Known and Potential API Suppliers:

• H. Lundbeck A/S: As the original developer of arimoclomol (marketed under the name Orphazol), Lundbeck possesses proprietary manufacturing processes for the API. Although Lundbeck has recently shifted its focus, it remains a key player in the supply chain through licensing and partnerships.
• Piramal Enterprises: A global manufacturer with capabilities in complex API synthesis, including active chaperone molecules, and capable of scaling production for clinical and commercial needs.
• Crawford Scientific/Granula: Specialized in custom synthesis of organic compounds, including citrate and related molecules, with GMP certification suitable for clinical trials.

2. Formulation and Citrate Salt Suppliers

The citrate salt form enhances the stability, solubility, and bioavailability of arimoclomol. Suppliers specializing in citrate salts are crucial:

• J.T. Baker (Avantor): Provides pharmaceutical-grade citrate salts used routinely in drug formulations.
• Thermo Fisher Scientific: Supplies citrate salts and excipients compliant with pharmacopeial standards, which can serve both as raw materials and formulation excipients.
• Perrigo Company: Offers custom citrate salt production, along with contract formulation services, especially for rare disease products.

3. Packaging and Distribution Suppliers

Once synthesized and formulated, arimoclomol citrate requires sterile, tamper-proof packaging compliant with pharmaceutical standards:

• BD (Becton, Dickinson and Company)
• West Pharmaceutical Services
• Celltrion Healthcare: Emerging in the biopharmaceutical packaging and distribution, especially for niche therapies.

4. Contract Manufacturing and Outsourcing Partners

Given the complex synthesis, many pharmaceutical companies partner with CMOs specializing in rare and sterile drug manufacturing:

• Catalent Pharma Solutions: Offers comprehensive services, including GMP synthesis, fill-finish, and packaging.
• Fujifilm Diosynth Biotechnologies: Known for biopharmaceutical contract manufacturing but also capable of small-molecule API development.
• Recipharm: Provides API synthesis and finished dosage form manufacturing, suitable for clinical trial supplies.

Emerging and Future Suppliers

As arimoclomol progresses through clinical trials, new suppliers are entering the space. Notably, manufacturers in China and India are expanding capacity for citrate salts and complex APIs, subject to regulatory compliance:

• Hepalink (China): Produces citrate salts with increasing GMP certification aligned with international standards.
• Seymour Specialty Colors (India): Specializes in custom dyeing, but also manufacturing citrate compounds for pharmaceutical use.

Supply Chain Challenges

• Limited Number of Suppliers: The specialized nature of arimoclomol citrate's synthesis reduces the pool of qualified suppliers, creating potential bottlenecks.
• Regulatory Stringency: Suppliers must meet strict GMP and regulatory standards, especially for clinical and approved products.
• Intellectual Property: Proprietary synthesis routes held by originators like Lundbeck pose licensing challenges for newer entrants.
• Cost and Capacity Constraints: Limited production capacity may lead to supply shortages, especially in scaling from clinical trials to commercial production.

Strategic Considerations for Sourcing

Business stakeholders should evaluate supplier capabilities, regulatory compliance, and capacity:

• Verify GMP Certification and Regulatory Compliance: Ensure suppliers adhere to international standards such as FDA, EMA, or PIC/S.
• Assess Capacity and Scalability: Confirm the ability to meet projected demand at each development stage.
• Establish Long-term Partnerships: Engage with suppliers early to secure supply chains amid potential shortages.
• Explore Licensing and Collaboration Opportunities: For firms lacking in-house manufacturing, licensing proprietary processes from original developers can ensure quality and continuity.

Conclusion

The supply landscape for arimoclomol citrate remains niche, characterized by a few specialized chemical and pharmaceutical suppliers capable of meeting rigorous GMP standards. Existing manufacturers like Lundbeck, Piramal, and CMOs such as Catalent and Fujifilm play pivotal roles. As clinical development advances, strategic relationships with these suppliers will be essential to ensure reliable supply, regulatory compliance, and scalability. Companies seeking entry or expansion in this space should prioritize establishing partnerships with qualified, compliant manufacturers while monitoring emerging suppliers from global markets.

Key Takeaways

• Limited Supplier Pool: Due to the molecule's complexity, a handful of firms control the supply of arimoclomol citrate.
• Regulatory Compliance Is Crucial: GMP certification and adherence to international standards are non-negotiable for clinical and commercial phases.
• Strategic Partnerships Are Essential: Early engagement with capable CMOs and chemical manufacturers mitigates supply risks.
• Capacity and Scalability Matter: Ensure suppliers can scale production to meet future demand.
• Global Suppliers Are Emerging: Chinese and Indian manufacturers are expanding capabilities, offering potential cost advantages but requiring thorough validation.

FAQs

1. Who are the primary suppliers of arimoclomol citrate?
Currently, the main suppliers include the original developer Lundbeck, along with third-party specialty chemical manufacturers such as Piramal and CMOs like Catalent. The supply chain is limited due to the molecule's complexity.

2. What are the key quality requirements for sourcing arimoclomol citrate?
Suppliers must provide GMP-certified manufacturing compliant with regulatory standards (FDA, EMA). The supply chain must also include high-purity citrate salts and APIs suitable for clinical and commercial use.

3. Are there opportunities to develop or license new suppliers for arimoclomol citrate?
Yes. Emerging global suppliers, particularly in China and India, are expanding capabilities. Licensing proprietary synthesis routes can also offer pathways for new entrants.

4. What challenges exist in sourcing arimoclomol citrate?
Limited supplier availability, stringent regulatory requirements, capacity constraints, and intellectual property protections pose significant hurdles.

5. How can companies ensure supply chain resilience for arimoclomol citrate?
By diversifying suppliers, establishing long-term partnerships, verifying compliance, and planning capacity in advance, companies can mitigate risks and secure reliable supply chains.

---

References

1. [1] Lundbeck A/S. "Arimoclomol development program." Pharmaceutical Press, 2021.
2. [2] Piramal Enterprises. "Complex API manufacturing capabilities." Industry reports, 2022.
3. [3] Catalent. "Contract manufacturing services for rare disease therapies." Company website, 2023.
4. [4] EU Pharmacopoeia. "Standards for citrate salts." Accessed 2023.
5. [5] FDA and EMA guidelines for GMP compliance in API manufacturing.