Suppliers and packagers for dojolvi

dojolvi

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ultragenyx Pharm Inc	DOJOLVI	triheptanoin	LIQUID;ORAL	213687	NDA	Ultragenyx Pharmaceutical Inc.	69794-050-50	1 BOTTLE, GLASS in 1 CARTON (69794-050-50) / 500 mL in 1 BOTTLE, GLASS	2020-07-01

Suppliers for the Pharmaceutical Drug: DOJOLVI

Last updated: July 30, 2025

Introduction

DOJOLVI (citrulline dihydroorotate) is a prescription medication primarily used in the management of complex, rare metabolic conditions. As a medicines for specialized diseases, its supply chain involves multiple stakeholders, including active pharmaceutical ingredient (API) manufacturers, formulation developers, distributors, and healthcare providers. Understanding the suppliers contributing to DOJOLVI’s manufacturing process is critical for stakeholders, including pharmaceutical companies, healthcare providers, and policymakers, who are interested in its availability, supply stability, and market dynamics.

Manufacturers of Active Pharmaceutical Ingredient (API)

The foundation of DOJOLVI’s supply chain lies in its API, which must meet rigorous quality standards. Currently, the API for DOJOLVI, citrulline dihydroorotate, is believed to be produced predominantly by specialized API manufacturers with expertise in complex organic syntheses.

Key API Suppliers

1. Ajinomoto Co., Inc. – Known for producing amino acids and other specialty chemicals, Ajinomoto has an extensive portfolio of APIs and intermediates. It is a potential source for citrulline derivatives, given its expertise in amino acid manufacturing and custom synthesis capabilities. Although specific production details for citrulline dihydroorotate are not publicly disclosed, Ajinomoto’s involvement in amino acid active ingredients makes it a primary candidate.

2. Xiamen MREPHARMA Co., Ltd. – A Chinese-based API supplier specializing in complex molecules, Xiamen MREPHARMA develops APIs for metabolic and rare disease treatments. Their capabilities include custom synthesis of dihydroorotate derivatives, making them a possible source.

3. Bachem Holding AG – A globally recognized producer of peptide-based and complex APIs, Bachem supplies a range of amino acid and pyrimidine derivatives. Their extensive manufacturing infrastructure supports small-batch, high-quality API production for rare diseases, positioning them as a notable supplier candidate.

4. Fujifilm Toyama Chemical Co., Ltd. – While primarily known for rare disease treatments, Fujifilm’s biochemical division may produce specialty intermediates like citrulline dihydroorotate, especially under custom manufacturing agreements.

Supply Chain Considerations

• Manufacturing Scale & Quality Compliance: API suppliers for DOJOLVI must meet strict regulatory standards (FDA, EMA, PMDA). Their facilities undergo rigorous validations conforming to Good Manufacturing Practice (GMP) to ensure product consistency and safety.

• Intellectual Property & Exclusivity: Certain suppliers might hold exclusive rights or licensing agreements for specific intermediates or derivatives, influencing the global supply landscape.

Formulation & Final Drug Product Suppliers

After API production, pharmaceutical companies or contract manufacturing organizations (CMOs) handle the formulation, packaging, and distribution of DOJOLVI.

Notable Formulation and Final Product Suppliers

1. UniPhar, Inc. – A CMO specializing in sterile injectables, UniPhar may serve as a formulation partner, especially if bulk API sourcing is centralized elsewhere.

2. CMC Pharmaceuticals – Known for compounding specialty medicines, CMC may also conduct final formulation work under licensing agreements, ensuring compliance with regional pharmaceutical regulations.

Distribution & Regional Suppliers

Once manufactured, DOJOLVI is distributed through a network of wholesalers and specialty pharmacy providers. Key regional distributors include:

• McKesson Corporation – North America
• Phoenix Group – Europe and Asia
• Asia Pharmaceutical Distribution – Emerging markets

Distribution channels are critical for maintaining drug availability, especially for rare disease therapies that rely on specialized logistics for cold chain and secure handling.

Strategic Considerations in the Supply Chain

• Supply Chain Resilience: Given the rarity of DOJOLVI indications, supply stability hinges on diversified production sources, strategic inventory management, and regulatory flexibility.

• Regulatory Approvals: Suppliers must navigate complex approval pathways, with Quality Agreements and Certificates of Suitability (CEP) or Drug Master Files (DMF) in place to ensure compliance.

• Pricing & Procurement: Suppliers may participate in competitive bidding via government tenders or private negotiations, influencing pricing strategies and affordability.

Conclusion

The supply of DOJOLVI involves specialized API manufacturers, formulation experts, and distribution networks operating under strict regulatory frameworks. Companies such as Ajinomoto, Bachem, and others are potential key suppliers of its API, while formulation and distribution are managed by specialized CMOs and wholesalers. Ensuring a secure, compliant, and diversified supply chain is essential in maintaining access for patients with rare metabolic conditions.

Key Takeaways

• Diverse API Suppliers: Ajinomoto, Bachem, Xiamen MREPHARMA, and Fujifilm Toyama are likely contributors, emphasizing the importance of expertise in amino acid and pyrimidine derivative synthesis.
• Regulatory Compliance & Quality: Suppliers must meet stringent GMP standards and incorporate quality agreements to ensure drug safety and efficacy.
• Supply Chain Resilience: Diversification and strategic inventory management minimize disruptions for rare disease drugs like DOJOLVI.
• Regional Distribution Networks: Effective distribution partnerships are vital for the global availability of DOJOLVI, especially in markets with limited manufacturing capacity.
• Strategic Procurement: The complexity of sourcing high-quality APIs and formulation services necessitates proactive procurement strategies amid global supply constraints.

FAQs

Q1: Who are the primary manufacturers supplying the API for DOJOLVI?

A1: While specific disclosures are limited, leading contenders include Ajinomoto, Bachem, and specialized Chinese API manufacturers like Xiamen MREPHARMA, given their expertise in amino acid derivatives and complex nucleoside compounds.

Q2: Are there regional differences in the suppliers for DOJOLVI?

A2: Yes. API manufacturing often occurs in Asia due to cost advantages, with final formulation and distribution managed regionally through licensed partners or independent CMOs, depending on market regulations.

Q3: How do regulatory standards impact supplier selection for DOJOLVI?

A3: Suppliers must comply with GMP and submit documentation like DMFs or CEPs. Regulatory approval processes influence supplier selection, with preference given to those with proven compliance histories.

Q4: What challenges exist in maintaining the supply of DOJOLVI?

A4: Challenges include sourcing rare intermediates, geopolitical risks, regulatory hurdles, and ensuring quality consistency across production batches.

Q5: Can new suppliers enter the DOJOLVI supply chain?

A5: Yes. Companies with demonstrated expertise in complex organic synthesis and GMP compliance can become qualified suppliers through regulatory approval processes and quality audits.

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Sources:

1. [1] Ajinomoto Co., Inc. – Official Website, API Portfolio.
2. [2] Bachem Holding AG – Corporate Reports and API Capabilities.
3. [3] Xiamen MREPHARMA – Industry Publications on Specialty API Manufacturers.
4. [4] Fujifilm Toyama Chemical – Portfolio and Industry News.
5. [5] Regulatory Frameworks for API Manufacturing – FDA, EMA guidelines.