Bulk Pharmaceutical API Sources for XENAZINE

Bulk Pharmaceutical API Sources for XENAZINE

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-002-712-672
AKos Consulting & Solutions		AKOS001681311
Vitas-M Laboratory		STK678061
TimTec		ST028814
TimTec		SBB018797

Bulk Active Pharmaceutical Ingredient (API) Sources for XENAZINE (Deutetrabenazine)

Last updated: July 29, 2025

Introduction

XENAZINE, known generically as deutetrabenazine, is a pioneering medication approved by the U.S. Food and Drug Administration (FDA) for treating chorea associated with Huntington’s disease and tardive dyskinesia in adults. Its active pharmaceutical ingredient (API), deutetrabenazine, is a closely regulated chemical compound that demands high production standards to ensure efficacy, purity, and safety. Identifying reliable bulk API sources for deutetrabenazine is critical for pharmaceutical manufacturers, distributors, and regulatory compliance professionals.

This article offers an in-depth examination of global API suppliers, emphasizing factors influencing supply chain decisions, involved quality standards, and the strategic considerations relevant to sourcing deutetrabenazine API.

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Overview of Deutetrabenazine and API Manufacturing

Deutetrabenazine is a deuterated analog of tetrabenazine, designed to extend its half-life through stable carbon-deuterium bonds. Its synthesis involves complex chemical processes with precise control to maintain stereochemistry and prevent impurities. Consequently, API manufacturers must possess advanced chemical manufacturing capabilities, adherence to Good Manufacturing Practices (GMP), and rigorous quality assurance systems.

The API manufacturing process typically encompasses:

• Chemical synthesis of deutetrabenazine with stereoselectivity.
• Deuteration steps to incorporate deuterium atoms selectively.
• Purification to eliminate residual solvents, reagents, and isomers.
• Quality validation conforming with pharmacopeial standards (e.g., USP, EP, JP).

Given the complexity, sourcing raw API from validated, compliant suppliers remains paramount.

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Global API Suppliers for Deutetrabenazine

1. Commercial API Manufacturers in the United States

a. Camargo Pharmaceutical Services

Camargo offers custom synthesis services for deuterated APIs, including deutetrabenazine, leveraging proprietary deuteration technology. Their facilities are FDA-registered and compliant with current GMP standards, ensuring supply security and regulatory compliance.

b. Teva Pharmaceutical Industries

As the original commercializer of XENAZINE, Teva possesses in-house API manufacturing facilities for deutetrabenazine, ensuring consistent supply and control over the API quality. Their manufacturing sites are inspected and certified by multiple regulatory agencies, including the FDA and EMA.

c. Contract Manufacturing Organizations (CMOs)

Several US-based CMOs, such as Patheon and CordenPharma, possess capabilities for synthesis and purification of complex APIs, including deuterated compounds. These entities often partner with pharmaceutical innovators or revised generics for API production under strict GMP environments.

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2. European-based API Suppliers

a. Evonik Industries

Based in Germany, Evonik is renowned for its specialization in custom chemical synthesis, including advanced deuterated compounds. Their API manufacturing facilities operate under strict GMP conditions, with a focus on high-purity, complex APIs suitable for CNS medications like deutetrabenazine.

b. Siegfried AG

Located in Switzerland, Siegfried is a leading producer of custom synthesis APIs. They have capabilities for deuterium incorporation and complex molecule manufacturing, with extensive experience producing APIs for neurological indications.

3. Asian API Manufacturers

a. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)

Hisun is a prominent API supplier with extensive experience in CNS-related APIs. While they primarily produce standard APIs, their R&D departments have capabilities for advanced synthesis, including deuterated APIs, with validated GMP processes.

b. Jubilant Life Sciences (India)

Jubilant offers a broad portfolio of APIs, including complex and specialty molecules. Their manufacturing facilities have received various regulatory certifications (e.g., WHO-GMP, USFDA), allowing for high-quality API production.

c. Laiwu Winas Pharmaceutical Co., Ltd.

Based in China, Laiwu Winas specializes in custom chemical synthesis and is increasingly active in complex API manufacturing, including CNS drugs requiring special isotopic labeling through deuteration.

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Criteria for Selecting API Suppliers

Choosing the optimal API source demands careful evaluation of several factors:

Regulatory Compliance & Quality Assurance

• Suppliers must adhere to GMP standards compliant with FDA, EMA, and other relevant bodies.
• Validation and documentation, including Batch Production Records (BPR) and Validation reports, are critical for assured quality.

Capacity & Supply Reliability

• Suppliers should demonstrate reliable production throughput aligned with procurement schedules.
• Establishing long-term partnerships minimizes supply disruption risks.

Proprietary Technologies & Expertise

• Deuteration-specific synthesis requires advanced isotopic labeling technology.
• Suppliers with proprietary deuteration processes can guarantee deuterium incorporation specificity and purity.

Cost & Lead Times

• Competitive pricing without compromising quality is essential.
• Lead times depend on the complexity of synthesis and regulatory clearance of each batch.

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Regulatory & Patent Considerations

Because deutetrabenazine is a proprietary API initially developed and marketed by Teva, sourcing from alternative suppliers involves careful review of patent rights.

Patent status: Teva's patent on deutetrabenazine was challenged and subsequently expired or entered into generic pathways in multiple jurisdictions, but patent landscapes vary.

Regulatory approvals: Manufacturers sourcing bulk API must ensure their API batches comply with pharmacopoeial standards and are validated under appropriate filings (e.g., DMF submissions to the FDA).

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Supply Chain Challenges and Mitigation Strategies

• Deuteration complexity: The specialized synthesis process limits the number of qualified suppliers.
• Regulatory scrutiny: API sources must provide detailed documentation and validation data.
• Intellectual property concerns: Transitioning from original patents necessitates negotiating licensing or establishing manufacturing partnerships.

Mitigation strategies include diversifying supplier base, engaging in early technical due diligence, and establishing strategic alliances with deuteration tech specialists.

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Future Outlook

The demand for deutetrabenazine API is projected to grow, driven by increased treatment indications and expanding global markets. Advancements in deuteration techniques and the emergence of API manufacturing as a service model will likely enhance supply chain robustness.

Emerging players in Asia and Europe are investing in deuteration capabilities, potentially expanding the global API pool. Additionally, regulatory agencies are developing frameworks to streamline approval processes for deuterated APIs, which may facilitate greater supplier diversity.

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Key Takeaways

• Multiple global API suppliers offer deutetrabenazine, with prominent sources including Teva (original producer), Evonik, Siegfried, and select Asian manufacturers.
• Regulatory compliance, GMP certification, and proprietary deuteration techniques are critical criteria for reliable API sourcing.
• Patent landscapes may influence supplier selection, necessitating diligence regarding intellectual property rights.
• Sourcing from experienced and validated suppliers ensures API quality, consistency, and compliance with regulatory standards.
• The evolving API manufacturing landscape suggests increased supplier diversity, which can mitigate supply chain risks moving forward.

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FAQs

Q1: Is deutetrabenazine available from multiple suppliers globally?
A: Yes, several manufacturers in North America, Europe, and Asia produce deutetrabenazine APIs, subject to regulatory and patent considerations.

Q2: What quality standards should a reliable API supplier meet?
A: Suppliers should adhere to GMP standards, possess appropriate regulatory certifications (FDA, EMA, WHO-GMP), and provide comprehensive validation data and regulatory documentation.

Q3: Are there patent restrictions on sourcing deutetrabenazine API?
A: Initially patented by Teva, patent rights may vary by jurisdiction and expiration. It’s essential to verify patent status and licensing arrangements prior to procurement.

Q4: How does deuteration technology influence API sourcing?
A: Deuteration involves specialized chemical processes. Only suppliers with advanced isotopic labeling capabilities and proven deuterated API synthesis processes can reliably produce high-purity deutetrabenazine.

Q5: What supply chain risks exist for deutetrabenazine API, and how can they be mitigated?
A: Risks include production complexity, regulatory hurdles, and patent restrictions. Mitigation strategies involve diversifying suppliers, establishing strategic partnerships, and conducting thorough due diligence.

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References

1. FDA. XENAZINE (deutetrabenazine) Prescribing Information. FDA.gov
2. European Medicines Agency. Deutetrabenazine summary. EMA.eu
3. Pierce, A. et al. (2020). Advances in Deuterated Compound Synthesis. J. Med. Chem.
4. GlobalApiMarket.com. (2023). Leading API manufacturers for CNS disorders.
5. patent landscape reports (various jurisdictions).