Suppliers and packagers for austedo

austedo

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Teva Branded Pharm	AUSTEDO	deutetrabenazine	TABLET;ORAL	208082	NDA	Teva Neuroscience, Inc.	68546-170-60	60 TABLET, COATED in 1 BOTTLE (68546-170-60)	2017-04-12
Teva Branded Pharm	AUSTEDO	deutetrabenazine	TABLET;ORAL	208082	NDA	Teva Neuroscience, Inc.	68546-171-60	60 TABLET, COATED in 1 BOTTLE (68546-171-60)	2017-04-12
Teva Branded Pharm	AUSTEDO	deutetrabenazine	TABLET;ORAL	208082	NDA	Teva Neuroscience, Inc.	68546-172-60	60 TABLET, COATED in 1 BOTTLE (68546-172-60)	2017-04-12

Suppliers for the Pharmaceutical Drug Austedo (Deutetrabenazine)

Last updated: July 27, 2025

Introduction

Austedo (deutetrabenazine) is a prescription medication primarily indicated for the treatment of chorea associated with Huntington’s disease and tardive dyskinesia in adults. Developed by Teva Pharmaceuticals, Austedo belongs to a class of drugs known as VMAT2 (vesicular monoamine transporter 2) inhibitors. Given its complex synthesis, sourcing high-quality API (Active Pharmaceutical Ingredient) and ancillary materials is vital for ensuring global supply stability. This report provides a comprehensive overview of the primary suppliers involved in the manufacturing of Austedo, focusing on the API, formulation components, and distribution channels, with an emphasis on supply chain resilience and regulatory considerations.

API Suppliers for Austedo

1. Teva Pharmaceuticals – Manufacturer and Distributor

Teva Pharmaceuticals is the originator of Austedo. The company controls the entire drug lifecycle, from API synthesis to marketing. While Teva's in-house manufacturing facilities produce the API, they often collaborate with third-party suppliers to diversify sourcing and mitigate supply risks.

2. Third-Party API Suppliers

Teva’s strategic approach involves sourcing APIs from reputable third-party manufacturers, often located in regions with established pharmaceutical manufacturing expertise, such as India, China, and Europe.

• Indian API Manufacturers: India hosts a large, consolidated API manufacturing industry led by companies such as Laurus Labs, Hetero Labs, and Sun Pharmaceutical Industries. These companies supply bulk API intermediates or finished formulations, subject to strict cGMP compliance and regulatory approvals.

• Chinese API Suppliers: China remains a significant supplier of pharmaceutical intermediates and APIs, with manufacturers like Zhejiang Huangyan Heaven Pharmaceutical, Hubei Wufeng Pharmaceutical, and others providing raw materials due to cost competitiveness and manufacturing capacity.

Regulatory considerations: Teva and its partners ensure that all suppliers comply with international standards, including Good Manufacturing Practice (GMP) and USFDA, EMA, or other relevant authorities' regulations, to maintain product quality and regulatory approvals.

3. API Synthesis and Quality Control

Deutetrabenazine’s synthesis involves multiple chemical steps, including the asymmetric synthesis of the deuterated molecule, which requires specialized catalysts and processes. Suppliers with expertise in deuterium chemistry and high-purity intermediates are critical; only select manufacturers possess the capabilities to meet these stringent requirements.

Formulation and Excipients Suppliers

Aside from the API, Austedo’s formulation process involves excipients to ensure stability, bioavailability, and patient tolerability.

1. Excipients Suppliers

Major excipients used in Austedo capsules include diluents, disintegrants, lubricants, and coatings.

• Global excipient suppliers: Companies like Evonik, FMC, and BASF supply pharmaceutical-grade excipients, often under strict quality agreements to ensure consistency and compliance.

2. Packaging Materials

Pharmaceutical packaging suppliers such as Corning or Schott provide blister packs, bottles, and foil seals that meet regulatory standards for moisture and light barrier properties essential for maintaining drug stability.

Distribution and Logistics

1. Global Logistics Providers

The distribution of Austedo involves a complex logistics network employing major pharmaceutical logistics firms like DHL Life Sciences, FedEx Pharmaceutical Services, and UPS Healthcare. These providers specialize in temperature-controlled, secure shipments to meet regulatory storage standards across international borders.

2. Regulatory and Customs Clearance

Coordinate with regional regulatory agencies such as the US FDA, EMA, and other local authorities, ensuring compliance with import/export controls, especially in markets with stringent drug import regulations.

Supply Chain Resilience and Risks

• Geopolitical Risks: Dependency on API suppliers from India and China introduces geopolitical risks, including export controls and trade restrictions, emphasizing the importance of diversified supplier bases.

• Quality Assurance: Maintaining high-quality standards is critical given the complexity of deutetrabenazine synthesis; failures can lead to shortages or regulatory action.

• Manufacturing Capacity: Capacity constraints at third-party API manufacturers might impact supply; thus, strategic stockpiling and multi-supplier agreements are advisable.

Regulatory and Patent Landscape

While Austedo’s patent protections have evolved, generic versions of deutetrabenazine are subject to regulatory approval based on bioequivalence and manufacturing quality. Manufacturer compliance with evolving regulatory standards is mandatory for maintaining supply authorization and market access.

Conclusion

The supply chain for Austedo involves multiple pivotal elements, from complex API manufacturing—primarily sourced from certified suppliers in India and China—to high-quality excipients and global logistics networks. Ensuring supply chain resilience requires diversification, rigorous quality control, and proactive regulatory engagement. As demand for this neurological treatment expands, establishing strategic partnerships with reliable suppliers and investing in supply chain transparency will be paramount for sustaining consistent market availability.

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Key Takeaways

• Austedo relies heavily on specialized API suppliers with expertise in deuterium chemistry, primarily from India and China.
• Ensuring compliance with GMP and international regulatory standards is fundamental for both API and excipient suppliers.
• Diversification of supply sources and strategic inventory management reduce risks related to geopolitical disruptions and capacity constraints.
• Effective logistics and customs clearance are vital for maintaining a steady supply chain, especially across regulated markets.
• Continuous monitoring of regulatory developments and patent landscapes is necessary to adapt sourcing strategies accordingly.

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FAQs

1. Who are the primary API suppliers for Austedo?
   Teva Pharmaceuticals sources the API from various qualified third-party manufacturers, mainly in India and China, with strict adherence to GMP standards.

2. Is the API synthesis for deutetrabenazine complex?
   Yes, it involves specialized processes, including asymmetric synthesis and deuterium incorporation, requiring advanced chemical expertise.

3. Are there risks associated with depending on Chinese and Indian suppliers?
   Yes, geopolitical factors, trade restrictions, and capacity limitations pose risks. Diversification and quality oversight mitigate these risks.

4. How does regulatory compliance affect supply stability?
   Regulatory compliance ensures continuous approval for manufacturing facilities and prevents disruptions due to non-compliance or quality issues.

5. What role do logistics companies play in Austedo’s supply chain?
   They facilitate secure, temperature-controlled transportation and timely delivery across global markets, essential for maintaining drug integrity and availability.

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References

[1] Teva Pharmaceuticals. Austedo (deutetrabenazine) prescribing information.
[2] IQVIA. Global API manufacturing industry overview.
[3] USFDA. Guidance documents on API manufacturing and quality standards.
[4] Industry reports on deuterium chemistry and specialized API synthesis.