Suppliers and packagers for SYMBYAX

SYMBYAX

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Lilly	SYMBYAX	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	021520	NDA	Eli Lilly and Company	0002-3230-30	30 CAPSULE in 1 BOTTLE (0002-3230-30)	2007-04-09
Lilly	SYMBYAX	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	021520	NDA	Eli Lilly and Company	0002-3231-30	30 CAPSULE in 1 BOTTLE (0002-3231-30)	2003-12-24

Last updated: August 1, 2025

ppliers for the Pharmaceutical Drug: SYMBYAX

Introduction

SYMBYAX is a prescription medication primarily used for the treatment of major depressive disorder (MDD). It combines two active ingredients: bupropion hydrochloride and escitalopram oxalate. As a complex combination drug, SYMBYAX’s manufacturing and distribution rely heavily on a network of specialized suppliers, including active pharmaceutical ingredient (API) manufacturers, excipients suppliers, formulation contractors, and packaging entities. Understanding its supply chain is crucial for stakeholders seeking to assess supply stability, risk management, and procurement strategies.

Active Pharmaceutical Ingredient (API) Suppliers

The foundation of SYMBYAX’s supply chain is its APIs—bupropion hydrochloride and escitalopram oxalate. These APIs are produced by global pharmaceutical manufacturers specializing in complex chemical synthesis and compliance with Good Manufacturing Practice (GMP) standards.

Bupropion Hydrochloride Suppliers:
Bupropion, an atypical antidepressant, has multiple API manufacturers worldwide. Major suppliers include:

• Mitsubishi Tanabe Pharma Corporation: Historically a primary producer of bupropion API, with production facilities in Japan and other locations, ensuring high-quality standards.
• Hetero Labs: An Indian pharmaceutical API manufacturer with extensive experience in producing antidepressant APIs, including bupropion.
• Torrent Pharmaceuticals: Another key Indian API producer with capacity for large-scale bupropion hydrochloride synthesis.

Escitalopram Oxalate Suppliers:
Escitalopram, a selective serotonin reuptake inhibitor (SSRI), is produced by specialized API manufacturers, notably:

• Lundbeck: As the original developer of escitalopram (marketed as Lexapro), Lundbeck supplies bulk APIs to multicenter pharmaceutical supply chains globally.
• Cipla: An Indian pharmaceutical company manufacturing generic escitalopram APIs in compliance with international GMP standards.
• Hetero Labs: Also supplies escitalopram APIs, leveraging their extensive R&D capabilities.

These suppliers rely on robust quality assurance systems, given the strict regulatory environments governing APIs.

Excipient and Formulation Suppliers

SYMBYAX’s formulation involves excipients such as fillers, disintegrants, binders, and coating agents, sourced from established excipients manufacturers. These include:

• Avient Corporation (formerly Clariant): Suppliers of pharmaceutical-grade excipients like microcrystalline cellulose and binders.
• Ashland Global Holdings Inc.: Providers of inert fillers and disintegrants used in tablet formulations.
• FMC Corporation: Supplies various excipients, including coatings and stabilizers, adhering to pharmacopeial standards.

The formulation process involves third-party contract manufacturing organizations (CMOs) with specialized expertise in fixed-dose combinations, including companies like Patheon, Catalent, and Lonza.

Contract Manufacturing and Packaging

Few pharmaceutical companies produce SYMBYAX in-house; instead, they outsource to CMOs with high-level expertise in stability, formulation, and packaging processes, ensuring compliance with regulatory standards. Notable contract manufacturers include:

• Catalent: Provides comprehensive manufacturing, blister packaging, and serialization services.
• Lonza: Offers formulation development, manufacturing, and quality control for complex medications.
• Patheon (a part of Thermo Fisher Scientific): Contracted for the bulk manufacturing of both APIs and finished dosage forms in multiple geographies.

Packaging suppliers ensure tamper-evident, compliant packaging, often sourcing from global suppliers like WestRock or Berry Global.

Distribution and Supply Chain Risks

Given the globalization of pharmaceutical supply chains, the sourcing of SYMBYAX involves navigating risks such as geopolitical instability, supply shortages, and regulatory variations. The complexity of sourcing high-purity APIs from multiple vendors underscores the importance of diversified supplier portfolios. Recently, the COVID-19 pandemic spotlighted vulnerabilities in API supply chains, prompting companies to diversify sourcing and establish safety stock levels.

Regulatory Compliance and Supplier Qualification

All suppliers involved in the SYMBYAX supply chain must comply with stringent regulations from agencies like the FDA, EMA, and other health authorities. Pre-qualification processes involve audits, quality audits, and validation of manufacturing processes to ensure compliance with GMP. Contract manufacturers and API suppliers often undergo rigorous qualification and continuous monitoring to mitigate risks of regulatory non-compliance.

Emerging Trends and Strategic Implications

In response to supply chain challenges, many pharmaceutical firms are investing in:

• Vertical Integration: Some manufacturers are acquiring or building internal API production capabilities, reducing dependency on external suppliers.
• Supply Chain Digitization: Implementing real-time supply chain monitoring and analytics to identify bottlenecks proactively.
• Regional Diversification: Establishing regional API production facilities in North America, Europe, and Asia to mitigate geopolitical and logistical risks.

Conclusion

The supply chain for SYMBYAX is characterized by a diversified network of API manufacturers, excipient suppliers, and contract manufacturers across multiple geographies. Ensuring supply continuity requires vigilant supplier qualification, regulatory compliance, and risk mitigation strategies that adapt to geopolitical and market evolutions. Stakeholders must maintain transparency and collaboration across the supply chain to sustain uninterrupted availability of this complex combination drug.

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Key Takeaways

• Diverse API sourcing from global leaders like Mitsubishi Tanabe (bupropion) and Lundbeck (escitalopram) underpins SYMBYAX's supply stability.
• Robust supplier qualification and GMP compliance are critical for managing regulatory and quality risks.
• CMO partnerships with companies such as Catalent and Lonza facilitate formulation, manufacturing, and packaging functions.
• Supply chain diversification and digital monitoring improve resilience against geopolitical, logistical, and production disruptions.
• Regulatory compliance remains paramount across all tiers of the supply chain to ensure drug safety and efficacy.

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FAQs

1. Who are the primary API suppliers for SYMBYAX?
Major API suppliers include Mitsubishi Tanabe Pharma (bupropion) and Lundbeck or Cipla (escitalopram), both adhering to GMP standards and with extensive global footprints.

2. How do manufacturers mitigate supply chain disruptions for SYMBYAX?
By diversifying supplier bases, investing in regional production, maintaining safety stocks, and leveraging advanced supply chain management systems.

3. Are there regional differences in SYMBYAX suppliers?
Yes. North American and European markets often source APIs from established global suppliers, while Indian companies like Cipla and Hetero cater heavily to emerging markets.

4. What role do contract manufacturing organizations play in SYMBYAX’s supply chain?
CMOs handle formulation, manufacturing, and packaging processes, providing flexibility, adherence to quality standards, and rapid scalability.

5. How does regulatory compliance impact SYMBYAX’s supply chain?
Strict adherence to GMP and regulatory authority inspections ensure product quality, safety, and consistent supply, influencing supplier qualification and ongoing audits.

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Sources:

1. [1] Lundbeck. (2022). Escitalopram API Manufacturing.
2. [2] Mitsubishi Tanabe Pharma. (2022). API Supply Chain Overview.
3. [3] Indian Pharmaceutical Industry Reports. (2021). API Production in India.
4. [4] U.S. FDA. (2022). GMP Guidelines for Active Pharmaceutical Ingredients.
5. [5] Contract Manufacturing Organizations Annual Reports. (2022).