Bulk Pharmaceutical API Sources for vortioxetine hydrobromide

Bulk Pharmaceutical API Sources for vortioxetine hydrobromide

Vendor	Vendor Homepage	Vendor Sku	API Url
Key Organics/BIONET		HG-0011
AbaChemScene		CS-1472
MedChemexpress MCE		HY-15414A

Bulk Active Pharmaceutical Ingredient (API) Sources for Vortioxetine Hydrobromide

Last updated: August 3, 2025

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Introduction

Vortioxetine hydrobromide, marketed primarily under brand names such as Trintellix and Brintellix, is a novel multimodal antidepressant approved by regulatory agencies like the U.S. Food and Drug Administration (FDA). Its therapeutic utility spans major depressive disorder (MDD), leveraging a complex mechanism involving serotonergic modulation. As global demand increases, reliable sourcing of high-quality bulk API—specifically vortioxetine hydrobromide—is critical for pharmaceutical manufacturers. This report evaluates key API suppliers, highlighting their capacities, compliance standards, and market positioning.

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Market Overview of Vortioxetine Hydrobromide API

Vortioxetine's complex chemical nature—an analytically demanding molecule synthesized via multi-step processes—limits the number of qualified suppliers capable of consistent high-quality production. Currently, the bulk of vortioxetine hydrobromide APIs are sourced from a select group of multinational pharmaceutical ingredient manufacturers, often integrated within larger contract manufacturing organizations (CMOs) specializing in serotonergic compounds or complex organic APIs.

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Key API Manufacturers and Research Suppliers

1. Syneos Health (formerly Patheon/Takeda)
Syneos, a prominent CMO with extensive experience in complex molecule synthesis, supplies vortioxetine API to several pharmaceutical firms after successful validation and strict adherence to Good Manufacturing Practices (GMP). The company's manufacturing facilities are certified compliant with international standards such as FDA 21 CFR Part 11, EU GMP, and ICH guidelines. Their capacity ensures bulk supply to large multinational clients, supported by robust quality assurance protocols.

2. WuXi AppTec
WuXi AppTec has established a reputation for comprehensive API manufacturing, including serotonergic and CNS-active compounds. Their process development and scale-up capabilities include multi-step synthesis of vortioxetine hydrobromide. The company emphasizes quality control with ISO-certified facilities, ensuring consistent APIs with high purity (>99%), critical for regulatory approval.

3. Aenova Group / Bachem AG
While traditionally focused on peptide and biotech APIs, Aenova Group and Bachem AG have expanded into small molecule APIs including vortioxetine, especially for niche or customized formulations. These providers maintain stringent quality standards and flexible production scales, suitable for both clinical trial material and commercial batches.

4. Hikal Limited
An India-based API manufacturer, Hikal offers a competitive alternative for vortioxetine hydrobromide API. The company emphasizes cost-effective solutions combined with compliance to regulatory standards, making it a preferred source for generic pharmacies and emerging markets. Their API manufacturing facilities are inspected regularly by global authorities.

5. Zhejiang Hisun Pharmaceutical
A leading Chinese API manufacturer, Hisun provides vortioxetine hydrobromide API to regional markets. Their facilities adhere to GMP guidelines and have been approved by the NMPA (formerly CFDA). Their supply capacity aligns with rising global demand, with quality parameters compliant with international standards suitable for export.

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Emerging API Developers and Research Suppliers

• EuroAPI (formerly part of Solvay) offers potential for future large-scale supply, driven by their expanding portfolio of CNS APIs.
• Siegfried AG specializes in complex chemical synthesis and could serve as an alternative source, especially in Europe.
• Contract Research Organizations (CROs) such as Pharmaron and Avance Biosciences, who possess in-house synthesis capabilities, are increasingly participating in small-batch API supply for clinical development.

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Regulatory and Quality Considerations

Selecting an API supplier mandates rigorous validation of their GMP compliance, impurity profile, and documentation transparency. Suppliers with root certifications (FDA, EMA, NMPA, or TGA compliance) and proven track records in CNS-active APIs provide competitive assurance. The chemical purity of vortioxetine hydrobromide should exceed 99%, with low residual solvents and controlled impurity levels, aligning with ICH Q3 guidelines.

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Supply Chain and Geographical Distribution

Most API suppliers are concentrated in North America, China, and India, offering diverse logistical advantages. North American and European suppliers typically provide higher regulatory assurance but at higher costs, whereas Asian manufacturers often deliver cost-effective solutions with expanding regulatory approvals.

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Conclusion

The global bulk sourcing landscape for vortioxetine hydrobromide API is characterized by a handful of established, GMP-compliant suppliers capable of delivering high-quality material. Top-tier providers like WuXi AppTec, Syneos Health, and Hikal stand out due to their validated manufacturing processes, capacity, and compliance standards. Emerging suppliers from China and India offer cost considerations and increasing reliability, contributing to a competitive API supply chain.

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Key Takeaways

• Prioritize GMP-certified suppliers with a proven track record in CNS API production for regulatory assurance.
• Assess supply capacity needs carefully, especially under increased market demand, to ensure consistent procurement.
• Evaluate impurity and purity parameters in line with regulatory standards, emphasizing high chemical purity and low residual solvents.
• Consider geographical advantages—cost, lead time, and regulatory oversight—when selecting suppliers.
• Engage in transparency and due diligence with potential partners, including site audits and review of quality documentation, to mitigate supply risks.

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FAQs

1. What are the main challenges in sourcing vortioxetine hydrobromide API?
The complex synthesis process limits the number of qualified manufacturers and adds challenges related to maintaining high purity, consistency, and regulatory compliance.

2. How do regulatory standards impact API sourcing decisions?
Suppliers must meet international GMP standards (FDA, EU, NMPA) to ensure APIs can be used safely in approved pharmaceutical products, influencing supplier eligibility.

3. Are there regional differences in API quality standards?
Yes. While North America and Europe often demand stricter oversight, Asian manufacturers are increasingly aligning with global standards but require thorough validation.

4. Can emerging market suppliers reliably provide vortioxetine API?
Emerging suppliers in India and China are improving compliance and quality control, making them viable options for cost-sensitive applications, provided rigorous qualification is conducted.

5. What role do Contract Manufacturing Organizations (CMOs) play in API sourcing?
CMOs like WuXi AppTec and Syneos can manufacture and supply vortioxetine API at scale, offering a blend of expertise, quality assurance, and regulatory compliance.

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References

1. FDA Drug Database. Vortioxetine (Trintellix) indication and approval details.
2. International Conference on Harmonisation (ICH) guidelines on impurities.
3. Official manufacturer websites and GMP certification listings.
4. Market reports on CNS API production and global supply chains.