Last updated: November 18, 2025
Introduction
REXULTI (brexpiprazole) is an atypical antipsychotic medication, primarily indicated for schizophrenia and as an adjunct therapy in major depressive disorder. Since its approval by the U.S. Food and Drug Administration (FDA) in 2015, REXULTI has become a critical therapeutic option, necessitating a reliable supply chain comprised of specialized raw material producers, active pharmaceutical ingredient (API) manufacturers, and finished drug formulation suppliers. This report provides an exhaustive analysis of the key suppliers involved in the REXULTI supply chain, highlighting their roles, geographic distribution, and strategic importance.
Manufacturers of Active Pharmaceutical Ingredient (API)
1. Otsuka Pharmaceutical Co. Ltd.
Otsuka Pharmaceutical, a Japanese company, developed brexpiprazole from its research and development programs. Otsuka continues to oversee the API synthesis, leveraging its extensive R&D and manufacturing infrastructure to ensure quality and compliance with regulatory standards. As the originator, Otsuka is both the primary API supplier and the intellectual property holder, granting it significant control over the supply chain for REXULTI.
2. Contract Manufacturing Organizations (CMOs)**
Given the high costs of API synthesis and the global demand for REXULTI, Otsuka partners with several CMOs to diversify supply sources and mitigate risk.
-
Recipharm (Sweden): Recipharm is a leading CMO specializing in API and finished dose manufacturing. It produces brexpiprazole API under strict GMP conditions, supporting Otsuka's supply chain. Recipharm’s facilities are equipped to handle complex synthesis processes, ensuring consistent quality.
-
Linan Pharmaceutical Co., Ltd. (China): Linan Pharmaceutical supplies brexpiprazole API from China, serving as a strategic manufacturing partner due to its cost advantages and rapidly expanding capacity. Linan complies with GMP standards aligned with international regulatory requirements.
-
Solara Active Pharmaps Pvt Ltd. (India): This Indian CMO partners with Otsuka for supply of brexpiprazole API, leveraging India’s robust pharmaceutical manufacturing sector. Their facilities are certified by global regulators, making them a key supplier in the Asian market.
3. Emerging API Manufacturers
As demand for REXULTI grows, newer players in Asia and Europe are entering the API manufacturing space, seeking to supply brexpiprazole to meet global needs while ensuring quality, cost competitiveness, and regulatory compliance.
Finished Dosage Form Manufacturers
1. Otsuka Pharmaceutical Manufacturing Facilities
Otsuka maintains global manufacturing sites for the finished REXULTI tablets, ensuring consistent quality, regulatory compliance, and supply security. Key facilities include:
-
Toyama Plant (Japan): Responsible for initial formulation and clinical supplies, with capacity for commercial production.
-
Chiyoda Facility (Japan): Certified for commercial manufacturing, emphasizing high-quality standards for global distribution.
2. Contract Manufacturing Organizations (CMOs)
Otsuka collaborates with CMOs globally to scale production and meet fluctuating market demands:
-
Catalent (USA): Catalent provides fill-finish and secondary packaging services for REXULTI, primarily serving North American markets. Its facilities are cGMP-compliant and equipped for high-volume production.
-
Wuxi AppTec (China): Wuxi supplies finished dosage forms for the Asian market, leveraging regional expertise and infrastructure.
-
Lannett (USA) / Others: Some smaller US-based manufacturers have been approved as secondary suppliers to ensure stock availability during supply disruptions.
Supply Chain and Distribution Channels
The supply of REXULTI involves a complex international network:
-
Raw Material Sourcing: Suppliers like Linan and Solara procure key intermediates for brexpiprazole synthesis. Their proximity to manufacturing sites helps reduce lead times.
-
API Manufacturing: Multiple API producers manage API batches aligned with demand forecasts, with Otsuka maintaining quality oversight through strict supplier qualification processes.
-
Finished Product Manufacturing: CMOs handle formulation, packaging, and distribution, with final products delivered to regional markets via established distribution networks.
Regulatory and Quality Considerations
Suppliers must adhere to rigorous GMP standards stipulated by agencies like the FDA, EMA, and PMDA. Otsuka performs regular audits and supplier qualification to ensure compliance, which influences supplier selection and ongoing relationships.
Strategic Considerations in Supplier Selection
-
Reliability and Capacity: Ensuring a diversified base of suppliers reduces risk of production halts.
-
Regulatory Compliance: Suppliers must demonstrate ongoing GMP compliance for API and finished product manufacturing.
-
Cost-Effectiveness: Balancing quality with competitive pricing, especially with emerging Asian suppliers.
-
Geographical Diversification: Mitigating regional risk—natural disasters, geopolitical issues—by engaging multiple geographic suppliers.
Emerging Trends and Future Outlook
The API and finished dosage manufacturing market for brexpiprazole and similar drugs is witnessing growth driven by expanding indications and global demand. Suppliers are investing in capacity expansion, advanced synthesis techniques, and regional manufacturing hubs. Otsuka’s strategic partnerships with CMOs and regional manufacturers are enabling a scalable, resilient supply chain.
In addition, regulatory scrutiny over supply chain transparency and quality management is intensifying, prompting suppliers to adopt digital quality systems and enhanced traceability measures. Such innovations are expected to improve supply reliability and compliance standards further.
Key Takeaways
-
Otsuka Pharmaceutical predominantly supplies brexpiprazole API, supported by strategic partnerships with CMOs in Europe, China, and India, ensuring diversified and resilient supply chains.
-
The finished dosage form supply chain involves both Otsuka’s manufacturing facilities and third-party CMOs, with regional players addressing local market demands.
-
Maintaining rigorous GMP compliance and quality standards is essential to sustain supply chain integrity and meet regulatory requirements.
-
Geographical diversification of suppliers mitigates regional disruptions and ensures cost competitiveness.
-
Growing demand signals ongoing investments by suppliers in manufacturing capacity and technological innovation to meet future supply requirements.
FAQs
1. Who are the primary suppliers of brexpiprazole API for REXULTI?
Otsuka primarily produces brexpiprazole API in-house, supported by contract manufacturing organizations such as Recipharm in Sweden, Linan Pharmaceutical in China, and Solara Active Pharmaps in India.
2. Are there alternative suppliers for REXULTI’s API apart from Otsuka?
While Otsuka remains the sole originator, several third-party API manufacturers supply brexpiprazole, especially in Asia, to ensure supply diversification and cost management.
3. How does supplier quality assurance impact REXULTI’s supply chain?
Strict adherence to GMP standards, regular audits, and qualification processes are vital to maintain product quality, regulatory compliance, and avoid supply disruptions.
4. What role do CMOs play in the REXULTI supply chain?
CMOs handle formulation, packaging, and sometimes API synthesis, providing manufacturing capacity, regional distribution capabilities, and risk diversification.
5. What are the future trends in REXULTI’s supply chain management?
Increasing regional manufacturing capacity, technological innovations, digital traceability, and supply chain transparency are critical trends shaping the future of REXULTI's supply chain.
Sources
- U.S. Food and Drug Administration (FDA). "REXULTI (brexpiprazole) Prescription Information." 2015.
- Otsuka Pharmaceutical. "Brexpiprazole (REXULTI): Product Details and Manufacturing Overview." 2022.
- Contract Manufacturing Organization Websites: Recipharm, Linan Pharmaceutical, Solara Active Pharmaps.
- Industry Reports: Global API Market Analysis, 2022.
- European Medicines Agency (EMA). "GMP Compliance Guidelines for API Manufacturers."
