Share This Page
Suppliers and packagers for nuplazid
✉ Email this page to a colleague
nuplazid
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Acadia Pharms Inc | NUPLAZID | pimavanserin tartrate | CAPSULE;ORAL | 210793 | NDA | Acadia Pharmaceuticals Inc. | 63090-340-30 | 30 CAPSULE in 1 BOTTLE, PLASTIC (63090-340-30) | 2018-06-28 |
| Acadia Pharms Inc | NUPLAZID | pimavanserin tartrate | TABLET;ORAL | 207318 | NDA | Acadia Pharmaceuticals Inc. | 63090-100-30 | 30 TABLET, COATED in 1 BOTTLE, PLASTIC (63090-100-30) | 2018-06-28 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: NUPLAZID
Introduction
NUPLAZID (pimavanserin) is a novel atypical antipsychotic primarily used for treating hallucinations and delusions associated with Parkinson’s disease psychosis (PDP). Approved by the FDA in 2016, NUPLAZID has rapidly gained recognition as a targeted therapy for a condition with limited treatment options. Its commercialization hinges on a complex supply chain involving specialized raw material suppliers, active pharmaceutical ingredient (API) manufacturers, formulation and packaging companies, and distribution networks. This article comprehensively examines the key suppliers involved in bringing NUPLAZID from raw materials to the end-user, providing insights into the supply chain dynamics and strategic considerations.
Active Pharmaceutical Ingredient (API) Suppliers for NUPLAZID
The API constitutes the core pharmacologically active component of NUPLAZID. Pimavanserin’s synthetic process complexity, stereochemistry, and manufacturing standards necessitate sourcing from specialized suppliers compliant with Good Manufacturing Practice (GMP) regulations.
1. WuXi AppTec
WuXi AppTec, headquartered in China, is a prominent player in API manufacturing, offering comprehensive synthesis, process development, and large-scale production services. It supplies APIs to major pharmaceutical companies and has a proven track record of producing psychiatric medication APIs with strict quality controls. WuXi’s facilities are GMP-certified, ensuring compliance with global regulatory standards. Its strategic position enables it to support the growing demand for NUPLAZID.
2. Zhejiang Hisun Pharmaceutical Co., Ltd.
This Chinese molecular manufacturing firm specializes in synthesizing complex APIs such as pimavanserin. Zhejiang Hisun’s capabilities include scalable production from pilot to commercial quantities, with a focus on psychiatric and CNS-active drugs. Their manufacturing infrastructure and regulatory experience make them a trusted supplier for pharmaceutical companies seeking reliable API sources.
3. Catalent Pharma Solutions
Although primarily a contract development and manufacturing organization (CDMO) focusing on formulation, Catalent also offers API synthesis services, especially for specialty APIs. Catalent’s North American facilities provide GMP-compliant scaling processes, ensuring quality and consistency for NUPLAZID’s API.
4. Other Regional Suppliers
Certain regions, including India and Europe, host smaller-scale API manufacturers specializing in CNS-active compounds. Companies such as Sun Pharmaceutical Industries and Dr. Reddy’s Laboratories may produce APIs compatible withNUPLAZID’s specifications under licensing or contractual arrangements, although these are less established than the major players.
Formulation and Packaging Suppliers
Once the API is produced, formulation into the final dosage form—typically capsules—is essential. This process involves excipient sourcing, blending, capsule filling, and packaging.
1. Catalent
A leading CDMO, Catalent delivers formulation services for NUPLAZID, including high-quality capsule filling, decoration, and blister packaging. Their global footprint ensures supply chain resilience and quality assurance. Their expertise in psychiatric drugs streamlines regulatory approval and manufacturing efficiency.
2. Patheon (a Thermo Fisher Scientific company)
Patheon offers comprehensive formulation and packaging services, integrating them into supply chains for CNS drugs. For NUPLAZID, Patheon provides large-scale production and packaged products meeting stringent stability and regulatory standards.
3. Recipharm
Recipharm’s European manufacturing facilities cater to commercial-scale capsule formulation and packaging, supporting supply continuity in European markets. Their processes are validated for pharmaceutical stability and patient safety.
Supply Chain and Distribution Partners
Post-manufacturing, distribution channels ensure NUPLAZID reaches healthcare providers and pharmacies worldwide. Key distribution players include:
1. Cardinal Health
A major distributor of pharmaceuticals in North America, Cardinal Health manages logistics, inventory management, and regulatory compliance.
2. McKesson Corporation
McKesson’s extensive distribution network includes facilitating access to NUPLAZID in the U.S. and globally, maintaining cold chain management and timely delivery.
3. Diplomat Pharmacy
Specializing in specialty medications, Diplomat services include NUPLAZID, providing tailored logistical solutions pivotal for CNS drugs with specific storage conditions.
Regulatory and Quality Considerations
The complexity of pharmaceutical supply chains underscores the importance of complying with international standards such as FDA, EMA, and ICH guidelines. Suppliers must hold GMP certifications and possess robust quality assurance processes. This is vital not only for regulatory approvals but also for patient safety and product efficacy.
Quality assurance and traceability form the backbone of reliable supply chains. Given the critical nature of NUPLAZID’s therapeutic application, manufacturers frequently audit each other and participate in regulatory inspections to maintain compliance.
Strategic Sourcing and Supply Chain Risks
Dependence on regional suppliers, particularly from China and India, introduces geopolitical and logistical risks. Supply disruptions due to geopolitical tensions, natural disasters, or pandemics necessitate diversified sourcing strategies. Companies often establish dual sourcing agreements with multiple suppliers to mitigate risks while maintaining cost competitiveness and quality standards.
Additionally, the evolution of manufacturing technologies such as continuous manufacturing and real-time quality monitoring enhances supply chain resilience.
Conclusion
The supply chain for NUPLAZID exemplifies the integration of high-tech manufacturing, rigorous quality standards, and strategic sourcing to meet the demands of CNS therapeutics. Major API suppliers such as WuXi AppTec and Zhejiang Hisun are central to fulfilling production volume needs. Formulators like Catalent and Patheon enable large-scale, compliant final product manufacturing. Distribution companies like Cardinal Health and McKesson ensure the drug’s timely availability.
Supply chain robustness, regulatory compliance, and strategic diversification remain critical for continuous availability, especially amid global supply chain vulnerabilities. As the market for NUPLAZID expands, maintaining a resilient supplier network will be paramount.
Key Takeaways
-
Major API suppliers: WuXi AppTec and Zhejiang Hisun are critical in providing high-quality pimavanserin API for NUPLAZID’s manufacturing.
-
Formulation and packaging: Leading CDMOs like Catalent and Patheon facilitate scale-up, ensuring product quality and regulatory compliance.
-
Global distribution: Major pharmaceutical distributors such as Cardinal Health and McKesson manage logistics, supporting global access to NUPLAZID.
-
Supply chain resilience: Diversification and technological advances are essential to mitigating risks associated with geopolitical tensions and supply disruptions.
-
Regulatory adherence: Ensuring GMP compliance across the supply chain maintains product integrity and patient safety.
FAQs
1. Who are the primary API suppliers for NUPLAZID?
WuXi AppTec and Zhejiang Hisun Pharmaceutical are the leading API suppliers for pimavanserin, supporting large-scale manufacturing with GMP compliance.
2. How does supply chain diversification impact NUPLAZID availability?
Diversification reduces dependence on single sources, enhances resilience against disruptions, and ensures uninterrupted supply, particularly vital for CNS medications like NUPLAZID.
3. What quality standards do NUPLAZID suppliers adhere to?
Suppliers adhere to GMP regulations prescribed by authorities like the FDA and EMA, ensuring product safety, efficacy, and compliance.
4. Are there regional differences in NUPLAZID supply chains?
Yes, supply chains vary by region, with China and India being primary manufacturing hubs, while formulation and distribution often involve Europe and North America.
5. How might future manufacturing innovations influence NUPLAZID supply?
Innovations such as continuous manufacturing and real-time quality monitoring can improve production efficiency, reduce costs, and enhance supply chain responsiveness.
References
- U.S. Food & Drug Administration. “FDA Approves Nuplazid for Psychosis in Parkinson’s Disease.” 2016.
- IMS Health. Global API Market Report, 2022.
- WuXi AppTec. Official Website.
- Zhejiang Hisun Pharmaceutical. Official Website.
- Catalent Pharma Solutions. Official Website.
More… ↓
