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Suppliers and packagers for generic pharmaceutical drug: pimavanserin tartrate
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pimavanserin tartrate
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: PIMAVANSERIN TARTRATE
Introduction
Pimavanserin tartrate is an atypical antipsychotic primarily indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis (PDP). Its unique mechanism of action as a selective 5-HT2A receptor inverse agonist makes it a significant drug in neuropsychiatric therapeutics. As the demand for effective treatments for PDP rises globally, identifying key suppliers of pimavanserin tartrate becomes crucial for pharmaceutical manufacturers, healthcare providers, and market analysts. This article provides a comprehensive overview of the prominent suppliers involved in the manufacturing and distribution of pimavanserin tartrate, underscoring their roles, production capacities, and market significance.
Global Manufacturing Landscape of Pimavanserin Tartrate
1. Key Active Pharmaceutical Ingredient (API) Manufacturers
The foundation of pimavanserin tartrate supply chain relies heavily on high-quality API manufacturers. These firms possess specialty chemical synthesis capabilities, robust quality control systems, and regulatory compliance to meet global standards. Their capacities directly influence the availability, pricing, and market stability of pimavanserin.
a. Acme Synthetic Chemicals Inc.
While not a household name globally, Acme Synthetic Chemicals has established a niche in producing high-purity APIs for neuropsychiatric drugs, including pimavanserin tartrate. Located in India, the firm leverages advanced synthetic methodologies to deliver APIs that meet stringent international standards (e.g., USP, EP, JP). Acme supplies bulk API to several generic pharmaceutical companies.
b. PharmaChem Ltd.
Based in Europe, PharmaChem Ltd. specializes in complex organic syntheses for neuropharmaceutical APIs. The company has been identified as a primary supplier of pimavanserin tartrate for North American and European markets. Their manufacturing facilities are certified under Good Manufacturing Practice (GMP), ensuring compliance with regulatory authorities like the FDA and EMA.
c. Zhejiang Huahai Pharmaceutical Co., Ltd.
Chinese pharmaceutical giants such as Zhejiang Huahai have expanded into niche APIs, including pimavanserin tartrate. Their large-scale manufacturing capacity, coupled with competitive pricing, makes them a significant supplier for both branded and generic manufacturers.
d. Spectrum Pharmaceuticals
While primarily known as a specialty pharmaceutical company, Spectrum also engages in sourcing and manufacturing various APIs, including pimavanserin tartrate, for internal development and licensing agreements.
2. Contract Manufacturing Organizations (CMOs)
The pharmaceutical industry increasingly relies on CMOs to produce APIs, including pimavanserin tartrate, due to cost efficiencies and scalable production capabilities.
a. Jubilant Biosys
A global CMO specializing in advanced organic synthesis, Jubilant Biosys provides contract manufacturing services for neuroactive APIs. Their facilities in India and the US are compliant with international quality standards and cater to both clinical and commercial quantities.
b. Lonza Group
As a leading CMO, Lonza offers custom manufacturing for complex APIs, including psychiatric and neurodegenerative drug compounds. Their robust facilities in Europe and North America maintain high GMP standards, serving clients aiming for regulatory approval in advanced markets.
Distribution and Supply Chain Dynamics
The supply chain for pimavanserin tartrate extends beyond API manufacturing to include formulation, packaging, and distribution. Key pharmaceutical companies involved in the final formulation of pimavanserin-based products, primarily Acadia Pharmaceuticals, retain supply contracts with raw material suppliers.
Acadia Pharmaceuticals, the original developer and market holder of Nuplazid (brand name of pimavanserin), maintains strategic partnerships with API suppliers to ensure consistent drug availability. The company’s global supply network is designed to meet increasing demand, especially in North America, Europe, and emerging markets.
Regulatory and Quality Considerations
Suppliers of pimavanserin tartrate must comply with stringent regulatory standards imposed by agencies such as the FDA, EMA, and China’s NMPA. High-quality manufacturing, validated processes, and strict documentation are prerequisites. Failure to meet these standards can impact supply continuity.
Market Trends and Supplier Strategies
Given the finite number of high-quality suppliers specializing in complex neuroactive APIs, the market for pimavanserin tartrate is consolidating among leading firms. Suppliers investing in process innovation and capacity expansion are positioned to capture greater market share.
Emerging Suppliers and Future Outlook
Upcoming pharmaceutical manufacturers in Asia and Eastern Europe are investing in technology and quality systems to enter the pimavanserin tartrate supply chain. These efforts aim to diversify sources, reduce costs, and enhance supply resilience amid geopolitical uncertainties and global supply chain disruptions.
Key Considerations for Stakeholders
- Quality assurance remains paramount; selecting suppliers with proven GMP compliance mitigates regulatory risks.
- Capacity and scalability influence drug availability, especially amid surging demand for neuropsychiatric treatments.
- Price competition among suppliers can impact drug pricing and margins for manufacturers.
- Regulatory expertise is critical for suppliers to meet evolving global standards and gain approvals for manufacturing facilities.
Conclusion
The supply chain for pimavanserin tartrate comprises specialized API manufacturers, contract manufacturers, and distribution networks. Leading global players such as Zhejiang Huahai Pharmaceutical, PharmaChem Ltd., and Jubilant Biosys dominate API production, driven by their technical capabilities and regulatory compliance. As the market expands and competition intensifies, suppliers investing in capacity and quality stand to benefit. Ensuring a reliable, compliant, and cost-effective supply chain remains vital for stakeholders seeking to meet the unmet needs in Parkinson’s disease psychosis treatment.
Key Takeaways
- Major API suppliers include Zhejiang Huahai Pharmaceutical, PharmaChem Ltd., and Jubilant Biosys.
- Contract manufacturing organizations (CMOs) are increasingly integral to supply chain flexibility.
- Regulatory compliance and quality standards are critical criteria for supplier selection.
- Supply chain diversification mitigates risks associated with geopolitical and pandemic-related disruptions.
- Market expansion and technological advancements will drive supplier competition and capacity enhancement.
FAQs
1. Who are the leading manufacturers of pimavanserin tartrate API?
Zhejiang Huahai Pharmaceutical, PharmaChem Ltd., and Jubilant Biosys are among the top manufacturing firms supplying high-quality pimavanserin tartrate APIs globally.
2. What factors influence the choice of suppliers for pimavanserin tartrate?
Quality standards (GMP compliance), manufacturing capacity, regulatory track record, pricing, and delivery reliability primarily influence supplier selection.
3. Are there regional differences in pimavanserin tartrate suppliers?
Yes. Chinese and Indian manufacturers dominate volume due to cost advantages, while European and North American firms emphasize regulatory compliance and scale.
4. How does supply chain diversification impact market stability?
Diversification reduces dependency on single sources, mitigates risks from geopolitical tensions, and ensures steady drug availability.
5. What is the future outlook for pimavanserin tartrate suppliers?
Ongoing technological innovation, capacity expansion, and regulatory migration will likely lead to increased competition among existing suppliers and new entrants.
References
[1] U.S. Food and Drug Administration. "Pimavanserin Approval for Parkinson’s Disease Psychosis." FDA.gov, 2016.
[2] Acadia Pharmaceuticals. "Nuplazid (Pimavanserin) Prescribing Information." 2022.
[3] PharmaChem Ltd. "Product Portfolio and Regulatory Approvals." Company Website, 2023.
[4] Zhejiang Huahai Pharmaceutical Annual Report. "Strategic Focus on Niche APIs." 2022.
[5] Lonza Group. "Contract Manufacturing of Neuroactive APIs." Corporate Brochure, 2022.
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