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Suppliers and packagers for ASENAPINE MALEATE
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ASENAPINE MALEATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Alembic | ASENAPINE MALEATE | asenapine maleate | TABLET;SUBLINGUAL | 206098 | ANDA | Alembic Pharmaceuticals Limited | 46708-198-31 | 100 BLISTER PACK in 1 CARTON (46708-198-31) / 10 TABLET in 1 BLISTER PACK | 2020-12-10 |
| Alembic | ASENAPINE MALEATE | asenapine maleate | TABLET;SUBLINGUAL | 206098 | ANDA | Alembic Pharmaceuticals Limited | 46708-198-60 | 60 BLISTER PACK in 1 CARTON (46708-198-60) / 10 TABLET in 1 BLISTER PACK (46708-198-10) | 2020-12-10 |
| Alembic | ASENAPINE MALEATE | asenapine maleate | TABLET;SUBLINGUAL | 206098 | ANDA | Alembic Pharmaceuticals Limited | 46708-199-31 | 100 BLISTER PACK in 1 CARTON (46708-199-31) / 10 TABLET in 1 BLISTER PACK | 2020-12-10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Asenapine Maleate
Introduction
Asenapine maleate stands as a critical antipsychotic agent utilized primarily in the treatment of schizophrenia and bipolar disorder. Its unique pharmacological profile and clinical efficacy have prompted a diversified global supply chain comprising branded manufacturers, generic producers, and contract manufacturing organizations (CMOs). This article offers a comprehensive overview of key suppliers involved in the production and distribution of asenapine maleate, analyzing the landscape's dynamics, market players, and strategic implications for stakeholders in the pharmaceutical industry.
Pharmaceutical Manufacturing Landscape for Asenapine Maleate
Asenapine maleate is a synthetic compound requiring stringent production standards owing to its complex chemical structure and the need for high purity. Development and manufacturing involve multiple steps, including synthesis, purification, formulation, and packaging. Major pharmaceutical companies and contract manufacturers play pivotal roles in ensuring global access through authorized supply channels.
Branded Drug Manufacturers
Initially developed and marketed by Sunovion Pharmaceuticals Inc., asenapine maleate is commercially available under the brand name Saphris (also known as Sycrest in some markets). As the originator, Sunovion holds key patents and manufacturing rights, ensuring control over production quality and distribution.
Generic Suppliers
Following patent expirations or in markets with patent challenges, numerous generic pharmaceutical companies have emerged as prominent suppliers of asenapine maleate. Generics aim to provide more cost-effective options, expanding access, especially in emerging markets. These companies often source active pharmaceutical ingredients (APIs) from specialized contract manufacturers before final formulation.
Contract Manufacturing Organizations (CMOs)
Given the complexity of asenapine maleate synthesis, many pharmaceutical firms outsource manufacturing to CMOs. These organizations have established facilities with the necessary regulatory approvals (e.g., FDA, EMA) to produce APIs and finished dosage forms at scale.
Major Suppliers and Market Players
1. Sunovion Pharmaceuticals Inc.
- Market Role: Originator, exclusive rights holder for Saphris.
- Supply Chain: Vertically integrated; responsible for manufacturing, quality assurance, and distribution.
- Strategic Focus: Maintaining manufacturing compliance and scaling supply to meet global demand.
2. Pfizer Inc.
- Market Role: Licensed or biosimilar manufacturers in certain regions.
- Notes: While Pfizer primarily markets newer antipsychotics, its presence in the generic asenapine maleate market signifies collaborations or licensing agreements to expand therapeutic options.
3. Teva Pharmaceutical Industries Ltd.
- Market Role: Leading generic drug supplier, including asenapine maleate.
- Strengths: Extensive global manufacturing footprint, significant R&D capabilities, and experience in producing complex generics.
4. Mylan (Now part of Viatris Inc.)
- Market Role: Major generics producer, with approved formulations of asenapine maleate.
- Notes: Focused on expanding access in emerging markets, leveraging their large-scale API synthesis and formulation facilities.
5. Hetero Drugs Ltd.
- Market Role: Indian-based generic manufacturer offering affordable asenapine maleate formulations.
- Strengths: Cost-efficient manufacturing aligning with low-cost markets’ needs.
6. Zhejiang Hisun Pharmaceutical Co., Ltd.
- Market Role: Chinese pharmaceutical enterprise producing active ingredients and finished dosage forms.
- Notes: Focused on expanding API manufacturing capacity and meeting local market demands.
7. Contract Development and Manufacturing Organisations
Several CMOs, including Patheon (Thermo Fisher Scientific), Catalent, and Boehringer Ingelheim, offer contract services for API synthesis and formulation. Partnerships with these organizations enable pharmaceutical companies to meet quality standards while optimizing costs.
Supply Chain Challenges and Considerations
The manufacturing and supply of asenapine maleate face several challenges:
- Regulatory Compliance: Ensuring adherence to Good Manufacturing Practices (GMP) across jurisdictions.
- Chemical Synthesis Complexity: The multi-step synthesis requires specialized expertise and infrastructure.
- Supply Disruptions: Political, economic, or pandemic-related disruptions can impact raw material availability and manufacturing continuity.
- Intellectual Property: Patent protections restrict generic manufacturing in certain markets, influencing the geographic availability of suppliers.
- Quality Assurance: Maintaining consistent API purity and bioavailability standards across suppliers is crucial for efficacy and safety.
Global Distribution and Market Access
Supply chains are highly regionalized; North America, Europe, and Asia remain dominant markets. While Western pharmaceutical giants lead in initial manufacturing, Asian firms have gained prominence in API production, offering competitive pricing and capacity expansion. Governments and industry stakeholders increasingly focus on securing supply chains through strategic partnerships, licensing agreements, and capacity building.
Key Industry Trends
- Increasing Outsourcing to CMOs: To reduce costs and accelerate time-to-market.
- Regional API Production Growth: Especially in India and China, driven by cost and capacity advantages.
- Regulatory Harmonization: Facilitating cross-border distribution and licensing.
- Innovation in Synthesis Techniques: Enhancing yield, purity, and sustainability.
Conclusion
The landscape of suppliers for asenapine maleate is characterized by a combination of originator companies, generic manufacturers, and specialized contract manufacturing organizations. Strategic sourcing and robust supply chain management are critical for ensuring continuous availability, regulatory compliance, and cost competitiveness. As demand continues to grow, especially in emerging markets, understanding these key players and their operational strengths can guide stakeholders in making informed decisions regarding procurement, licensing, and supply chain resilience.
Key Takeaways
- Dominant Originator: Sunovion remains the primary supplier, holding exclusivity in most markets.
- Growing Generic Market: Companies like Teva, Mylan, and Hetero are expanding access through cost-effective manufacturing.
- Supply Chain Complexity: Manufacturing complexity and regulatory requirements mandate high-quality standards and strategic partnerships with CMOs.
- Regional Manufacturing Growth: Asia, notably India and China, are increasing API production capacity, impacting global supply dynamics.
- Strategic Considerations: Stakeholders should assess supplier reliability, regulatory status, and capacity commitments when planning procurement or licensing strategies.
FAQs
1. Who are the primary manufactures of asenapine maleate globally?
The original manufacturer is Sunovion Pharmaceuticals Inc., with key generic producers including Teva, Mylan (Viatris), Hetero, and Zhejiang Hisun, supported by contract manufacturing organizations.
2. Is asenapine maleate available as a generic drug?
Yes. Following patent expirations and licensing agreements, multiple generic manufacturers produce and시장 distribute asenapine maleate formulations worldwide.
3. What are the challenges faced by suppliers of asenapine maleate?
Major challenges include maintaining GMP standards, sourcing high-purity raw materials, managing supply disruptions, navigating patent protections, and ensuring consistent quality across production lots.
4. How does regional manufacturing influence the availability of asenapine maleate?
Regional manufacturing in countries like India and China has increased API supply capacity, improving access in emerging markets and reducing costs. However, regulatory differences can impact distribution and approval processes.
5. What role do contract manufacturing organizations play in the supply of asenapine maleate?
CMOs provide specialized synthesis, formulation, and packaging services, enabling pharmaceutical companies to meet demand efficiently while maintaining quality standards, especially for complex molecules like asenapine maleate.
References
- [1] DrugPatentWatch. "Asenapine Maleate: Patent and Market Information." Accessed 2023.
- [2] Sunovion Pharmaceuticals Inc. Product Information. "Saphris." 2022.
- [3] IQVIA. "Global Active Pharmaceutical Ingredient Production and Market Dynamics." 2022.
- [4] PharmSource. "Contract Manufacturing Trends in Psychiatry Drugs." 2022.
- [5] European Medicines Agency. Regulatory Overview for Generic Antipsychotics. 2022.
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