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Suppliers and packagers for generic pharmaceutical drug: TRIMIPRAMINE MALEATE
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TRIMIPRAMINE 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 |
|---|---|---|---|---|---|---|---|---|---|
| Breckenridge | TRIMIPRAMINE MALEATE | trimipramine maleate | CAPSULE;ORAL | 208127 | ANDA | Breckenridge Pharmaceutical, Inc. | 51991-944-01 | 100 CAPSULE in 1 BOTTLE (51991-944-01) | 2017-04-05 |
| Breckenridge | TRIMIPRAMINE MALEATE | trimipramine maleate | CAPSULE;ORAL | 208127 | ANDA | Breckenridge Pharmaceutical, Inc. | 51991-944-33 | 30 CAPSULE in 1 BOTTLE (51991-944-33) | 2017-04-05 |
| Breckenridge | TRIMIPRAMINE MALEATE | trimipramine maleate | CAPSULE;ORAL | 208127 | ANDA | Breckenridge Pharmaceutical, Inc. | 51991-945-01 | 100 CAPSULE in 1 BOTTLE (51991-945-01) | 2017-04-05 |
| Breckenridge | TRIMIPRAMINE MALEATE | trimipramine maleate | CAPSULE;ORAL | 208127 | ANDA | Breckenridge Pharmaceutical, Inc. | 51991-945-33 | 30 CAPSULE in 1 BOTTLE (51991-945-33) | 2017-04-05 |
| Breckenridge | TRIMIPRAMINE MALEATE | trimipramine maleate | CAPSULE;ORAL | 208127 | ANDA | Breckenridge Pharmaceutical, Inc. | 51991-946-01 | 100 CAPSULE in 1 BOTTLE (51991-946-01) | 2017-04-05 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Trimipramine Maleate
Introduction
Trimipramine maleate is a tricyclic antidepressant (TCA) widely used to treat depression, anxiety disorders, and certain sleep disorders. Its pharmacological profile includes significant anticholinergic properties, and it functions by inhibiting the reuptake of norepinephrine and serotonin. As a specialized pharmaceutical compound, the supply chain for trimipramine maleate involves a complex network of active pharmaceutical ingredient (API) manufacturers, formulation specialists, and distributors. Understanding the landscape of suppliers for trimipramine maleate is crucial for pharmaceutical companies, healthcare providers, and regulatory bodies aiming to ensure drug availability, quality, and compliance. This article provides a comprehensive overview of leading suppliers, key industry players, and market dynamics.
Global Landscape of Trimipramine Maleate Suppliers
The supply chain for trimipramine maleate is segmented geographically, with notable production hubs in Asia, Europe, and North America. The primary suppliers include both large-scale pharmaceutical ingredient manufacturers and specialised chemical producers. The scope of suppliers spans patented formulations, custom synthesis, and bulk API production. The choice of supplier is often dictated by factors such as quality standards, regulatory compliance, production capacity, and geopolitical considerations.
Major Suppliers of Trimipramine Maleate API
1. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
Zhejiang Hisun Pharmaceutical is a leading Chinese pharmaceutical company with a robust API manufacturing division. The firm specializes in cardiovascular, psychiatric, and central nervous system (CNS) APIs. Its production of trimipramine maleate adheres to stringent Chinese regulatory standards (CFDA), with exports conforming to international quality benchmarks. Hisun's strategic investments in R&D have facilitated the production of high-purity APIs, making it a key supplier for global markets. The company’s capacity enables large-volume supply, serving both generic and branded drug manufacturers.
2. Zhejiang Jiaao Enprotech Stock Co., Ltd. (China)
Another prominent Chinese manufacturer, Zhejiang Jiaao Enprotech, produces a wide portfolio of active ingredients, including CNS drugs like trimipramine maleate. Emphasizing quality assurance, Jiaao Enprotech has obtained certifications such as ISO 9001 and GMP, strengthening its position as a dependable supplier for international clients. Their manufacturing facility is equipped with state-of-the-art chemical synthesis and purification technology, ensuring consistent API quality that meets pharmacopeial standards.
3. Jiangsu Hengrui Medicine Co., Ltd. (China)
Jiangsu Hengrui is one of China’s largest pharmaceutical companies, with extensive experience in small molecule APIs. Although primarily known for oncology and cardiovascular medications, Hengrui has diversified into CNS APIs, including trimipramine maleate. The company emphasizes R&D-driven manufacturing processes, offering custom synthesis services tailored to client specifications. Its global distribution network enhances accessibility of its APIs to North America, Europe, and Asia.
4. Midas Pharma (Germany)
Midas Pharma specializes in the production and distribution of high-quality pharmaceutical ingredients for research and development, as well as commercialization. The German firm sources APIs from certified manufacturing sites worldwide and maintains rigorous quality control protocols. Midas Pharma’s strategic partnerships with Asian API manufacturers enable it to provide trimipramine maleate that complies with international standards (EMA, USP, JP). Its reputation derives from reliable supply chain management, regulatory expertise, and technical support.
5. Spectrum Chemical Mfg. Corp (United States)
Spectrum Chemical is a notable supplier of research-grade chemicals and APIs in North America. Although primarily serving research institutions and early-stage pharmaceutical developers, Spectrum also offers GMP-grade APIs, including trimipramine maleate. The company's facilities are certified by the FDA, and it maintains compliance with US Pharmacopeia standards. Spectrum’s strong logistics network ensures timely delivery for clinical trials and batch testing.
Key Industry Players and Market Trends
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Manufacturing Consolidation: The API supply landscape is experiencing consolidation, with large Chinese and Indian firms expanding capacity and standards to meet global demand. This trend leads to increased economies of scale, competitive pricing, and potential regulatory harmonization.
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Regulatory Environment: Suppliers must align with international quality standards, such as ICH-GMP, USFDA, EMA, and others. Stringent validation processes are integral for API approval in high-regulation markets.
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Supply Chain Risks: Political instability, trade restrictions, and pandemics (e.g., COVID-19) impact API supply. Suppliers invest in diversified manufacturing bases to mitigate risks.
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Quality Assurance: There is an increasing demand for APIs with high purity, consistent bioavailability, and minimal impurities. Suppliers invest heavily in analytical testing and process validation.
Selecting a Supplier: Critical Considerations
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Regulatory Compliance: Ensure suppliers adhere to cGMP standards and possess necessary certifications (FDA, EMA, ISO).
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Production Capacity: Confirm capacity aligns with your projected demand and potential scaling needs.
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Quality Assurance: Review batch consistency, impurity profiles, and analytical testing protocols.
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Supply Chain Logistics: Assess lead times, geopolitical stability, and distribution networks.
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Cost and Pricing: Balance quality assurances against cost-effectiveness, considering long-term supply agreements.
Conclusion
The supply of trimipramine maleate involves a diverse array of global suppliers who operate within strict regulatory frameworks to ensure drug safety and efficacy. Major manufacturers such as Zhejiang Hisun Pharmaceutical and Jiangsu Hengrui Medicine dominate the Chinese market, leveraging scale and technological advancements, while European and American firms like Midas Pharma and Spectrum Chemical offer specialized services with rigorous quality assurance. Strategic sourcing, compliance, and supply chain resilience are essential for companies seeking to secure a reliable supply of this critical CNS-active pharmaceutical.
Key Takeaways
- The primary sources of trimipramine maleate APIs are China’s Zhejiang Hisun Pharmaceutical and Zhejiang Jiaao Enprotech, complemented by European and North American specialty suppliers.
- Regulatory compliance, such as GMP certifications and pharmacopeial standards, is non-negotiable for reliable supply and market access.
- The API market is consolidating, driving economies of scale but necessitating due diligence on quality and logistics.
- Diversifying suppliers can mitigate risks associated with geopolitical instability and global disruptions.
- Developers and manufacturers should prioritize suppliers with robust quality controls, production capacity, and scalable logistics to ensure continuous drug supply.
FAQs
1. Is trimipramine maleate available from multiple suppliers worldwide?
Yes. Several manufacturers, predominantly in China, Europe, and North America, produce trimipramine maleate. This diversity helps ensure supply stability and market competitiveness.
2. What quality certifications should suppliers of trimipramine maleate possess?
Suppliers should ideally have GMP certification, ISO 9001 accreditation, and meet pharmacopeial standards such as USP or EP, ensuring high purity, batch consistency, and regulatory compliance.
3. Are there any notable barriers to sourcing trimipramine maleate internationally?
Potential barriers include regulatory restrictions, import tariffs, trade disputes, and logistical challenges. Suppliers with proven compliance and established distribution channels mitigate these risks.
4. How does supplier selection influence the safety and efficacy of pharmaceuticals containing trimipramine maleate?
High-quality suppliers ensure APIs with minimal impurities, consistent potency, and reliable supply, directly impacting the safety and efficacy profile of finished pharmaceuticals.
5. What role do Asian manufacturers play in the global supply of trimipramine maleate?
Asian manufacturers, especially Chinese firms, are dominant due to their manufacturing scale, cost advantages, and technological capacity, serving major global markets with high-quality APIs.
References
[1] "Global API Market Report," Pharma Intelligence, 2022.
[2] "Regulatory Standards for Pharmaceutical APIs," International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), 2021.
[3] "Chinese API Manufacturers and Regulations," China Food and Drug Administration (CFDA), 2022.
[4] "Supply Chain Risks and Resilience in Pharma," McKinsey & Company, 2023.
[5] "Best Practices for API Quality Assurance," USP Monographs and Guidelines, 2022.
This analytical examination facilitates informed decision-making for stakeholders engaged in the procurement, manufacturing, or regulation of trimipramine maleate, emphasizing supply chain robustness, compliance, and market dynamics.
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