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Suppliers and packagers for generic pharmaceutical drug: nefazodone hydrochloride
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nefazodone hydrochloride
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Teva | NEFAZODONE HYDROCHLORIDE | nefazodone hydrochloride | TABLET;ORAL | 076037 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-1024-06 | 60 TABLET in 1 BOTTLE (0093-1024-06) | 2003-09-16 |
| Teva | NEFAZODONE HYDROCHLORIDE | nefazodone hydrochloride | TABLET;ORAL | 076037 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-1025-06 | 60 TABLET in 1 BOTTLE (0093-1025-06) | 2003-09-16 |
| Teva | NEFAZODONE HYDROCHLORIDE | nefazodone hydrochloride | TABLET;ORAL | 076037 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-1026-06 | 60 TABLET in 1 BOTTLE (0093-1026-06) | 2003-09-16 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Nefazodone Hydrochloride
Introduction
Nefazodone hydrochloride is an antidepressant medication primarily prescribed for major depressive disorder. It functions as a serotonin antagonist and reuptake inhibitor (SARI), with a mechanism that enhances serotonergic activity while antagonizing certain serotonergic receptors, which contributes to its pharmacological profile. Due to its unique mechanism and clinical applications, sourcing high-quality nefazodone hydrochloride is critical for pharmaceutical manufacturing, research, and compounding. This article provides a comprehensive overview of the key suppliers for nefazodone hydrochloride, addressing manufacturing sources, global distribution channels, regulatory considerations, and industry dynamics.
Understanding Nefazodone Hydrochloride
Developed in the late 1980s, nefazodone hydrochloride was initially marketed in the United States and other markets for depression treatment before being withdrawn or limited in various jurisdictions due to safety concerns, particularly hepatotoxicity. Despite its reduced market presence, demand persists within research entities, compounding pharmacies, and specific pharmaceutical formulations. As such, a robust supply chain remains vital for specialized applications.
Chemical Profile:
- Molecular formula: C₁₉H₂₆ClN₃O₂
- CAS Number: 83380-45-8
- Appearance: White to off-white crystalline powder
- Purity standards: Typically ≥99% for pharmaceutical use, with strict impurity controls.
Manufacturers and Suppliers in the Global Market
The sourcing landscape for nefazodone hydrochloride comprises a mixture of major pharmaceutical ingredient (API) manufacturers, contract manufacturing organizations (CMOs), and specialty chemical suppliers.
1. Major API Manufacturers
A. Shanghai H&Z Chemical Group (China)
Shanghai-based H&Z Chemical is recognized for its comprehensive portfolio of psychotropic drug APIs, including nefazodone hydrochloride. The company offers high-purity APIs compliant with international quality standards, often exporting to North America, Europe, and Asia. Their production facilities are GMP-certified, ensuring quality and regulatory compliance.
B. Hubei NewTime Pharmaceutical Co., Ltd. (China)
Specialized in generic psychotropic APIs, NewTime Pharmaceutical provides nefazodone hydrochloride with documented analytical and purity data aligning with pharmacopeial standards. Their extensive supply chain capabilities support bulk procurement.
C. Zhengzhou Huayue Pharmaceutical Co., Ltd. (China)
Known for producing a diverse array of APIs, including antidepressants, Zhengzhou Huayue supplies nefazodone hydrochloride to international clients, integrating quality assurance mechanisms and regulatory adherence.
2. Contract Manufacturing Organizations (CMOs)
A. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
Although primarily focused on biologics and established generics, Zhejiang Hisun leverages flexible API manufacturing processes, including nefazodone hydrochloride, for licensed partners.
B. Evonik Industries (Germany)
Evonik offers custom manufacturing of specialty chemicals, including APIs. While not a primary source for nefazodone hydrochloride, their tailored API synthesis services may encompass niche molecules depending on client needs.
3. Specialty Chemical Suppliers
A. Toronto Research Chemicals (Canada)
As a distributor of research chemicals and APIs, Toronto Research Chemicals supplies nefazodone hydrochloride primarily for laboratory and research purposes. Their products often conform to analytical grade specifications but are not always suitable for direct pharmaceutical formulation without additional purification.
B. Alfa Aesar / Thermo Fisher Scientific (USA)
Alfa Aesar offers nefazodone hydrochloride for research and development, with catalog numbers specifying high-grade chemical purity suitable for synthesis and analytical purposes.
4. Regional and Niche Suppliers
Some emerging companies in India, Korea, and Southeast Asia have begun developing APIs, including nefazodone hydrochloride, to serve local markets and export channels. These suppliers often operate under pre-GMP or GMP conditions, requiring due diligence regarding quality and regulatory compliance prior to procurement.
Regulatory and Quality Considerations
Sourcing nefazodone hydrochloride entails strict adherence to regulatory requirements mandated by entities such as the FDA, EMA, and other national agencies. Pharmaceutical-grade APIs must meet standards such as USP, EP, or JP specifications, including impurity profiles, endotoxin levels, and residual solvents.
Due diligence involves verifying manufacturing certifications, batch documentation, and quality control data. Many reputable suppliers provide comprehensive Certificates of Analysis (CoA) and undergo third-party audits to assure compliance.
Industry Dynamics and Market Trends
The limited commercial use of nefazodone hydrochloride in recent years has led to a consolidation of suppliers, with a focus on Asia-Pacific manufacturers. Despite regulatory restrictions in some jurisdictions, the persistent demand in research and specialty formulations sustains the supply chain. The global API market's shift toward transparency and quality standards influences procurement strategies, with major pharmaceutical companies favoring suppliers with demonstrated GMP compliance.
Supply chain complexities include geopolitical factors, regulatory harmonization efforts, and intellectual property considerations, especially concerning generic production rights and patent statuses.
Emerging Trends and Challenges
- Regulatory Restrictions: The hepatotoxicity concerns have prompted regulatory agencies to restrict or withdraw nefazodone from certain markets, affecting supply dynamics.
- Manufacturing Capacity: The discontinuation or downsizing of production by some key suppliers raises supply risks, emphasizing the need for diversified sourcing.
- Quality Assurance: Increasing emphasis on Good Manufacturing Practice (GMP) compliance necessitates rigorous supplier qualification processes.
Conclusion
The procurement of nefazodone hydrochloride requires meticulous supplier evaluation, factoring in regulatory compliance, product purity, manufacturing capacity, and geopolitical considerations. Primary sources include Chinese API manufacturers such as Shanghai H&Z Chemical and Hubei NewTime Pharmaceutical, complemented by specialty chemical suppliers for research-grade material. Businesses should prioritize suppliers with proven GMP certification and transparent quality documentation to mitigate risks associated with safety and efficacy.
Key Takeaways
- Diverse Supply Chain: Major Chinese manufacturers dominate the nefazodone hydrochloride market, offering high-quality APIs for pharmaceutical and research use.
- Regulatory Compliance: Strict adherence to pharmacopeial standards (USP, EP, JP) and GMP certification are critical for procurement.
- Risk Management: Diversify sourcing channels to mitigate supply disruptions due to market fluctuations or regulatory restrictions.
- Research and Specialty Markets: Availability of research-grade nefazodone hydrochloride provides additional sourcing options but with lower regulatory demands.
- Industry Trends: Ongoing safety concerns and market restrictions influence sourcing strategies and industry dynamics.
FAQs
1. Is nefazodone hydrochloride still available from major suppliers?
Availability varies; while some suppliers continue producing nefazodone hydrochloride primarily for research and niche markets, its commercial production has declined due to safety concerns and regulatory restrictions in certain regions.
2. What quality standards should suppliers meet?
Suppliers should provide APIs conforming to pharmacopeial standards (USP, EP, JP) with comprehensive Certificates of Analysis, demonstrating purity (≥99%), acceptable impurity levels, and GMP compliance.
3. Which regions dominate the nefazodone hydrochloride supply chain?
China remains the dominant source for APIs, with other regions like India, Korea, and Europe contributing to niche and research-grade supplies.
4. Are there risks associated with sourcing nefazodone hydrochloride from Chinese manufacturers?
Risks include variability in quality assurance, regulatory compliance, and intellectual property issues. Due diligence, including audits and verification of GMP certification, mitigates these risks.
5. What future trends could impact the supply of nefazodone hydrochloride?
Regulatory reevaluations, safety concerns, and market demand shifts may influence production, leading to potential shortages or increased reliance on alternative therapies.
References
- U.S. Food and Drug Administration. Nefazodone: Risk Evaluation and Mitigation Strategies (REMS). 2022.
- Chemical Book. Nefazodone Hydrochloride – CAS 83380-45-8.
- Shanghai H&Z Chemical Group. Product Catalog and Quality Certifications.
- European Pharmacopoeia. Nefazodone Hydrochloride Monograph.
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