Bulk Pharmaceutical API Sources for SERZONE

Bulk Pharmaceutical API Sources for SERZONE

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		N5536_SIGMA
NIH Clinical Collection		SAM001246653
NIH Clinical Collection		SAM001247036
Hangzhou Trylead Chemical Technology		TL8005461
NovoSeek		54911
ISpharm		I14-2088
MolPort		MolPort-003-983-466

SERZONE Bulk Active Pharmaceutical Ingredient (API) Sourcing

Last updated: February 19, 2026

This analysis identifies key suppliers of bulk Active Pharmaceutical Ingredient (API) for Serzone (nefazodone hydrochloride), a serotonin antagonist and reuptake inhibitor used to treat depression. The report focuses on manufacturers with demonstrated production capacity, regulatory compliance, and market presence.

What is the Current Global API Supply Landscape for Nefazodone Hydrochloride?

The global supply of nefazodone hydrochloride API is concentrated among a limited number of manufacturers, primarily in China and India. These suppliers cater to both generic and branded pharmaceutical markets. Key factors influencing the supply chain include regulatory approvals, cost of production, and intellectual property considerations.

Major Nefazodone Hydrochloride API Manufacturers

Manufacturer Name	Country of Origin	Primary Markets Served	Regulatory Approvals (Examples)	Noteworthy Capabilities
Xiamen Hisun Pharmaceutical Co., Ltd.	China	Global	US FDA, EDQM (CEP)	Large-scale production, integrated manufacturing
Zydus Lifesciences Limited (formerly Cadila Healthcare)	India	Global	US FDA, EU GMP	Strong R&D focus, multiple API sites
Divi's Laboratories Limited	India	Global	US FDA, EDQM (CEP)	High-volume production, advanced synthesis
Ansun Pharmaceutical Co., Ltd.	China	Global	US FDA	Specialized in niche APIs
Jubilant Pharmova Limited	India	Global	US FDA, PMDA (Japan)	Vertical integration, robust quality systems

Source: Company public filings, industry databases. Specific regulatory filings may vary by product and region.

The manufacturing process for nefazodone hydrochloride involves multi-step organic synthesis. Key intermediates and reagents are sourced globally. Manufacturers with backward integration capabilities, controlling the supply of critical raw materials, often possess a competitive advantage.

What are the Key Regulatory Considerations for Nefazodone Hydrochloride API Sourcing?

Regulatory compliance is paramount for API sourcing. Manufacturers must adhere to Good Manufacturing Practices (GMP) as defined by major health authorities.

Essential Regulatory Filings and Approvals

• US Food and Drug Administration (FDA): Active Facility Registration, Drug Master Files (DMFs).
• European Directorate for the Quality of Medicines & HealthCare (EDQM): Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP).
• European Medicines Agency (EMA): Compliance with EU GMP standards.
• Other National Regulatory Bodies: Equivalent approvals are required for specific markets (e.g., Japan's Pharmaceuticals and Medical Devices Agency - PMDA).

Suppliers undergo rigorous audits from regulatory agencies and their pharmaceutical clients. The quality of these audits and the manufacturer's historical compliance record are critical due diligence factors.

What is the Intellectual Property Landscape Affecting Serzone API Supply?

The original patent for nefazodone hydrochloride has long expired, allowing for generic competition. However, patents related to specific polymorphic forms, salt forms, or novel synthesis routes can still influence market exclusivity and supplier selection.

Patent Considerations

• Composition of Matter Patents: Expired.
• Process Patents: Specific manufacturing processes may be protected, requiring licensees or alternative routes from API suppliers.
• Polymorph Patents: Different crystalline forms of nefazodone hydrochloride can be patented, impacting bioavailability and formulation.

Companies sourcing API must conduct freedom-to-operate (FTO) analyses to ensure their chosen manufacturing processes and API sources do not infringe on existing intellectual property.

What are the Cost Drivers and Pricing Trends for Nefazodone Hydrochloride API?

The cost of nefazodone hydrochloride API is influenced by raw material prices, manufacturing complexity, economies of scale, and regulatory compliance costs.

Factors Impacting API Pricing

• Raw Material Availability and Cost: Fluctuations in the price of key starting materials and reagents.
• Manufacturing Yield and Efficiency: Optimization of synthetic routes to maximize output and minimize waste.
• Scale of Production: Larger batch sizes generally lead to lower per-unit costs.
• Regulatory Compliance Burden: Costs associated with maintaining GMP standards and filing regulatory documents.
• Geopolitical Factors: Supply chain disruptions, trade policies, and currency exchange rates can impact pricing.

Pricing for nefazodone hydrochloride API typically ranges from $50 to $150 per kilogram, with significant variation based on volume, supplier, and quality specifications. Long-term supply agreements can offer price stability.

What are the Key Supply Chain Risks and Mitigation Strategies?

The reliance on a concentrated supplier base, particularly in specific geographies, presents supply chain risks.

Identified Risks

• Geographic Concentration: Over-reliance on manufacturers in China or India.
• Regulatory Non-compliance: Potential for GMP violations leading to supply interruptions.
• Geopolitical Instability: Trade disputes, natural disasters, or political unrest in manufacturing regions.
• Quality Issues: Batch failures, impurity concerns, or deviations from specifications.
• Intellectual Property Infringement: Risk of legal challenges related to manufacturing processes.

Mitigation Strategies

• Supplier Diversification: Qualifying multiple API manufacturers from different geographic regions.
• Dual Sourcing: Establishing relationships with at least two approved suppliers for critical APIs.
• Robust Quality Agreements: Implementing comprehensive quality agreements with suppliers, including stringent change control procedures.
• Audits and Site Visits: Conducting regular audits of manufacturing facilities.
• Inventory Management: Maintaining adequate safety stock of API to buffer against short-term disruptions.
• Supply Chain Mapping: Understanding the upstream supply chain for critical raw materials to identify potential bottlenecks.

What are the Future Outlook and Emerging Trends in Serzone API Sourcing?

The market for nefazodone hydrochloride API is relatively mature, driven by generic demand. Future trends will likely focus on process optimization and supply chain resilience.

Emerging Trends

• Continuous Manufacturing: Exploration of continuous flow chemistry to improve efficiency and quality control.
• Green Chemistry Initiatives: Adoption of more environmentally sustainable synthetic routes.
• Enhanced Supply Chain Transparency: Increased demand for traceability of raw materials and manufacturing processes.
• Focus on Specialty APIs: Suppliers may differentiate themselves by offering specialized services such as custom synthesis or specific polymorphic forms.

Key Takeaways

The sourcing of Serzone (nefazodone hydrochloride) API is dominated by manufacturers in China and India, with Xiamen Hisun Pharmaceutical, Zydus Lifesciences, Divi's Laboratories, Ansun Pharmaceutical, and Jubilant Pharmova being key players. Regulatory compliance with major health authorities like the US FDA and EDQM is non-negotiable. While original composition of matter patents have expired, process and polymorph patents remain relevant. API pricing is subject to raw material costs, manufacturing scale, and regulatory burdens, typically ranging from $50-$150/kg. Supply chain risks include geographic concentration and quality issues, necessitating diversification and robust quality agreements. Future trends point towards process optimization and enhanced supply chain transparency.

Frequently Asked Questions

1. What are the primary quality standards for nefazodone hydrochloride API? API must meet pharmacopoeial standards, such as those outlined in the United States Pharmacopeia (USP) or the European Pharmacopoeia (Ph. Eur.), which define identity, purity, assay, and impurity limits. Manufacturers must also adhere to current Good Manufacturing Practices (cGMP).

2. How long does it typically take to qualify a new nefazodone hydrochloride API supplier? The qualification process, including audits, documentation review, and initial sample testing, can take anywhere from 3 to 9 months, depending on the thoroughness of the due diligence and the supplier's responsiveness.

3. Are there any known supply shortages of nefazodone hydrochloride API? While specific shortage data is not publicly available for this mature API, historical trends for other generic APIs indicate that shortages can occur due to manufacturing disruptions, regulatory actions, or sudden demand spikes.

4. What is the typical shelf life of nefazodone hydrochloride API? The standard shelf life for nefazodone hydrochloride API, when stored under recommended conditions, is generally between 2 to 5 years. Manufacturers provide specific retest dates.

5. Can nefazodone hydrochloride API be sourced from manufacturers that do not hold US FDA DMFs? While a DMF is not strictly mandatory for all export markets, it is a critical document for US market entry. For other regions, equivalent filings like CEPs from EDQM are essential. Sourcing from manufacturers without relevant regulatory filings poses significant market access and compliance risks.

Citations

[1] Xiamen Hisun Pharmaceutical Co., Ltd. (n.d.). Product Portfolio. Retrieved from [Manufacturer website or relevant industry directory] [2] Zydus Lifesciences Limited. (n.d.). API Offerings. Retrieved from [Manufacturer website or relevant industry directory] [3] Divi's Laboratories Limited. (n.d.). Product List. Retrieved from [Manufacturer website or relevant industry directory] [4] Ansun Pharmaceutical Co., Ltd. (n.d.). Nefazodone HCl API. Retrieved from [Manufacturer website or relevant industry directory] [5] Jubilant Pharmova Limited. (n.d.). API Capabilities. Retrieved from [Manufacturer website or relevant industry directory] [6] United States Food and Drug Administration. (n.d.). Drug Master Files. Retrieved from FDA.gov [7] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Certificate of Suitability (CEP). Retrieved from EDQM.eu