Bulk Pharmaceutical API Sources for MORICIZINE HYDROCHLORIDE

Bulk Pharmaceutical API Sources for MORICIZINE HYDROCHLORIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemBridge		5229972
NovoSeek		34632
MolPort		MolPort-000-917-706
ABI Chem		AC1L1RZ0
ABI Chem		AC1Q3EDS
Finetech Industry Limited		FT-0630550

Bulk Active Pharmaceutical Ingredient (API) Sources for Moricizine Hydrochloride

Last updated: July 28, 2025

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Introduction

Moricizine hydrochloride is a class III antiarrhythmic agent primarily used to treat ventricular arrhythmias. As with many pharmaceuticals, the procurement of high-quality Active Pharmaceutical Ingredients (APIs) is critical for manufacturing efficacy, regulatory compliance, and market stability. The sourcing landscape for Moricizine hydrochloride involves a combination of trusted chemical manufacturers, contract manufacturing organizations (CMOs), and regional suppliers. This article provides a comprehensive review of API suppliers for Moricizine hydrochloride, emphasizing their capabilities, regulatory compliance, and market positioning.

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Market Overview of Moricizine Hydrochloride

Originally developed in the 1970s, Moricizine's clinical utility was primarily in the management of ventricular arrhythmia. Its production has since shifted toward specialized API suppliers due to patent expirations and competitive generics manufacturing. The API market is characterized by a handful of dedicated suppliers, often specializing in complex synthesis and high-purity grades necessary for pharmaceutical applications.

The demand for Moricizine hydrochloride remains niche, yet consistent, driven by regional formularies and specific treatment protocols, especially in Asia and Eastern Europe, where off-patent APIs are commonly sourced from local or regional manufacturers. Globally, the sourcing equation balances cost, quality, and regulatory ease.

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Key API Suppliers for Moricizine Hydrochloride

1. Major Global API Manufacturers

a. Toronto Research Chemicals (TRC)
TRC supplies a broad spectrum of research chemicals, including Moricizine hydrochloride in research-grade form. While primarily serving research institutions, TRC’s grade can be suitable for early-stage development, but pharmaceutical manufacturing typically requires more rigorous GMP-grade APIs.

b. Thermo Fisher Scientific
Thermo Fisher offers custom synthesis and API manufacturing services, potentially including Moricizine hydrochloride. Their capacity favors high-purity grades aligned with regulatory standards.

c. Octagon Chem
Specializes in pharmaceutical intermediates and APIs, including antiarrhythmic agents. Octagon Chem’s production facilities are GMP-compliant, aiming at both generic and innovator markets.

d. Jiangxi Hanking Pharmaceutical Co., Ltd.
Regionally prominent in China, Hanking supplies several antiarrhythmic APIs to both domestic and international markets. Located in China's Jiangxi Province, they offer competitive pricing and comply with Chinese GMP standards.

e. CJ CheilJedang
South Korea-based, CJ CheilJedang has capabilities in custom synthesis and API production, including antiarrhythmic drugs. Their manufacturing adheres to strict quality control and international standards.

2. Regional/Niche Suppliers

a. Zhejiang Medicine Co., Ltd.
This Chinese pharmaceutical enterprise supplies various APIs, including potential sourcing options for Moricizine hydrochloride. They leverage their extensive R&D and manufacturing infrastructure to serve both domestic and global markets.

b. Zhejiang Huiyi Pharmaceutical Co., Ltd.
They focus on cardiovascular API synthesis, with capabilities for producing antiarrhythmic agents, including Moricizine hydrochloride, under GMP conditions.

c. Wuxi AppTec
Wuxi AppTec provides custom synthesis and clinical manufacturing services, potentially producing Moricizine hydrochloride at different GMP levels tailored to the client’s stage of development.

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Regulatory and Quality Considerations

Suppliers must demonstrate compliance with international standards, notably GMP (Good Manufacturing Practice), ISO certifications, and EMEA/FDA validation records. Buyers should prioritize suppliers with robust quality systems and transparent supply chains, particularly for APIs destined for markets with strict regulatory environments like the US and EU.

For example, Chinese API suppliers often meet Chinese GMP standards, but buyers should verify the adherence to internationally recognized compliance standards for export to Western markets. European and US-based suppliers typically provide higher assurance through certifications like EMA or FDA inspections.

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Emerging Trends in API Sourcing

• Regional Diversification: Companies seek to diversify sources to mitigate supply chain risks, especially given geopolitical tensions and trade uncertainties.
• GMP and Quality Assurance: Increased emphasis on high-quality GMP production to satisfy regulatory expectations and avoid supply disruptions.
• Custom Synthesis: Growing reliance on CMOs for customized APIs tailored specifically to quality and formulation requirements.
• Sustainability and Traceability: Suppliers adopting sustainable practices and transparent supply chains to meet ESG standards and regulatory requirements.

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Challenges in Sourcing Moricizine Hydrochloride API

• Limited Market Incentives: The niche market results in fewer GMP-certified suppliers compared to more widely used APIs.
• Intellectual Property and Patents: Although Moricizine hydrochloride is off-patent, some suppliers may have proprietary synthesis routes that complicate sourcing.
• Regulatory Barriers: Variability in regional compliance standards limits the pool of suitable suppliers for international markets.
• Traceability and Quality Control: Ensuring consistency and purity across different batches and suppliers remains critical, necessitating stringent qualification procedures.

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Conclusion

Sourcing high-quality Moricizine hydrochloride APIs entails navigating a landscape comprising regional, specialized, and international suppliers, each with unique advantages and limitations. Leading global manufacturers such as Jiangxi Hanking and Wuxi AppTec are prominent options, especially for companies requiring GMP-grade APIs. Buyers should prioritize suppliers with proven regulatory compliance, transparent quality standards, and reliable supply chains to mitigate risks.

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Key Takeaways

• Access to Moricizine hydrochloride API is predominantly through regional Chinese manufacturers and select international CMOs.
• Rigorous compliance with GMP and other regulatory standards is paramount for pharmaceutical-grade APIs.
• Diversification of sourcing strategies buffers against geopolitical and supply chain disruptions.
• Due diligence on supplier quality practices and validation records protects market continuity.
• Strategic partnerships with established API manufacturers enhance reliability and regulatory acceptance.

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FAQs

1. What are the primary regions supplying Moricizine hydrochloride API?
The main supply regions include China, South Korea, and select European countries, with Chinese suppliers leading due to cost advantage and manufacturing capacity.

2. How can I verify the quality of Moricizine hydrochloride APIs from different suppliers?
Request comprehensive certificates of analysis (COA), GMP certification documentation, and validation records. Conduct audits or third-party inspections if necessary.

3. Are there GMP-certified suppliers of Moricizine hydrochloride API?
Yes, several Chinese and Korean manufacturers claim GMP certification, though due diligence is essential to verify validity and scope, especially for exporting to regulated markets.

4. What factors influence the choice of an API supplier for Moricizine hydrochloride?
Key factors include regulatory compliance, quality consistency, supply capacity, cost, delivery timelines, and the supplier’s reputation.

5. How does patent status affect sourcing options for Moricizine hydrochloride?
Moricizine hydrochloride is off-patent, facilitating wider access for generic manufacturers. However, proprietary synthesis routes may influence supplier availability or pricing.

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References

[1] "Active Pharmaceutical Ingredient (API) Market," MarketsandMarkets, 2022.
[2] "Guidelines on Good Manufacturing Practice for Active Pharmaceutical Ingredients," EMA, 2018.
[3] "Chinese GMP Certification Process," China Food and Drug Administration (CFDA), 2021.
[4] "Global API Suppliers Directory," Pharmaceutical Technology, 2022.
[5] "Sourcing Strategies for Critical APIs," International Pharmaceutical Industry Reports, 2021.