Bulk Pharmaceutical API Sources for ETHOPROPAZINE HYDROCHLORIDE

Bulk Pharmaceutical API Sources for ETHOPROPAZINE HYDROCHLORIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		122824
MolPort		MolPort-003-666-188
AAA Chemistry		AR-1I7814
ABI Chem		AC1L3VBR
ABI Chem		AC1Q3FBW
ISpharm		I14-15990

Bulk Active Pharmaceutical Ingredient (API) Sources for Ethopropazine Hydrochloride

Last updated: August 18, 2025

Introduction

Ethopropazine hydrochloride, a reversible cholinergic antagonist, primarily treats gastrointestinal motility disorders and certain neurological conditions. As a critical pharmaceutical ingredient, the sourcing of high-quality bulk APIs is essential for manufacturers to ensure product safety, efficacy, and regulatory compliance. The global supply landscape for ethopropazine hydrochloride APIs features diverse suppliers, ranging from established pharmaceutical ingredient manufacturers in Asia to emerging suppliers in Europe and North America.

Global API Suppliers for Ethopropazine Hydrochloride

1. Asian Manufacturers

Asia remains the predominant hub for the manufacturing and export of bulk APIs due to cost advantages, extensive production capacities, and a well-developed API manufacturing ecosystem.

• Chinese API Producers: China is a leading supplier of ethopropazine hydrochloride APIs, with several licensed manufacturers capable of producing both GMP-compliant and non-GMP-grade products. Companies like Hebei Shuangji Chemical Co., Ltd. and Zhejiang Kangle Pharmaceutical Co., Ltd. have been recognized for their production capacities. These manufacturers often supply APIs to various markets, including Europe, North America, and emerging markets.

• Indian Manufacturers: India’s pharmaceutical industry hosts multiple suppliers specializing in small-molecule APIs, including ethopropazine hydrochloride. Firms such as Sunny Pharmaceutical and Granules India provide bulk APIs, often under GMP certification, catering to both domestic and export markets.

2. European Suppliers

While European manufacturers are fewer compared to Asian counterparts, they tend to emphasize higher regulatory standards, including stringent GMP compliance, and often supply APIs suitable for regulated markets.

• European Contract Manufacturing Organizations (CMOs): Companies like Catalent and Recipharm host capabilities for synthesis and supply of niche APIs, including ethopropazine hydrochloride, mainly targeting clinical trials and high-quality production.

• Specialized API Suppliers: Certain European chemical companies, such as Fareva and GMP-grade API producers in Germany and France, may produce ethopropazine hydrochloride, especially for clients requiring high-purity grades conforming to EMA standards.

3. North American Suppliers

The North American market relies heavily on imports for ethopropazine hydrochloride APIs due to limited local production. However, some North American companies maintain strategic stockpiles or distribution agreements.

• Contract API Manufacturers: Companies like Alcami and Carbosynth affiliate with global API suppliers or manufacture limited custom synthesis programs to meet demand.

Regulatory Considerations

Suppliers across regions are required to adhere to cGMP standards to ensure API quality and traceability. Regulatory agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and China's NMPA (National Medical Products Administration) govern manufacturing practices. Ensuring compliance is critical for API sourcing, especially for large-scale commercial manufacture.

Factors Influencing API Supplier Selection

• Quality Certifications: GMP compliance, ISO certifications, and batch consistency.
• Regulatory Reputation: Manufacturer’s history within regulatory agencies, inspections, and audits.
• Supply Reliability: Production capacity, lead times, and scalability.
• Cost Factors: Price competitiveness, transportation costs, and payment terms.
• Traceability and Documentation: Robust lot tracking, stability data, and batch documentation.

Emerging Trends and Considerations

The API supply landscape is evolving with increased supply chain resilience, quality assurance, and the adoption of digital traceability tools. Diversification of supplier base to mitigate geopolitical and logistical risks is gaining prominence. Additionally, the demand for higher-purity, pharmaceutical-grade APIs compels manufacturers to prioritize suppliers with proven compliance and quality management systems.

Conclusion

The sourcing of bulk ethopropazine hydrochloride APIs spans globally, with key production centers in China, India, Europe, and North America. Effective procurement hinges on assessing regulatory compliance, supply stability, and product quality. As the pharmaceutical industry emphasizes supply chain integrity, selecting verified, GMP-compliant suppliers aligned with regulatory standards is imperative for consistent product manufacturing.

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Key Takeaways

• Asia dominates the ethopropazine hydrochloride API market, offering cost-effective, high-capacity manufacturing options primarily in China and India.
• European and North American suppliers generally focus on higher regulatory standards, catering to markets with stringent compliance demands.
• Regulatory compliance (GMP) remains the cornerstone for supplier qualification, ensuring API quality and traceability.
• Diversifying supplier sources mitigates risks associated with geopolitical, logistical, and supply chain disruptions.
• Emerging trends include increased adoption of digital traceability, focus on higher purity standards, and supply chain resilience measures.

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Frequently Asked Questions (FAQs)

1. What factors should I consider when sourcing ethopropazine hydrochloride API?
Prioritize GMP compliance, supplier reputation, production capacity, regulatory track record, and cost competitiveness. Verify documentation and conduct audits if possible.

2. Are there regional differences in API quality standards for ethopropazine hydrochloride?
Yes. European and North American suppliers often adhere to stricter standards set by EMA and FDA, respectively, while Asian manufacturers may have varying compliance levels, making regulatory verification essential.

3. How do I ensure the quality of APIs from overseas suppliers?
Require comprehensive documentation, certifications (GMP, ISO), batch testing results, and, if feasible, conduct supplier audits or third-party inspections.

4. Is China still the dominant supplier for ethopropazine hydrochloride APIs?
Yes. Chinese manufacturers continue to be major players due to high capacity and competitive pricing, but buyers should ensure rigorous compliance verification.

5. What are the risks associated with sourcing APIs from emerging suppliers?
Risks include inconsistent quality, regulatory non-compliance, supply delays, and lack of adequate documentation. Mitigating these risks involves thorough vetting and establishing quality agreements.

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References

[1] European Directorate for the Quality of Medicines & HealthCare. “Good Manufacturing Practices (GMP) for Medicinal Products.” 2022.
[2] U.S. Food and Drug Administration. “Guidance for Industry: GOOD MANUFACTURING PRACTICE FOR ACTIVE PHARMACEUTICAL INGREDIENTS.” 2021.
[3] Global API Market Reports, IQVIA. “Pharmaceutical Ingredient Supply Chain Insights.” 2022.
[4] China Pharmaceutical Industry Association. “API Manufacturing Standards and Compliance Reports.” 2022.
[5] Indian Pharmaceutical Alliance. “API Industry Overview and Regulatory Standards.” 2022.