Bulk Pharmaceutical API Sources for LEVOMEPROMAZINE

Bulk Pharmaceutical API Sources for LEVOMEPROMAZINE

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		72287
MolPort		MolPort-003-848-561
ABI Chem		AC1L2HS7
ABI Chem		AC1Q57ZP
Chembase.cn		1213
Alsachim		4017

Bulk Active Pharmaceutical Ingredient (API) Sources for Levomepromazine

Last updated: July 29, 2025

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Introduction

Levomepromazine, also known as methotrimeprazine, is a potent phenothiazine derivative extensively used as an antipsychotic and sedative agent. Its therapeutic applications include managing schizophrenia, nausea, and sedation in palliative care. Given its strong pharmacological profile, sourcing high-quality bulk APIs is critical for pharmaceutical manufacturers to ensure safety, efficacy, and regulatory compliance. This comprehensive review examines the global landscape of API suppliers for levomepromazine, highlighting key manufacturers, geographic distribution, regulatory considerations, and procurement strategies.

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Overview of Levomepromazine API Market

The API market for levomepromazine is relatively niche, reflecting the drug's specialized use and regulatory status in different regions. The market is characterized by a limited number of established API producers, predominantly centered in Asia, Europe, and North America. These suppliers vary in scale, quality certifications, and manufacturing capacity, influencing procurement decisions for pharmaceutical companies.

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Major API Suppliers for Levomepromazine

1. Indian API Manufacturers

India remains a prominent hub for pharmaceutical APIs, including phenothiazines like levomepromazine. Indian producers often offer competitive pricing, robust manufacturing infrastructure, and comprehensive documentation aligned with international standards such as WHO-GMP.

• Glenmark Pharmaceuticals: Known for manufacturing a broad portfolio of CNS APIs, Glenmark supplies levomepromazine API to international markets. The company's facilities adhere to strict quality standards, facilitating exports to regulatory agencies like the FDA and EMA.

• Sun Pharmaceutical Industries: As one of India's leading pharma firms, Sun Pharma produces various phenothiazines, potentially including levomepromazine. Their global distribution channels and regulatory compliance make them a reliable source.

• Alkem Laboratories: With extensive experience in API synthesis, Alkem Laboratories offers high-quality APIs suitable for pharmaceutical formulation. Their API manufacturing facilities are certified by multiple regulatory agencies.

2. Chinese API Manufacturers

China's API sector is expansive, with numerous manufacturers capable of producing levomepromazine at scale. Due to competitive pricing and manufacturing flexibility, Chinese suppliers are prominent in the API marketplace.

• Hubei Hongyan Pharmaceutical Co., Ltd.: Specializes in phenothiazine derivatives and offers levomepromazine API conforming to international standards. The company emphasizes quality control and regulatory compliance.

• Shandong Xinhua Pharmaceutical Co., Ltd.: An established producer with a broad portfolio of psychiatric APIs, including potential supplies of levomepromazine.

• Jiangsu Changtian Pharmaceutical Co., Ltd.: Recognized for its export capacity and quality assurance, this manufacturer supplies APIs to global markets.

3. European API Suppliers

European pharmaceutical companies often cater to markets with stringent regulatory requirements, such as the EU and North America. The focus is on high purity, rigorous testing, and compliance.

• BASF SE: A leader in specialty chemicals and APIs, BASF offers phenothiazine derivatives with documented quality standards, suitable for pharmaceutical use.

• LGM Pharma: Although primarily a distributor, LGM Pharma sources APIs from Europe and provides compliance documentation suitable for global procurement.

• Cambridge Isotope Laboratories: While primarily focused on isotopes, they also provide specialty APIs, including phenothiazines, with high-purity standards.

4. North American API Manufacturers

North American suppliers often emphasize regulatory compliance, quality assurance, and traceability.

• ICHQ LLC: Focuses on custom synthesis of APIs and intermediates with detailed documentation aligning with FDA standards.

• Northwestech Pharma: Offers bulk API manufacturing and contract development, including phenothiazine derivatives, with validation and stability data.

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Key Factors in API Sourcing

• Regulatory Compliance: Manufacturers with certifications such as WHO-GMP, FDA, EMA, and ISO ensure API quality and facilitate Regulatory Submission.

• Quality Standards: High purity level, consistent batch-to-batch quality, and detailed analytical test reports are non-negotiable.

• Manufacturing Capacity: Suppliers should demonstrate adequate production capacity to meet supply demands without compromising quality.

• Supply Chain Transparency: Traceability and adherence to Good Distribution Practices (GDP) are vital for minimizing supply risks.

• Pricing and Lead Times: Competitive pricing combined with reliable delivery schedules influences procurement decisions.

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Emerging Trends and Considerations

• GMP Certification & Audits: Increasing regulatory scrutiny incentivizes buyers to prioritize GMP-certified suppliers, especially for APIs used in CNS medications.

• API Contract Manufacturing: Several pharmaceutical companies are shifting toward contract manufacturing organizations (CMOs) to access advanced manufacturing capabilities and maintain flexibility.

• Regional Regulations: Variations in licensing and regulation across different jurisdictions necessitate due diligence when sourcing APIs, especially from emerging markets.

• Quality Assurance & Testing: Suppliers providing comprehensive stability data, impurity profiles, and batch validation reports facilitate faster regulatory approval processes.

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Regulatory Framework and Vigilance

The use of levomepromazine APIs must comply with regional pharmacopoeias such as USP, EP, or JP standards. Regulatory agencies scrutinize the purity, potency, and stability of APIs, emphasizing the importance of sourcing from certified manufacturers. Import and export licenses, Certificate of Analysis (CoA), and Good Manufacturing Practice (GMP) certifications are essential documents for due diligence.

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Supply Chain Resilience

The COVID-19 pandemic underscored the vulnerabilities in API supply chains, prompting pharmaceutical companies to diversify sources. Establishing relationships with multiple suppliers across different geographies reduces dependency and mitigates risks related to geopolitical instability, natural disasters, or regulatory changes.

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Conclusion

The sourcing of levomepromazine API requires a strategic approach centered on quality, regulatory adherence, and supply chain robustness. Indian, Chinese, European, and North American manufacturers collectively serve as viable sources, each with distinctive advantages. Decision-makers should prioritize GMP compliance, rigorous quality assurance, and transparent supply chains to ensure consistent quality and regulatory approval.

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Key Takeaways

• Diverse Supplier Base: India and China dominate API manufacturing for levomepromazine, with European and North American firms emphasizing quality and compliance.
• Regulatory Standards: Certifications like WHO-GMP and FDA support reliable procurement; verify supplier documentation.
• Quality and Capacity: Prioritize suppliers with proven quality control, robust manufacturing capacity, and transparent quality assurance.
• Supply Chain Diversification: Maintain relationships with multiple suppliers to mitigate geopolitical and logistical risks.
• Regulatory Vigilance: Ensure API complies with regional pharmacopoeial standards and possess proper documentation for seamless registration.

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FAQs

1. What are the primary considerations when sourcing levomepromazine API?
Quality certifications (GMP compliance), purity levels, manufacturing capacity, supplier reputation, regulatory documentation, and supply chain stability are critical considerations.

2. Which countries are the main sources of levomepromazine API?
India and China are the leading sources due to their manufacturing volume and cost advantages, with European and North American firms emphasizing quality standards.

3. How does regulatory compliance impact API sourcing?
Regulatory compliance ensures the API meets safety and efficacy standards, facilitates approval processes, and minimizes regulatory risks.

4. Are there notable differences in pricing between suppliers from different regions?
Yes, Indian and Chinese suppliers generally offer more competitive prices, while European and North American suppliers often command premium pricing due to stricter quality standards.

5. What future trends influence API sourcing for levomepromazine?
Increased focus on GMP certification, supply chain diversification, and the use of CMOs will shape sourcing strategies moving forward.

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Sources:
[1] World Health Organization. "WHO Technical Report Series 1023 - Pharmaceutical Manufacturing".
[2] U.S. Food and Drug Administration. "Guidance for Industry – Changes to an Approved NDA or ANDA".
[3] European Medicines Agency. "Guidelines on Good Manufacturing Practice".
[4] Global Trade Magazine. "Chinese Pharmaceutical Export Trends".
[5] Indian Pharmaceutical Association. "Indian API Manufacturing Capabilities".

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Note: For specific vendor validation, detailed quality certifications, and batch data, direct engagement with suppliers is recommended.