Bulk Pharmaceutical API Sources for EVEKEO ODT

Bulk Pharmaceutical API Sources for EVEKEO ODT

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		6055
AAA Chemistry		AR-1C5353
ABI Chem		AC1L1LPC
ABI Chem		AC1Q6XE8
Chembase.cn		131805
ChemTik		CTK8D7022
Sigma-Aldrich		A1263_SIGMA

Bulk Active Pharmaceutical Ingredient (API) Sources for EVEKEO ODT

Last updated: July 31, 2025

Introduction

EVEKEO ODT (Orally Disintegrating Tablet) is a prescription drug primarily used for the treatment of adult and adolescent patients with schizophrenia and bipolar I disorder. Its efficacy hinges on the active pharmaceutical ingredient (API), which in this case is quetiapine fumarate. Ensuring a reliable, high-quality supply of quetiapine fumarate API is crucial for pharmaceutical manufacturers aiming to produce EVEKEO ODT at scale. This article provides an in-depth analysis of potential API sources, their market dynamics, and quality considerations pertinent to manufacturers and stakeholders in the pharmaceutical supply chain.

Understanding Quetiapine Fumarate API

Quetiapine fumarate is a second-generation antipsychotic with a complex synthesis process. It is critical to source APIs that meet stringent quality standards, including compliance with the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and other regulatory requirements. Suppliers must demonstrate Good Manufacturing Practice (GMP) compliance, robust quality assurance systems, and reliable logistics.

Global API Manufacturing Landscape for Quetiapine Fumarate

The global market for quetiapine fumarate API is characterized by a mixture of established multinational pharmaceutical ingredient producers and emerging regional manufacturers. These suppliers are distributed primarily among India, China, Europe, and the United States, each offering distinct advantages regarding cost, quality, and certification.

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Leading API Suppliers for Quetiapine Fumarate

1. India

India remains the dominant hub for generic API manufacturing, including quetiapine fumarate, due to its cost-effectiveness, extensive manufacturing capacity, and compliance with international quality standards.

• Sun Pharmaceutical Industries Ltd.: As one of India's largest pharmaceutical companies, Sun Pharma produces a range of APIs, including quetiapine fumarate, exported globally under strict GMP guidelines. The company’s API facilities are WHO-GMP and USFDA compliant.

• Lupin Limited: Lupin manufactures quetiapine fumarate API in its GMP-certified plants. It supports a significant portion of the global generics market with its robust supply chain and quality assurance systems.

• Aurobindo Pharma: Aurobindo offers high-quality APIs with facilities approved by major regulators. They have a strong export footprint, especially for North American and European markets.

• Cipla Limited: Cipla's API manufacturing arm produces quetiapine fumarate with a focus on quality and European and US compliance, supporting both branded and generic formulations.

2. China

China's API sector is notable for massive production capacity, competitive pricing, and increasingly stringent quality controls.

• Zhejiang Hisun Pharmaceuticals: A Chinese company with a growing portfolio in psychiatric APIs, including quetiapine fumarate, supported by GMP certification and export licenses worldwide.

• Zhejiang Huahai Pharmaceutical: Known for complex synthetic APIs, Huahai supplies various antipsychotics, including quetiapine fumarate, with certifications conforming to international standards.

• Shandong Fuhui Pharmaceutical: A regional supplier with emerging presence in the global market, offering competitively priced APIs with GMP approvals.

3. Europe

European API producers tend to focus on high purity, stringent quality control, and compliance with European Medicines Agency (EMA) standards.

• Van Vlierberghe Pharma: Based in Belgium, specializes in psychiatric APIs, including quetiapine fumarate, with GMP certification adhering to EMA guidelines.

• Famar (Greece/France): A reliable supplier of high-quality APIs, Famar maintains GMP compliance and provides APIs meeting both EU and US standards.

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US and Other North American API Providers

While fewer US-based manufacturers produce quetiapine fumarate API due to manufacturing costs, some smaller companies or repackers may serve niche markets or offer intermediates.

• NDA-certified suppliers in North America: These include select players with FDA-approved facilities capable of producing high-purity APIs, often serving specialty or clinical needs.

Quality & Regulatory Considerations

Selecting an API supplier for EVEKEO ODT demands vigilant evaluation of several factors:

• GMP Compliance: Suppliers should have current Good Manufacturing Practice (GMP) certifications from major regulatory agencies (FDA, EMA, TGA, WHO).

• Certifications & Documentation: Certificates of Analysis (CoA), Certificate of Suitability (CoS), and raw material certifications are essential for validation.

• Manufacturing Capacity & Lead Time: Consistent supply capabilities, scalability, and logistical reliability are crucial, especially amid global supply chain disruptions.

• Quality Assurance & Control Measures: Suppliers must adhere to pharmacopoeial standards, with rigorous in-process and finished product testing.

• Pricing Dynamics: Cost competitiveness is influenced by regional manufacturing costs, scale, and regulatory compliance expenses.

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Emerging Trends and Future Outlook

The COVID-19 pandemic has accentuated supply chain vulnerabilities, prompting pharmaceutical companies to diversify sourcing strategies. There is increasing interest in establishing dual sourcing agreements to mitigate risks of interruptions and ensure API quality.

Furthermore, advancements in synthetic chemistry and process optimization are enabling suppliers to improve yields, reduce costs, and enhance API purity. Companies investing in continuous manufacturing and quality management systems are better positioned for long-term partnerships.

Regulatory Harmonization efforts between regions, like ICH guidelines, facilitate easier market access for APIs from diverse geographies, broadening the supplier base.

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Conclusion

The landscape of bulk API sourcing for quetiapine fumarate—central to EVEKEO ODT production—is poised for continued evolution, shaped by regulatory standards, manufacturing innovations, and geopolitical factors. Indian and Chinese suppliers dominate globally owing to cost advantages and production capacity, while European manufacturers emphasize quality and compliance. Collaborating with reputable, certified suppliers is essential for pharmaceutical companies seeking reliable, high-quality API sources.

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Key Takeaways

• Diversification mitigates risk: Relying on multiple suppliers across regions ensures supply continuity.
• Regulatory compliance is non-negotiable: Ensure suppliers hold GMP certifications and provide necessary regulatory documentation.
• Capacity and scalability matter: Select partners capable of meeting production demands consistently.
• Regional advantages: Indian and Chinese suppliers offer cost benefits; European suppliers emphasize quality and compliance.
• Ongoing due diligence: Regular audits, supplier qualification, and quality assessments sustain supply chain integrity.

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FAQs

1. What are the primary regions producing quetiapine fumarate API?
India and China account for the majority of global quetiapine fumarate API manufacturing, supported by European producers emphasizing high standards.

2. How do quality requirements differ between suppliers?
Suppliers from Europe typically maintain more rigorous adherence to EMA standards, whereas Indian and Chinese manufacturers meet WHO-GMP and USFDA standards, depending on certification and client needs.

3. Is sourcing from China riskier than from India?
Risks relate to regulatory compliance and quality adherence. However, many Chinese manufacturers now possess internationally recognized GMP certifications, reducing such concerns.

4. How can manufacturers verify API supplier compliance?
Through audits, reviewing certifications (GMP, CoA, CoS), visiting facilities, and ongoing quality monitoring.

5. What future trends impact API sourcing for psychiatric drugs like quetiapine fumarate?
Increased regulation harmonization, supply chain diversification post-pandemic, and technological advancements in manufacturing will shape sourcing strategies.

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Sources

1. [1] Indian Pharmaceutical Industry Overview, Pharmacompass.
2. [2] China API Manufacturers Directory, Chinese Pharmaceutical Association.
3. [3] European Pharmacopoeia Monographs, EMA.
4. [4] USFDA Approved API Facilities, FDA Database.
5. [5] Global API Supply Chain Report, IQVIA.