Bulk Pharmaceutical API Sources for SEROQUEL XR

Bulk Pharmaceutical API Sources for SEROQUEL XR

Vendor	Vendor Homepage	Vendor Sku	API Url
Hangzhou APIChem Technology		AC-4236
Molport		MolPort-006-069-133
AKos Consulting & Solutions		AKOS015855887
Finetech Industry Limited		FT-0655313
Key Organics/BIONET		KS-1099
AvaChem Scientific		1703
AvaChem Scientific		111974-72-2

Bulk Active Pharmaceutical Ingredient (API) Sources for: SEROQUEL XR

Last updated: August 4, 2025

Introduction

SEROQUEL XR, known generically as quetiapine fumarate, is an atypical antipsychotic medication prescribed for schizophrenia, bipolar disorder, and adjunctive depression treatment. As a highly regulated pharmaceutical, the supply chain for its active pharmaceutical ingredient (API) is critical to ensure product quality, regulatory compliance, and consistent market availability. This report explores the leading sources of quetiapine fumarate API, evaluating their manufacturing capabilities, quality standards, regulatory status, and market presence.

Market Landscape for Quetiapine Fumarate API

The global API market has seen significant growth driven by rising mental health disorders, expanded therapeutic indications, and the increase in generic drug approvals. The API for SEROQUEL XR is produced predominantly in regions with mature pharmaceutical manufacturing infrastructure, including India, China, and certain European countries. These regions offer cost-effective production, robust quality standards, and strong export capabilities.

The primary considerations for sourcing quetiapine fumarate API include regulatory compliance (particularly with the US FDA and EMA standards), manufacturing capacity, quality assurance systems, and the ability to meet high-volume demands typical of large pharmaceutical companies.[1]

Leading API Manufacturers for Quetiapine Fumarate

1. Mylan (Now part of Viatris)

Mylan, acquired by Viatris in 2020, has established a comprehensive API manufacturing network with facilities in India and Europe. Their manufacturing sites are US FDA and EMA approved, adhering to stringent cGMP standards. Mylan’s portfolio includes various APIs, notably quetiapine fumarate, with a focus on high quality, regulatory compliance, and consistent supply.[2]

2. Aurobindo Pharma

Aurobindo Pharma is a major Indian API producer with a robust pipeline that includes quetiapine fumarate. Their manufacturing plants in Hyderabad and other regions operate under cGMP conditions, with US FDA approval for multiple API facilities. Aurobindo emphasizes cost competitiveness while maintaining high quality, making them a prominent supplier in the global API market.[3]

3. Sandoz (Novartis)

Sandoz, the generics division of Novartis, supplies quetiapine fumarate API primarily from their facilities in Europe and India. Sandoz maintains high manufacturing standards and regulatory certifications, offering APIs that meet global quality benchmarks. Their presence in multiple regions allows for a diversified supply chain.[4]

4. Hetero Labs

Hetero Labs, based in India, is an established API manufacturer with US FDA approval for several products, including quetiapine fumarate. Hetero's focus on quality and innovative manufacturing processes has earned it a significant share in the API export market. Their facilities adhere to cGMP standards, supporting the supply needs of large-scale pharmaceutical companies.[5]

5. Zhejiang Hisun Pharmaceutical Co., Ltd.

This Chinese API producer is recognized for its extensive portfolio of psychiatric and central nervous system APIs, including quetiapine fumarate. Zhejiang Hisun's manufacturing facilities comply with international quality standards, and the company focuses on expanding its global export footprint, making it a key regional supplier.[6]

6. Dr. Reddy’s Laboratories

Dr. Reddy’s, an India-based pharmaceutical and API manufacturer, supplies quetiapine fumarate validated by multiple global regulatory agencies. Their API facilities are cGMP compliant, and the company emphasizes continuous quality improvement and scalable manufacturing capacity.[7]

7. Zhejiang Huahai Pharmaceutical Co., Ltd.

Zhejiang Huahai is a significant Chinese API producer with approval from the US FDA and other agencies. Their manufacturing sites incorporate advanced synthetic processes, ensuring high purity APIs that meet international standards.[8]

Regulatory and Quality Considerations

For sourcing APIs like quetiapine fumarate, regulatory oversight plays an essential role in ensuring product safety, efficacy, and compliance. Suppliers must adhere to current Good Manufacturing Practices (cGMP) and be approved by agencies such as the US FDA, EMA, or other regulatory bodies in key markets.

• US FDA Approval: Guarantees compliance with cGMP, robust quality systems, and contaminant control.
• EMA Approval: Similar standards to the FDA, with an emphasis on safety and efficacy.
• ISO Certification: Indicates adherence to quality management standards but does not replace regulatory approvals for APIs intended for pharmaceutical use.

Manufacturers with multiple certifications and proven track records tend to be preferred, especially for large-scale and long-term supply arrangements.[9]

Global Supply Chain Dynamics

The sourcing landscape for quetiapine fumarate API is characterized by regional strengths:

• India: Cost-effective, regulatory-compliant manufacturing, with a high number of cGMP-certified facilities. Indian API producers are key global suppliers with extensive export networks.
• China: Rapidly expanding capacity, with recent improvements in regulatory oversight, leading to increased trust from multinational pharmaceutical companies.
• Europe: Focused more on high-quality, niche API production, often serving markets with strict standards like the US and EU.

Supply chain resilience has become paramount, especially given trade tensions, regulatory changes, and pandemic-driven disruptions. Companies increasingly diversify their API sourcing to mitigate risks associated with geopolitical and logistical challenges.[10]

Emerging Trends

• API Quality Standardization: Enhanced focus on harmonized quality control, facilitated by international regulatory cooperation.
• Vertical Integration: Larger pharmaceutical manufacturers investing in their own API production to secure supply chains.
• Green Chemistry Initiatives: Adoption of environmentally sustainable manufacturing processes to reduce ecological impacts.
• Technological Innovations: Utilization of continuous manufacturing and process analytical technology to improve API quality and consistency.

Conclusion

The API sourcing landscape for SEROQUEL XR (quetiapine fumarate) is driven by the need for high-quality,-regulatory compliant, and reliably available supply. Major manufacturers—including Mylan (Viatris), Aurobindo, Sandoz, Hetero Labs, Zhejiang Hisun, Dr. Reddy’s, and Zhejiang Huahai—stand out as key global suppliers. Their diversified geographic footprints and adherence to strict regulatory standards facilitate secure supply chains vital to the sustained production of SEROQUEL XR.

Key Takeaways

• Diversify Supplier Portfolio: Rely on multiple reputable API manufacturers across regions to mitigate risks.
• Prioritize Regulatory Compliance: Confirm suppliers possess necessary approvals (FDA, EMA) and certifications (cGMP, ISO).
• Assess Supply Chain Resilience: Consider geopolitical factors and manufacturing capacity to ensure continuous supply.
• Stay Updated on Industry Trends: Monitor innovations such as green chemistry and continuous manufacturing, which influence API quality and sustainability.
• Negotiate Long-term Agreements: Establish strategic partnerships with reliable API suppliers to secure pricing, quality, and supply commitments.

FAQs

1. How do I verify the regulatory compliance of quetiapine fumarate API manufacturers?
Verify approval status through regulatory agency databases (e.g., US FDA’s ORA database), review cGMP certificates, and request recent audit reports or certifications to ensure adherence to international standards.

2. What are the benefits of sourcing APIs from Indian versus Chinese manufacturers?
Indian APIs often offer cost advantages and are widely approved globally, while Chinese manufacturers have expanded their capacity and regulatory compliance. Both regions have reputable suppliers; choice depends on regulatory preferences, cost, and supply chain considerations.

3. How does the quality of quetiapine fumarate API impact SEROQUEL XR’s efficacy?
High-quality API ensures consistent potency, purity, and stability, directly affecting drug safety and therapeutic efficacy. Substandard APIs can lead to variability, side effects, or regulatory issues.

4. What are the emerging risks in the global API supply chain?
Risks include geopolitical tensions, trade restrictions, regulatory changes, pandemic-related disruptions, and environmental challenges affecting manufacturing operations and supply continuity.

5. How can pharmaceutical companies mitigate API supply risks for SEROQUEL XR?
Diversify supplier sources, maintain safety stock, develop relationships with multiple approved manufacturers, and include contractual clauses ensuring supply continuity and quality assurance.

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Sources:

[1] MarketWatch. “Active Pharmaceutical Ingredients (API) Market Size, Trends & Growth Analysis.” 2022.
[2] Viatris (formerly Mylan). Corporate Reports and Regulatory Filings, 2022.
[3] Aurobindo Pharma. Annual Report 2022.
[4] Sandoz. Product Portfolio and Regulatory Approvals, 2022.
[5] Hetero Labs. API Manufacturing Capabilities, 2022.
[6] Zhejiang Hisun Pharmaceutical Co., Ltd. Regulatory Certificates, 2022.
[7] Dr. Reddy’s Laboratories. Annual Review, 2022.
[8] Zhejiang Huahai Pharmaceutical. FDA Inspection Reports, 2022.
[9] U.S. FDA. Guidance for Industry on API Quality, 2020.
[10] IQVIA. Global Supply Chain Risks Report, 2022.