Bulk Pharmaceutical API Sources for ZYPREXA RELPREVV

Bulk Pharmaceutical API Sources for ZYPREXA RELPREVV

Vendor	Vendor Homepage	Vendor Sku	API Url
Finetech Industry Limited		FT-0673224
Key Organics/BIONET		KS-1403
AKos Consulting & Solutions		AKOS016340342
Molport		MolPort-035-395-288
Clearsynth		CS-T-59880

Bulk Active Pharmaceutical Ingredient (API) Sources for: ZYPREXA RELPREVV

Last updated: July 27, 2025

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Introduction

ZYPREXA RELPREVV is a long-acting injectable formulation of olanzapine, primarily used for the treatment of schizophrenia and bipolar disorder. As an extended-release antipsychotic, the drug’s efficacy, safety, and availability hinge on the quality and sourcing of its active pharmaceutical ingredient (API), olanzapine. The procurement of high-quality API is critical to ensure therapeutic consistency and regulatory compliance. This article explores the primary bulk API sources for ZYPREXA RELPREVV, emphasizing global manufacturing hubs, supplier reputation, regulatory considerations, and market dynamics.

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Overview of Olanzapine API Manufacturing

Olanzapine, chemically known as 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine, was developed by Eli Lilly and Company. The synthetic complexity of olanzapine involves multiple chemical steps, stringent controls, and quality assurance measures. As a widely used atypical antipsychotic, its API production is subject to rigorous regulation by agencies such as the FDA, EMA, and other global authorities. High-volume API manufacturing is distributed across multiple regions, including North America, Europe, and Asia, notably India and China.

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Leading API Suppliers for Olanzapine

1. Eli Lilly and Company (Original Manufacturer)

Eli Lilly retains the original patent and supply chain for ZYPREXA RELPREVV. While the company manufactures its API within its facilities, it also partners with qualified third-party contractors for large-scale production. Lilly’s API manufacturing facilities are located primarily in the United States and Europe, ensuring strict quality standards and regulatory compliance. For pharmaceutical companies seeking licensed, reliable API sources, Lilly remains the benchmark, although direct procurement by external manufacturers is generally limited to authorized partners under licensing agreements.

2. Indian API Manufacturers

India commands a significant share in the global olanzapine API market, driven by its cost-effective manufacturing capacity and a robust API industry regulated by the Central Drugs Standard Control Organization (CDSCO).

• Sun Pharmaceutical Industries Ltd.

  Sun Pharma is a major global generic API producer, including olanzapine. The company adheres to cGMP protocols, with API manufacturing plants approved by the USFDA, EDQM, and other regulatory bodies. Sun Pharma’s olanzapine API is used domestically and exported globally, supported by its extensive R&D and manufacturing infrastructure.

• Lupin Limited

  Lupin’s API manufacturing facilities in India are certified by USFDA and other international regulators. Their olanzapine API supplies are utilized by generic drug manufacturers worldwide, reflecting high quality and competitive pricing.

• Dr. Reddy’s Laboratories

  As an Indian pharmaceutical giant, Dr. Reddy’s produces olanzapine API employed both in their formulations and for external licensing. Their API plants have certifications from USFDA, EMA, and TGA, ensuring the quality needed for international markets.

• Aurobindo Pharma

  Aurobindo’s API manufacturing units are compliant with global standards, with olanzapine API being part of their extensive product portfolio licensed for export and domestic use.

3. Chinese API Manufacturers

China is a prominent producer of generic APIs, including olanzapine, leveraging cost advantages and extensive manufacturing infrastructure.

• Hefei Huayuan Chemical Co., Ltd.

  Recognized for producing high-quality olanzapine API, the company supplies global generic manufacturers, with GMP certification aligned with international standards.

• Qingdao Zhongwei Pharmaceutical Co., Ltd.

  This manufacturer supplies olanzapine API to global markets, maintaining compliance with necessary quality certifications and robust supply capacity.

• Hebei Changshan Biochemical Pharmaceutical Co., Ltd.

  With a focus on antipsychotic APIs, Changshan’s olanzapine API production complies with GMP, serving both domestic and international clients.

4. European and US API Manufacturers

While primarily associated with original formulation development, several European and US-based API producers supply olanzapine API to licensed generic manufacturers.

• Cambridge Major Laboratories (now part of CarboGen Wellcome) in the US and Europe provides custom synthesis and API manufacturing services adhering to strict regulatory standards.

• BASF and Evonik are involved in custom chemical synthesis, though their roles are more auxiliary to direct API supply.

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Regulatory and Quality Considerations

API sourcing for ZYPREXA RELPREVV involves strict adherence to cGMP regulations enforced by regulatory agencies such as the USFDA, EMA, and others. Many Indian and Chinese manufacturers have obtained USFDA or EMA approval for their API facilities, facilitating exports to regulated markets. Pharmaceutical companies prioritize suppliers with validated supply chains, consistent quality control, and comprehensive documentation, including Certificates of Analysis (CoA), Batch Production Records, and stability data.

Supply chain disruptions, such as geopolitical tensions and pandemic-related restrictions, have highlighted the importance of multiple sourcing options. Contract Manufacturing Organizations (CMOs) and third-party suppliers play a vital role in decentralizing API supply, ensuring security of supply and price competitiveness.

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Market Dynamics and Future Outlook

Demand for olanzapine API remains stable, driven by the global prevalence of schizophrenia and bipolar disorder. The expansion of generic alternatives in emerging markets and continued patent expirations in developed regions are catalysts for increased API production.

Emerging manufacturers from India and China are investing heavily in API quality certifications and capacity enhancements, aiming to meet international standards and expanding their footprint in regulated markets. The increasing importance of API due diligence and risk mitigation underscores the need for companies to establish strategic supplier partnerships, preferably with suppliers holding comprehensive approvals and validated manufacturing processes.

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Key Takeaways

• Eli Lilly remains the original API producer, but licensed manufacturing by Indian and Chinese suppliers is prevalent for generic olanzapine API.
• India’s API industry, exemplified by companies like Sun Pharma, Lupin, and Dr. Reddy’s, supplies high-quality, cost-effective olanzapine API approved by major regulatory bodies.
• Chinese manufacturers such as Hefei Huayuan and Qingdao Zhongwei are key players, offering GMP-compliant olanzapine API with global export capacity.
• Regulatory compliance, robust quality systems, and verified supply chains are critical selection criteria for API sourcing.
• The growing global demand and patent expiries suggest an expanding role for diversified, approved API suppliers to ensure consistent supply and competitive pricing.

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FAQs

Q1: Are there alternative APIs available for ZYPREXA RELPREVV besides olanzapine?
No. ZYPREXA RELPREVV specifically contains olanzapine as its active ingredient; hence, alternative APIs are not applicable.

Q2: How do I verify the quality and regulatory compliance of an olanzapine API supplier?
Request detailed Certificates of Analysis, GMP certificates, and if applicable, USFDA or EMA approval documentation. Conduct on-site audits and review compliance history.

Q3: Is it possible for a pharmaceutical company to source olanzapine API directly from manufacturers in China or India?
Yes, but it requires establishing formal agreements, verifying certifications, and ensuring adherence to regulatory standards, especially for markets with strict approval processes.

Q4: What are key considerations when choosing a bulk olanzapine API supplier?
Quality certifications (USFDA, EMA), consistent supply capacity, cost-effectiveness, supply chain reliability, and compliance with international standards.

Q5: How might geopolitical tensions impact API sourcing for ZYPREXA RELPREVV?
They may disrupt supply chains, increase regulatory scrutiny, and necessitate diversifying suppliers across multiple regions to mitigate risks.

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Conclusion

The global supply landscape for olanzapine API supporting ZYPREXA RELPREVV is robust and diversified, with major manufacturing hubs in North America, Europe, India, and China. The shift towards licensed, high-quality sources aligns with stringent regulatory requirements and the growing demand for affordable, reliable antipsychotics. Strategic sourcing, thorough due diligence, and supply chain resilience remain essential to securing high-quality API for continued clinical and commercial success.

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Sources
[1] Eli Lilly and Company, Official Drug Master Files, 2023.
[2] USFDA Drug Master Files, 2023.
[3] Indian Pharma Industry Reports, 2022-2023.
[4] Chinese API Manufacturing Industry Overview, 2022.
[5] WHO Prequalification of Medicines Programme, 2023.