Suppliers and packagers for generic pharmaceutical drug: ILOPERIDONE

ILOPERIDONE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Vanda Pharms Inc	FANAPT	iloperidone	TABLET;ORAL	022192	NDA	Vanda Pharmaceuticals Inc.	43068-101-02	60 TABLET in 1 BOTTLE (43068-101-02)	2016-05-01
Vanda Pharms Inc	FANAPT	iloperidone	TABLET;ORAL	022192	NDA	Vanda Pharmaceuticals Inc.	43068-102-02	60 TABLET in 1 BOTTLE (43068-102-02)	2016-08-01
Vanda Pharms Inc	FANAPT	iloperidone	TABLET;ORAL	022192	NDA	Vanda Pharmaceuticals Inc.	43068-104-02	60 TABLET in 1 BOTTLE (43068-104-02)	2015-12-15

Suppliers for the Pharmaceutical Drug: ILOPERIDONE

Last updated: July 28, 2025

Introduction

Iloperidone, marketed under brand names such as Fanapt, is an atypical antipsychotic primarily prescribed for schizophrenia. Developed by Vanda Pharmaceuticals, it functions as a dopamine D2 and serotonin 5-HT2A receptor antagonist. As a specialized pharmaceutical, its production and distribution involve a complex web of suppliers spanning active pharmaceutical ingredient (API) manufacturing, formulation, packaging, and distribution. This article thoroughly explores the key suppliers involved in the iloperidone supply chain, analyzing their roles, regional presence, and market significance.

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Overview of the Iloperidone Supply Chain

The supply of iloperidone encompasses:

• Active Pharmaceutical Ingredient (API) Production: The core chemical component.
• Formulation and Finished Dosage Manufacturing: Conversion of API into tablets or capsules.
• Packaging and Distribution: Ensuring product integrity and delivery to markets globally.

The critical bottleneck resides at the API supply level, which often involves specialized chemical synthesis, ensuring regulatory compliance, and meeting quality standards.

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API Manufacturers for Iloperidone

1. Vanda Pharmaceuticals

Though Vanda Pharmaceuticals is the patent holder and marketer of iloperidone, they typically do not manufacture the API internally. Instead, they collaborate with third-party API producers, emphasizing the importance of contract manufacturing organizations (CMOs).

2. Contract Manufacturing Organizations (CMOs)

Many pharmaceutical companies outsource API synthesis to CMOs with expertise in complex chemical processes. Several well-known CMOs are recognized within the pharmaceutical industry for producing APIs like iloperidone:

• Junsei Chemical Co., Ltd. (Japan)
  Junsei specializes in fine chemicals and intermediates for pharmaceutical synthesis. Although their portfolio is extensive, specific involvement in iloperidone API manufacturing remains proprietary or unconfirmed publicly.

• H. Reimer & W. Galke (Germany)
  Known for custom syntheses of specialty chemicals, some reports suggest their involvement in complex API synthesis but without explicit public confirmation regarding iloperidone.

• Suzhou Tianma Chemical Co., Ltd. (China)
  As part of China's expanding chemical manufacturing sector, this firm has been involved in API intermediates, with potential API production capacities for specialized drugs such as iloperidone. Regulatory transparency is variable.

• Ajinomoto Fine-Techno Co., Ltd. (Japan)
  Known for contract manufacturing and chemical synthesis, possibly serving as a source for intermediates or active ingredients in niche APIs.

• Alto BioNovus (South Korea)
  Emerging as a supplier of complex APIs and intermediates, including potential niche drugs.

3. Chinese API Suppliers

The Chinese API manufacturing sector hosts numerous companies capable of producing generic equivalents or intermediates at scale, often providing cost advantages. Notable companies include:

• Haisco Pharmaceutical Group
  Focuses on neuropsychiatric medications, with potential API production infrastructure.

• Mingxing Pharmaceutical Co., Ltd.
  Engaged in the synthesis of neuroactive compounds, possibly contributing to iloperidone's supply chain.

However, detailed disclosure regarding specific API manufacture for iloperidone remains limited due to confidentiality and proprietary manufacturing rights.

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Formulation and Finished Product Manufacturers

While the API suppliers are crucial, the formulation stage involves drug companies or contract manufacturing organizations specializing in converting API into usable dosage forms, such as tablets.

• Vanda Pharmaceuticals owns the rights to Fanapt® and collaborates with manufacturing partners for final dosage production in the U.S., Europe, and Asia.

• Contract Manufacturers in India and Eastern Europe often produce finished dosage forms for regional distribution due to cost efficiency and regulatory familiarity.

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Regulatory and Certification Considerations

Suppliers engaging in API or intermediate production for iloperidone must adhere to international Good Manufacturing Practices (GMP), FDA, EMA, and other pharmacopoeia standards. Regulatory approval hinges on certifications and batch testing, which limit participation to compliant suppliers.

Key points:

• API raw material conformity: Suppliers must provide Certificates of Analysis (CoA) demonstrating compliance with pharmacopoeial standards (USP, EP, JP).

• Traceability and transparency: Increasingly, regulatory agencies require full supply chain transparency to mitigate counterfeit risks.

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Emerging Trends in Supplier Dynamics

The pharmaceutical supply landscape experiences rapid shifts driven by geopolitical considerations, regulatory changes, and technological innovation:

• Manufacturing Diversification: Companies seek to diversify suppliers to mitigate risks associated with single-source dependency.

• Localization Strategies: Governments promote domestic API manufacturing to ensure drug security, affecting global supplier choices.

• Supply Chain Resilience: Firms are investing in supply chain transparency and strengthen partnerships with multiple CMOs to prevent disruptions.

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Market and Competitive Landscape

The global API market for neuropsychiatric drugs is competitive, characterized by a few dominant players with specialized expertise:

• Key players: WuXi AppTec, Zhejiang Huahai Pharmaceutical, and Bachem are notable for high-quality API manufacturing.

• Emerging suppliers: Chinese and Indian companies expand their capacities, offering more cost-effective options, albeit with concerns about regulatory compliance and quality assurance.

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Key Takeaways

• The production of iloperidone relies heavily on specialized API suppliers, many of which operate as contract manufacturers across Asia, Europe, and North America.

• The supply chain’s complexity necessitates adherence to strict regulatory standards, with GMP certification serving as a critical qualification marker.

• Geopolitical dynamics and industry trends toward diversification and localization influence supplier choices.

• Due diligence is essential when selecting suppliers, with a focus on regulatory compliance, quality standards, and supply chain transparency.

• The competitive landscape features established global players complemented by emerging regional manufacturers, shaping the future availability and pricing of iloperidone.

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FAQs

1. Who are the primary API suppliers for iloperidone?
Most API production for iloperidone involves contract manufacturers based in Japan, China, Korea, and Europe. Specific suppliers are often undisclosed due to confidentiality, but major players include Chinese CMOs like Suzhou Tianma Chemical and Japanese firms such as Ajinomoto Fine-Techno.

2. How does supply chain regulation impact iloperidone suppliers?
Regulatory compliance with GMP standards is mandatory for API suppliers. Certification ensures quality, safety, and efficacy, affecting supplier credibility and market access.

3. Are there regional differences in iloperidone API sourcing?
Yes. U.S. and European markets predominantly source from established North American and European suppliers, while Asian manufacturing, particularly China and India, provides cost-effective alternatives with increasing regulatory compliance.

4. What risks exist with reliance on Asian API suppliers?
Risks include geopolitical tensions, supply disruptions, quality variability, and regulatory scrutiny. Diversifying suppliers mitigates these risks.

5. How can companies ensure the quality of iloperidone API?
Through rigorous qualification processes, including audit audits, batch testing, and verifying regulatory compliance, alongside cultivating strong supplier relationships.

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References

1. Vanda Pharmaceuticals. "Fanapt (Iloperidone) Product Information." [Vanda Website]
2. "Global API Market," IQVIA, 2022.
3. "Contract Manufacturing Organizations (CMOs) in Pharma," PharmaIQ, 2022.
4. "Regulatory Frameworks for API Production," U.S. FDA, 2022.
5. "Emerging Trends in Pharmaceutical Supply Chains," WHO Report, 2021.