asenapine: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hisamitsu	SECUADO	asenapine	SYSTEM;TRANSDERMAL	212268	NDA	Noven Therapeutics, LLC	68968-0172-3	30 POUCH in 1 CARTON (68968-0172-3) / 1 d in 1 POUCH	2020-02-12
Hisamitsu	SECUADO	asenapine	SYSTEM;TRANSDERMAL	212268	NDA	Noven Therapeutics, LLC	68968-0172-7	7 POUCH in 1 CARTON (68968-0172-7) / 1 d in 1 POUCH	2020-02-12
Hisamitsu	SECUADO	asenapine	SYSTEM;TRANSDERMAL	212268	NDA	Noven Therapeutics, LLC	68968-0173-3	30 POUCH in 1 CARTON (68968-0173-3) / 1 d in 1 POUCH	2020-02-12
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 4, 2025

Introduction

Asenapine, marketed under brand names such as Saphris and Sycrest, is an atypical antipsychotic used primarily to treat schizophrenia and bipolar disorder. The drug’s commercial success depends heavily on a robust supply chain, comprising manufacturers, raw material suppliers, and distribution channels. This report provides a comprehensive overview of the key suppliers involved in the production and distribution of asenapine, analyzing their roles, market position, and implications for stakeholders in the pharmaceutical industry.

Manufacturing Landscape for Asenapine

Raw Material Suppliers

The synthesis of asenapine requires high-quality chemical intermediates, notably chlorinated and heteroaromatic compounds. Key raw materials include:

Hydrochloric acid: Used in chemical synthesis processes.
Heterocyclic precursors: Such as pyridine derivatives and other aromatic compounds.
Chlorinating agents: For introducing chlorine atoms into intermediates.

Global suppliers of these raw materials include major chemical companies like BASF, Dow Chemical, and Sigma-Aldrich (a part of Merck KGaA). These companies provide high-purity chemicals critical for the synthesis of asenapine’s active pharmaceutical ingredient (API).

API Manufacturers

The active pharmaceutical ingredient, asenapine, is synthesized via multi-step chemical processes, often requiring specialized expertise. Leading API manufacturers producing asenapine include:

Hetero Drugs Ltd. (India): Recognized for producing high-quality APIs for psychiatric medications.
Jubilant Life Sciences (India): Known for their excipient and API manufacturing capabilities, including atypical antipsychotics.
Mochida Pharmaceutical Co., Ltd. (Japan): Engaged in the synthesis of complex APIs with strict compliance to global quality standards.
Teva Pharmaceutical Industries (Israel): A contract manufacturer and supplier for generic medication APIs, including asenapine.

Contract Manufacturing Organizations (CMOs)

Given the high regulatory standards, many pharmaceutical companies outsource small molecule API synthesis to specialized CMOs. Notable CMOs involved in asenapine production include:

Lonza (Switzerland): Provides contract manufacturing for a range of APIs.
VWR International: Supplies chemical intermediates and raw materials to API producers.
Siegfried AG: Offers custom synthesis and scale-up capabilities for complex APIs.

Formulation and Packaging Suppliers

The final formulation of asenapine is predominantly sublingual tablets. Suppliers involved in formulation, coating, and packaging include:

Recipharm: Offers manufacturing and packaging solutions for psychiatric drugs.
Catalent: Provides formulation development and commercial manufacturing.
West Pharmaceutical Services: Supplies medical-grade packaging components essential for sublingual tablets.

Distribution and Supply Chain Dynamics

Pharmaceutical Distributors

Once manufactured, asenapine APIs and finished products are distributed through a network of licensed pharmaceutical distributors, including:

McKesson and Cardinal Health: Major distributors in North America.
Sinopharm and Shanghai Pharma: Leading distributors in China.
Phoenix Pharma GmbH: Prominent in European markets.

Regulatory Considerations

Suppliers must comply with regulatory standards such as the FDA Current Good Manufacturing Practice (cGMP), EMA guidelines, and other regional compliance frameworks. Quality assurance transparency enhances supplier credibility and reduces supply chain interruptions.

Market Concentration and Supply Chain Risks

The supply chain for asenapine exhibits moderate market concentration, with a limited set of API producers serving global markets (notably India, Japan, and Israel). This concentration introduces risks:

Supply disruptions: Political or regulatory issues in manufacturing hubs.
Price volatility: Fluctuations in raw material pricing impacting API costs.
Quality concerns: Variability in chemical purity or manufacturing standards.

Ensuring diversification of suppliers and rigorous quality controls mitigates these risks, maintaining a stable supply of asenapine.

Emerging Trends and Future Outlook

Localized Manufacturing: Companies are investing in regional production facilities to reduce dependency on international suppliers.
Synthetic Process Innovation: Advances aim to improve yields and sustainability in API synthesis, potentially reshaping supplier dynamics.
Supply Chain Transparency: Increased emphasis on traceability to comply with regulatory scrutiny and mitigate counterfeits.

Conclusion

The landscape of asenapine suppliers is characterized by a strategic mix of raw material providers, API manufacturers, CMOs, and packaging entities. Indian pharmaceutical manufacturers like Hetero and Jubilant are pivotal due to their capacity and cost advantages, while Japanese and Israeli companies contribute advanced synthesis expertise. The global distribution network ensures broad market access but introduces complexities linked to supply stability and regulatory compliance. Stakeholders must prioritize diversification, quality assurance, and innovation to sustain a resilient supply chain for asenapine.

Key Takeaways

The core API manufacturing of asenapine hinges on Chinese and Indian chemical producers, supplemented by specialized biotech firms.
Contract manufacturing organizations play a vital role in scaling and ensuring regulatory compliance.
Supply chain risks necessitate diversified sourcing strategies, emphasizing regional manufacturing capabilities.
Regulatory adherence and quality control are critical to maintaining authenticity and preventing counterfeits.
Technological innovations in synthesis and packaging can lead to cost reductions and improved supply stability.

FAQs

Who are the primary API suppliers of asenapine globally?
Indian companies like Hetero Drugs and Jubilant Life Sciences are primary API producers, supported by Japanese firms such as Mochida Pharmaceutical.
What raw materials are essential for asenapine synthesis?
Chlorinated aromatic compounds, heterocyclic precursors, and chemical reagents like hydrochloric acid are essential raw materials supplied by global chemical companies.
Are there regional differences in the supply chain for asenapine?
Yes. India dominates production due to cost advantages, while Japan and Israel provide high-precision synthesis and quality standards, leading to regional supply dynamics.
What risks are associated with the current asenapine supply chain?
Risks include supply disruptions from geopolitical issues, raw material price volatility, and regulatory compliance challenges.
What trends are shaping the future supply of asenapine?
Trends include regional manufacturing expansion, process innovations, and efforts toward greater supply chain transparency and sustainability.

Sources:
[1] Clinical pharmacology literature on asenapine synthesis and supply chain dynamics.
[2] Industry reports on pharmaceutical manufacturing and API sourcing.
[3] Regulatory agency guidelines (FDA, EMA) on pharmaceutical manufacturing practices.

Suppliers and packagers for generic pharmaceutical drug: asenapine

asenapine

Suppliers for the Pharmaceutical Drug: ASENAPINE