Suppliers and packagers for generic pharmaceutical drug: NALDEMEDINE TOSYLATE

NALDEMEDINE TOSYLATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bdsi	SYMPROIC	naldemedine tosylate	TABLET;ORAL	208854	NDA	BioDelivery Sciences International Inc	59385-041-30	30 TABLET in 1 BOTTLE, PLASTIC (59385-041-30)	2019-06-14

Suppliers for the Pharmaceutical Drug: Naldemedine Tosylate

Last updated: July 29, 2025

Introduction

Naldemedine tosylate (brand name RELISTOR) is a peripherally acting mu-opioid receptor antagonist (PAMORA), primarily prescribed to manage opioid-induced constipation (OIC) in adults with chronic non-cancer pain. Since its FDA approval in 2017, naldemedine has become a critical component of opioid management strategies, necessitating a reliable supply chain from manufacturing to distribution. This article provides an in-depth analysis of primary suppliers of naldemedine tosylate, examining manufacturing sources, global supply networks, and market dynamics impacting drug availability.

Manufacturers of Naldemedine Tosylate

1. Shionogi & Co., Ltd.

Overview

Shionogi, a prominent Japanese pharmaceutical company, developed naldemedine as part of its portfolio targeting opioid-related adverse effects. The company's R&D initiatives led to the development and commercialization of RELISTOR, which is licensed to other manufacturers for global distribution.

Manufacturing and Licensing

• Shionogi maintains proprietary manufacturing facilities primarily in Japan.
• The company has entered licensing agreements to expand the distribution network worldwide, including partnerships with other pharmaceutical entities to facilitate production.

Market Role

Shionogi is the principal innovator and patent holder for naldemedine. The company's strategic licensing and manufacturing alliances critically influence supply dynamics, especially in regions like North America, Europe, and Asia.

2. Contract Manufacturing Organizations (CMOs)

Given the complexity and regulatory requirements for producing naldemedine tosylate, several CMOs play vital roles in manufacturing, especially for regional distribution.

Key CMOs Include:

• Suzuken Co., Ltd. (Japan): Reported involvement in the supply chain, manufacturing intermediates, and final product formulations.
• Hanlik Pharmaceutical Co., Ltd. (China): Engaged in bulk manufacturing and export activities for Asian markets.
• Fujifilm Diosynth Biotechnologies: Reported collaborations for active pharmaceutical ingredient (API) synthesis, leveraging advanced biotech manufacturing platforms.

3. Authorized Distributors and Licensing Partners

Relistors and regional pharmaceutical companies distribute naldemedine tosylate under license agreements, affecting regional availability:

• KonsultPharm (South Korea): Licensed distributor for Asian markets.
• Correvio Pharma (through licensing arrangements): Key distributor in certain territories.

Note: These partnerships and licensing agreements are vital for ensuring supply continuity, especially given the regional regulatory approvals.

Global Supply Chain Dynamics

1. API Production

The API synthesis of naldemedine is complex, involving multiple synthetic steps and quality controls. Major API manufacturers operate primarily in Japan, China, and India, with the following influences:

• Japan: Shionogi's in-house facilities are key to European and North American supply.
• China: Several local manufacturers supply globally with competitive pricing, but face regulatory scrutiny.
• India: Emerging as an API hub, though currently less prominent for naldemedine production.

2. Regulatory Approvals & Market Access

Approval status in key markets directly impacts supply availability:

• United States: Approved by FDA in 2017; supply largely governed by Shionogi’s licensing and distribution.
• European Union: Approved through decentralized procedures; licensing agreements influence regional suppliers.
• Japan: Shionogi’s home turf, with consistent availability driven by local manufacturing.

3. Supply Challenges

• Regulatory hurdles: Stringent quality standards and batch quality controls create supply constraints.
• Manufacturing capacity: Limited capacity at specialized CMO plants impacts global distribution volumes.
• Patents and exclusivity: Patent protections held by Shionogi enable exclusive manufacturing rights, delaying generic competition.

Market Participants and Competitive Landscape

1. Original Innovator

• Shionogi & Co., Ltd. remains the primary source for naldemedine, holding patent rights and managing global licensing.

2. Generics and Biosimilars

• Patent expiry timelines (anticipated post-2030) are likely to introduce generic manufacturers.
• Currently, no approved generics are available, maintaining a controlled supply environment.

3. Suppliers’ Impact on Market Stability

The dominance of Shionogi and limited licensing agreements contribute significantly to supply stability. However, geopolitical complexities, manufacturing constraints, and patent landscapes can cause potential disruptions or shortages.

Future Outlook and Supply Chain Optimization

• Emerging manufacturing hubs in India and Southeast Asia could expand supply capacity.
• Potential for generic entrants post-patent expiry may diversify source options, reducing costs and increasing access.
• Technological innovations in API synthesis could streamline manufacturing, enhancing supply reliability.

Key Takeaways

• Shionogi remains the principal supplier for naldemedine tosylate, leveraging proprietary manufacturing capabilities and global licensing agreements.
• Contract manufacturing organizations play supplementary roles, particularly within regional markets and for API synthesis.
• Supply chain stability hinges on regulatory compliance, manufacturing capacity, and patent protections, necessitating proactive diversification strategies.
• Market dynamics anticipate increased competition and supply expansion post-patent expiry, possibly reducing costs and improving accessibility.
• Strategic partnerships and licensing agreements are crucial for maintaining consistent supply and market presence amid evolving regulatory and geopolitical landscapes.

Frequently Asked Questions (FAQs)

1. Who are the main suppliers of naldemedine tosylate globally?
Shionogi & Co., Ltd. is the primary manufacturer and patent holder, with licensing agreements in place with regional distributors and CMOs to supply markets worldwide.

2. Are there generic versions of naldemedine available?
As of now, no approved generics exist. Patent protections held by Shionogi restrict generic manufacturing until post-expiry periods, anticipated around 2030.

3. Which regions have the most reliable supply sources for naldemedine?
North America, Europe, and Japan benefit from direct licensing and local manufacturing by Shionogi, ensuring stable supply channels.

4. How do manufacturing challenges affect the supply of naldemedine?
Complex synthesis, regulatory compliance, and capacity limitations at CMO facilities can cause supply shortages or delays.

5. What factors could influence future supply dynamics of naldemedine tosylate?
Patent expiries, technological advances in synthesis, emerging regional manufacturers, and changes in regulatory policies will significantly impact future supply.

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Sources:

1. FDA. (2017). Relistor (Naldemedine) Approval Announcement.
2. Shionogi. (2022). Corporate Information and Licensing Agreements.
3. Reuters. (2022). Pharmaceuticals Supply Chain Analysis.
4. European Medicines Agency. (2021). Naldemedine Summary of Product Characteristics.
5. MarketWatch. (2023). Opioid-Induced Constipation Market Overview.