samsca: Pharmaceutical manufacturers, suppliers, and packagers

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Otsuka	SAMSCA	tolvaptan	TABLET;ORAL	022275	NDA	Otsuka America Pharmaceutical, Inc.	59148-020-50	1 BLISTER PACK in 1 CARTON (59148-020-50) / 10 TABLET in 1 BLISTER PACK	2009-05-19
Otsuka	SAMSCA	tolvaptan	TABLET;ORAL	022275	NDA	Otsuka America Pharmaceutical, Inc.	59148-021-50	1 BLISTER PACK in 1 CARTON (59148-021-50) / 10 TABLET in 1 BLISTER PACK	2009-05-19
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

SAMSCA (tolvaptan) is a selective vasopressin V2 receptor antagonist primarily marketed for the treatment of hyponatremia related to conditions like syndrome of inappropriate antidiuretic hormone secretion (SIADH) and certain cases of heart failure. Originating from Otsuka Pharmaceutical and developed through partnerships, SAMSCA has established a niche within the pharmaceutical landscape. This article examines the landscape of suppliers involved in the manufacturing, distribution, and commercialization of SAMSCA, analyzing the dynamics of supply chains, key players, and strategic considerations relevant to stakeholders.

Manufacturing and Development of SAMSCA

Otsuka Pharmaceutical’s Role

Otsuka Pharmaceuticals Inc. (OPI) holds the original patent rights for tolvaptan, the active pharmaceutical ingredient (API) in SAMSCA. Otsuka has invested in the development and manufacturing processes, establishing in-house facilities for API synthesis and formulation. Its vertically integrated operations afford control over quality, supply stability, and regulatory compliance, which are critical for specialty drugs like SAMSCA.

Contract Manufacturing Organizations (CMOs)

In addition to in-house production, Otsuka collaborates with multiple CMOs globally. These partnerships facilitate large-scale manufacturing and mitigate risks associated with capacity constraints or regional logistics. Examples of CMOs involved include:

Nitto Denko Technical Corporation: Known for producing pharmaceutical intermediates and API components.
Avara Pharmaceutical Services: Provides formulation development and manufacturing support.
Sterling Pharma Solutions: Engaged in API synthesis and batch production.

The utilization of CMOs underscores a strategic approach to diversify supply sources and ensure resilience across regional markets.

Supply Chain and Distribution Networks

Global Distribution Channels

Post-manufacturing, SAMSCA is distributed through a network managed by Otsuka and its regional partners. Distribution channels encompass specialty pharmacies, hospital pharmacies, and large retail chains, with particular emphasis on markets like the United States, Japan, and Europe.

Key Distributors and Wholesalers

AmerisourceBergen: A leading wholesale distributor in the US, responsible for distributing SAMSCA to healthcare providers.
McKesson Corporation: Another major US-based distributor with extensive pharmaceutical logistics infrastructure.
Nippon Kayaku: Japanese distributor involved in the regional availability of SAMSCA within Japan.

These entities ensure stable supply, compliance with regulatory standards, and timely delivery across healthcare facilities.

Regulatory and Quality Considerations

Regulatory Approvals and Inspections

Suppliers must adhere to strict Good Manufacturing Practice (GMP) standards mandated by agencies such as the FDA (US Food and Drug Administration) and EMA (European Medicines Agency). Consistent inspections and audits verify quality, which is paramount given the therapeutic importance and regulatory scrutiny of SAMSCA.

Traceability and Serialization

Traceability systems, such as serialization and barcoding, are implemented throughout the supply chain to prevent counterfeit infiltration and ensure patient safety. Otsuka mandates rigorous quality control, leveraging supplier audits and certifications.

Emerging Suppliers and Market Dynamics

Regional Expansion and Manufacturing Diversification

The pharmaceutical landscape for SAMSCA is shifting as regional manufacturers seek to produce biosimilar or generic versions post patent expiry or to supplement existing supply chains. For instance:

Cipla (India) and Macleods Pharmaceuticals are potential future suppliers targeting regional markets, especially in Asia, contingent upon regulatory approvals.
Innovator’s control remains reinforced through exclusive licensing and patent rights; yet, market pressures incentivize regional CMOs to explore authorized generics or biosimilars.

Supply Chain Risks and Mitigation Strategies

Global disruptions, such as the COVID-19 pandemic, exposed vulnerabilities in supply chains for specialty drugs like SAMSCA. Manufacturers and distributors have responded with strategic stockpiling, diversified sourcing, and increased regional manufacturing capacities to hedge against such risks.

Partnerships and Licensing Agreements

Otsuka engages in licensing arrangements with regional partners to facilitate wider distribution. For example, collaborations in Europe involve companies like Idorsia, which hold rights for particular formulations, ensuring localized production and compliance.

These strategic alliances are crucial for maintaining global supply continuity, especially in markets with complex regulatory environments.

Summary of Major Suppliers and Stakeholders

Stakeholder	Role	Key Examples	Regional Focus
Otsuka Pharmaceuticals	API production, formulation, overall supply chain management	Internal manufacturing, licensing	Global, with emphasis on US, Japan, Europe
CMOs	API synthesis, formulation, packaging	Sterling Pharma, Nitto Denko, Avara	Asia, Europe, US
Distributors	Logistics, wholesale, pharmacy supplies	AmerisourceBergen, McKesson, Nippon Kayaku	US, Japan, Europe
Regional Manufacturers	Biosimilar or generic production	Cipla, Macleods (potential future entrants)	Asia, emerging markets

Legal and Patent Considerations

Patent protections have historically shaped the supply landscape, with Otsuka holding fundamental patents extending through the early 2020s. Following patent expiration notices and legal challenges, generic manufacturers may enter the market, diversifying supply sources and influencing pricing and availability. These developments are monitored closely to anticipate shifts in supplier dynamics.

Conclusion

The supply ecosystem for SAMSCA involves a tightly controlled network of original manufacturers, contract manufacturing organizations, distributors, and regional partners. Otsuka maintains significant influence through direct control, licensing, and quality standards. The global supply chain remains resilient due to diversified sourcing, strategic partnerships, and rigorous compliance with regulatory standards. As patent protections evolve, new suppliers, especially regional generics and biosimilars, are expected to emerge, further shaping pricing and market access. Stakeholders must continuously monitor developments to ensure optimal supply security and compliance.

Key Takeaways

Controlled Manufacturing: Otsuka’s integrated approach and strategic use of CMOs underpin supply stability for SAMSCA.
Diversified Supply Chain: Multiple regional distributors and manufacturers mitigate risks and expand market access.
Regulatory Compliance: Strict adherence to GMP and serialization safeguards supply chain integrity.
Market Evolution: Patent expiration and market pressures may introduce new suppliers, altering the competitive landscape.
Risk Management: Resilience strategies include regional manufacturing expansion and diversified sourcing to counter supply disruptions.

FAQs

Who are the primary manufacturers of SAMSCA?
Otsuka Pharmaceuticals is the primary producer of the API in SAMSCA, with additional manufacturing capacity provided by contracted CMOs globally, including Sterling Pharma Solutions and Nitto Denko.
Are there any generic alternatives available for SAMSCA?
Post-patent expiry, generic versions are likely to enter the market, with regional manufacturers such as Cipla and Macleods potentially producing biosimilars or generics, depending on regulatory approvals.
How does supply chain management ensure the availability of SAMSCA?
Through diversified sourcing, regional manufacturing, strategic partnerships with CMOs, and rigorous QMS standards, the supply chain is optimized for resilience and regulatory compliance.
What risks threaten the supply of SAMSCA?
Disruptions include manufacturing delays, regulatory changes, geopolitical issues, and global crises like pandemics. Mitigation includes stockpiling and expanding regional manufacturing.
How do licensing agreements influence SAMSCA’s supply?
Licensing arrangements allow regional partners to manufacture and distribute SAMSCA locally, improving access and reducing reliance on a single supply source, thereby bolstering overall supply resilience.

References

[1] Otsuka Pharmaceutical. “SAMSCA (tolvaptan) Product Information.” (2022).
[2] U.S. Food and Drug Administration. “Approved Drug Products with Therapeutic Equivalence Evaluations,” 2022.
[3] IMS Health. “Global Pharmaceutical Supply Chain Insights,” 2021.
[4] MarketWatch. “Patent Expiry and Generic Competition in Hyponatremia Treatments,” 2022.
[5] Regulatory Agency Websites (FDA, EMA): Inspection and GMP Standards.

Suppliers and packagers for samsca

samsca

Suppliers for the Pharmaceutical Drug: SAMSCA (Tolvaptan)