Suppliers and packagers for generic pharmaceutical drug: solifenacin succinate

solifenacin succinate

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Astellas	VESICARE LS	solifenacin succinate	SUSPENSION;ORAL	209529	NDA	Astellas Pharma US, Inc.	51248-250-99	1 BOTTLE, PLASTIC in 1 CARTON (51248-250-99) / 150 mL in 1 BOTTLE, PLASTIC	2020-05-26
Ajanta Pharma Ltd	SOLIFENACIN SUCCINATE	solifenacin succinate	TABLET;ORAL	205483	ANDA	Ajanta Pharma USA Inc.	27241-037-03	30 TABLET, FILM COATED in 1 BOTTLE (27241-037-03)	2019-05-20
Ajanta Pharma Ltd	SOLIFENACIN SUCCINATE	solifenacin succinate	TABLET;ORAL	205483	ANDA	Ajanta Pharma USA Inc.	27241-037-09	90 TABLET, FILM COATED in 1 BOTTLE (27241-037-09)	2019-05-20
Ajanta Pharma Ltd	SOLIFENACIN SUCCINATE	solifenacin succinate	TABLET;ORAL	205483	ANDA	Ajanta Pharma USA Inc.	27241-038-03	30 TABLET, FILM COATED in 1 BOTTLE (27241-038-03)	2019-05-20

Suppliers for the Pharmaceutical Drug: Solifenacin Succinate

Last updated: July 29, 2025

Introduction

Solifenacin succinate, marketed under brand names such as Vesicare, is a competitive treatment for overactive bladder (OAB) characterized by symptoms such as urinary urgency and frequency. As a muscarinic receptor antagonist, solifenacin succinate requires a robust supply chain to meet global demand, especially considering its widespread adoption and established safety profile. This analysis provides a comprehensive overview of the primary suppliers involved in the production and distribution of solifenacin succinate, highlighting manufacturing capabilities, geographic footprints, and strategic partnerships to guide stakeholders’ procurement and investment decisions.

Manufacturers of Solifenacin Succinate

1. Astellas Pharma Inc.

Global Leader and Original Developer
Astellas Pharma, based in Japan, developed solifenacin succinate and maintains exclusive rights to its patent and commercialization. As the originator, Astellas supplies the drug primarily through licensing agreements and direct manufacturing. Its robust R&D and manufacturing facilities ensure high-quality production standards aligned with international regulatory requirements (e.g., FDA, EMA).

• Manufacturing Capabilities: Astellas owns multiple production facilities in Japan and the United States, dedicated to both active pharmaceutical ingredient (API) synthesis and finished dosage forms.
• Distribution Network: Astellas operates a broad, global distribution network, supplying solifenacin succinate across North America, Europe, Asia, and emerging markets through subsidiaries and authorized distributors.

Strategic Partnerships
Astellas often partners with third-party contract manufacturing organizations (CMOs) for scale-up and regional supply, emphasizing quality control and supply security.

2. Contract Manufacturing Organizations (CMOs)

Following patent expiration or through licensing agreements, several CMOs have entered the market to produce solifenacin succinate, primarily for generic formulations. Key players include:

• Hetero Labs (India): A leading CMO specializing in generic APIs and finished formulations, with extensive capacity for solifenacin succinate API production.
• Sun Pharmaceutical Industries (India): A major global pharmaceutical company with manufacturing facilities capable of producing high-purity APIs and finished drugs at scale.
• Mylan (now part of Viatris): Engages in manufacturing generics and biosimilar products, including solifenacin succinate, leveraging advanced synthesis technologies.

Regulatory Considerations
These CMOs adhere to Good Manufacturing Practices (GMP) standards, securing US FDA approval and European EMA certifications, facilitating regional distribution.

3. Generic Manufacturers

With patent expiry, numerous generics manufacturers have secured approvals to produce and market solifenacin succinate. These include:

• Teva Pharmaceutical Industries (Israel): Offers a broad portfolio of generics, including solifenacin succinate, through their global manufacturing and distribution channels.
• Sandoz (Novartis division): Provides high-quality generics with extensive international reach.
• Cipla (India): A key regional player producing cost-effective formulations for Asian and African markets.
• Dr. Reddy’s Laboratories (India): Supplies the drug across multiple continents with a focus on socio-economic markets.

Market Impact
The proliferation of generics, supported by multiple suppliers, has driven prices downward, increasing accessibility across lower-income regions and reducing the market share for the original patent holder.

Regional Suppliers and Market Dynamics

North America

Astellas remains the primary supplier through its authorized distributors, with Mylan and Teva providing competitive generics. The North American market is characterized by high regulatory standards, prompting rigorous quality assurance protocols.

Europe

Astellas maintains supply chains to Europe, supplemented by generic manufacturers like Sandoz. European authorities require comprehensive approval dossiers, which most generic manufacturers have acquired, emphasizing manufacturing quality and compliance.

Asia

India's pharmaceutical industry dominates solifenacin succinate production, with companies like Hetero, Cipla, and Dr. Reddy’s leading the supply chain. These manufacturers serve both domestic and export markets, often subject to regulatory approvals from local agencies like India’s Central Drugs Standard Control Organization (CDSCO).

Emerging Markets

Manufacturers from China and Brazil are expanding their capabilities. Localized production helps minimize costs and improve access, but concerns regarding regulatory rigor persist, necessitating due diligence.

Supply Chain and Regulatory Landscape

The stability of solifenacin succinate supplies hinges on several factors:

• Patent Status: With patent expiry in many regions, increased manufacturing activity has expanded supply sources.
• Regulatory Approvals: GMP compliance and submission of new drug applications (NDAs) or abbreviated new drug applications (ANDAs) are prerequisites for market entry in regulated markets.
• Raw Material Sourcing: API production depends on high-quality raw materials, with some manufacturers sourcing from China and India, which influences supply stability and cost.

Market Trends and Implications

• The number of suppliers has surged post-patent expiration, fostering price competition.
• Supply chain diversification minimizes risks associated with geopolitical fluctuations, trade restrictions, or manufacturing disruptions.
• Increasing regional manufacturing capabilities supports market growth in Africa and Southeast Asia.

Conclusion

The supply landscape for solifenacin succinate is characterized by the original innovator, Astellas Pharma, alongside a vibrant ecosystem of generic manufacturers and CMOs. Suppliers span North America, Europe, and key Asian markets, with regional players playing critical roles in expanding access. Ensuring regulatory compliance, manufacturing quality, and supply chain resilience remains central to mitigating risks and sustaining availability.

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Key Takeaways

• Original manufacturer dominance: Astellas Pharma remains the principal supplier, controlling high-quality API and finished formulations.
• Growing generic capacity: Multiple global manufacturers, especially from India and Israel, produce solifenacin succinate, driving competitive pricing.
• Regulatory landscape: GMP compliance and regional approvals are vital for market access and supply continuity.
• Supply chain diversification: Multiple suppliers and CMOs reduce dependency on single sources, enhancing resilience.
• Emerging markets: Local manufacturers are increasingly pivotal in expanding access to solifenacin succinate globally.

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FAQs

1. Who are the primary suppliers of solifenacin succinate in the global market?
The primary supplier is Astellas Pharma, the original developer, supported by various generic manufacturers such as Teva, Sandoz, Cipla, and Dr. Reddy's, particularly in regions where patent exclusivity has ended.

2. What regions have the most diversified supply sources for solifenacin succinate?
North America and Europe benefit from multiple generic suppliers, while India dominates Asia’s manufacturing capacity. These regions have extensive GMP-certified pharmaceutical industries capable of large-scale API and finished drug production.

3. How does patent expiration impact the supply and pricing of solifenacin succinate?
Patent expiration opens markets to numerous generics, increasing supply and promoting price competition. This trend generally improves affordability but demands strict regulatory oversight to maintain quality.

4. What role do contract manufacturing organizations play in the solifenacin supply chain?
CMOs facilitate scaling production, ensuring manufacturing flexibility, mitigating risks, and enabling rapid market entry for new or generic formulations.

5. What factors should stakeholders consider when sourcing solifenacin succinate?
Regulatory compliance, manufacturing quality, supply chain reliability, regional approval status, and raw material sourcing are critical to secure consistent, high-quality supply and minimize risks.

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Sources

[1] Astellas Pharma Inc. Official Website. "Vesicare (solifenacin succinate)".
[2] U.S. Food and Drug Administration. "ANDA approvals for solifenacin succinate".
[3] Indian Pharmaceutical Industry Reports. "Manufacturing capabilities of Hetero, Cipla, and Dr. Reddy’s".
[4] European Medicines Agency. "Market authorization for solifenacin in Europe."
[5] Market research reports on pharmaceutical supply chains and patent expiration impacts.