Suppliers and packagers for vesicare

vesicare

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	solifenacin succinate	TABLET;ORAL	021518	NDA	Astellas Pharma US, Inc.	51248-150-01	30 TABLET, FILM COATED in 1 BOTTLE (51248-150-01)	2005-01-05
Astellas	VESICARE	solifenacin succinate	TABLET;ORAL	021518	NDA	Astellas Pharma US, Inc.	51248-151-01	30 TABLET, FILM COATED in 1 BOTTLE (51248-151-01)	2005-01-05
Astellas	VESICARE	solifenacin succinate	TABLET;ORAL	021518	NDA	Astellas Pharma US, Inc.	51248-151-03	90 TABLET, FILM COATED in 1 BOTTLE (51248-151-03)	2005-01-05

Suppliers for the Pharmaceutical Drug: Vesicare

Last updated: July 27, 2025

Introduction

Vesicare (generic name: solifenacin succinate) is a prescription medication primarily used to treat overactive bladder with symptoms of urinary urgency, frequency, and incontinence. As a flagship product in the urology portfolio, Vesicare’s manufacturing relies on a complex global supply chain involving raw material suppliers, active pharmaceutical ingredient (API) producers, formulation developers, and packaging providers. This comprehensive analysis examines the key suppliers involved in Vesicare’s production, evaluates supply chain dynamics, and considers implications for stakeholders.

Active Pharmaceutical Ingredient (API) Suppliers

The production of Vesicare depends critically on high-quality solifenacin succinate APIs. Currently, the leading API suppliers are concentrated in Asia, notably in China and India, where the majority of bulk pharmaceutical chemicals are synthesized due to cost efficiencies and robust manufacturing infrastructure.

1. Chinese API Manufactures

Chinese API producers have historically been dominant in the global API market, leveraging extensive manufacturing capacities and competitive pricing. Companies such as Zhejiang Hisun Pharmaceutical Co., Ltd. and Shanghai Pharmaceuticals Holding Co., Ltd. are known for their capacity to supply solifenacin APIs that meet international standards (USP, EP, JP).

2. Indian API Producers

Indian pharmaceutical firms like Dr. Reddy’s Laboratories, Aurobindo Pharma, and Torrent Pharmaceuticals have developed API manufacturing capabilities for solifenacin. These firms often integrate API production with formulation, providing end-to-end solutions. Their facilities are regularly inspected by international regulatory agencies such as the US FDA and EMA, ensuring quality compliance.

3. Regulatory and Quality Considerations

Suppliers must adhere to rigorous GMP standards. API suppliers with a proven track record of regulatory compliance face less risk of supply disruptions and quality issues. Notably, in 2020, the US FDA issued warning letters to certain Chinese API manufacturers for GMP violations, highlighting the importance of supplier qualification and continuous oversight [1].

Formulation and Finished Product Manufacturers

After API procurement, the formulation of Vesicare involves several specialized contract manufacturing organizations (CMOs).

1. Contract Manufacturing Organizations (CMOs)

Major pharmaceutical companies manufacturing Vesicare often utilize CMOs with proven expertise in controlled-release oral dosage forms. Examples include Catalent, Lonza, and Patheon. These CMOs provide formulation development, scale-up, and commercial manufacturing services.

2. Major Pharmaceutical Companies

Bausch Health (formerly Valeant Pharmaceuticals), the original supplier of Vesicare, manages formulation and commercial manufacturing through internal facilities and partnerships. Their global manufacturing network ensures steady supply and global distribution.

Raw Material and Excipients Suppliers

Apart from APIs, excipients and raw materials critical for tablet formulation are sourced globally.

1. Excipients Suppliers

Leading excipients like microcrystalline cellulose, lactose, and magnesium stearate are supplied by firms such as DuPont, SPI Pharma, and Roquette. These suppliers ensure compliance with pharmacopeial standards and deliver consistent quality.

2. Packaging Component Suppliers

Packaging involves bottles, blisters, and cartons sourced from specialists like Gerresheimer and Schott AG, which supply pharmaceutical-grade packaging complying with regulatory standards.

Supply Chain Challenges and Considerations

Supply chain integrity for Vesicare continues to face challenges, including geopolitical disruptions, raw material shortages, and regulatory hurdles. The COVID-19 pandemic spotlighted vulnerabilities in global supply chains, leading to increased scrutiny of API suppliers, especially those in China and India [2].

Regulatory agencies are emphasizing supplier qualification, manufacturing data transparency, and contingency planning. Companies involved in Vesicare supply chains are increasingly diversifying suppliers and establishing strategic stockpiles to mitigate risks.

Emerging Trends

• Localization and Nearshoring: Suppliers and manufacturers are considering nearshoring to reduce dependency on Asian sources, especially amid geopolitical tensions.

• Regulatory Harmonization: International harmonization efforts aim to streamline acceptance of APIs from diverse sources, easing supply constraints.

• Vertical Integration: Some firms pursue vertical integration of API and formulation manufacturing to control quality and ensure timely supply.

Conclusion

Vesicare’s supply chain hinges on a globally dispersed network of API producers, formulary manufacturers, excipient and packaging suppliers, and regulatory oversight. While Chinese and Indian API suppliers dominate the market, increasing regulatory scrutiny and geopolitical considerations drive diversification strategies. Maintaining supply security requires rigorous supplier qualification, regulatory compliance, and strategic logistics planning.

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Key Takeaways

• The primary API suppliers for Vesicare are Chinese and Indian manufacturers, both of which must meet stringent quality standards to ensure consistent supply.

• Contract manufacturing organizations and major pharmaceutical firms distribute Vesicare globally, supported by robust excipient and packaging suppliers.

• Supply chain disruptions, particularly geopolitical and pandemic-related, underscore the need for diversification and strategic inventory management.

• Regulatory compliance and continuous quality assurance are critical in avoiding supply interruptions and maintaining product standards.

• Industry trends favor nearshoring and vertical integration to mitigate risks associated with global dependencies.

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FAQs

1. Who are the main API suppliers for Vesicare?
   Chinese companies like Zhejiang Hisun Pharmaceutical and Indian firms like Dr. Reddy’s Laboratories are leading suppliers of solifenacin succinate API.

2. Are there risks associated with the concentration of API suppliers in Asia?
   Yes. Reliance on Asian API suppliers can pose risks related to geopolitical tensions, regulatory changes, and supply disruptions, necessitating diversification.

3. What role do CMOs play in Vesicare’s manufacturing?
   CMOs handle formulation development, scale-up, and manufacturing, ensuring quality control and compliance, thus facilitating global distribution.

4. How has the COVID-19 pandemic affected Vesicare’s supply chain?
   It exposed vulnerabilities in API sourcing and logistics, prompting efforts to diversify supplier bases and increase inventory buffers.

5. What trends are shaping the future of Vesicare’s supply chain?
   Trends include nearshoring, regulatory harmonization, and vertical integration, aimed at enhancing supply stability and quality assurance.

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Sources

[1] U.S. Food & Drug Administration. “Warning Letters and Import Alerts,” 2020.
[2] PharmTech. “Global API Supply Chain Disruptions: Impact and Strategies,” 2021.