Suppliers and packagers for VESICARE LS

VESICARE LS

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

Suppliers for the Pharmaceutical Drug: VESICARE LS

Last updated: July 30, 2025

Introduction

Vesicare LS, an extended-release formulation of solifenacin succinate, is a prescription medication primarily indicated for the treatment of overactive bladder with symptoms of urinary frequency, urgency, and urge incontinence. As a specialized pharmaceutical product, the sourcing of Vesicare LS involves a complex supply chain comprising active pharmaceutical ingredient (API) manufacturers, finished drug formulators, and fill-finish service providers. Ensuring robust procurement channels is critical for pharmaceutical companies, healthcare providers, and distributors aiming to maintain product availability, quality assurance, and regulatory compliance.

This detailed analysis explores the key suppliers involved in the manufacturing and distribution of Vesicare LS, examining API producers, formulation partners, and packaging entities, alongside insights into global supply trends and strategic considerations.

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Active Pharmaceutical Ingredient (API) Suppliers

The foundation of Vesicare LS lies in its API—solifenacin succinate. The stability, purity, and sourcing of this component are crucial to the drug’s efficacy and safety profile.

Major API Manufacturers

1. Sun Pharmaceutical Industries Ltd.

   • Sun Pharma is a leading global pharmaceutical company based in India, known for manufacturing high-quality APIs, including solifenacin succinate.
   • The company’s API manufacturing plants are certified by global regulators like US FDA, EMA, and others, ensuring compliance with international standards.

2. Zhejiang Huahai Pharmaceutical Co., Ltd.

   • A prominent Chinese API manufacturer with a significant portfolio of generics and APIs, including solifenacin.
   • Known for cost-effective bulk production and reliable supply, often supplying APIs to global contracted manufacturing organizations (CMOs).

3. Mitsubishi Tanabe Pharma Corporation

   • The original developer of solifenacin, Mitsubishi provides the patented molecule for licensed manufacturers.
   • Their manufacturing facilities uphold the highest standards of quality, particularly when supplying to branded formulations.

4. Dr. Reddy’s Laboratories

   • An Indian pharmaceutical company with robust API manufacturing capabilities, including solifenacin succinate.
   • Focuses on API purity and comprehensive quality control measures.

Emerging API Suppliers

• Some newer entrants from Southeast Asia and Eastern Europe are increasingly investing in API quality assurance, filling supply gaps created by disruptions or scale-up needs.

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Formulation and Finished Product Manufacturers

Once the API is procured, companies focus on formulating Vesicare LS into the final, patient-ready product. Several CMOs and contract development organizations (CDOs) specialize in oral solid dose manufacturing, including controlled-release formulations like Vesicare LS.

Leading Formulation Partners

1. Pfizer Inc.

   • The original developer and patent holder of Vesicare (solifenacin) in its branded form.
   • Pfizer's manufacturing facilities for Vesicare LS encompass formulation, encapsulation, and packaging to ensure controlled-release characteristics.

2. Contract Manufacturing Organizations (CMOs)

   • Multiple CMOs, including Hikma Pharmaceuticals, Aenova Group, and Serum Life Sciences, possess manufacturing licenses for extended-release formulations of solifenacin.
   • These providers often operate under strict regulatory oversight, ensuring product compliance with FDA, EMA, and other agencies.

3. Generic Manufacturers

   • After patent expiration, several generic drug producers, including Teva Pharmaceuticals and Mylan, have entered the Vesicare LS market, sourcing APIs from the major suppliers and utilizing their own formulation expertise.

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Packaging and Distribution Suppliers

Once formulated, Vesicare LS requires packaging that aligns with regulatory standards for unit-dose and blister packaging, along with secure storage and distribution channels.

Major Packaging Partners

• SGS and Eurofins: Provide packaging validation, stability testing, and serialization services.
• Smaller specialized packaging firms focus on child-resistant blister packs for controlled delivery.

Distribution Networks

• Largest pharmaceutical distributors such as McKesson, AmerisourceBergen, and Cardinal Health serve as key channels for Vesicare LS distribution in North America.
• Internationally, regional distributors and wholesalers in Europe, Asia, Africa, and Latin America facilitate global access.

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Global Supply Chain Considerations

The supply chain of Vesicare LS is sensitive to geopolitical, regulatory, and manufacturing disruptions. API sourcing from multiple regions mitigates risk but can introduce variability in lead times and quality assurance standards.

• Regulatory compliance remains paramount. Suppliers must adhere to Good Manufacturing Practices (GMP) and demonstrate rigorous quality control.
• Supply chain resilience involves diversified API sources and flexible manufacturing partnerships to accommodate geopolitical events, pandemics, or raw material shortages.
• Partnerships and licensing agreements impact market presence. Pfizer’s licensing of solifenacin production to generic manufacturers expands access but requires careful supplier vetting.

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Strategic Implications for Buyers and Stakeholders

• Due Diligence: Ensuring API suppliers’ GMP certifications and quality track records.
• Cost Management: Balancing costs between high-quality suppliers and emerging, cost-effective manufacturers.
• Supply Security: Developing diversified supplier portfolios to prevent shortages.
• Regulatory Alignment: Maintaining compliance with evolving standards from agencies like the FDA, EMA, and national governing bodies.

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Key Takeaways

• The primary API for Vesicare LS, solifenacin succinate, is sourced from established manufacturers such as Sun Pharma, Zhejiang Huahai, Mitsubishi Tanabe, and Dr. Reddy’s.
• Contract formulation manufacturing is predominantly conducted by large, regulated CMOs that specialize in controlled-release oral formulations.
• Packaging and distribution are handled by specialized partners and major pharmaceutical distributors to ensure product integrity.
• Supply chain resilience depends on diversified sourcing, strict quality standards, and close regulatory compliance.
• Strategic supplier management can mitigate risks related to raw material shortages, geopolitical tensions, and regulatory changes.

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FAQs

1. Who are the main API suppliers for Vesicare LS?
   Leading API suppliers include Sun Pharmaceutical Industries, Zhejiang Huahai Pharmaceutical, Mitsubishi Tanabe Pharma, and Dr. Reddy’s Laboratories.

2. Are generic versions of Vesicare LS widely available?
   Yes, after patent expiry, numerous generic manufacturers such as Teva, Mylan, and others produce Vesicare LS, often sourcing APIs from the same established producers.

3. How is quality assured in Vesicare LS’s supply chain?
   Suppliers and manufacturers operate under stringent GMP standards, with certifications from agencies like the FDA and EMA, ensuring API purity, formulation quality, and packaging compliance.

4. What risks exist in the Vesicare LS supply chain?
   Risks include raw material shortages, geopolitical disruptions, regulatory compliance challenges, and manufacturing delays. Diversification of suppliers mitigates these risks.

5. How do manufacturers ensure product stability and efficacy?
   Through rigorous stability testing, validated manufacturing processes, and adherence to international quality standards, manufacturers ensure Vesicare LS maintains its intended efficacy through shelf life.

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References

[1] U.S. Food and Drug Administration. (2022). Drugs Approved for Overactive Bladder.
[2] Sun Pharmaceutical Industries Ltd. Corporate Website. (2023). API Manufacturing Capabilities.
[3] Zhejiang Huahai Pharmaceutical Co., Ltd. Official Reports. (2023). API Quality Standards.
[4] Mitsubishi Tanabe Pharma. Product Portfolio. (2023).
[5] Pfizer Inc. Vesicare (solifenacin) Product Information. (2022).