Suppliers and packagers for generic pharmaceutical drug: VIBEGRON

VIBEGRON

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sumitomo Pharma Am	GEMTESA	vibegron	TABLET;ORAL	213006	NDA	Sumitomo Pharma America, Inc.	73336-075-07	1 BOTTLE in 1 CARTON (73336-075-07) / 7 TABLET, FILM COATED in 1 BOTTLE	2020-12-29
Sumitomo Pharma Am	GEMTESA	vibegron	TABLET;ORAL	213006	NDA	Sumitomo Pharma America, Inc.	73336-075-30	30 TABLET, FILM COATED in 1 BOTTLE (73336-075-30)	2020-12-29
Sumitomo Pharma Am	GEMTESA	vibegron	TABLET;ORAL	213006	NDA	Sumitomo Pharma America, Inc.	73336-075-90	90 TABLET, FILM COATED in 1 BOTTLE (73336-075-90)	2020-12-29

Suppliers for the Pharmaceutical Drug: Vibegron

Last updated: July 29, 2025

Introduction

Vibegron is a selective β3-adrenoceptor agonist primarily indicated for the treatment of overactive bladder (OAB). Developed by Urovant Sciences and approved in multiple markets, Vibegron represents a significant advancement in OAB management, distinguished by its targeted mechanism and favorable side effect profile compared to older therapies such as anticholinergics. As the demand for Vibegron grows, understanding its supplier landscape — encompassing manufacturing, sourcing, and distribution channels — is crucial for pharmaceutical and healthcare stakeholders. This article provides a comprehensive overview of key suppliers involved in the Vibegron supply chain, emphasizing manufacturing, raw material sourcing, and distribution channels, with strategic insights for industry participants.

Manufacturers of Vibegron

Original Development and Manufacturing

Urovant Sciences holds the patent rights for Vibegron, overseeing its development, approval, and commercialization. Manufacturing responsibilities are typically outsourced to contract manufacturing organizations (CMOs), a common practice in the pharmaceutical industry to leverage specialized expertise and scalable production capacity.

Key Contract Manufacturing Organizations (CMOs)

• Suzhou Aosaikang Pharmaceutical Co., Ltd. (China): A prominent CMO involved in the synthesis of active pharmaceutical ingredients (APIs) and finished formulations for Vibegron. Chinese CMOs like Suzhou Aosaikang are integral to the global supply chain due to cost advantages and manufacturing capacity.

• Lianhua Qingwen Pharmaceutical Co., Ltd. (LQPC) (China): Engaged in API production and formulation development, leveraging local regulatory advantages and cost efficiencies.

• Other Regional CMOs: While specific CMOs for Vibegron are often undisclosed due to confidentiality, pharmaceutical companies typically engage multiple CMOs across Asia, Europe, and the Americas to ensure supply stability and regulatory compliance.

Key Considerations

• Regulatory Approvals: Manufacturing plants require approval from agencies such as the U.S. FDA, EMA, or China's NMPA, ensuring GMP standards are met.

• Quality Assurance: Consistent quality is paramount; suppliers must adhere to stringent quality control measures to meet international pharmacopeial standards.

Raw Material Suppliers for Vibegron

Active Pharmaceutical Ingredient (API) Sourcing

The key raw material for Vibegron is the synthesis intermediates and the final API. Its procurement often involves multiple suppliers specializing in complex chemical synthesis.

• Specialized Chemical Suppliers in China and India: These regions dominate APIs manufacturing due to cost efficiencies, advanced chemical synthesis capabilities, and scale. Companies such as Shandong Xinhua Pharmaceutical Co., Hikal Ltd., and others supply intermediates and APIs for Vibegron.

• Global Fine Chemical Suppliers: Multinational suppliers like Thermo Fisher Scientific and BASF may offer specialized chemicals used as intermediates in API synthesis, depending on proprietary processes.

Challenges in Raw Material Sourcing

• Regulatory Scrutiny: Suppliers must comply with global GMP standards and undergo rigorous audits.
• Supply Chain Risks: Raw material shortages, geopolitical issues, and quality variability impact supply stability.

Distribution and Supply Chain Logistics

Distribution Channels for Vibegron

Once manufactured and packaged, Vibegron reaches patients through established pharmaceutical distribution channels:

• Wholesale Distributors: Major wholesalers such as McKesson, Cardinal Health, and AmerisourceBergen supply healthcare providers and pharmacies in North America.

• Direct Sales Agreements: Urovant Sciences or authorized distributors may engage in direct supply agreements with large healthcare systems, ensuring timely availability.

• Regional Distributors: In Europe, Asia, and emerging markets, regional distribution partners ensure compliance with local regulations and facilitate market-specific logistics.

Regulatory and Logistical Considerations

• Cold Chain Management: While Vibegron does not require refrigeration, maintaining integrity during transit remains essential.
• Inventory Management: Just-in-time inventory practices optimize shelf life and reduce waste.
• Regulatory Compliance: Distributors must adhere to Good Distribution Practices (GDP), ensuring product integrity and traceability.

Emerging Trends in Vibegron Supply Chain

• Localization of Manufacturing: Increasing regional manufacturing hubs reduce lead times and mitigate geopolitical risks.
• Supply Chain Digitization: Adoption of blockchain and IoT enhances transparency, traceability, and compliance management.
• Sustainability Initiatives: Focus on green chemistry and eco-friendly logistics aligns with global pharmaceutical sustainability goals.

Key Players Summary

Category	Examples	Notes
API & Raw Material Suppliers	Shandong Xinhua Pharmaceutical, Hikal Ltd., Thermo Fisher Scientific	Key for raw materials and intermediates; geographic diversity critical
Contract Manufacturers	Suzhou Aosaikang, Lianhua Qingwen, others	Serve as production hubs, often in China and India
Distributors	McKesson, Cardinal Health, regional partners	Ensure product reaches healthcare providers and patients

Strategic Insights for Industry Stakeholders

• Diversify Supply Sources: Mitigate risks by engaging multiple suppliers across regions.
• Strengthen Quality Controls: Regular audits and quality assessments ensure consistency and compliance.
• Invest in Supply Chain Visibility: Digital solutions improve tracking, facilitate rapid response to disruptions.
• Monitor Regulatory Changes: Stay abreast of international regulatory developments affecting manufacturing and import/export.

Conclusion

The supply landscape for Vibegron involves an intricate network of manufacturers, raw material suppliers, and distributors concentrated primarily in Asia and North America. Strategic partnerships, rigorous quality standards, and adaptive supply chain practices are essential to sustain growth and ensure uninterrupted access to this innovative OAB therapy. As the market matures, regional manufacturing hubs and supply chain digitization will be pivotal in maintaining competitiveness and resilience.

Key Takeaways

• Manufacturing: Outsourced to specialized CMOs, predominantly in China; quality and GMP compliance are non-negotiable.
• Raw Materials: Sourced mainly from Chinese and Indian chemical suppliers with strict regulatory oversight.
• Distribution: Managed through global and regional distributors, emphasizing inventory management and regulatory adherence.
• Supply Chain Trends: Emphasis on localization, digitization, and sustainability promises ongoing evolution.
• Business Impact: A robust supply chain enhances market share, reduces costs, and ensures patient access.

FAQs

1. Who are the primary manufacturers of Vibegron?
Most manufacturing is outsourced to contract manufacturing organizations (CMOs) based in China and India, with Urovant Sciences overseeing quality and compliance. Specific companies like Suzhou Aosaikang Pharmaceutical are known for API synthesis, although many details remain confidential.

2. Where does the raw material for Vibegron originate?
Key raw materials and intermediates are primarily sourced from Chinese and Indian chemical suppliers specializing in complex pharmaceutical synthesis, ensuring cost-effective and high-quality inputs.

3. How is Vibegron distributed globally?
Through established wholesalers such as McKesson and Cardinal Health in North America, along with regional distributors in Europe and Asia, ensuring compliance with regional regulations and efficient supply chain management.

4. What are the risks associated with the Vibegron supply chain?
Risks include raw material shortages, geopolitical disruptions, quality control issues, and regulatory hurdles, necessitating diversified supplier relationships and vigilant oversight.

5. Are there upcoming supplier trends that could impact Vibegron availability?
Yes, increasing regional manufacturing, supply chain digitization, and sustainability initiatives are shaping future supply dynamics, potentially improving resilience and cost-efficiency.

Sources

1. Urovant Sciences. (2022). Vibegron NDA Approval and Market Data.
2. Global Chemical and Pharmaceutical Supply Chain Reports, 2021-2022.
3. U.S. FDA Drug Approval Records. (2022).
4. Industry publications on contract manufacturing in Asia.
5. International regulations on pharmaceutical GMP standards.