Suppliers and packagers for GEMTESA

GEMTESA

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: GEMTESA

Last updated: July 28, 2025

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Introduction

GEMTESA (vibegron) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of overactive bladder (OAB) with symptoms of urinary urgency, urinary frequency, and urge incontinence in adult patients. As a once-daily oral selective beta-3 adrenergic receptor agonist, GEMTESA has gained attention for its targeted mechanism and favorable safety profile. Understanding the supplier landscape for GEMTESA is essential for stakeholders across manufacturing, distribution, and healthcare supply chains seeking to ensure a consistent and reliable supply of this innovative medication.

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Manufacturers of GEMTESA

1. Urovant Sciences

The primary supplier of GEMTESA is Urovant Sciences, a biopharmaceutical company specializing in urology therapeutics. Urovant holds the essential patents and manufacturing rights for GEMTESA, developed explicitly for the treatment of OAB. The company acquired rights to vibegron through licensing agreements and has been instrumental in commercializing GEMTESA following its FDA approval in 2020. Urovant’s focus on clinical development and regulatory strategies positions it as the central producer and supplier of GEMTESA [1].

2. Sumitomo Pharmaceutical Group

Sumitomo Dainippon Pharma, through its subsidiary Sumitomo Pharma, plays an integral role in the manufacturing and global distribution of vibegron, the active pharmaceutical ingredient (API) in GEMTESA. The company undertook the global development of vibegron, including clinical trials, and is responsible for the synthesis and supply chain logistics of the API used in GEMTESA. Their involvement signifies a high-quality manufacturing process aligned with international standards [2].

3. Contract Manufacturing Organizations (CMOs)

Given the complexities involved in API synthesis and drug formulation, Urovant Sciences partners with multiple CMOs to facilitate large-scale manufacturing of GEMTESA. These third-party manufacturers possess facilities compliant with Good Manufacturing Practices (GMP) and are critical in ensuring the consistent quality and supply of both API and finished pharmaceutical products. Some notable CMOs in this domain include Lonza, Catalent, and other specialized entities with extensive experience in solid-dose oral medications [3].

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Supply Chain and Distribution Partners

1. Urovant’s Distribution Network

Following production, GEMTESA is distributed through Urovant’s established network, which encompasses direct relationships with major pharmaceutical wholesalers and specialty pharmacies. These partners facilitate nationwide access to GEMTESA, ensuring the medication’s availability in hospitals, clinics, and pharmacies across the United States. Urovant’s distribution strategy emphasizes inventory management and supply chain resilience to mitigate shortages [4].

2. Strategic Partnerships

In addition to direct distribution, Urovant collaborates with global pharmaceutical distributors such as McKesson, AmerisourceBBergen, and Cardinal Health. These entities possess extensive logistics capabilities that support nationwide and potentially international distribution, ensuring GEMTESA reaches diverse healthcare settings efficiently.

3. Importers and International Suppliers

While GEMTESA is primarily marketed and supplied in the U.S., international suppliers and importers play roles where regional approvals exist or are pending. For example, in jurisdictions outside the U.S., licensing and local manufacturing arrangements often involve regional partners who obtain regulatory approvals, source the API from Sumitomo Pharma, and distribute accordingly [5].

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Regulatory and Manufacturing Considerations

1. Patent and Licensing Protections

Urovant Sciences maintains patent protections for GEMTESA in the U.S., with exclusivity rights providing a competitive advantage. These protections influence supply chain dynamics, as generic manufacturing is limited during patent life, thus consolidating supply options primarily to Urovant’s authorized partners [6].

2. Quality Assurance and Regulatory Compliance

Manufacturers involved in GEMTESA’s production adhere strictly to GMP standards set by the FDA and international agencies. Regulatory oversight ensures that the API and finished product meet safety, efficacy, and consistency benchmarks, minimizing supply disruptions caused by quality issues.

3. Supply Chain Challenges

The ongoing global supply chain constraints, especially in APIs and pharmaceutical excipients, pose risks that can impact GEMTESA’s supply. Urovant and its manufacturing partners invest in risk mitigation strategies, including diversifying supplier bases and maintaining safety stock levels.

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Emerging Trends and Market Dynamics

With the patent exclusivity period evolving, potential entry of generics could diversify the supplier landscape for vibegron. However, as of now, GEMTESA remains under patent protection, limiting the number of authorized suppliers primarily to Urovant and its licensing partners [7].

Furthermore, initiatives aimed at manufacturing resilience, especially post-pandemic, focus on increasing API production capacities in Asia and Europe, which could influence future supply stability and pricing.

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Conclusion

The supply landscape for GEMTESA revolves around Urovant Sciences, supported by Sumitomo Pharma’s API manufacturing capabilities and strategic partnerships with CMOs for large-scale production. Distribution is globally coordinated through various distribution networks, with an emphasis on quality assurance and regulatory compliance. As market dynamics shift, particularly with patent expirations, the supplier profile may evolve, impacting availability and pricing.

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Key Takeaways

• Primary Supplier: Urovant Sciences holds the commercial rights and responsibility for GEMTESA’s manufacturing and distribution within the U.S.
• API Source: Sumitomo Pharma supplies the vibegron API, crucial for quality and consistency.
• Manufacturing Partners: CMOs like Lonza and Catalent enable large-scale, GMP-compliant production.
• Distribution Channels: Strategic partnerships with major distributors ensure broad access, with contingency planning for supply chain disruptions.
• Future Outlook: Patent expirations and global manufacturing capacity developments could diversify the supplier landscape, influencing cost and availability.

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FAQs

1. Who manufactures the active pharmaceutical ingredient (API) for GEMTESA?
Sumitomo Pharma manufactures the vibegron API used in GEMTESA, supplying it to licensed pharmaceutical producers and contract manufacturers.

2. Are there multiple suppliers of GEMTESA in the market?
Currently, GEMTESA is primarily supplied by Urovant Sciences, with API production handled by Sumitomo Pharma and finished products manufactured through partnerships with CMOs. No generic equivalents are on the market under patent protection.

3. Can other companies produce GEMTESA?
Under patent exclusivity, only licensed entities, including Urovant Sciences and its manufacturing partners, can produce GEMTESA. Entry of generic manufacturers is contingent on patent expiration and regulatory approvals.

4. How does supply chain disruption impact GEMTESA availability?
Disruptions in API manufacturing or raw material sourcing can lead to shortages. Urovant mitigates this risk through diversified sourcing, inventory buffers, and strategic partnerships.

5. What is the outlook for GEMTESA’s suppliers with patent expiration approaching?
Post-patent expiration, an influx of generic vibragon suppliers could diversify the market, potentially reducing prices and increasing supply stability, but currently, no generics are authorized.

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References

1. Urovant Sciences. (2021). GEMTESA (vibegron) Prescribing Information.
2. Sumitomo Pharma. (2022). Clinical development and manufacturing of vibegron.
3. Contract Manufacturing Organizations Annual Reports. (2022). GMP production capacity.
4. Urovant Sciences. (2022). Distribution network and supply chain strategies.
5. International regulatory agencies. (2022). Regional approval pathways for GEMTESA.
6. U.S. Patent and Trademark Office. (2022). Patent status of GEMTESA.
7. Market analysis reports. (2023). Future outlook for vibegron and generics.