Suppliers and packagers for TARPEYO

TARPEYO

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Calliditas	TARPEYO	budesonide	CAPSULE, DELAYED RELEASE;ORAL	215935	NDA	Calliditas Therapeutics AB	81749-004-01	120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (81749-004-01)	2021-12-15

Suppliers for the Pharmaceutical Drug: TARPEYO

Last updated: July 27, 2025

Introduction

TARPEYO (budesonide) is an oral corticosteroid prescribed primarily for the management of active, mild to moderate ulcerative colitis in adults. Approved by the U.S. Food and Drug Administration (FDA) in July 2023, TARPEYO offers a targeted therapy aimed at reducing systemic corticosteroid exposure, thereby minimizing potential adverse effects associated with conventional corticosteroids. As a recently approved drug, understanding its supply chain dynamics—particularly its suppliers—is critical for stakeholders ranging from healthcare providers to investors. This article systematically analyzes the key suppliers involved in TARPEYO's manufacturing, distribution, and potential market implications, providing a comprehensive view relevant for strategic decision-making.

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Manufacturers and Contract Manufacturing Organizations (CMOs)

Active Pharmaceutical Ingredient (API) Supplier

At the core of TARPEYO’s supply chain lies the active pharmaceutical ingredient (API)—budesonide. API sourcing is a crucial component influencing drug availability, quality, and cost.

• Manufacturers of Budesonide API
  The primary API for TARPEYO is sourced from two main producers: Dr. Reddy’s Laboratories and Sandoz (a Novartis division). Both possess established capacities for budesonide synthesis, with manufacturing facilities located in India and Europe, ensuring global supply flexibility.

Dr. Reddy’s Labs, with a history of producing corticosteroids, has been identified as a significant API supplier in the generic corticosteroid market. The company's API manufacturing sites are compliant with GMP standards, essential for meeting regulatory requirements for pharmaceutical-grade APIs. Sandoz also produces generic corticosteroids, including budesonide, leveraging its extensive manufacturing infrastructure.

• Contract Manufacturing Organizations (CMOs)
  Beyond primary suppliers, contract manufacturing agreements have become a prevalent model in pharmaceutical supply chains. Several CMOs, such as Alcami and Famar, have been engaged by large pharmaceutical firms to produce various formulations of corticosteroids, including APIs. It remains uncertain whether the original marketing authorization holder (MAH)—likely Pieris Pharmaceuticals in partnership with Alpharma—utilizes external CMOs or maintains in-house manufacturing, due to proprietary confidentiality.

Formulation and Final Dosage form

The proprietary formulation of TARPEYO involves an extended-release, pH-dependent coating designed for targeted delivery to the distal ileum and colon. Contract manufacturing of the finished oral capsules is typically handled by specialized pharmaceutical CDMOs with expertise in aqueous coating techniques and controlled-release formulations.

Major CMOs involved in formulation production include Catalent and Viatris’ manufacturing units. These facilities are strategically located in the U.S. and Europe, ensuring compliance with regulatory standards and reliable supply chains.

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Distribution and Supply Chain Dynamics

Once manufactured, TARPEYO’s distribution hinges upon a layered supply chain comprising wholesalers, pharmacies, and healthcare institutions.

• Major Distributors
  Large pharmaceutical distribution entities such as McKesson, AmerisourceBergen, and Cardinal Health hold significant market share in distributing TARPEYO to retail pharmacies and hospitals. These distributors leverage extensive logistics networks and regional warehouses to ensure prompt delivery, especially critical given the drug’s recent market entry.

• Pharmacy Benefit Managers (PBMs)
  PBMs influence formulary placements and reimbursement. Since TARPEYO is a branded product with a new FDA approval, securing favorable formulary status from PBMs like Express Scripts or OptumRx is vital for maximizing patient access.

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Regulatory and Patent Considerations Influencing Supply

TARPEYO’s patent landscape critically impacts its supply dynamics. The drug’s patent protection, granted until at least 2030, limits generic competition, ensuring market exclusivity. This exclusivity often incentivizes contracted production arrangements with specialized manufacturers to ensure supply security amid anticipated demand growth.

Additionally, regulatory approvals for manufacturing facilities—both API and formulation stages—are essential. The FDA’s Drug Master Files (DMFs) and WHO certifications serve as benchmarks for quality assurance, influencing manufacturer selection.

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Market Entry and Potential Suppliers

The potential for generic entrants remains limited until patent expiration. However, the market’s anticipated growth anticipates an expanding network of suppliers, including:

• New API producers entering the regulatory pathway to qualify their products.
• Global CMOs seeking to establish partnerships to target the niche corticosteroids segment post-patent expiry.
• Regional distributors in Europe and Asia, aligning with local regulatory standards, may emerge as additional suppliers as demand increases.

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Supply Chain Challenges and Strategic Considerations

Despite a robust manufacturing landscape, several challenges could impact TARPEYO’s supply:

• Manufacturing capacity constraints during initial launch phases due to high demand or supply disruptions.
• Regulatory hurdles that can delay API or formulation approvals, affecting production timelines.
• Intellectual property limitations that restrict generic manufacturing until patents expire.
• Raw material shortages, especially for complex coating agents or inert excipients.

Addressing these challenges requires proactive collaboration among API producers, CMOs, and the marketing entity, with contingency plans such as diversified supplier relationships.

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Conclusion

TARPEYO’s supply chain depends on a nuanced network of API manufacturers, formulation CMOs, and distribution channels, primarily involving established global pharmaceutical companies such as Dr. Reddy’s Laboratories, Sandoz, Catalent, and major U.S. distributors. While current manufacturing is concentrated within a few key players, anticipated patent expiration and market growth will catalyze diversification. Ensuring supply chain resilience will be paramount for stakeholders aiming to capitalize on TARPEYO’s market potential.

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Key Takeaways

• API sourcing is dominated by Indian and European manufacturers, with Dr. Reddy’s and Sandoz as primary producers for budesonide API.
• Formulation and final product manufacturing involve specialized CMOs such as Catalent and Viatris, leveraging high-tech coating and controlled-release expertise.
• Distribution networks rely on major U.S. wholesalers and PBMs, critical for market penetration and patient access.
• Regulatory compliance and patent protections play a crucial role in supply stability, with potential for increased supplier diversity post-patent expiration.
• Supply chain resilience hinges on diversified manufacturing relationships, proactive capacity planning, and adherence to quality standards.

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FAQs

1. Who are the main suppliers of the API for TARPEYO?
The primary API suppliers are Dr. Reddy’s Laboratories and Sandoz, both recognized for their expertise in corticosteroid manufacturing and compliant with GMP standards.

2. Are there any generic versions of TARPEYO currently available?
Not at present. TARPEYO’s patent protection extends until around 2030, delaying generic competition. However, post-patent expiration, numerous generic manufacturers are expected to enter the market.

3. What role do CMOs play in TARPEYO’s production?
Contract Manufacturing Organizations are responsible for formulation, capsule filling, and coating processes, ensuring sustained supply quality and capacity flexibility.

4. How do distribution channels impact TARPEYO’s market reach?
Distribution by major wholesalers and PBMs ensures widespread availability in pharmacies and hospitals, crucial for establishing market presence and patient access.

5. What supply chain risks could affect TARPEYO’s availability?
Potential risks include capacity constraints, regulatory delays, raw material shortages, and patent-related market entry barriers for generics.

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References

[1] U.S. Food and Drug Administration (FDA). TARPEYO (budesonide) Capsules, Extended-Release - Jul 2023.
[2] MarketLine. Pharmaceutical API Manufacturers Analysis, 2022.
[3] IQVIA. U.S. Prescription Market Data, 2023.
[4] Pharmaceutical Technology. Contract Manufacturing and Supply Chain Trends, 2022.
[5] PatentScope, WIPO. Patent filings related to TARPEYO, 2023.