Suppliers and packagers for odomzo

odomzo

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sun Pharm	ODOMZO	sonidegib phosphate	CAPSULE;ORAL	205266	NDA	Sun Pharmaceutical Industries, Inc.	47335-303-15	30 CAPSULE in 1 BOTTLE (47335-303-15)	2017-09-21
Sun Pharm	ODOMZO	sonidegib phosphate	CAPSULE;ORAL	205266	NDA	Sun Pharmaceutical Industries, Inc.	47335-303-83	30 CAPSULE in 1 BOTTLE (47335-303-83)	2017-09-21

Suppliers for the Pharmaceutical Drug: Odomzo

Last updated: August 2, 2025

Introduction

Odomzo (sonidegib) has emerged as a targeted therapy option for patients with locally advanced, unresectable basal cell carcinoma (BCC) and certain cases of metastatic BCC. Approved by the U.S. Food and Drug Administration (FDA) in 2018, Odomzo is a hedgehog pathway inhibitor, designed to address unmet treatment needs in this niche oncology market. As the demand for effective, targeted treatments grows, understanding the landscape of suppliers for Odomzo is crucial for stakeholders across the pharmaceutical, distribution, and healthcare sectors.

Manufacturing and Proprietary Production

The primary supplier of Odomzo is Sun Pharmaceutical Industries Limited, based in India. Sun Pharma is responsible for the manufacturing, development, and global distribution of Odomzo, leveraging its extensive portfolio of specialty medicines and robust manufacturing capabilities. The company acquired Odomzo's rights or licensed its production through strategic partnerships and licensing agreements, streamlining its entry into global markets.

Sun Pharma's Role in Odomzo Supply Chain:

• Research & Development (R&D): Sun Pharma's R&D division in India develops and refines the production process for Odomzo, ensuring quality and consistency.
• Manufacturing Facilities: The drug is produced in cGMP-compliant manufacturing plants operated by Sun Pharma, primarily located in India, ensuring compliance with international standards.
• Quality Assurance: Sun Pharma employs rigorous quality control protocols, including batch testing and stability assessments, to meet global regulatory requirements.

Global Distribution Network

Sun Pharma's extensive distribution infrastructure supports Odomzo's presence in major markets, including the United States, Europe, Asia, and other regions. These supply channels involve:

• Authorized Distributors: Licensed third-party distributors with licenses to import, store, and supply Odomzo within different regions.
• Partnerships with Local Pharmacies and Hospitals: Strategic alliances with healthcare providers and pharmacies to facilitate patient access.
• Direct Supply Agreements: Contractual arrangements with large healthcare systems and government procurement agencies, especially in the U.S., facilitated through GPOs (Group Purchasing Organizations).

Key Regional Suppliers and Distribution Partners

• United States: The drug is distributed through authorized specialty pharmacy networks and healthcare providers, primarily via Sun Pharma's U.S. subsidiary or licensing partners.
• European Union: Distribution handled through licensed importers complying with the European Medicines Agency (EMA) regulations.
• Asia and Emerging Markets: Local distribution agreements solidify Sun Pharma’s presence, leveraging regional logistics and regulatory compliance.

Supply Challenges and Strategic Responses

Manufacturers face persistent challenges in ensuring consistent supply, particularly with:

• Raw Material Availability: Securing pharmaceutical-grade raw materials, primarily for the active pharmaceutical ingredient (API), is critical. Sun Pharma sources raw materials globally, with manufacturing hubs in India and Asia.
• Regulatory Approvals: Variations in regional approvals impact the speed and volume of supplies.
• Production Scalability: As demand increases, Sun Pharma invests in expanding manufacturing capacity and optimizing supply chain logistics to prevent shortages.

Emerging Suppliers and Competition

Given the niche indication for Odomzo, little direct competition exists. However, potential future suppliers include:

• Biotechnology companies exploring alternative hedgehog pathway inhibitors.
• Contract Manufacturing Organizations (CMOs): These entities may produce generic or biosimilar versions if patents expire or licensing arrangements change.

Regulatory and Patent Landscape

Odomzo's patent protection was initially secured through patent filings covering the molecule, formulation, and specific uses. Since patent expiration approaches or if patent challenges arise, generic manufacturing could enter the market, increasing supply options. Currently, Sun Pharma maintains exclusivity and control over the supply chain, which is critical for quality assurance and market stability.

Conclusion

Sun Pharmaceutical Industries Limited is the primary supplier of Odomzo, supported by a comprehensive global distribution network. The company's investment in manufacturing capacity, quality assurance, and regional partnerships positions it as the dominant supplier, ensuring therapy availability. Monitoring patent protections, regional regulatory changes, and market demand remains essential for stakeholders planning supply chain resilience or considering entry points into biosimilar or generic markets.

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Key Takeaways

• Sun Pharma holds the primary role in manufacturing and distributing Odomzo globally.
• The drug benefits from a robust supply chain model in India, the U.S., Europe, and emerging markets facilitated through authorized distributors and strategic partnerships.
• Supply chain resilience depends on raw material sourcing, manufacturing capacity, and regulatory compliance.
• Market exclusivity and patent protections are pivotal in maintaining supply dominance; impending patent expirations could alter the supplier landscape.
• Stakeholders should continuously monitor regulatory developments, patent statuses, and potential biosimilar entries to adapt sourcing strategies.

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FAQs

1. Who is the main manufacturer of Odomzo?
Sun Pharmaceutical Industries Limited is the primary manufacturer responsible for producing and distributing Odomzo globally.

2. Are there any generic versions of Odomzo available?
As of now, Odomzo remains under patent protection with no approved generics. Patent expirations could change this landscape in the future.

3. How is Odomzo distributed in the United States?
Distribution in the U.S. is managed through licensed specialty pharmacies and healthcare providers, coordinated via Sun Pharma’s U.S. subsidiary.

4. What challenges impact the supply of Odomzo?
Key challenges include raw material availability, regional regulatory approvals, manufacturing scalability, and patent protections.

5. Could new suppliers enter the market?
Potentially, biosimilar or generic manufacturers could enter post-patent expiry, increasing competition and supply options.

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Sources
[1] FDA Drug Approvals and Public Records, 2018.
[2] Sun Pharma Annual Report, 2022.
[3] European Medicines Agency (EMA) Guidelines, 2021.
[4] Patent filings and legal literature on hedgehog pathway inhibitors.