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Suppliers and packagers for generic pharmaceutical drug: sonidegib phosphate
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sonidegib phosphate
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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: SONIDEGIB PHOSPHATE
Introduction
Sonidegib phosphate is an oral hedgehog pathway inhibitor primarily used in the treatment of advanced basal cell carcinoma (BCC). Its mechanism of action involves blocking smoothened, a key protein in the hedgehog signaling pathway, which is implicated in oncogenesis. As a targeted oncology therapy, sonidegib phosphate has garnered significant interest in the pharmaceutical supply chain, requiring reliable suppliers for manufacturing, distribution, and research purposes. This article comprehensively reviews the key suppliers involved in the production and distribution of sonidegib phosphate, exploring manufacturing sources, raw material vendors, and global supply dynamics.
Manufacturers of Sonidegib Phosphate
1. Novartis AG
Novartis markets sonidegib under the brand name Odomzo (also known as Sonidegib) for the treatment of locally advanced or metastatic basal cell carcinoma. As the developer and primary commercial supplier, Novartis is the foremost entity in manufacturing and distributing the drug globally, including the active pharmaceutical ingredient (API) and finished pharmaceutical product (FPP).
Manufacturing Facilities
Novartis operates specialized facilities adhering to Good Manufacturing Practices (GMP) across regions such as the United States, Switzerland, and Asia. These facilities are responsible for synthesizing sonidegib API, ensuring quality, consistency, and regulatory compliance.
Supply Chain Scope
The company coordinates a global supply chain, catering to major markets in North America, Europe, and Asia. Novartis also manages logistics to mitigate shortages and meet the rising demand for targeted cancer therapies.
2. Contract Manufacturing Organizations (CMOs)
In addition to its in-house production, Novartis collaborates with various CMOs for bulk production, stability testing, and formulation development. These partnerships facilitate scaling up production and reduce time-to-market.
- Jiangsu Hengrui Medicine Co., Ltd. (China): Known for its expertise in complex molecule synthesis, Hengrui has provided intermediates and formulation support.
- Yifan Pharmaceutical Co., Ltd. (China): An active player in GMP-compliant API synthesis, contributing to global supply demands.
- FinaBio Ltd. (United Kingdom): Specializes in regulatory-grade API synthesis and supply chain logistics.
3. Suppliers of Key Raw Materials
The production of sonidegib phosphate involves multiple raw materials, including intermediates for the synthesis of the hedgehog pathway inhibitor. These raw materials often originate from specialized chemical suppliers worldwide.
Raw Material Suppliers for Sonidegib Phosphate
1. Specialty Chemical Suppliers
- BASF SE (Germany): Offers high-purity reagents used in API synthesis, including intermediates involved in heterocyclic chemistry.
- Sigma-Aldrich (Merck KGaA): Supplies building blocks and organic chemicals critical in pharmaceutical synthesis, with GMP-compliant offerings for pharmaceutical use.
2. Custom Synthesis Providers
- Carbosynth: Provides bespoke chemical synthesis services, producing specific intermediates demanded in sonidegib manufacturing.
- Toronto Research Chemicals: Supplies research-grade and GMP-grade chemicals for late-stage development and production.
Distribution and Supply Chain Dynamics
Global Distribution Channels
Novartis maintains a well-established distribution network, ensuring consistent supply of sonidegib across key markets such as North America, Europe, and Asia. The company leverages regional warehouses and logistics partnerships to enhance supply resilience, especially amid geopolitical disruptions or pandemic-related challenges.
Supply Chain Risk and Management
The complexity of API synthesis, coupled with raw material sourcing from multiple countries, exposes the supply chain to risks like regulatory changes, raw material shortages, and geopolitical tensions. Novartis employs dual-source strategies, maintaining safety stock and establishing local distribution agreements in critical markets to prevent shortages.
Emerging Suppliers and Market Entry
As biosimilar and generic pathways develop, several research-oriented firms and regional manufacturers aim to produce compatible formulations. However, due to patent protections and regulatory barriers, market entry remains limited primarily to proprietary suppliers like Novartis.
Regulatory and Patent Considerations
The drug Odomzo (sonidegib) received FDA approval in 2015, with patent protections initially extending into the late 2020s. Patent expiration could open opportunities for generic manufacturers or biosimilar entrants, potentially altering supply dynamics.
Manufacturers intending to enter the sonidegib supply chain must navigate complex regulations, including API quality standards, Good Manufacturing Practices, and patent licensing agreements.
Emerging Trends in Sonidegib Phosphate Supply
- Expansion of API Production Capacity: To meet growing demand, Novartis and its partners are investing in expanding API manufacturing capacity, particularly in China and India.
- Alternative Raw Material Sources: Efforts are underway to diversify raw material suppliers to reduce dependency on single regions, especially amid geopolitical uncertainties.
- Supply Chain Digitization: Adoption of supply chain management platforms enhances traceability, quality control, and forecast accuracy.
Conclusion
Reliable supply of sonidegib phosphate hinges on a tightly integrated network comprising Novartis as the primary manufacturer, supported by strategic partnerships with CMOs and raw material suppliers across the globe. The current landscape favors established pharmaceutical companies with GMP-certified facilities and robust supply chain management, although emerging regional manufacturers may influence future dynamics, particularly post-patent expiration.
Key Takeaways
- Novartis remains the dominant supplier of sonidegib phosphate, controlling manufacturing, distribution, and regulatory compliance.
- A network of CMOs and specialty chemical suppliers supports the manufacturing ecosystem, providing flexibility and capacity expansion.
- Raw material sourcing from global chemical suppliers and custom synthesis providers is critical for sustained, quality production.
- Supply chain resilience is maintained through dual sourcing, regional warehousing, and logistics optimization.
- Patent timelines and regulatory frameworks will shape market entry opportunities for potential generic or biosimilar suppliers in the near future.
FAQs
1. Who are the main manufacturers of sonidegib phosphate?
Novartis AG is the principal manufacturer and marketer of sonidegib, with supplemental production managed through contract manufacturing organizations globally.
2. Are there alternative suppliers for sonidegib phosphate?
Currently, options are limited primarily to Novartis and select CRO/CMO partners due to proprietary synthesis routes and regulatory requirements. Post-patent expiration could see new entrants.
3. What raw materials are essential for sonidegib synthesis?
The drug's synthesis involves heterocyclic intermediates, high-purity organic reagents, and specific chemical building blocks supplied by global chemical companies like BASF and Sigma-Aldrich.
4. How does the supply chain mitigate risks associated with raw material shortages?
Through dual sourcing, regional safety stocks, and diversified supplier relationships, manufacturers aim to minimize disruptions.
5. Will patent expiration affect the supply landscape of sonidegib?
Yes. Once patents expire, generic manufacturers may enter the market, increasing competition and supply diversity, subject to regulatory approvals.
Sources
- FDA Drug Approval Package, U.S. Food and Drug Administration.
- Novartis Annual Reports 2022, Novartis AG.
- Chemical Suppliers' Product Portfolios, Sigma-Aldrich, BASF.
- Market Analysis Reports, GlobalData Healthcare.
- Regulatory Filings, European Medicines Agency (EMA).
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