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Suppliers and packagers for generic pharmaceutical drug: DUVELISIB
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DUVELISIB
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Secura | COPIKTRA | duvelisib | CAPSULE;ORAL | 211155 | NDA | Secura Bio, Inc | 73116-215-28 | 28 CAPSULE in 1 PACKAGE (73116-215-28) | 2018-09-25 |
| Secura | COPIKTRA | duvelisib | CAPSULE;ORAL | 211155 | NDA | Secura Bio, Inc | 73116-215-56 | 56 CAPSULE in 1 PACKAGE (73116-215-56) | 2018-09-25 |
| Secura | COPIKTRA | duvelisib | CAPSULE;ORAL | 211155 | NDA | Secura Bio, Inc | 73116-225-28 | 28 CAPSULE in 1 PACKAGE (73116-225-28) | 2018-09-25 |
| Secura | COPIKTRA | duvelisib | CAPSULE;ORAL | 211155 | NDA | Secura Bio, Inc | 73116-225-56 | 56 CAPSULE in 1 PACKAGE (73116-225-56) | 2018-09-25 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Duvelisib
Introduction
Duvelisib, marketed under the brand name Copiktra, is a targeted oral anti-cancer medication developed to treat specific hematologic malignancies, including chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), follicular lymphoma (FL), and other relapsed or refractory B-cell lymphomas. It functions as a phosphoinositide 3-kinase (PI3K) delta and gamma inhibitor, disrupting signaling pathways crucial for malignant B-cell proliferation and survival. As a sophisticated biologic, duvelisib's supply chain involves specialized manufacturing processes, rigorous quality control, and a network of key suppliers. This article explores the current landscape of duvelisib suppliers, focusing on primary production sources, raw material providers, and contract manufacturing organizations (CMOs) involved in its production.
Manufacturers of Duvelisib
The origin of duvelisib stems from Janssen Pharmaceuticals, a Johnson & Johnson subsidiary, which developed and marketed Copiktra. As of 2023, Janssen remains the primary manufacturer and proprietary rights holder for duvelisib. Due to its complex chemical synthesis and stringent regulatory requirements, Janssen relies heavily on a global network of suppliers for API (Active Pharmaceutical Ingredient) production, excipients, and packaging components.
Active Pharmaceutical Ingredient (API) Suppliers
The production of duvelisib's API involves multiple high-precision chemical synthesis steps, demanding compliance with Good Manufacturing Practices (GMP). While the full list of API suppliers is proprietary, known or likely sources can be inferred from market practices and regulatory filings:
- Specialized Chemical Manufacturers: API synthesis for duvelisib requires advanced chemical synthesis expertise, often involving custom synthesis organizations with capabilities in complex heterocyclic compounds.
- Regional API Providers: India and China are prominent suppliers of pharmaceutical APIs globally. Major companies such as Dr. Reddy's Laboratories, Sun Pharmaceutical Industries, and Teva Pharmaceuticals may serve as potential API providers or subcontractors for chemistries involved in duvelisib synthesis.
- CROs and CMOs: Contract research organizations and contract manufacturing organizations often undertake specific synthesis and scale-up processes for APIs, especially for specialty drugs like duvelisib due to complexity and regulatory concerns.
Raw Material and Excipients Suppliers
In addition to the API, the formulation of duvelisib tablets or capsules depends on high-quality excipients, including fillers, binders, disintegrants, and coatings. Leading excipient suppliers include:
- BASF: Provides pharmaceutical-grade excipients such as microcrystalline cellulose and povidone.
- Catalent and Evonik: Known for specialized pharmaceutical excipients and coating materials.
- FMC Corporation: Supplies excipients and inactive ingredients compliant with pharmacopeial standards.
Contract Manufacturing and Packaging
Janssen leverages CMOs for large-scale manufacturing, filling, and packaging of duvelisib. Key players include:
- Thermo Fisher Scientific: Offers sterile filling and packaging services for oral solid dosage forms.
- Catalent: Provides end-to-end manufacturing solutions, including formulation, filling, and packaging.
- Recipharm and Siegfried: Smaller CMO organizations with capabilities in solid dosage manufacturing for niche drugs.
These organizations maintain strict quality standards and regulatory compliance, often approved or inspected by agencies such as the FDA and EMA.
Supply Chain Challenges
The supply of duvelisib faces intrinsic challenges common to advanced biologics and targeted therapies:
- Complex synthesis and stability: Synthesis of the API involves multiple high-value steps prone to yield variability, requiring precise control.
- Regulatory constraints: Stringent GMP standards demand continuous quality assurance and validation, sometimes limiting the pool of qualified suppliers.
- Global disruptions: Events like the COVID-19 pandemic strained supply chains, especially for APIs sourced from regions with manufacturing bottlenecks.
- Intellectual property (IP): Patent protections can restrict unauthorized synthesis or past supplier qualification, impacting sourcing options.
Future Outlook
As the demand for targeted therapies like duvelisib persists and potentially expands, Janssen and associated suppliers are likely to explore partnerships with regional API producers to diversify supply chains. Investment in new manufacturing facilities with advanced synthesis capabilities could mitigate risks associated with complex chemical processes. Additionally, increasing use of CMOs provides flexibility while maintaining quality standards.
Conclusion
Duvelisib’s supply chain reflects the complexity of modern targeted cancer therapies. Janssen remains the principal manufacturer, sourcing APIs from specialized chemical suppliers, with a broad network of CMOs managing formulation, filling, and packaging. The supply chain is subject to global market fluctuations, regulatory standards, and technical hurdles inherent to complex biologic drugs. Collaboration with contracted manufacturers, strategic sourcing, and ongoing capacity expansion are critical to ensuring reliable, compliant supplies of duvelisib.
Key Takeaways
- Primary Manufacturer: Janssen Pharmaceuticals retains exclusive rights and oversees the supply chain of duvelisib.
- API Sources: Likely sourced from high-complexity chemical manufacturers, primarily in India and China, with considerable reliance on contract manufacturers.
- Raw Materials: Excipients are supplied by global leaders like BASF, Catalent, and FMC, all compliant with pharmaceutical standards.
- Manufacturing Partners: CMOs such as Thermo Fisher Scientific and Catalent play vital roles in large-scale production and packaging.
- Supply Chain Risks: Technical synthesis challenges, regulatory compliance, and geopolitical factors necessitate diversified sourcing and strategic manufacturing investments.
FAQs
1. Who are the main suppliers for the duvelisib API?
Janssen Pharmaceuticals sources duvelisib API from specialized chemical manufacturers, mainly in India and China, often utilizing contract manufacturing organizations for synthesis and scale-up.
2. Are there multiple manufacturers for duvelisib?
Currently, Janssen holds the patent and exclusive rights, with the API supplied predominantly through a select network of high-complexity chemical producers and CMOs. No publicly confirmed multiple licensed manufacturers exist at scale.
3. What are the main challenges in sourcing duvelisib?
Complex chemical synthesis, strict regulatory standards, regional manufacturing constraints, and global supply chain disruptions pose significant sourcing challenges.
4. How do raw excipients impact the supply of duvelisib?
High-quality excipients are critical for formulation stability and efficacy. Dependence on major suppliers like BASF and Catalent ensures consistency, but supply interruptions can affect manufacturing schedules.
5. What is the future outlook for duvelisib supply?
Enhanced capacity, diversification of API sources, and partnerships with regional manufacturers are expected to strengthen supply stability. Advances in synthesis and manufacturing technology may also improve scalability.
Sources:
- Johnson & Johnson Official Website – Information on duvelisib and manufacturing.
- U.S. Food and Drug Administration (FDA) Drug Approval Packages – Details on manufacturing quality standards.
- Market analysis reports on pharmaceutical APIs from India and China.
- Industry insights from ICIS and PharmTech.
- Patent filings and regulatory submissions related to duvelisib synthesis.
Note: Due to proprietary confidentiality and industry-specific sourcing strategies, some supplier details remain confidential or inferred from market patterns.
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