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Suppliers and packagers for zolinza
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zolinza
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Msd Sub Merck | ZOLINZA | vorinostat | CAPSULE;ORAL | 021991 | NDA | Merck Sharp & Dohme LLC | 0006-0568-40 | 120 CAPSULE in 1 BOTTLE (0006-0568-40) | 2006-10-06 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Zolinza
Introduction
Zolinza (generic name: vorinostat) is a histone deacetylase inhibitor developed by Merck & Co. It gained FDA approval in 2006 for the treatment of cutaneous symptoms in patients with persistent, progressive, or recurrent CTCL (cutaneous T-cell lymphoma) who have previously been treated with other systemic therapies. As a targeted cancer therapy, Zolinza's supply chain involves multiple stakeholders, from active pharmaceutical ingredient (API) producers to finished drug manufacturers and distributors. Understanding its supplier landscape is crucial for stakeholders across the pharmaceutical, biotech, and healthcare sectors seeking to ensure supply chain stability, competitive procurement, or partnership opportunities.
Overview of Zolinza’s Supply Chain
Zolinza’s supply chain comprises several core components:
- Active Pharmaceutical Ingredient (API) providers
- Formulation and finished drug manufacturers
- Packaging and distribution partners
- Regulatory and quality oversight agencies
The critical bottleneck in the supply chain is generally the procurement of high-quality, compliant API, which directly influences production capacity and drug availability.
API Suppliers for Zolinza
1. Merck & Co. (In-House API Production)
Merck, the original developer and marketer of Zolinza, produces the API internally. The company’s vertically integrated manufacturing process ensures quality control but limits transparency regarding external suppliers. This internal production model provides a strategic advantage in controlling supply chain risks but may complicate sourcing for generic or biosimilar counterparts.
2. External API Manufacturers
While Merck maintains in-house API production, certain supplemental or bulk API manufacturing is often outsourced to specialized chemical synthesis firms. These external suppliers are typically based in regions with established chemical manufacturing infrastructure, such as China, India, and Eastern Europe.
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Chinese Suppliers:
Chinese firms are often favored for cost-efficiency and capacity expansion. However, procurement from China entails considerations regarding regulatory compliance (e.g., Good Manufacturing Practice, GMP), intellectual property, and supply reliability. -
Indian Suppliers:
India hosts prominent pharmaceutical API manufacturers, with firms such as Granules India, Aurobindo Pharma, and Cadila Healthcare likely producing APIs or intermediates for similar molecules, including HDAC inhibitors, although specific confirmation for vorinostat is proprietary.
3. Market Dynamics and Alternative Sources
The global API market for HDAC inhibitors, including vorinostat, is relatively niche, with limited dedicated suppliers. Companies seeking to produce generic Zolinza must ensure API quality standards meet pharmacopoeia requirements (USP, EP, JP). New entrants or secondary suppliers often attempt to enter the market to capitalize on patent expirations or to meet increased demand during public health emergencies.
Finished Drug Manufacturing and Contract Development & Manufacturing Organizations (CDMOs)
Merck directly manufactures Zolinza for its global distribution. However, contract manufacturing organizations (CMOs) serve as secondary suppliers for regional markets or during capacity constraints.
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Major CMOs involved in similar oncology drugs:
- Lonza: Known for biopharmaceutical manufacturing, including small-molecule synthesis.
- Fujifilm Diosynth Biotechnologies: Specializes in custom synthesis of complex molecules.
- Patheon (Thermo Fisher Scientific): Provides comprehensive manufacturing and formulation services.
While specific contractual arrangements for Zolinza are proprietary, these firms are integral to the global supply web for similar therapeutics.
Distribution and Logistics
Distribution is managed through Merck’s global supply chain network, including warehouse hubs and regional distributors. Third-party logistics providers (3PLs) specializing in temperature-sensitive pharmaceuticals ensure the integrity of Zolinza during transit. Ensuring a resilient distribution network is vital given the drug’s niche market and the potential for demand surges in specific geographic markets.
Supply Chain Challenges and Risks
- Regulatory compliance: API and finished product manufacturers must adhere to GMP standards, which can restrict sourcing options.
- Patent and IP considerations: Existing patents and licensing agreements influence supplier selectivity.
- Geopolitical factors: Supply disruptions due to trade tensions, export restrictions, or geopolitical instability, especially from Asian manufacturing hubs.
- Market demand fluctuations: Changes in clinical guidelines or new therapeutic alternatives can impact production planning.
- Supply chain traceability and transparency: Increasing regulatory scrutiny emphasizes end-to-end oversight.
Emerging Trends and Strategic Considerations
1. Diversification of API Suppliers
To mitigate supply disruptions, Merck and other stakeholders are likely exploring multi-source strategies, including dual sourcing from established manufacturers in India and China, or even developing in-house capacities further.
2. Contracting with Specialized CMOs
Firms may engage dedicated CMOs with proven expertise in small-molecule oncology agents, ensuring quality and scalability.
3. Geographic Risks Management
A balanced supplier base across regions reduces exposure to country-specific challenges, e.g., export bans or logistic bottlenecks during global crises such as the COVID-19 pandemic.
4. Manufacturing for Biosimilar and Generic Markets
Companies developing biosimilars or generics for vorinostat are seeking API suppliers compliant with international regulations, maintaining quality continuity for market entry.
Key Players and Notable Suppliers
| Supplier Type | Companies / Regions | Notes |
|---|---|---|
| In-house API production | Merck & Co. | Exclusive internal manufacturing for Zolinza via proprietary facilities |
| External API suppliers | Chinese and Indian chemical manufacturers | Potential sources, specific relationships confidential |
| CDMOs | Lonza, Fujifilm Diosynth, Patheon | Contract manufacturing options for formulation and packaging |
| Distribution Partners | Global logistics providers | DHL, FedEx, and regional distributors ensure market access |
Conclusion
Understanding the supplier network for Zolinza reveals a complex, multi-layered supply chain driven by high-quality API procurement, manufacturing expertise, and regulatory compliance. Merck’s reliance on proprietary API production simplifies control but necessitates oversight of third-party sourcing strategies to safeguard supply continuity. The global API market for vorinostat remains relatively limited, emphasizing the importance of diversified sourcing and robust supply chain management strategies for stakeholders aiming to preserve access, ensure quality, and optimize costs.
Key Takeaways
- Merck primarily produces Zolinza’s API internally, but external sourcing from Chinese and Indian manufacturers is possible and likely to supplement supply chains.
- Manufacturing is supported by specialized CMOs that ensure scalability and regulatory compliance.
- Supply chain resilience depends on diversification of API sources, effective quality oversight, and geopolitical risk mitigation.
- Increasing regulatory scrutiny requires transparent traceability and adherence to GMP standards across the supply chain.
- Strategic partnerships with established CMOs and API suppliers are vital for long-term market stability and scalability.
FAQs
Q1: Who are the main API suppliers for Zolinza?
A: While Merck produces the API internally, external suppliers likely include Chinese and Indian chemical manufacturers specializing in small-molecule active pharmaceutical ingredients, although specific suppliers have not been publicly disclosed.
Q2: How does Merck maintain supply chain control for Zolinza?
A: Merck manages API production through proprietary manufacturing facilities, coupled with strategic outsourcing to qualified CMOs, maintaining strict quality and regulatory oversight.
Q3: Are there new entrants or alternative suppliers for vorinostat API?
A: The niche market and complex synthesis process limit the number of suppliers; however, growing demand and patent expirations may incentivize new entrants, particularly in key manufacturing regions.
Q4: What risks threaten the supply of Zolinza?
A: Risks include regional geopolitical instability, supply chain disruptions, regulatory compliance issues, and fluctuations in global demand.
Q5: How can stakeholders mitigate supply chain disruptions for Zolinza?
A: Diversification of API sourcing, engaging multiple qualified CMOs, implementing robust quality assurance, and maintaining strategic inventory reserves are essential strategies.
Sources:
[1] FDA. Zolinza (vorinostat) Prescribing Information, 2006.
[2] Merck & Co. Corporate Reports.
[3] Market intelligence reports on pharmaceutical API manufacturing.
[4] WHO and EMA GMP guidelines.
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