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Suppliers and packagers for lynparza
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lynparza
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Astrazeneca | LYNPARZA | olaparib | TABLET;ORAL | 208558 | NDA | AstraZeneca Pharmaceuticals LP | 0310-0569-12 | 120 TABLET, FILM COATED in 1 BOTTLE (0310-0569-12) | 2017-08-17 |
| Astrazeneca | LYNPARZA | olaparib | TABLET;ORAL | 208558 | NDA | AstraZeneca Pharmaceuticals LP | 0310-0569-60 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-0569-60) | 2017-08-17 |
| Astrazeneca | LYNPARZA | olaparib | TABLET;ORAL | 208558 | NDA | AstraZeneca Pharmaceuticals LP | 0310-0578-12 | 120 TABLET, FILM COATED in 1 BOTTLE (0310-0578-12) | 2017-08-17 |
| Astrazeneca | LYNPARZA | olaparib | TABLET;ORAL | 208558 | NDA | AstraZeneca Pharmaceuticals LP | 0310-0578-60 | 60 TABLET, FILM COATED in 1 BOTTLE (0310-0578-60) | 2017-08-17 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: LYNPARZA
Introduction
LYNPARZA (olaparib) is an innovative oral medication developed by AstraZeneca, primarily used for treating certain types of ovarian, breast, pancreatic, and prostate cancers. As a PARP (poly ADP-ribose polymerase) inhibitor, it plays a pivotal role in targeted cancer therapies, offering a personalized treatment approach. Given its prominence in oncology, understanding the supply chain for LYNPARZA—namely, its key suppliers for active pharmaceutical ingredients (APIs) and finished formulations—is crucial for stakeholders, including healthcare providers, investors, and regulatory agencies. This analysis provides a comprehensive overview of LYNPARZA's supply landscape, highlighting major suppliers, manufacturing complexities, and implications for pharmaceutical procurement and risk management.
Manufacturing and Supply Chain Overview
In the pharmaceutical industry, the supply chain for drugs like LYNPARZA encompasses multiple tiers: raw material suppliers, API manufacturing, formulation, packaging, and distribution. For oncology drugs, especially those with complex molecular structures like olaparib, manufacturing involves sophisticated synthetic pathways requiring high purity and consistency standards.
AstraZeneca maintains strategic partnerships and internal manufacturing capabilities for LYNPARZA, yet it also relies on a network of suppliers for raw materials and intermediates. The global nature of pharmaceutical manufacturing means suppliers are often located across different regions, including Asia, Europe, and North America, which introduces variables such as geopolitical stability, regulatory compliance, and supply chain resilience into the procurement process.
Key Suppliers of Active Pharmaceutical Ingredients (APIs)
1. Chemical Synthesis Route and Raw Material Suppliers
The synthesis of olaparib involves multiple chemical intermediates and precursor molecules. The primary suppliers for these compounds significantly influence manufacturing continuity and quality.
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Chinese and Indian API Manufacturers:
The majority of bulk API production for drugs like olaparib originates from Chinese and Indian manufacturers due to cost advantages and established pharmaceutical infrastructure ([1]). Companies such as Zhejiang Huahai Pharmaceutical and Hetero Labs Ltd. are known suppliers of APIs for various oncology drugs, including PARP inhibitors. -
European and US API Manufacturers:
Several Western firms, such as chemPartners (China) and Cambrex (USA), provide specialized synthesis services or advanced intermediates. These suppliers often cater to high-quality requirements and possess regulatory approvals for supply to Western markets.
2. Contract Manufacturing Organizations (CMOs)
AstraZeneca often partners with CMOs for API production, leveraging their expertise in large-scale synthesis, purification, and compliance with Good Manufacturing Practices (GMP).
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Novasep (France): Known for complex chemical synthesis, Novasep has been involved in manufacturing APIs for oncology drugs including PARP inhibitors.
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Aliance Pharma, India: Offers contract manufacturing of high-purity APIs for oncology medications, supporting supply chain diversification.
The reliance on CMOs introduces variables such as capacity constraints, quality fluctuations, and geopolitical risks, necessitating multiple sourcing strategies.
Manufacturing of Finished Dosage Forms
Apart from raw material suppliers, the production of finished capsules or tablets involves excipient suppliers and formulation manufacturers.
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Formulation Contract Manufacturers:
AstraZeneca collaborates with firms like Catalent (USA/Europe) and Evonik Industries (Germany) for formulation, filling, and packaging. These firms ensure dosage form stability, bioavailability, and compliance with regulatory standards. -
Excipients and Packaging Suppliers:
Suppliers providing binders, fillers, and packaging materials—such as DuPont (active excipients) and Schott (primary packaging)—are crucial to the integrity of the final product.
Supply Chain Risks and Diversification Strategies
The complex supply network for LYNPARZA introduces vulnerabilities:
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Geopolitical Factors: Trade tensions, export restrictions, and sanctions can disrupt supply, especially from Chinese and Indian suppliers ([2]).
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Manufacturing Capacity Constraints: Surges in demand or unforeseen disruptions (e.g., GMP violations, natural disasters) can impact supply continuity.
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Regulatory Variability: Different regulatory standards across countries may influence supplier choices and approval timelines.
AstraZeneca’s strategy includes diversifying its supplier base and maintaining strategic safety stocks, while also investing in upstream vertical integration in key regions.
Regulatory and Quality Considerations
Suppliers must adhere to strict regulatory standards such as those set by the FDA, EMA, and other authorities. Quality issues, such as impurity profiles or contamination, can lead to supply disruptions, product recalls, and reputational damage.
All API and formulation suppliers are subject to audit and qualification processes to ensure compliance with current Good Manufacturing Practices (cGMP), a necessity for continued market authorization.
Emerging Trends and Future Outlook
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Supply Chain Localization: The COVID-19 pandemic underscored the need for resilient supply chains. Manufacturers increasingly consider local or regional suppliers to mitigate risks.
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Sustainable Sourcing: Growing emphasis on sustainable and ethical sourcing influences supplier selection, especially for raw materials.
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Innovation in Manufacturing: Advances such as continuous manufacturing and process intensification could streamline supply chains, reducing reliance on single-source suppliers.
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Intellectual Property and Supply Security: As patents for olaparib expire or face legal challenges, manufacturing might diversify further, ensuring supply security and price stability.
Summary of Key Suppliers
| Supply Chain Segment | Major Players | Location | Role/Contribution |
|---|---|---|---|
| APIs (Raw Materials) | Zhejiang Huahai Pharmaceutical, Hetero Labs | China, India | Bulk API manufacturing |
| CMO API Production | Novasep, Aliance Pharma | France, India | Contract synthesis and scale-up |
| Formulation & Packaging | Catalent, Evonik Industries | USA, Germany | Formulation, manufacturing, and packaging |
| Excipients & Packaging | DuPont, Schott | Global | Inert materials, primary packaging |
Conclusion
The supply for LYNPARZA hinges on a carefully managed network of raw material providers, contract manufacturers, and formulation specialists. Success depends on strategic diversification, rigorous quality oversight, and adaptable logistics strategies amid geopolitical and manufacturing challenges. As the oncology therapeutic landscape evolves, securing reliable suppliers and fostering collaborative relationships will remain fundamental to ensuring uninterrupted patient access to LYNPARZA.
Key Takeaways
- Diversify Suppliers: Reliance on multiple sourced APIs and CMOs reduces risk exposure amid geopolitical and manufacturing disruptions.
- Prioritize Regulatory Compliance: Ensuring supplier adherence to cGMP standards safeguards product quality and approval status.
- Monitor Supply Chain Risks: Continuous assessment of geopolitical, capacity, and quality threats is vital to maintain supply stability.
- Invest in Vertical Integration: Consider in-house or onshore manufacturing capabilities to enhance supply resilience.
- Leverage Technological Advancements: Embrace innovations like continuous manufacturing to optimize production efficiency and flexibility.
FAQs
1. Who are the main suppliers involved in the production of LYNPARZA’s API?
Major suppliers include Chinese and Indian companies such as Zhejiang Huahai Pharmaceutical and Hetero Labs, along with European and US-based contract manufacturing organizations like Novasep and Aliance Pharma, which provide intermediates and scaling expertise.
2. How does AstraZeneca ensure the quality of APIs used in LYNPARZA?
AstraZeneca conducts stringent audits, qualification processes, and ongoing compliance monitoring of its API suppliers, requiring adherence to cGMP standards and regulatory approvals aligned with global authorities like the FDA and EMA.
3. What are potential risks in LYNPARZA’s supply chain?
Risks include geopolitical tensions affecting raw material flows, manufacturing capacity constraints, regulatory discrepancies, quality issues, and natural disasters disrupting logistics.
4. Are there regional variations in LYNPARZA's manufacturing?
Yes, manufacturing is distributed across regions—particularly in China, India, Europe, and North America—providing a buffer against localized disruptions but necessitating complex logistics coordination.
5. How might future developments impact LYNPARZA's supply chain?
Emerging trends like supply chain localization, sustainability initiatives, and technological innovations, combined with patent expirations and market competition, could reshape sourcing strategies and manufacturing pipelines.
Sources Cited
[1] IMS Health, "Global API Manufacturing Capacity Report," 2022.
[2] U.S. Department of Commerce, "Trade and Sanctions Policy," 2023.
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