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Suppliers and packagers for iressa
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iressa
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 | IRESSA | gefitinib | TABLET;ORAL | 206995 | NDA | AstraZeneca Pharmaceuticals LP | 0310-0482-30 | 30 TABLET, COATED in 1 BOTTLE (0310-0482-30) | 2015-07-13 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: IRESSA (Gefitinib)
Introduction
IRESSA, the brand name for gefitinib, is an oral targeted therapy used primarily for non-small cell lung cancer (NSCLC) harboring specific epidermal growth factor receptor (EGFR) mutations. Since its approval in the early 2000s, IRESSA has become a cornerstone in personalized oncology. Its complex manufacturing process and patent protections have shaped its supply chain, involving numerous suppliers across different stages—from active pharmaceutical ingredient (API) production to formulation, packaging, and distribution. This report offers a comprehensive overview of the key suppliers underpinning the IRESSA supply chain, highlighting their roles, geographic presence, and strategic significance.
Manufacturing of Gefitinib Active Pharmaceutical Ingredient
API Production
Gefitinib's efficacy hinges on its unique molecular structure, synthesized through a multi-step chemical process. Several pharmaceutical companies hold manufacturing rights or produce gefitinib API under licensing agreements, with notable players including:
- AbbVie (formerly AstraZeneca): Originally developed gefitinib and holds key patents covering its synthesis. After selling rights to other manufacturers, certain API production licenses may still be held or sublicensed.
- Lunan Pharmaceutical Group: Based in China, Lunan is one of the prominent licensed manufacturers of gefitinib API, aligning with China's rising role in generic drug manufacturing [1].
- Sino Biopharmaceutical Limited: Also operating in China, involved in the API synthesis of gefitinib to meet regional and international demands.
- Others: Various Contract Manufacturing Organizations (CMOs) and generic producers in India and China manufacture gefitinib API under licensing agreements, including companies like Zydus Cadila and Cipla, especially for the generic market.
Synthesis & Quality Control
Gefitinib API synthesis demands rigorous quality control, with suppliers adhering to Good Manufacturing Practices (GMP). These suppliers often obtain certification from regulatory agencies like the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA).
Formulation and Final Product Manufacturing
Once API production completes, manufacturers focus on formulation, quality testing, and packaging:
- Original Manufacturer: AstraZeneca (now part of AstraZeneca PLC), developed and initially marketed IRESSA, tightly controlling production and supply.
- Generic Manufacturers: Post-patent expiry, generic companies—such as Teva, Sun Pharma, and others—enter the market, sourcing gefitinib API from licensed manufacturers and producing their formulations.
- Contract Manufacturers: A significant portion of formulation and packaging is outsourced to CMOs specializing in sterile and non-sterile oral solid production, ensuring scale and compliance.
Distribution and Supply Chain Logistics
Distribution involves multiple layers:
- Regional Distributors: Partnered with national health authorities and private pharmacies to ensure supply. In key markets such as the U.S., Europe, China, and emerging economies, local distributors facilitate timely delivery.
- Supply Chain Resilience: Manufacturers and distributors maintain strategic stockpiles and contingency plans, vital given the critical nature of oncology drugs.
Global Supply Dynamics
The global supply chain for gefitinib has evolved with patent protections, regional manufacturing hubs, and regulatory requirements. In high-income markets, supply chains are predominantly centralized in Europe and North America, with licensed API supplied from Chinese and Indian manufacturers for generic versions.
Key Suppliers and Licensing Agreements
1. Original Innovator: AstraZeneca
AstraZeneca patented gefitinib, under the brand IRESSA, with manufacturing initially conducted by dedicated facilities directed by the company. While the patent expiry opened markets for generics, AstraZeneca continues to oversee regulatory and manufacturing quality for its branded product.
2. Chinese API Manufacturers
Chinese pharmaceutical firms such as Lunan Pharmaceutical, Shenzhen Salubris Pharmaceuticals, and Sino Biopharmaceutical have obtained licenses from AstraZeneca or other licensors to produce gefitinib API for regional markets. These companies have scaled API production, contributing significantly to the global supply, especially in Asia.
3. Indian Generic Manufacturers
Indian pharmaceutical manufacturers like Cipla and Zydus Cadila are authorized to produce generic gefitinib formulations, sourcing API from licensed Chinese manufacturers or through direct licensing agreements with patent holders. Such companies supply both domestic and export markets.
4. Contract Manufacturing Organizations (CMOs)
CMOs play a critical role in formulation, packaging, and distribution. They serve both branded and generic producers, ensuring capacity for global supply. Examples include Bosch Packaging Technology and Catalent, which provide specialized manufacturing services.
Regulatory Considerations and Impact on Suppliers
Regulatory approval remains pivotal. Suppliers must comply with stringent standards mandated by agencies such as the FDA, EMA, and China’s NMPA to ensure manufacturing quality, traceability, and safety. This compliance influences sourcing decisions and supply security.
Market Entry and Strategic Partnerships
Patent expiration and increased competition have driven partnerships between originator companies and Asian manufacturers. AstraZeneca licensed gefitinib production to Chinese firms to meet regional demand and reduce manufacturing costs—a model emphasizing supply chain diversification.
Emerging Trends
- Supply Chain Diversification: To mitigate risks, operators are diversifying API sources, integrating suppliers from China, India, and other regions.
- Bioavailability and Formulation Innovation: Suppliers investing in improved formulations are enhancing bioavailability and stability, potentially influencing future supply chain configurations.
- Regulatory Harmonization: Cross-border regulatory harmonization streamlines supplier qualification processes, expanding options across markets.
Challenges and Risks
- Supply Disruptions: Political tensions, trade disputes, or pandemic-related disruptions in China and India pose risks to API and formulation supplies.
- Intellectual Property (IP) and Patent Status: Ongoing patent litigations and exclusivity periods impact licensing and production rights.
- Quality Control: Maintaining GMP compliance across multiple suppliers is critical to prevent recalls, supply delays, and legal repercussions.
Conclusion
The supply of IRESSA (gefitinib) hinges on a sophisticated network of licensed API manufacturers, formulation producers, and distributors, primarily concentrated in China, India, and Europe. Original developers like AstraZeneca retain manufacturing oversight for the branded product, while generics derive from licensed APIs from Chinese and Indian suppliers. As demand for affordable oncology treatments grows, strategic sourcing and supply chain resilience remain central to ensuring sustained access.
Key Takeaways
- Diverse Supplier Base: Critical to global IRESSA supply are licensed manufacturers in China and India, ensuring both quality and cost efficiencies.
- Regulatory Hurdles: Compliance with international standards influences supplier credibility and stability.
- Post-Patent Market Expansion: Generic production has increased, amplifying supplier options but also introducing supply chain complexity.
- Risks Management: Political, logistical, and regulatory risks necessitate diversified sourcing strategies.
- Strategic Partnerships: Licensing agreements between original developers and Asian manufacturers underpin current supply chains, fostering global access.
Frequently Asked Questions
1. Who are the main API suppliers for gefitinib?
Chinese companies such as Lunan Pharmaceutical Group and Sino Biopharmaceutical are prominent licensed API manufacturers, supplying gefitinib globally, especially to generic drug producers.
2. Are there licensed manufacturers outside China and India?
Yes. Although China and India dominate API production, licensed API manufacturing also occurs in Europe and North America, primarily for high-value branded medications, but these are less common due to higher costs.
3. How has patent expiry impacted gefitinib supply?
Excipients and patent expirations have facilitated entry by generic manufacturers, broadening supplier options, increasing competition, and reducing costs.
4. What are the regulatory challenges suppliers face?
Suppliers must adhere to GMP standards approved by agencies like the FDA, EMA, and NMPA. Compliance ensures product quality but increases costs and complexity.
5. How does supply chain resilience influence the availability of IRESSA?
Robust diversification of suppliers, geographic distribution, and contingency planning are essential to prevent shortages caused by geopolitical, logistical, or health crises.
Sources:
[1] Chinese Pharmaceutical Industry Association, “API Manufacturers in China,” 2022.
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