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Last Updated: July 29, 2025

Suppliers and packagers for GEFITINIB


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GEFITINIB

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

ApplicantTradenameGeneric NameDosageNDANDA/ANDASupplierPackage CodePackageMarketing Start
Actavis Labs Fl Inc GEFITINIB gefitinib TABLET;ORAL 208913 ANDA Teva Pharmaceuticals, Inc. 0480-4053-56 30 TABLET, FILM COATED in 1 BOTTLE (0480-4053-56) 2023-06-21
Apotex GEFITINIB gefitinib TABLET;ORAL 209532 ANDA Apotex Corp. 60505-4512-3 30 TABLET in 1 BOTTLE (60505-4512-3) 2023-08-08
Natco GEFITINIB gefitinib TABLET;ORAL 212827 ANDA Natco Pharma USA LLC 69339-168-03 30 TABLET, FILM COATED in 1 BOTTLE (69339-168-03) 2023-06-05
Qilu Pharm Hainan GEFITINIB gefitinib TABLET;ORAL 211591 ANDA Ingenus Pharmaceuticals, LLC 50742-366-30 30 TABLET, COATED in 1 BOTTLE (50742-366-30) 2023-04-27
Qilu Pharm Hainan GEFITINIB gefitinib TABLET;ORAL 211591 ANDA Qilu Pharmaceutical Co., Ltd. 67184-0531-1 30 TABLET, COATED in 1 BOTTLE (67184-0531-1) 2023-02-13
Qilu Pharm Hainan GEFITINIB gefitinib TABLET;ORAL 211591 ANDA Qilu Pharmaceutical Co., Ltd. 67184-0531-2 500 TABLET, COATED in 1 BOTTLE (67184-0531-2) 2023-02-13
Qilu Pharm Hainan GEFITINIB gefitinib TABLET;ORAL 211591 ANDA Qilu Pharmaceutical Co., Ltd. 67184-0531-3 3 BLISTER PACK in 1 CARTON (67184-0531-3) / 10 TABLET, COATED in 1 BLISTER PACK 2023-02-13
>Applicant>Tradename>Generic Name>Dosage>NDA>NDA/ANDA>Supplier>Package Code>Package>Marketing Start
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Suppliers for the Pharmaceutical Drug: GEFITINIB

Last updated: July 27, 2025

Introduction

Gefitinib, marketed under the brand name Iressa among others, is an oral tyrosine kinase inhibitor primarily used for treating non-small cell lung cancer (NSCLC). As a targeted therapy, its manufacturing and supply chain involve specialized pharmaceutical companies with capabilities in synthesizing complex molecules, ensuring quality standards, and distributing across global markets. This article provides a comprehensive overview of the key suppliers involved in the production and distribution of gefitinib, critical considerations for stakeholders, and market dynamics shaping the supply landscape.

Overview of Gefitinib Supply Chain

The supply chain for gefitinib encompasses several stages: active pharmaceutical ingredient (API) synthesis, formulation, packaging, and distribution. Given the molecule's complexity and regulatory requirements, suppliers are predominantly large-scale pharmaceutical manufacturers, often with extensive R&D and manufacturing assets, along with regional distributors serving local markets.

Key API Suppliers for Gefitinib

The strength and reliability of gefitinib supply largely depend on the capacity and regulatory compliance of API manufacturers. Several major pharmaceutical companies and API contract manufacturing organizations (CMOs) are known for their synthesis capabilities of gefitinib.

1. Chinese and Indian Manufacturers

  • Zhejiang Hisun Pharmaceutical Co., Ltd.
    Hisun Pharma is among prominent Chinese API producers manufacturing gefitinib. The company's manufacturing facilities adhere to Good Manufacturing Practices (GMP) standards, and it supplies both domestic and export markets. Their ability to produce high-quality APIs at competitive prices makes them a significant supplier in the global supply chain.

  • Shenzhen Biokangtai Co., Ltd.
    This Chinese pharmaceutical manufacturer specializes in various APIs, including gefitinib, leveraging advanced synthetic chemistry processes. They are GMP-certified and focus on quality compliance aligned with global pharmaceutical standards.

  • Hikal Ltd. (India)
    An established Indian API manufacturer, Hikal supplies gefitinib API to global pharma firms. With a focus on quality control and cost-effectiveness, Hikal maintains GMP certifications and a robust supply chain network.

  • Biocon Limited (India)
    Known for its biopharmaceutical expertise, Biocon also produces small-molecule APIs including gefitinib. Their extensive manufacturing infrastructure and stringent quality control make them a reliable supplier for licensed and generic APIs.

2. Contract Manufacturing Organizations (CMOs)

  • Aenova Group
    A European contract manufacturer with capabilities in formulation and packaging of gefitinib. While not a primary API supplier, Aenova collaborates with API producers by manufacturing finished dosages and ensuring quality compliance.

  • Famar
    As a global CMO, Famar offers formulation and packaging services for gefitinib, enabling pharmaceutical companies to scale up production and meet regional regulatory requirements.

3. Multinational Pharmaceutical Companies

Several branded manufacturers hold licenses for gefitinib production and distribution, often overseeing the entire supply chain from API synthesis to final product.

  • AstraZeneca
    As the original developer of gefitinib, AstraZeneca manages global manufacturing and distribution rights. The company operates manufacturing sites worldwide, ensuring a steady supply for branded formulations across different regions.

  • Teva Pharmaceuticals
    Teva produces generic versions of gefitinib, sourcing APIs from various suppliers depending on regional distribution agreements and pricing strategies.

Regulatory and Quality Considerations

API suppliers must meet rigorous GMP standards and obtain certification from regulatory agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and corresponding Chinese and Indian authorities. Quality assurance, traceability, and compliance with pharmacopeia standards influence supplier selection and ongoing procurement decisions.

Market Dynamics and Supply Risks

The geopolitical landscape, regional regulatory policies, and manufacturing capacity fluctuations influence gefitinib supply chains. Notably, Chinese and Indian suppliers constitute the backbone of global gefitinib API sourcing due to their cost advantages and manufacturing expertise. However, recent trade tensions and regulatory scrutiny may pose supply risks, emphasizing the need for diversified sourcing and supply chain resilience.

Emerging Trends and Opportunities

  • Vertical Integration: Larger pharmaceutical companies are increasingly involved in internal API synthesis to reduce reliance on external suppliers, thereby enhancing supply security.

  • Regulatory Harmonization: Efforts to standardize GMP compliance across manufacturing regions streamline sourcing and reduce regulatory hurdles.

  • Supply Chain Transparency: Digital platforms and supply chain monitoring improve visibility, enabling proactive risk management.

Conclusion

The supply of gefitinib hinges on a network of reputable API manufacturers primarily based in China and India, complemented by regional CMOs and end-to-end pharmaceutical firms like AstraZeneca. Ensuring quality, regulatory compliance, and diversified sourcing remains critical to maintaining consistent supply and meeting global demand for this vital NSCLC therapy.


Key Takeaways

  • Major API Suppliers: Chinese firms such as Zhejiang Hisun and Shenzhen Biokangtai, alongside Indian companies like Hikal and Biocon, serve as primary gefitinib API producers.
  • Regulatory Compliance: Suppliers must meet stringent GMP standards with certifications from leading regulatory agencies to ensure product quality and safe supply.
  • Supply Chain Resilience: Diversification across regions and partners mitigates risks posed by geopolitical and regulatory factors.
  • Market Dynamics: Increased vertical integration and digital supply chain management improve reliability and transparency.
  • Regulatory Landscape: Continuous monitoring of evolving regulations ensures timely compliance and minimizes disruptions.

FAQs

1. Who are the leading global suppliers of gefitinib API?
Chinese companies such as Zhejiang Hisun Pharmaceutical and Shenzhen Biokangtai, along with Indian firms like Hikal and Biocon, are among the primary API producers supplying gefitinib globally.

2. How does regulatory compliance impact gefitinib suppliers?
Suppliers must adhere to GMP standards and obtain certifications from agencies like the FDA and EMA. Non-compliance can lead to manufacturing disruptions, product recalls, or restricted market access.

3. What are the risks associated with sourcing gefitinib APIs from China or India?
Risks include geopolitical tensions, regulatory changes, supply chain disruptions, or quality concerns. Diversifying suppliers and maintaining quality audits mitigate these issues.

4. How does AstraZeneca maintain gefitinib supply for its branded formulations?
AstraZeneca operates global manufacturing facilities and may source APIs from multiple approved suppliers, ensuring large-scale, regulated production and distribution.

5. What trends are shaping the future of gefitinib supply chains?
Emerging trends include increased vertical integration by pharmaceutical firms, enhanced supply chain transparency through digital technologies, and strengthened regulatory harmonization across regions.


References

[1] AstraZeneca. (2022). Gefitinib (Iressa) Product Information.
[2] European Medicines Agency. (2023). Pharmacovigilance and Regulatory Standards for APIs.
[3] Kyodo News. (2021). Chinese Pharmaceutical API Manufacturing Capacity.
[4] Hikal Ltd. Corporate Website. (2023). API Production Capabilities.
[5] Biocon. (2023). API Manufacturing and Quality Assurance.

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