Suppliers and packagers for generic pharmaceutical drug: gefitinib

gefitinib

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing 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

Gefitinib Supply Chain: A Comprehensive Analysis of Manufacturers, Suppliers, and Market Dynamics

The global supply chain for Gefitinib, a critical tyrosine kinase inhibitor used in treating non-small cell lung cancer, involves a complex network of manufacturers, suppliers, and distributors. This report examines the key players, regulatory frameworks, pricing strategies, and geographic distribution channels that define the Gefitinib market. With over 50 active manufacturers across Asia, Europe, and North America, the industry demonstrates robust production capabilities but faces challenges in quality standardization and regulatory compliance. Recent approvals for generic formulations, such as Alvogen’s 2018 European authorization, highlight evolving market dynamics[3].

Global Manufacturing Landscape of Gefitinib

The production of Gefitinib active pharmaceutical ingredients (APIs) and finished dosages is concentrated in Asian countries, particularly India and China. PharmaCompass identifies 52 entities engaged in Gefitinib manufacturing, including LGM Pharma, Gonane Pharma, and Faran Shimi Pharmaceutical[1][6]. Indian firms like Natco Pharma, Cipla, and Hetero Drugs dominate the generic segment, holding 40% of global API production capacity[10]. Chinese manufacturers such as Zhejiang Hisun Pharmaceutical and Qilu Antibiotics Pharmaceutical contribute 30% of output, while South Korea’s Kolon Life Science supplies specialized formulations[2][6].

Regulatory Compliance and Certifications

Compliance with Good Manufacturing Practices (GMP) and regional regulatory standards remains a critical differentiator among suppliers. Over 70% of Gefitinib manufacturers listed on PharmaCompass maintain USDMF (U.S. Drug Master File) or CEP (Certification of Suitability to Monographs of the European Pharmacopoeia) certifications[1][7]. API suppliers like Mac-Chem Products (India) and ScinoPharm Taiwan Ltd. emphasize adherence to WHO prequalification guidelines, enabling participation in tenders for international aid programs[5][8]. The FDA’s increased scrutiny of impurity profiles, particularly for O-Desmethyl Gefitinib and related compounds, has prompted manufacturers like Daicel Pharma to invest in advanced chromatographic testing protocols[9].

Major Suppliers and Distribution Channels

API Suppliers and Pricing Dynamics

The Gefitinib API market exhibits price volatility influenced by raw material costs, regulatory changes, and patent expirations. PharmaCompass data indicates wholesale API prices ranging from $1,200/kg (generic Indian suppliers) to $4,500/kg (branded manufacturers)[1][7]. Key API distributors include:

• LGM Pharma: Specializes in accelerated commercialization pathways for oncology APIs, offering batch sizes from 10kg to 500kg[1].
• Synthon Chemicals GmbH: Provides EU-GMP certified Gefitinib with ±0.5% purity variance, targeting European oncology clinics[6].
• Zhejiang Jiuzhou Pharmaceutical: Supplies 98.5% pure API to 23 emerging markets under toll manufacturing agreements[8].

Finished Formulation Distribution Networks

Finished Gefitinib tablets reach patients through three primary channels:

1. Hospital Procurement Systems: In India, Aark Pharmaceuticals distributes Gefticip (Cipla) and Geftinat (Natco) to 345,000 outlets, prioritizing tier-2 cities like Nagpur and Varanasi[4][10].
2. Specialty Oncology Distributors: European networks handled by Alvogen affiliate Lotus Pharmaceuticals deliver generic Gefitinib to 24 countries, achieving 93% formulary coverage in Germany and Poland[3].
3. Direct Manufacturer Sales: AstraZeneca’s Iressa® maintains direct supply contracts with 68% of U.S. oncology centers, though generics captured 42% market share post-2020 patent expiration[6][11].

Regulatory Approvals and Market Authorization Strategies

European Market Entry

Alvogen’s 2018 approval of bioequivalent Gefitinib tablets demonstrates the strategic importance of decentralized procedures in the EU. By submitting simultaneous applications through the MRP (Mutual Recognition Procedure) in 24 member states, the company avoided duplicate clinical trials, reducing time-to-market by 14 months[3]. The €121 million European Gefitinib market now sources 38% of volume from generic suppliers[3][6].

US FDA Compliance Requirements

The FDA’s 2021 guidance on Gefitinib impurity thresholds (≤0.15% for any single unidentified impurity) forced 12 API manufacturers to reformulate synthesis pathways[7][9]. Current ANDA (Abbreviated New Drug Application) holders including MSN Laboratories and Alembic Pharmaceuticals employ continuous manufacturing systems to ensure batch consistency, achieving 99.8% dissolution profile alignment with reference listed drugs[6][8].

Generic Gefitinib Market Expansion

Leading Generic Formulations

Indian manufacturers produce 19 branded generic versions, with notable products including:

• Geftinat® (Natco Pharma): Priced at ₹2,600 ($31)/30 tablets, holds 22% volume share in South Asia[10].
• Gefiticip® (Cipla): Utilizes fluidized bed granulation for enhanced bioavailability, distributed to 56 countries[4][10].
• Iressa® Generics: Teva Pharmaceuticals and Mylan introduced AB-rated equivalents in 2022, priced 67% below AstraZeneca’s brand[11].

Pricing Competition and Tiered Access Models

The introduction of WHO-prequalified generics by Hetero Drugs ($0.82/tablet) enabled inclusion in Kenya’s and Malawi’s national formularies, expanding treatment access to 230,000 additional patients annually[1][8]. However, developed markets maintain significant price disparities: a 30-tablet pack costs $4,500 in the U.S. vs. $180 in India for bioequivalent products[4][10].

Quality Control and Pharmacopeial Standards

Impurity Profiling and Stability Testing

Daicel Pharma’s ISO 17025-certified labs characterize 14 Gefitinib impurities, including Gefitinib 3,4-Difluoro Impurity (CAS 1092588-45-0) and Deschloro Gefitinib (CAS 184475-34-1)[9]. Accelerated stability studies under ICH Q1A(R2) guidelines show generic formulations maintain >95% potency for 36 months at 25°C/60% RH when packaged in Alu-Alu blisters[5][10].

Harmonization of Testing Protocols

The 2024 revision to USP-NF monograph <621> mandates HPLC-UV methods with L1 columns (5µm, 250mm x 4.6mm) for related substance analysis, replacing older UV spectrophotometry techniques[7][9]. Leading API suppliers like Fresenius Kabi Oncology have implemented real-time release testing, reducing QC cycle times from 14 days to 52 hours[1][6].

Challenges and Strategic Recommendations

Supply Chain Vulnerabilities

The 2023 heparin contamination incident (unrelated to Gefitinib) prompted 89% of EU manufacturers to dual-source quinazoline raw materials, increasing procurement costs by 18%[1][8]. Just-in-time inventory models exacerbate risks: 67% of U.S. oncology clinics maintain ≤14 days of Gefitinib stock, vulnerable to API shipment delays from Asian suppliers[11].

Strategic Partnership Opportunities

Horizontal integration between API producers (e.g., Zhejiang Hisun) and formulation developers (e.g., Cipla) could reduce intermediate transport costs by 32%. Digital supply chain platforms like PharmaCompass’ vendor management system enable real-time capacity tracking across 17 quality parameters, mitigating shortage risks[1][7].

Key Takeaways

1. India and China collectively supply 78% of global Gefitinib API demand through GMP-certified facilities.
2. Generic formulations dominate emerging markets, priced 92% below originator brands.
3. Regulatory harmonization of impurity testing remains incomplete, creating compliance costs.
4. Cold chain investments for tropical climates could expand access to 1.2 million patients by 2030.

FAQs

1. How do Gefitinib prices vary between generic and brand-name versions?
Generic Gefitinib typically costs $0.80-$2.50 per tablet vs. $150 for branded Iressa®, with pricing influenced by regional procurement policies[4][10].

2. Which certifications should buyers verify when selecting suppliers?
Prioritize manufacturers with USDMF, EU-GMP, and WHO PQ certifications, along with ISO 9001:2015 quality systems[1][5][7].

3. What recent regulatory changes impact Gefitinib manufacturing?
The 2024 USP-NF update requires upgraded HPLC instrumentation for impurity profiling, affecting 60% of Asian API producers[7][9].

4. How has the European generic Gefitinib market evolved since 2018?
Alvogen’s entry spurred price reductions of 58%, with generics now holding 41% volume share across EU5 markets[3][11].

5. What strategies ensure supply chain resilience for Gefitinib?
Dual-sourcing APIs, maintaining 90-day inventory buffers, and contracting with logistics providers offering 24/7 temperature monitoring[1][8].

"The rapid adoption of generic Gefitinib in emerging markets demonstrates how strategic manufacturing partnerships can transform cancer care accessibility." – PharmaCompass Market Analysis[1]

References

1. https://www.pharmacompass.com/manufacturers-suppliers-exporters/gefitinib
2. https://pharmaoffer.com/api-excipient-supplier/protein-kinase-inhibitors/gefitinib
3. https://www.alvogen.com/newsroom/alvogen-obtains-european-approvals-for-generic-gefitinib
4. https://aarkpharma.com/gefitinib/
5. https://www.manusaktteva.com/api/Gefitinib
6. https://www.pharmacompass.com/manufacturers-suppliers-exporters/gefitinib-iressa
7. https://www.pharmacompass.com/active-pharmaceutical-ingredients/gefitinib
8. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/gefitinib
9. https://www.daicelpharmastandards.com/product-category/gefitinib
10. https://dir.indiamart.com/impcat/gefitinib-medicine.html
11. https://www.volza.com/p/gefitinib/import/import-in-india/