How India Exports Gefitinib to the World

As of March 2026, the U.S. Food and Drug Administration (FDA) has approved multiple Abbreviated New Drug Applications (ANDAs) for gefitinib, as listed in the FDA's Orange Book. These approvals indicate the availability of generic versions of gefitinib in the U.S. market, reflecting the drug's established safety and efficacy profile. The regulatory pathway for gefitinib involves demonstrating bioequivalence to the reference listed drug (RLD), Iressa, and compliance with FDA's stringent manufacturing and quality standards.

Notably, the presence of 80 active Indian exporters underscores India's significant role in supplying gefitinib to global markets, including the U.S. This extensive exporter base highlights the importance of adhering to FDA regulations to ensure market access and competitiveness.

In the European Union, gefitinib received marketing authorization under the brand name Iressa in June 2009. Subsequently, generic versions, such as Gefitinib Mylan, were approved. However, on 27 September 2024, the European Commission withdrew the marketing authorization for Gefitinib Mylan at the request of the marketing authorization holder, Mylan Pharmaceuticals Limited, due to commercial reasons. This withdrawal indicates a dynamic regulatory environment where market decisions can impact the availability of generic medicines.

The United Kingdom, post-Brexit, continues to align with the European Medicines Agency (EMA) standards through the Medicines and Healthcare products Regulatory Agency (MHRA). Manufacturers exporting gefitinib to the UK must comply with the UK's Good Manufacturing Practice (GMP) requirements, ensuring product quality and safety.

Gefitinib is included in the World Health Organization's (WHO) Model List of Essential Medicines, underscoring its importance in treating NSCLC. This inclusion facilitates its adoption in national formularies and supports global health initiatives. Additionally, gefitinib is recognized in various pharmacopoeias, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), ensuring standardized quality benchmarks across different regions.

In India, gefitinib is classified under Schedule H of the Drugs and Cosmetics Act, indicating that it is a prescription-only medication. The National Pharmaceutical Pricing Authority (NPPA) oversees the pricing of essential medicines; however, as of March 2026, gefitinib is not listed under the Drug Price Control Order (DPCO), allowing market-driven pricing. For exports, manufacturers must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT), ensuring compliance with national regulations and monitoring of pharmaceutical exports.

The primary patent for gefitinib has expired, leading to increased generic competition globally. This patent expiration has enabled multiple manufacturers, including those from India, to produce and export generic versions, contributing to the drug's affordability and accessibility worldwide.

In August 2025, CuraTeQ Biologics, a subsidiary of Aurobindo Pharma Ltd., received marketing authorization from the UK's MHRA for Dazublys, a biosimilar version of trastuzumab, indicating a growing trend of Indian pharmaceutical companies gaining footholds in regulated markets.

In October 2024, the European Commission withdrew the marketing authorization for Gefitinib Mylan at the request of Mylan Pharmaceuticals Limited, reflecting strategic market decisions impacting the availability of generic medicines in the EU.

In April 2025, the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Dazublys, recommending its marketing authorization, showcasing the ongoing efforts of Indian manufacturers to expand their product portfolios in the European market.

These developments highlight the dynamic nature of the pharmaceutical industry, where regulatory decisions, market strategies, and competitive actions continually shape the landscape for gefitinib and similar oncology drugs.

Gefitinib, a tyrosine kinase inhibitor used in cancer treatment, relies on Active Pharmaceutical Ingredients (APIs) primarily manufactured in India. However, the production of these APIs is heavily dependent on Key Starting Materials (KSMs) sourced from China. According to the U.S. Pharmacopeia, 58% of KSMs used for U.S.-approved APIs are sole-sourced from a single country, with 41% originating from China and 16% from India. This concentration poses a significant risk, as any disruption in China's supply chain can directly impact the availability of APIs in India.

Recent geopolitical tensions have exacerbated these vulnerabilities. In February 2026, the closure of the Strait of Hormuz following U.S. and Israeli military actions against Iran led to significant disruptions in the supply of raw materials to Asia's petrochemical industry. Facilities relying on Middle Eastern naphtha experienced procurement delays, resulting in force majeure declarations and production cutbacks. Such disruptions highlight the fragility of the supply chain for critical raw materials essential for API production.

Our proprietary trade data indicates that the top five Indian exporters account for 94.6% of Gefitinib exports, with CIPLA LIMITED alone contributing 56.5% ($3.8 million USD). This high supplier concentration increases the risk of supply disruptions, as any operational issues within these key companies could significantly impact global availability.

To mitigate such risks, the Indian government has implemented the Production Linked Incentive (PLI) scheme, aiming to boost domestic manufacturing of APIs and reduce dependency on imports. However, the effectiveness of this initiative in diversifying the supplier base for Gefitinib remains to be seen.

The closure of the Strait of Hormuz in March 2026, following military actions by the U.S. and Israel against Iran, has severely disrupted global shipping routes. This strategic chokepoint handles approximately 20% of the world's daily oil supply, and its closure has led to significant delays and increased shipping costs. Pharmaceutical supply chains, including those for Gefitinib, are particularly vulnerable to such disruptions, given their reliance on timely delivery of raw materials and finished products.

Additionally, tensions in the Red Sea and the Strait of Hormuz have heightened risks for commercial shipping. Incidents of vessel attacks and increased insurance premiums have prompted major shipping companies to suspend operations in these regions, further complicating logistics for pharmaceutical exports. These geopolitical factors contribute to the instability of supply chains critical for the distribution of Gefitinib.

• Diversify KSM Sourcing: Identify and qualify alternative suppliers for KSMs outside of China to reduce dependency and enhance supply chain resilience.

• Strengthen Domestic API Production: Leverage government incentives like the PLI scheme to bolster domestic manufacturing capabilities for APIs, decreasing reliance on imports.

• Enhance Supplier Due Diligence: Conduct comprehensive assessments of key suppliers, focusing on their capacity to withstand geopolitical and logistical disruptions.

• Develop Contingency Logistics Plans: Establish alternative shipping routes and logistics strategies to mitigate the impact of regional conflicts on transportation.

• Monitor Regulatory Compliance: Stay informed about FDA and EMA alerts regarding potential shortages and quality issues to proactively address supply chain vulnerabilities.

RISK_LEVEL: HIGH