Gefitinib Export Market Intelligence: India's 80 Suppliers Shipping to 47 Countries — TransData Nexus 2026

Q: Who are the top gefitinib exporters from India?

The top gefitinib exporters from India are: 1. CIPLA LIMITED — $3.8M (56.5% market share); 2. NATCO PHARMA LIMITED — $1.7M (25.4% market share); 3. JODAS EXPOIM PRIVATE LIMITED — $395.7K (5.8% market share); 4. NAPROD LIFE SCIENCES PRIVATE LIMITED — $327.9K (4.8% market share); 5. KHANDELWAL LABORATORIES PRIVATE LIMITED — $139.8K (2.1% market share). Together they account for 94.6% of India's total gefitinib export value.

Q: What is the total export value of gefitinib from India?

The total export value of gefitinib from India is $6.8M USD, recorded across 297 shipment transactions from 80 active exporters to 47 destination countries. The average shipment value is $22.8K.

Q: Which countries import gefitinib from India?

India exports gefitinib to 47 countries worldwide. The top importing countries are: BRAZIL (41.7% share, $2.8M), IRAQ (34.9% share, $2.4M), PHILIPPINES (5.5% share, $374.1K), RUSSIA (3.7% share, $253.1K), MYANMAR (2.2% share, $149.0K). These five markets account for 88.0% of total export value.

Q: What is the HS code for gefitinib exports from India?

The primary HS code for gefitinib exports from India is 30049049. This 8-digit classification falls under Chapter 30 (pharmaceutical products) of the Harmonized System and is used by Indian Customs (DGFT) for tracking and reporting pharmaceutical trade flows.

Q: What is the average price of gefitinib exports from India?

The average unit price for gefitinib exports from India is $27.71 USD per unit, with prices ranging from $0.10 to $386.34 depending on formulation, packaging, and order volume. The total market is valued at $6.8M across 297 shipments.

Q: Which ports handle gefitinib exports from India?

The primary ports for gefitinib exports from India are SAHAR AIR CARGO ACC (INBOM4) (24.2% of shipments), SAHAR AIR (18.9% of shipments), DELHI AIR CARGO ACC (INDEL4) (11.4% of shipments), DELHI AIR (8.4% of shipments), Bombay Air (7.7% of shipments). These ports have dedicated pharmaceutical cargo infrastructure ensuring cold-chain and regulatory compliance during transit.

Q: Why is India a leading exporter of gefitinib?

India is one of the world's leading exporters of gefitinib due to its large base of 80 WHO-GMP and US FDA approved manufacturers, significantly lower production costs compared to Western markets, well-established API (Active Pharmaceutical Ingredient) supply chains, and strong government support for pharmaceutical exports through the Pharmaceuticals Export Promotion Council (Pharmexcil). India exports gefitinib to 47 countries, demonstrating 24% global market coverage.

Q: What certifications do Indian gefitinib exporters need?

Indian gefitinib exporters typically require WHO-GMP (Good Manufacturing Practice) certification for most regulated markets, US FDA approval for exports to the United States, EU GMP certification for European markets, and country-specific regulatory approvals for markets in Africa, Asia, and Latin America. Additional certifications may include ISO 9001, Schedule M compliance under Indian drug laws, and Free Sale Certificates issued by the Central Drugs Standard Control Organization (CDSCO).

Q: How many buyers import gefitinib from India?

There are 135 registered buyers importing gefitinib from India, spread across 47 countries. The repeat buyer rate is 43.0%, indicating strong long-term trade relationships and consistent product quality.

Q: What is the market share of the top gefitinib supplier from India?

CIPLA LIMITED is the leading gefitinib exporter from India with a market share of 56.5% and total export value of $3.8M across 21 shipments. The top 5 suppliers together control 94.6% of total export value.

Suresh Sormare

Gefitinib

India Pharmaceutical Trade Intelligence

$6.8M80 Suppliers47 CountriesHS 30049049

ExportsIndia → BRAZIL41.7%India → IRAQ34.9%

ImportsUNITED STATES → India$67.4K JAPAN → India$42.0K

#1 Supplier: CIPLA LIMITED

Gefitinib Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Gefitinib to the World

Between 2022 and 2026, India exported $6.8M worth of gefitinib across 297 verified shipments to 47 countries — covering 24% of world markets in the Advanced Oncology segment. The largest destination is BRAZIL (41.7%). CIPLA LIMITED leads with a 56.5% share. All figures are drawn from Indian Customs (DGFT) shipping bill records spanning four years of trade activity.

Source: Indian Customs (DGFT)·Published March 2026·Updated March 2026·HS 30049049

Gefitinib export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Gefitinib export data snapshot — $6.8M · 80 exporters · 47 countriesTransData Nexus · Indian Customs Data

Top Gefitinib Exporters from India

80 active exporters · Ranked by export value

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Top Gefitinib Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	CIPLA LIMITED	$3.8M	21	3	56.5%
2	NATCO PHARMA LIMITED

Top Countries Importing Gefitinib from India

47 destination markets · Ranked by import value

All 47 countries →

Top Countries Importing Gefitinib from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	BRAZIL	$2.8M	41.7%
2	IRAQ	$2.4M	34.9%
3	PHILIPPINES	$374.1K	5.5%
4	RUSSIA	$253.1K	3.7%
5	MYANMAR	$149.0K	2.2%
6	FRANCE	$144.4K	2.1%
7	VIETNAM	$116.9K	1.7%
8	AUSTRALIA	$81.3K	1.2%
9	LAOS	$56.3K	0.8%
10	UNITED STATES	$54.4K	0.8%

BRAZIL is India's largest gefitinib export destination, absorbing 41.7% of total exports worth $2.8M. The top 5 importing countries — BRAZIL, IRAQ, PHILIPPINES, RUSSIA, MYANMAR — together account for 88.0% of India's total gefitinib export value. The remaining 42 destination countries collectively receive the other 12.0%, indicating a focused distribution strategy targeting key markets.

Who Supplies Gefitinib to India?

6 origin countries · Total import value: $140.5K

India imports gefitinib from 6 countries with a combined import value of $140.5K. The largest supplier is UNITED STATES ($67.4K, 1 shipments), followed by JAPAN and GERMANY. All values are from Indian Customs (DGFT) import records.

Countries Supplying Gefitinib to India — Ranked by Import Value
#	Origin Country	Import Value (USD)	Shipments	Share
1	UNITED STATES	$67.4K	1	47.9%
2	JAPAN	$42.0K	1	29.9%
3	GERMANY	$17.2K	1	12.3%
4	UNITED KINGDOM	$12.7K	1	9.1%
5	CHINA	$1.1K	4	0.8%
6	TAIWAN	$76	2	0.1%

UNITED STATES is the largest supplier of gefitinib to India, accounting for 47.9% of total import value. The top 5 origin countries — UNITED STATES, JAPAN, GERMANY, UNITED KINGDOM, CHINA — together supply 99.9% of India's gefitinib imports. Click any country to see detailed supplier and buyer data for that import corridor.

Regulatory Landscape — Gefitinib

Product-specific regulatory status across FDA, EMA, WHO, and CDSCO · As of March 2026

1FDA & US Market Regulatory Status

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.

2EU & UK Regulatory Framework

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.

3WHO Essential Medicines & Global Standards

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.

4India Regulatory Classification

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.

5Patent & Exclusivity Status

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.

6Recent Industry Developments

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.

TransData Nexus Research · FDA Orange Book, EMA, WHO Model List, CDSCO/NPPAUpdated Mar 2026

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Global Price Benchmark — Gefitinib

Retail & reference prices across 9 markets vs. India FOB export price of $27.71/unit

Global Price Benchmark for Gefitinib across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	$200	USD	According to the FDA's Orange Book, Gefitinib is approved for use in the U.S.
United Kingdom	$195	GBP	Listed in the NHS Drug Tariff as of March 2026.
Germany	$200	EUR	Regulated by the Federal Joint Committee (G-BA) under the AMNOG process.
Australia	$175	AUD	Listed on the Pharmaceutical Benefits Scheme (PBS) as of March 2026.

Supply Chain Risk Assessment — Gefitinib

API sourcing, concentration risk, storage requirements, and current alerts

HIGH RISK

1API Sourcing & Raw Material Dependency

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.

2Supplier Concentration & Single-Source Risk

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.

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Frequently Asked Questions — Gefitinib Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top gefitinib exporters from India?

The leading gefitinib exporters from India are CIPLA LIMITED, NATCO PHARMA LIMITED, JODAS EXPOIM PRIVATE LIMITED, and 7 others. CIPLA LIMITED leads with 56.5% market share ($3.8M). The top 5 suppliers together control 94.6% of total export value.

What is the total export value of gefitinib from India?

The total export value of gefitinib from India is $6.8M, recorded across 297 shipments from 80 active exporters to 47 countries. The average shipment value is $22.8K.

Which countries import gefitinib from India?

India exports gefitinib to 47 countries. The top importing countries are BRAZIL (41.7%), IRAQ (34.9%), PHILIPPINES (5.5%), RUSSIA (3.7%), MYANMAR (2.2%), which together account for 88.0% of total export value.

What is the HS code for gefitinib exports from India?

The primary HS code for gefitinib exports from India is 30049049. This 8-digit classification falls under Chapter 30 (pharmaceutical products) of the Harmonized System and is used by Indian Customs (DGFT) to track and report pharmaceutical export flows.

Official References & Regulatory Resources

Research Methodology & Data Transparency

Suresh Sormare

Verified Author

Pharmaceutical Export-Import Analyst & Trade Intelligence Expert

Suresh Sormare is a pharmaceutical export-import analyst with deep expertise in Indian Customs (DGFT) data, HS code classification, and global pharmaceutical supply chains. His analysis covers 10M+ shipment records across 150+ countries and is used by manufacturers, procurement agencies, and trade consultants worldwide. Suresh specializes in identifying verified suppliers and buyers from customs records, mapping bilateral pharmaceutical trade corridors, analyzing tariff structures and regulatory frameworks across 170+ destination markets, and benchmarking competitive positioning for finished pharmaceutical formulations. His methodology combines granular customs transaction data with regulatory intelligence from FDA, EMA, WHO, CDSCO, and 40+ national drug authorities to deliver actionable trade insights for the pharmaceutical formulations sector.

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Primary Data Source

All trade data is sourced from Indian Customs (DGFT) official shipping bill records — the authoritative government database for India's pharmaceutical trade. Each verified record contains exporter name, consignee (buyer) name, detailed product description, quantity, declared FOB value (USD), port of loading, destination country, and shipment date.

Gefitinib

Gefitinib

Top Gefitinib Exporters from India

Top Countries Importing Gefitinib from India

Who Supplies Gefitinib to India?

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Regulatory Landscape — Gefitinib

1FDA & US Market Regulatory Status

2EU & UK Regulatory Framework

3WHO Essential Medicines & Global Standards

4India Regulatory Classification

5Patent & Exclusivity Status

6Recent Industry Developments

Global Price Benchmark — Gefitinib

Supply Chain Risk Assessment — Gefitinib

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Gefitinib Trade Intelligence

Frequently Asked Questions — Gefitinib Exports from India

Who are the top gefitinib exporters from India?

What is the total export value of gefitinib from India?

Which countries import gefitinib from India?

What is the HS code for gefitinib exports from India?

Official References & Regulatory Resources

Research Methodology & Data Transparency

Suresh Sormare

Primary Data Source

India Cost Advantage

3Geopolitical & Shipping Disruptions

4Risk Mitigation Recommendations

What is the average price of gefitinib exports from India?

Which ports handle gefitinib exports from India?

Why is India a leading exporter of gefitinib?

What certifications do Indian gefitinib exporters need?

How many buyers import gefitinib from India?

What is the market share of the top gefitinib exporter from India?

Analysis Methodology