Erlotinib Export Market Intelligence: India's 94 Suppliers Shipping to 55 Countries — TransData Nexus 2026

Q: Who are the top erlotinib exporters from India?

The top erlotinib exporters from India are: 1. NATCO PHARMA LIMITED — $547.2K (20.4% market share); 2. MSN LABORATORIES PRIVATE LIMITED — $529.7K (19.8% market share); 3. CIPLA LIMITED — $409.5K (15.3% market share); 4. VEXXA LIFESCIENCES PVT. LTD. — $253.4K (9.5% market share); 5. ALEMBIC PHARMACEUTICALS LIMITED — $129.5K (4.8% market share). Together they account for 69.7% of India's total erlotinib export value.

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

The total export value of erlotinib from India is $2.7M USD, recorded across 336 shipment transactions from 94 active exporters to 55 destination countries. The average shipment value is $8.0K.

Q: Which countries import erlotinib from India?

India exports erlotinib to 55 countries worldwide. The top importing countries are: UNITED STATES (21.0% share, $562.1K), THAILAND (18.9% share, $506.0K), PHILIPPINES (12.4% share, $331.5K), SAUDI ARABIA (12.3% share, $330.7K), PERU (5.7% share, $152.0K). These five markets account for 70.2% of total export value.

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

The primary HS code for erlotinib 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 erlotinib exports from India?

The average unit price for erlotinib exports from India is $47.90 USD per unit, with prices ranging from $0.04 to $3896.10 depending on formulation, packaging, and order volume. The total market is valued at $2.7M across 336 shipments.

Q: Which ports handle erlotinib exports from India?

The primary ports for erlotinib exports from India are SAHAR AIR (21.1% of shipments), SAHAR AIR CARGO ACC (INBOM4) (19.3% of shipments), DELHI AIR CARGO ACC (INDEL4) (10.1% of shipments), DELHI AIR (8.0% of shipments), HYDERABAD AIR (7.1% 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 erlotinib?

India is one of the world's leading exporters of erlotinib due to its large base of 94 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 erlotinib to 55 countries, demonstrating 28% global market coverage.

Q: What certifications do Indian erlotinib exporters need?

Indian erlotinib 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 erlotinib from India?

There are 144 registered buyers importing erlotinib from India, spread across 55 countries. The repeat buyer rate is 47.2%, indicating strong long-term trade relationships and consistent product quality.

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

NATCO PHARMA LIMITED is the leading erlotinib exporter from India with a market share of 20.4% and total export value of $547.2K across 11 shipments. The top 5 suppliers together control 69.7% of total export value.

Suresh Sormare

Erlotinib

India Pharmaceutical Trade Intelligence

$2.7M94 Suppliers55 CountriesHS 30049049

ExportsIndia → UNITED STATES21.0%India → THAILAND18.9%

ImportsITALY → India$377.7K BRAZIL → India$19.7K

#1 Supplier: NATCO PHARMA #1 Buyer: ATLANTA MEDICARE

Erlotinib Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Erlotinib to the World

Between 2022 and 2026, India exported $2.7M worth of erlotinib across 336 verified shipments to 55 countries — covering 28% of world markets in the Advanced Oncology segment. The largest destination is UNITED STATES (21.0%). NATCO PHARMA LIMITED leads with a 20.4% 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

Erlotinib export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Erlotinib export data snapshot — $2.7M · 94 exporters · 55 countriesTransData Nexus · Indian Customs Data

Top Erlotinib Exporters from India

94 active exporters · Ranked by export value

View all 94 →

Top Erlotinib Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	NATCO PHARMA LIMITED	$547.2K	11	3	20.4%
2	MSN LABORATORIES PRIVATE LIMITED

Top Countries Importing Erlotinib from India

55 destination markets · Ranked by import value

All 55 countries →

Top Countries Importing Erlotinib from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	UNITED STATES	$562.1K	21.0%
2	THAILAND	$506.0K	18.9%
3	PHILIPPINES	$331.5K	12.4%
4	SAUDI ARABIA	$330.7K	12.3%
5	PERU	$152.0K	5.7%
6	MYANMAR	$119.0K	4.4%
7	BELARUS	$106.0K	4.0%
8	CHILE	$81.8K	3.1%
9	SOUTH AFRICA	$78.8K	2.9%
10	MOROCCO	$62.5K	2.3%

UNITED STATES is India's largest erlotinib export destination, absorbing 21.0% of total exports worth $562.1K. The top 5 importing countries — UNITED STATES, THAILAND, PHILIPPINES, SAUDI ARABIA, PERU — together account for 70.2% of India's total erlotinib export value. The remaining 50 destination countries collectively receive the other 29.8%, indicating a broadly diversified export footprint across multiple regions.

Who Supplies Erlotinib to India?

7 origin countries · Total import value: $408.5K

India imports erlotinib from 7 countries with a combined import value of $408.5K. The largest supplier is ITALY ($377.7K, 6 shipments), followed by BRAZIL and GERMANY. All values are from Indian Customs (DGFT) import records.

Countries Supplying Erlotinib to India — Ranked by Import Value
#	Origin Country	Import Value (USD)	Shipments	Share
1	ITALY	$377.7K	6	92.5%
2	BRAZIL	$19.7K	1	4.8%
3	GERMANY	$4.8K	2	1.2%
4	CYPRUS	$4.4K	2	1.1%
5	CHINA	$1.5K	1	0.4%
6	MALAYSIA	$351	3	0.1%
7	COLOMBIA	$150	1	0.0%

ITALY is the largest supplier of erlotinib to India, accounting for 92.5% of total import value. The top 5 origin countries — ITALY, BRAZIL, GERMANY, CYPRUS, CHINA — together supply 99.9% of India's erlotinib imports. Click any country to see detailed supplier and buyer data for that import corridor.

Regulatory Landscape — Erlotinib

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

1FDA & US Market Regulatory Status

In the United States, erlotinib is marketed under the brand name Tarceva. The FDA has approved multiple Abbreviated New Drug Applications (ANDAs) for generic versions of erlotinib, facilitating market entry for Indian exporters. The presence of 94 active Indian exporters underscores the competitive landscape and the importance of adhering to FDA regulations to maintain market access.

2EU & UK Regulatory Framework

The European Medicines Agency (EMA) granted marketing authorization for Tarceva (erlotinib) on September 19, 2005, for the treatment of NSCLC. Generic versions, such as Erlotinib Accord, have also been evaluated; however, Accord Healthcare S.L.U. withdrew its application on May 11, 2020, due to inadequate bioequivalence data. (ema.europa.eu) Compliance with EU Good Manufacturing Practice (GMP) standards is mandatory for market entry, necessitating rigorous quality assurance measures from Indian exporters.

3WHO Essential Medicines & Global Standards

Erlotinib is included in the 21st edition of the WHO Model List of Essential Medicines, highlighting its significance in global cancer treatment protocols. While not listed in the WHO Prequalification Programme, erlotinib must conform to international pharmacopoeia standards, including those of the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP). Adherence to these standards ensures the quality and efficacy of erlotinib in international markets.

4India Regulatory Classification

In India, erlotinib is classified under Schedule H of the Drugs and Cosmetics Rules, 1945, indicating it is a prescription-only medication. The National Pharmaceutical Pricing Authority (NPPA) has not imposed a ceiling price on erlotinib, allowing market-driven pricing. For exports, the Directorate General of Foreign Trade (DGFT) mandates a No Objection Certificate (NOC), ensuring compliance with national regulations and monitoring of pharmaceutical exports.

5Patent & Exclusivity Status

The primary patents for erlotinib have expired, leading to increased generic competition. This has enabled numerous Indian pharmaceutical companies to manufacture and export generic versions, contributing to the $2.7 million USD export value recorded between 2022 and 2026.

6Recent Industry Developments

- July 2025: The FDA granted orphan drug designation to erlotinib for the treatment of pachyonychia congenita, expanding its therapeutic applications.

- 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. (ema.europa.eu)

- May 2020: Accord Healthcare S.L.U. withdrew its application for marketing authorization of Erlotinib Accord in the EU, citing inadequate bioequivalence data. (ema.europa.eu)

These developments underscore the dynamic regulatory environment surrounding erlotinib, necessitating continuous monitoring and compliance by Indian exporters to maintain and expand their market presence.

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

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Global Price Benchmark — Erlotinib

Retail & reference prices across 9 markets vs. India FOB export price of $47.90/unit

Global Price Benchmark for Erlotinib across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	$6,000	USD	According to the FDA's Orange Book, Erlotinib is an approved medication in the U.S.
United Kingdom	Approximately $3,250	GBP	The NHS Drug Tariff lists Erlotinib as a reimbursable medication.
Germany	Approximately $3,300	EUR	Erlotinib is regulated by the Federal Joint Committee (G-BA) in Germany.
Australia	Approximately $3,150	AUD

Supply Chain Risk Assessment — Erlotinib

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

HIGH RISK

1API Sourcing & Raw Material Dependency

Erlotinib's Active Pharmaceutical Ingredient (API) is predominantly manufactured in India, a leading global producer of generic pharmaceuticals. However, India's API production heavily relies on importing Key Starting Materials (KSMs) and intermediates from China, which supplies approximately 70–80% of the global KSMs and 60–70% of intermediates. This dependency exposes the supply chain to risks associated with geopolitical tensions, trade disputes, and regulatory changes in China.

Recent disruptions have underscored these vulnerabilities. For instance, in March 2026, the closure of the Strait of Hormuz due to escalating Middle East conflicts disrupted the supply of raw materials to Asia's petrochemical industry, leading to force majeure declarations and production cutbacks. Such events highlight the fragility of supply chains dependent on specific regions for critical inputs.

2Supplier Concentration & Single-Source Risk

Our proprietary trade data indicates that the top five Indian exporters of Erlotinib account for 69.7% of total exports, with NATCO PHARMA LIMITED leading at a 20.4% share. This high supplier concentration poses a significant risk; any operational or regulatory issues affecting these key players could disrupt the global supply of Erlotinib.

To mitigate such risks, the Indian government has implemented the Production Linked Incentive (PLI) scheme, aiming to bolster domestic API and KSM manufacturing capacity. This initiative seeks to reduce reliance on imports and enhance supply chain resilience. (pharmanow.live) However, the effectiveness of the PLI scheme in diversifying the supplier base and reducing single-source dependency remains to be fully realized.

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Frequently Asked Questions — Erlotinib Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top erlotinib exporters from India?

The leading erlotinib exporters from India are NATCO PHARMA LIMITED, MSN LABORATORIES PRIVATE LIMITED, CIPLA LIMITED, and 7 others. NATCO PHARMA LIMITED leads with 20.4% market share ($547.2K). The top 5 suppliers together control 69.7% of total export value.

What is the total export value of erlotinib from India?

The total export value of erlotinib from India is $2.7M, recorded across 336 shipments from 94 active exporters to 55 countries. The average shipment value is $8.0K.

Which countries import erlotinib from India?

India exports erlotinib to 55 countries. The top importing countries are UNITED STATES (21.0%), THAILAND (18.9%), PHILIPPINES (12.4%), SAUDI ARABIA (12.3%), PERU (5.7%), which together account for 70.2% of total export value.

What is the HS code for erlotinib exports from India?

The primary HS code for erlotinib 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.

linkedin.com/in/sureshsormare

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.

Erlotinib

Erlotinib

Top Erlotinib Exporters from India

Top Countries Importing Erlotinib from India

Who Supplies Erlotinib to India?

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Regulatory Landscape — Erlotinib

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 — Erlotinib

Supply Chain Risk Assessment — Erlotinib

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Erlotinib Trade Intelligence

Frequently Asked Questions — Erlotinib Exports from India

Who are the top erlotinib exporters from India?

What is the total export value of erlotinib from India?

Which countries import erlotinib from India?

What is the HS code for erlotinib 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 erlotinib exports from India?

Which ports handle erlotinib exports from India?

Why is India a leading exporter of erlotinib?

What certifications do Indian erlotinib exporters need?

How many buyers import erlotinib from India?

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

Analysis Methodology