Gemcitabine Export Market Intelligence: India's 248 Suppliers Shipping to 125 Countries — TransData Nexus 2026

Q: Who are the top gemcitabine exporters from India?

The top gemcitabine exporters from India are: 1. FRESENIUS KABI ONCOLOGY LIMITED — $6.9M (14.8% market share); 2. EUGIA PHARMA SPECIALITIES LIMITED — $5.9M (12.7% market share); 3. SUN PHARMACEUTICAL INDUSTRIES LIMITED — $5.8M (12.5% market share); 4. MYLAN LABORATORIES LIMITED — $3.7M (8.0% market share); 5. INTAS PHARMACEUTICALS LIMITED — $3.7M (7.9% market share). Together they account for 55.8% of India's total gemcitabine export value.

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

The total export value of gemcitabine from India is $46.5M USD, recorded across 2,938 shipment transactions from 248 active exporters to 125 destination countries. The average shipment value is $15.8K.

Q: Which countries import gemcitabine from India?

India exports gemcitabine to 125 countries worldwide. The top importing countries are: UNITED STATES (16.8% share, $7.8M), BELGIUM (12.7% share, $5.9M), MALTA (11.6% share, $5.4M), ALGERIA (7.6% share, $3.5M), RUSSIA (6.3% share, $2.9M). These five markets account for 55.0% of total export value.

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

The primary HS code for gemcitabine 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 gemcitabine exports from India?

The average unit price for gemcitabine exports from India is $10.70 USD per unit, with prices ranging from $0.03 to $2290.14 depending on formulation, packaging, and order volume. The total market is valued at $46.5M across 2,938 shipments.

Q: Which ports handle gemcitabine exports from India?

The primary ports for gemcitabine exports from India are DELHI AIR CARGO ACC (INDEL4) (18.3% of shipments), SAHAR AIR CARGO ACC (INBOM4) (13.4% of shipments), SAHAR AIR (12.6% of shipments), DELHI AIR (12.2% of shipments), Delhi Air (4.5% 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 gemcitabine?

India is one of the world's leading exporters of gemcitabine due to its large base of 248 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 gemcitabine to 125 countries, demonstrating 64% global market coverage.

Q: What certifications do Indian gemcitabine exporters need?

Indian gemcitabine 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 gemcitabine from India?

There are 676 registered buyers importing gemcitabine from India, spread across 125 countries. The repeat buyer rate is 60.4%, indicating strong long-term trade relationships and consistent product quality.

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

FRESENIUS KABI ONCOLOGY LIMITED is the leading gemcitabine exporter from India with a market share of 14.8% and total export value of $6.9M across 339 shipments. The top 5 suppliers together control 55.8% of total export value.

Suresh Sormare

Gemcitabine

India Pharmaceutical Trade Intelligence

$46.5M248 Suppliers125 CountriesHS 30049049

ExportsIndia → UNITED STATES16.8%India → BELGIUM12.7%

ImportsUNITED STATES → India$133.8M FRANCE → India$35.5M

#1 Supplier: FRESENIUS KABI #1 Buyer: YUSEN LOGISTICS

Gemcitabine Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Gemcitabine to the World

Between 2022 and 2026, India exported $46.5M worth of gemcitabine across 2,938 verified shipments to 125 countries — covering 64% of world markets in the Oncology segment. The largest destination is UNITED STATES (16.8%). FRESENIUS KABI ONCOLOGY LIMITED leads with a 14.8% 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

Gemcitabine export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Gemcitabine export data snapshot — $46.5M · 248 exporters · 125 countriesTransData Nexus · Indian Customs Data

Top Gemcitabine Exporters from India

248 active exporters · Ranked by export value

View all 248 →

Top Gemcitabine Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	FRESENIUS KABI ONCOLOGY LIMITED	$6.9M	339	20	14.8%
2	EUGIA PHARMA SPECIALITIES LIMITED

Top Countries Importing Gemcitabine from India

125 destination markets · Ranked by import value

All 125 countries →

Top Countries Importing Gemcitabine from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	UNITED STATES	$7.8M	16.8%
2	BELGIUM	$5.9M	12.7%
3	MALTA	$5.4M	11.6%
4	ALGERIA	$3.5M	7.6%
5	RUSSIA	$2.9M	6.3%
6	THAILAND	$2.3M	4.9%
7	GERMANY	$1.6M	3.5%
8	MOROCCO	$1.5M	3.2%
9	MALAYSIA	$1.4M	3.0%
10	SOUTH AFRICA	$1.1M	2.3%

UNITED STATES is India's largest gemcitabine export destination, absorbing 16.8% of total exports worth $7.8M. The top 5 importing countries — UNITED STATES, BELGIUM, MALTA, ALGERIA, RUSSIA — together account for 55.0% of India's total gemcitabine export value. The remaining 120 destination countries collectively receive the other 45.0%, indicating a well-diversified global distribution network spanning all major continents.

Who Supplies Gemcitabine to India?

12 origin countries · Total import value: $169.5M

India imports gemcitabine from 12 countries with a combined import value of $169.5M. The largest supplier is UNITED STATES ($133.8M, 36 shipments), followed by FRANCE and SWITZERLAND. All values are from Indian Customs (DGFT) import records.

Countries Supplying Gemcitabine to India — Ranked by Import Value
#	Origin Country	Import Value (USD)	Shipments	Share
1	UNITED STATES	$133.8M	36	78.9%
2	FRANCE	$35.5M	14	20.9%
3	SWITZERLAND	$163.1K	5	0.1%
4	BELGIUM	$84.3K	53	0.0%
5	GERMANY	$19.7K	10	0.0%
6	CHINA	$10.0K	1	0.0%
7	UNITED KINGDOM	$3.5K	1	0.0%
8	NETHERLANDS	$1.6K	2	0.0%
9	ITALY	$1.1K	2	0.0%
10	AUSTRIA	$1.0K	2	0.0%

Showing top 10 of 12 origin countries

UNITED STATES is the largest supplier of gemcitabine to India, accounting for 78.9% of total import value. The top 5 origin countries — UNITED STATES, FRANCE, SWITZERLAND, BELGIUM, GERMANY — together supply 100.0% of India's gemcitabine imports. Click any country to see detailed supplier and buyer data for that import corridor.

Regulatory Landscape — Gemcitabine

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

1FDA & US Market Regulatory Status

In the United States, gemcitabine is approved for various oncological indications. The FDA's Orange Book lists multiple approved Abbreviated New Drug Applications (ANDAs) for gemcitabine, indicating a competitive generic market. Notably, on July 1, 2025, the FDA granted orphan drug designation to gemcitabine liposome injection for the treatment of biliary tract carcinomas, as per the FDA's Orphan Drug Designations and Approvals database. This designation provides incentives like tax credits and market exclusivity to encourage the development of treatments for rare diseases. The substantial number of Indian exporters (248) underscores India's significant role in supplying gemcitabine to the U.S. market.

2EU & UK Regulatory Framework

In the European Union, gemcitabine is authorized for use in various cancer treatments. The European Medicines Agency (EMA) has harmonized the product information for gemcitabine-containing medicines to ensure consistent safety and efficacy information across member states. This harmonization process was completed in September 2008, as detailed in the EMA's referral procedure documentation. Manufacturers exporting to the EU must comply with Good Manufacturing Practice (GMP) standards, which are essential for ensuring product quality and patient safety.

3WHO Essential Medicines & Global Standards

Gemcitabine is included in the World Health Organization's Model List of Essential Medicines, highlighting its importance in a basic health system. The drug is also subject to international pharmacopoeia standards, including those of the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), ensuring consistent quality across different markets.

4India Regulatory Classification

In India, gemcitabine is classified as a Schedule H drug under the Drugs and Cosmetics Act, requiring a prescription for its sale. The National Pharmaceutical Pricing Authority (NPPA) regulates the pricing of essential medicines, including gemcitabine, to ensure affordability. Exporters must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT) for the export of pharmaceutical products, ensuring compliance with national regulations.

5Patent & Exclusivity Status

The primary patents for gemcitabine have expired, leading to the availability of generic versions and increased competition in the market. This has resulted in more affordable treatment options for patients globally.

6Recent Industry Developments

In July 2025, the FDA granted orphan drug designation to gemcitabine liposome injection for the treatment of biliary tract carcinomas, as per the FDA's Orphan Drug Designations and Approvals database. This designation aims to encourage the development of treatments for rare diseases by providing benefits like tax credits and market exclusivity.

In October 2023, the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) recommended updates to the product information for gemcitabine-containing medicines to enhance safety information, as detailed in the EMA's periodic safety update report. This underscores the importance of continuous monitoring and updating of safety information for pharmaceuticals.

These developments reflect the dynamic regulatory landscape surrounding gemcitabine, emphasizing the need for manufacturers and exporters to stay informed and compliant with evolving standards and requirements.

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

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Global Price Benchmark — Gemcitabine

Retail & reference prices across 9 markets vs. India FOB export price of $10.70/unit

Global Price Benchmark for Gemcitabine across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	$120	USD	According to the FDA's Orange Book, Gemcitabine is approved for use in the United States.
United Kingdom	$115	GBP	Gemcitabine is listed in the NHS Drug Tariff as an approved medication.
Germany	$110	EUR	The European Medicines Agency (EMA) has authorized the use of Gemcitabine in Germany.
Australia	$100	AUD

Supply Chain Risk Assessment — Gemcitabine

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

MEDIUM RISK

1API Sourcing & Raw Material Dependency

India's pharmaceutical industry, renowned for its generic drug production, heavily relies on China for Key Starting Materials (KSMs) essential in Active Pharmaceutical Ingredient (API) synthesis. Approximately 60–70% of these critical inputs are imported from China, creating a significant dependency. This reliance exposes the supply chain to vulnerabilities, as any disruption in Chinese production or export policies can directly impact India's API manufacturing capabilities.

Recent geopolitical tensions have exacerbated these risks. In February 2026, the closure of the Strait of Hormuz disrupted the supply of raw materials to Asia's petrochemical industry, leading to production cutbacks and force majeure declarations. Such events underscore the fragility of the supply chain, where geopolitical conflicts can halt the flow of essential materials, affecting pharmaceutical production timelines and costs.

2Supplier Concentration & Single-Source Risk

Our proprietary trade data indicates that the top five exporters of Gemcitabine from India account for 55.8% of the total export value, with FRESENIUS KABI ONCOLOGY LIMITED leading at 14.8%. This concentration suggests a moderate risk, as disruptions affecting these key suppliers could significantly impact global Gemcitabine availability.

To mitigate such risks, the Indian government has implemented the Production Linked Incentive (PLI) scheme, aiming to bolster domestic API and KSM production. In November 2024, two greenfield plants were inaugurated under this scheme to manufacture critical molecules like Penicillin G and Clavulanic Acid, reducing import dependence. While these initiatives are steps toward self-reliance, their impact on reducing supplier concentration in the Gemcitabine supply chain remains to be seen.

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Frequently Asked Questions — Gemcitabine Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top gemcitabine exporters from India?

The leading gemcitabine exporters from India are FRESENIUS KABI ONCOLOGY LIMITED, EUGIA PHARMA SPECIALITIES LIMITED, SUN PHARMACEUTICAL INDUSTRIES LIMITED, and 12 others. FRESENIUS KABI ONCOLOGY LIMITED leads with 14.8% market share ($6.9M). The top 5 suppliers together control 55.8% of total export value.

What is the total export value of gemcitabine from India?

The total export value of gemcitabine from India is $46.5M, recorded across 2,938 shipments from 248 active exporters to 125 countries. The average shipment value is $15.8K.

Which countries import gemcitabine from India?

India exports gemcitabine to 125 countries. The top importing countries are UNITED STATES (16.8%), BELGIUM (12.7%), MALTA (11.6%), ALGERIA (7.6%), RUSSIA (6.3%), which together account for 55.0% of total export value.

What is the HS code for gemcitabine exports from India?

The primary HS code for gemcitabine 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.

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Top Gemcitabine Exporters from India

Top Countries Importing Gemcitabine from India

Who Supplies Gemcitabine to India?

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Regulatory Landscape — Gemcitabine

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 — Gemcitabine

Supply Chain Risk Assessment — Gemcitabine

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Gemcitabine Trade Intelligence

Frequently Asked Questions — Gemcitabine Exports from India

Who are the top gemcitabine exporters from India?

What is the total export value of gemcitabine from India?

Which countries import gemcitabine from India?

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

Which ports handle gemcitabine exports from India?

Why is India a leading exporter of gemcitabine?

What certifications do Indian gemcitabine exporters need?

How many buyers import gemcitabine from India?

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

Analysis Methodology