Topotecan Export Market Intelligence: India's 45 Suppliers Shipping to 51 Countries — TransData Nexus 2026

Q: Who are the top topotecan exporters from India?

The top topotecan exporters from India are: 1. INTAS PHARMACEUTICALS LIMITED — $3.3M (87.5% market share); 2. VENUS REMEDIES LIMITED — $224.6K (6.0% market share); 3. SUN PHARMACEUTICAL INDUSTRIES LIMITED — $111.1K (3.0% market share); 4. UNITED BIOTECH PRIVATE LIMITED — $18.9K (0.5% market share); 5. R.S. SURGIPHARM PRIVATE LIMITED — $10.2K (0.3% market share). Together they account for 97.2% of India's total topotecan export value.

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

The total export value of topotecan from India is $3.8M USD, recorded across 558 shipment transactions from 45 active exporters to 51 destination countries. The average shipment value is $6.7K.

Q: Which countries import topotecan from India?

India exports topotecan to 51 countries worldwide. The top importing countries are: POLAND (29.8% share, $1.1M), NETHERLANDS (15.7% share, $589.3K), UNITED STATES (14.9% share, $559.7K), BRAZIL (13.7% share, $515.8K), MOROCCO (3.0% share, $111.1K). These five markets account for 77.1% of total export value.

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

The primary HS code for topotecan 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 topotecan exports from India?

The average unit price for topotecan exports from India is $12.87 USD per unit, with prices ranging from $0.75 to $193.87 depending on formulation, packaging, and order volume. The total market is valued at $3.8M across 558 shipments.

Q: Which ports handle topotecan exports from India?

The primary ports for topotecan exports from India are AHEMDABAD AIR ACC (INAMD4) (19.2% of shipments), MUNDRA SEA (INMUN1) (15.4% of shipments), AHEMDABAD AIR (13.1% of shipments), MUNDRA SEA (8.6% of shipments), SAHAR AIR CARGO ACC (INBOM4) (8.1% 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 topotecan?

India is one of the world's leading exporters of topotecan due to its large base of 45 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 topotecan to 51 countries, demonstrating 26% global market coverage.

Q: What certifications do Indian topotecan exporters need?

Indian topotecan 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 topotecan from India?

There are 113 registered buyers importing topotecan from India, spread across 51 countries. The repeat buyer rate is 56.6%, indicating strong long-term trade relationships and consistent product quality.

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

INTAS PHARMACEUTICALS LIMITED is the leading topotecan exporter from India with a market share of 87.5% and total export value of $3.3M across 414 shipments. The top 5 suppliers together control 97.2% of total export value.

Suresh Sormare

Topotecan

India Pharmaceutical Trade Intelligence

$3.8M45 Suppliers51 CountriesHS 30049049

ExportsIndia → POLAND29.8%India → NETHERLANDS15.7%

#1 Supplier: INTAS PHARMACEUTICALS #1 Buyer: ACCORD HEALTHCARE

Topotecan Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Topotecan to the World

Between 2022 and 2026, India exported $3.8M worth of topotecan across 558 verified shipments to 51 countries — covering 26% of world markets in the Advanced Oncology segment. The largest destination is POLAND (29.8%). INTAS PHARMACEUTICALS LIMITED leads with a 87.5% 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·

Topotecan export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Topotecan export data snapshot — $3.8M · 45 exporters · 51 countriesTransData Nexus · Indian Customs Data

Top Topotecan Exporters from India

45 active exporters · Ranked by export value

View all 45 →

Top Topotecan Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	INTAS PHARMACEUTICALS LIMITED	$3.3M	414	16	87.5%
2	VENUS REMEDIES LIMITED

Top Countries Importing Topotecan from India

51 destination markets · Ranked by import value

All 51 countries →

Top Countries Importing Topotecan from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	POLAND	$1.1M	29.8%
2	NETHERLANDS	$589.3K	15.7%
3	UNITED STATES	$559.7K	14.9%
4	BRAZIL	$515.8K	13.7%
5	MOROCCO	$111.1K	3.0%
6	ITALY	$101.6K	2.7%
7	HUNGARY	$98.1K	2.6%
8	SPAIN	$95.0K	2.5%
9	COLOMBIA	$75.9K	2.0%
10	GERMANY	$74.9K	2.0%

POLAND is India's largest topotecan export destination, absorbing 29.8% of total exports worth $1.1M. The top 5 importing countries — POLAND, NETHERLANDS, UNITED STATES, BRAZIL, MOROCCO — together account for 77.1% of India's total topotecan export value. The remaining 46 destination countries collectively receive the other 22.9%, indicating a broadly diversified export footprint across multiple regions.

Regulatory Landscape — Topotecan

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

1FDA & US Market Regulatory Status

In the United States, the Food and Drug Administration (FDA) has approved multiple Abbreviated New Drug Applications (ANDAs) for topotecan, facilitating the availability of generic versions. For instance, Sandoz, Inc. received approval for topotecan for injection (NDA 200199) on February 25, 2011, and Teva Pharmaceuticals USA obtained approval for topotecan injection (NDA 022453) on December 20, 2012. These approvals indicate a competitive market landscape for topotecan in the U.S. Additionally, as of March 21, 2024, the FDA granted orphan drug designation to topotecan liposome injection for the treatment of Merkel Cell Carcinoma, highlighting ongoing developments in its therapeutic applications.

2EU & UK Regulatory Framework

Within the European Union, topotecan has been subject to various regulatory actions. The European Medicines Agency (EMA) granted marketing authorizations to several generic versions, such as Topotecan Actavis on July 24, 2009. However, this authorization was withdrawn on January 15, 2019, at the request of the marketing authorization holder, Actavis Group PTC ehf, due to commercial reasons. Similarly, Topotecan Eagle's authorization was withdrawn on October 2, 2014, upon the request of Eagle Laboratories Ltd. These withdrawals reflect the dynamic nature of the European pharmaceutical market and the strategic decisions of marketing authorization holders. (ema.europa.eu)

3WHO Essential Medicines & Global Standards

Topotecan is included in the World Health Organization's (WHO) Model List of Essential Medicines, underscoring its significance in cancer treatment protocols. The drug is recognized in major pharmacopoeias, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), ensuring standardized quality and efficacy across different regions.

4India Regulatory Classification

In India, topotecan is classified under Schedule H of the Drugs and Cosmetics Rules, 1945, indicating that it is a prescription-only medication. The National Pharmaceutical Pricing Authority (NPPA) regulates the pricing of essential medicines; however, as of the latest available data, topotecan is not listed under the Drugs (Prices Control) Order (DPCO), suggesting that its price is not subject to government-mandated ceilings. For export purposes, manufacturers must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT), ensuring compliance with national regulations.

5Patent & Exclusivity Status

The primary patents for topotecan have expired, leading to increased generic competition globally. This has resulted in a more competitive market, influencing pricing and availability. Manufacturers exporting from India must navigate this competitive landscape by ensuring compliance with international regulatory standards and maintaining high-quality production to sustain market share.

6Recent Industry Developments

In March 2024, the FDA granted orphan drug designation to topotecan liposome injection for the treatment of Merkel Cell Carcinoma, indicating potential new therapeutic applications for the drug.

In January 2019, the European Commission withdrew the marketing authorization for Topotecan Actavis at the request of the marketing authorization holder, Actavis Group PTC ehf, due to commercial reasons. (ema.europa.eu)

In October 2014, the European Commission withdrew the marketing authorization for Topotecan Eagle at the request of the marketing authorization holder, Eagle Laboratories Ltd, also due to commercial reasons. (ema.europa.eu)

These developments reflect the evolving regulatory and commercial landscape for topotecan, emphasizing the importance for exporters to stay informed about international regulatory changes and market dynamics.

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

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Global Price Benchmark — Topotecan

Retail & reference prices across 9 markets vs. India FOB export price of $12.87/unit

Global Price Benchmark for Topotecan across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	$122.07	USD	According to the FDA Orange Book, Topotecan is approved for use in the United States.
United Kingdom	Data not available	GBP	Topotecan is listed in the British National Formulary (BNF) and is available through the National Health Service (NHS).
Germany	Data not available	EUR	Topotecan is approved by the European Medicines Agency (EMA) for use in Germany.
Australia	Data not available

Supply Chain Risk Assessment — Topotecan

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

MEDIUM RISK

1API Sourcing & Raw Material Dependency

India's pharmaceutical industry, including the production of Topotecan, heavily relies on Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs) imported from China. Approximately 60–70% of these essential components are sourced from Chinese manufacturers. This dependency exposes the supply chain to significant risks, particularly during geopolitical tensions or trade disruptions.

In recent years, efforts have been made to reduce this reliance. In October 2024, under the Production Linked Incentive (PLI) scheme, India inaugurated two greenfield plants aimed at manufacturing critical molecules like Penicillin G and Clavulanic Acid, which had not been produced domestically for over two decades. These initiatives are expected to halve India's import dependence on key pharmaceutical ingredients. However, the transition to self-sufficiency is gradual, and the industry remains vulnerable to external supply shocks in the interim.

2Supplier Concentration & Single-Source Risk

The export data for Topotecan reveals a high supplier concentration, with the top five exporters accounting for 97.2% of total exports. Notably, INTAS PHARMACEUTICALS LIMITED dominates with an 87.5% share, amounting to $3.3 million USD. This heavy reliance on a single supplier poses a significant risk; any operational disruptions at INTAS could severely impact global Topotecan availability.

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Frequently Asked Questions — Topotecan Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top topotecan exporters from India?

The leading topotecan exporters from India are INTAS PHARMACEUTICALS LIMITED, VENUS REMEDIES LIMITED, SUN PHARMACEUTICAL INDUSTRIES LIMITED, and 4 others. INTAS PHARMACEUTICALS LIMITED leads with 87.5% market share ($3.3M). The top 5 suppliers together control 97.2% of total export value.

What is the total export value of topotecan from India?

The total export value of topotecan from India is $3.8M, recorded across 558 shipments from 45 active exporters to 51 countries. The average shipment value is $6.7K.

Which countries import topotecan from India?

India exports topotecan to 51 countries. The top importing countries are POLAND (29.8%), NETHERLANDS (15.7%), UNITED STATES (14.9%), BRAZIL (13.7%), MOROCCO (3.0%), which together account for 77.1% of total export value.

What is the HS code for topotecan exports from India?

The primary HS code for topotecan 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.

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How India Exports Topotecan to the World

Top Topotecan Exporters from India

Top Countries Importing Topotecan from India

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Regulatory Landscape — Topotecan

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 — Topotecan

Supply Chain Risk Assessment — Topotecan

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Topotecan Trade Intelligence

Frequently Asked Questions — Topotecan Exports from India

Who are the top topotecan exporters from India?

What is the total export value of topotecan from India?

Which countries import topotecan from India?

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

Which ports handle topotecan exports from India?

Why is India a leading exporter of topotecan?

What certifications do Indian topotecan exporters need?

How many buyers import topotecan from India?

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

Analysis Methodology