Topotecan HS Code Trade Classification — 7 Codes, $3.8M Trade

Q: How much Topotecan is exported under HS code 30049049?

Under HS code 30049049, India exports $3.7M worth of Topotecan, representing 98.1% of total Topotecan trade. This involves 504 shipments from 31 Indian exporters to 121 buyers in 68 countries.

Q: Which countries import the most Topotecan from India?

The top importing countries for Topotecan from India are Poland, Netherlands, United States. The leading importer Poland accounts for $1.1M in trade value. In total, Topotecan is exported to buyers across multiple countries under 7 HS code classifications.

Q: Who are the top Topotecan exporters from India?

The leading Topotecan exporters from India include INTAS PHARMACEUTICALS LIMITED ($2.4M), INTAS PHARMACEUTICALS LIMITED ($839.8K), VENUS REMEDIES LIMITED ($151.0K). These suppliers export across multiple HS code classifications with a combined trade value of $3.8M.

Q: Which Topotecan HS code has the highest unit price?

HS code 30049039 has the highest average unit price at $45.74 per unit for Topotecan exports. This compares to the overall market average of $6727.08 per transaction. The most traded code HS 30049049 averages $11.06 per unit.

TransData Nexus

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 HS Codes (2026) — 7 Classifications, $3.8M Trade | TransData Nexus | TransData Nexus

Topotecan HS Code Analysis (2026)

India exports Topotecan under 7 distinct HS code classifications, representing a total trade value of $3.8M across 558 shipments. The dominant classification is HS 30049049 (Other gastrointestinal preparations (retail)), accounting for 98.1% of all Topotecan trade at $3.7M. HS 30049099 (Other medicaments, put up in measured doses or for retail sale) follows at 1.3% ($50.3K). The top 5 HS codes together account for 100.0% of total Topotecan trade from India. The average transaction value is $6727. Key importing markets include Poland, Netherlands, United States. Leading exporters include INTAS PHARMACEUTICALS LIMITED and INTAS PHARMACEUTICALS LIMITED . Data sourced from Indian Customs (DGFT) shipping bill records.

Source:

Topotecan HS Code Analysis — 7 classifications, $3.8M trade value, top HS codes breakdown and distribution — Topotecan HS code analysis — 7 classifications · $3.8M trade value · 558 shipmentsTransData Nexus · Indian Customs Data

Top Topotecan HS Code Classifications

Ranked by trade value from Indian Customs (DGFT) data

Rank	HS Code	Trade Value	Share	Transactions	Avg Price	Suppliers	Countries
#1	30049049	$3.7M	98.1%	504	$11.06	31	68
#2	30049099	$50.3K	1.3%

HS 30049049

Other gastrointestinal preparations (retail) · 98.1% of Topotecan trade

$3.7M

Trade Value

98.1%

Market Share

504

Transactions

$11.06

Avg Unit Price

Suppliers: 31Buyers: 121Countries: 68

Common Product Descriptions:

PHARMA DRUGS & MEDI TOPOTECAN INJ1MG/ML,

PHARMA DRUGS & MEDI TOPOTECAN RTU,1MG/ML

PHARMA DRUGS & MEDI TOPOTECAN INJ RTU,1M

HS 30049099

Other medicaments, put up in measured doses or for retail sale · 1.3% of Topotecan trade

$50.3K

Trade Value

1.3%

Market Share

Transactions

$30.07

Avg Unit Price

Suppliers: 25Buyers: 23Countries: 24

Common Product Descriptions:

PHARMA PRODUCT-TOPOTEC 2.5(TOPOTECAN INJ

TOPOTEC 2.5MG (2.5ML VIAL) TOPOTECAN INJ

TOPOTDN 2.5MG TOPOTECAN HCL FOR INJECTIO

HS 30049049

Other medicaments of mixed or unmixed products (retail) · 0.5% of Topotecan trade

$18.0K

Trade Value

0.5%

Market Share

Transactions

$21.12

Avg Unit Price

Suppliers: 2Buyers: 3Countries: 3

Common Product Descriptions:

PHARMA DRUGS & MEDI TOPOTECAN INJ1MG/ML,1ML RTU(AC...

ASPER INVOICE NO: ZPPL/XP/2425/011 DATE:01/04/2024...

PHA.DRU & MEDI, TOPOTECAN RTU 1MG/ML, 4ML 1V(ACC-U...

HS 30044990

Other medicaments containing alkaloids or derivatives (retail) · 0.0% of Topotecan trade

$1.1K

Trade Value

0.0%

Market Share

Transactions

$27.31

Avg Unit Price

Suppliers: 1Buyers: 1Countries: 1

Common Product Descriptions:

TOPOTON 2.5MG TOPOTECAN IP 2.5MG/2.5ML INJECTION (...

HS 30049039

Other anti-infective/anti-parasitic medicaments (retail) · 0.0% of Topotecan trade

$457

Trade Value

0.0%

Market Share

Transactions

$45.74

Avg Unit Price

Suppliers: 1Buyers: 1Countries: 1

Common Product Descriptions:

TOPOTEC 2.5MG INJECTION [10 VIAL ]EACH VIAL CONT T...

HS 30042049

Other quinolone/fluoroquinolone preparations (retail) · 0.0% of Topotecan trade

$369

Trade Value

0.0%

Market Share

Transactions

$36.87

Avg Unit Price

Suppliers: 1Buyers: 1Countries: 1

Common Product Descriptions:

PHARMACEUTICAL PRODUCTS TOPOWIN 2.5 MG INJ VIAL GE...

HS 30049099

Other medicaments of mixed or unmixed products (retail) · 0.0% of Topotecan trade

$170

Trade Value

0.0%

Market Share

Transactions

$16.96

Avg Unit Price

Suppliers: 1Buyers: 1Countries: 1

Common Product Descriptions:

HARMLESS LIFE SAVING PHARMACEUTICAL MEDICINE: Topo...

Where Topotecan is Exported — Geographic HS Code Analysis

Import destinations for Topotecan from India, by trade value

India exports Topotecan to 10+ countries under 7 HS code classifications. The largest import destination is Poland ($1.1M), followed by Netherlands ($589.3K) and United States ($559.7K). These markets collectively account for the majority of India's Topotecan pharmaceutical exports.

Rank	Country	Trade Value	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%

Pharmaceutical buyers in these markets import Topotecan primarily under HS code 30049049 (Other gastrointestinal preparations (retail)). Import duties, regulatory requirements, and product registration vary by destination country. Contact TransData Nexus for country-specific import intelligence.

Understanding Topotecan HS Codes

The Harmonized System (HS) is an internationally standardized system of names and numbers to classify traded products. Developed by the World Customs Organization (WCO), it is used by over 200 countries for customs tariffs, trade statistics, and regulatory compliance. Each HS code is a 6-digit number (extended to 8 digits in India's Customs Tariff Schedule) that precisely identifies a product category.

How Topotecan HS Codes Work

Topotecan falls under Chapter 30 (Pharmaceutical Products) of the Harmonized System. The 7 codes used for Topotecan exports span multiple headings:

Heading 3003 — Medicaments not put up in measured doses or for retail sale (bulk APIs, intermediates)
Heading 3004 — Medicaments put up in measured doses or for retail sale (finished formulations)
Heading 3005 — Wadding, gauze, bandages for medical use
Heading 3006 — Pharmaceutical goods (sutures, reagents, dental cements)

The most significant distinction for Topotecan is between HS 3003 (bulk/unmeasured) and HS 3004 (retail-ready). HS 3004 codes account for the majority of Topotecan trade (including the dominant code 30049049 at 98.1%). The 8-digit Indian Customs Tariff code further specifies the therapeutic class — for example, HS 30049049 refers to "Other gastrointestinal preparations (retail)".

Regulatory & Compliance — Topotecan Export Classification

Correct HS code classification is critical for Topotecan exports from India. Misclassification can result in customs delays, incorrect duty assessment, and regulatory penalties. Key compliance considerations for pharmaceutical stakeholders:

Import Duty Classification

Topotecan import duties vary significantly by HS code and destination country. HS 3004 (finished formulations) typically attracts different duty rates than HS 3003 (bulk APIs). Many developing countries offer preferential rates for essential medicines including Topotecan.

DGFT & Indian Customs Requirements

Indian exporters must declare the correct 8-digit ITC-HS code on shipping bills filed with the Directorate General of Foreign Trade (DGFT). Topotecan exports require Drug Controller General of India (DCGI) approval and must comply with Drug & Cosmetics Act regulations.

WHO Prequalification

For international procurement (UNICEF, Global Fund), Topotecan products must meet WHO Prequalification standards. WHO PQ status affects which HS codes are eligible for preferential procurement pricing and duty exemptions in recipient countries.

Country-Specific Registration

Each destination country requires product registration before import. Key markets like Poland and Netherlands have specific pharmaceutical regulatory bodies that must approve the product before customs clearance.

Related Advanced Oncology — Products Sharing Similar HS Codes

Other products in the Advanced Oncology therapeutic category that may share HS code classifications with Topotecan

actinomycin anastrozole axitinib

Tariff Schedule — Top Markets

TransData Nexus Topotecan HS code trade compliance intelligence

1Tariff Schedule — Top Markets

Topotecan, classified under HS code 30049049, is subject to varying Most Favored Nation (MFN) tariff rates across different countries. Below is an overview of the applicable rates and any preferential treatments under Free Trade Agreements (FTAs) with India:

Poland and Netherlands (European Union): The European Union's Common External Tariff applies a 0% MFN rate to pharmaceutical products under HS code 30049049. India and the EU have not established a comprehensive FTA; however, specific pharmaceutical products may benefit from reduced tariffs under the Generalized System of Preferences (GSP).

United States: The U.S. Harmonized Tariff Schedule (HTS) lists pharmaceutical products under HS code 30049049 with an MFN rate of 0%. The U.S. does not have an FTA with India that affects this classification, but certain products may qualify for duty-free treatment under the GSP, subject to eligibility criteria.

Brazil: As a member of the Mercosur trade bloc, Brazil applies a Common External Tariff (CET). Pharmaceutical products under HS code 30049049 typically face an MFN rate of 0%. Brazil and India have engaged in trade discussions, but no specific FTA currently affects this classification.

Classification Disputes & Misclassification Risks

TransData Nexus Topotecan HS code trade compliance intelligence

1Classification Disputes & Misclassification Risks

Topotecan, an antineoplastic agent, is primarily classified under HS code 30049049, which covers "Other medicaments containing alkaloids or derivatives thereof." Our data indicates that 98.1% of Topotecan shipments utilize this classification.

Classification disputes may arise when determining whether Topotecan should be classified under HS code 3003 (medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses) versus HS code 3004 (medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or forms). The distinction hinges on the product's presentation:

HS 3003: Applies to bulk forms not packaged for retail sale.

HS 3004: Applies to products in measured doses or retail packaging.

Common misclassification errors include:

Classifying bulk Topotecan under HS 3004 instead of HS 3003.

Misidentifying the product's composition, leading to incorrect subheading classification.

Such misclassifications can result in customs penalties, including fines and delays. Recent rulings by the World Customs Organization (WCO) and national customs authorities emphasize the importance of accurate classification based on product form and composition.

Pharmacopoeia & Quality Standards

TransData Nexus Topotecan HS code trade compliance intelligence

1Pharmacopoeia & Quality Standards

Topotecan is recognized in various pharmacopoeias, each establishing specific quality standards:

United States Pharmacopeia (USP): Provides a monograph for Topotecan hydrochloride, detailing purity, assay requirements, and storage conditions. The USP reference standard specifies an empirical formula of C₂₃H₂₃N₃O₅·HCl and a molecular weight of 457.91.

European Pharmacopoeia (Ph. Eur.): As of recent assessments, no monograph for Topotecan exists in the Ph. Eur. Manufacturers adhere to in-house specifications aligned with ICH guidelines, covering appearance, identification, assay, purity, specific rotation, residual solvents, heavy metals, water content, chloride content, residue on ignition, and bacterial endotoxins. (ema.europa.eu)

British Pharmacopoeia (BP) and Indian Pharmacopoeia (IP): Current information indicates the absence of specific monographs for Topotecan in these pharmacopoeias.

Quality standards for Topotecan include:

Purity/Assay Requirements: Assay methods, typically High-Performance Liquid Chromatography (HPLC), ensure the active substance meets specified purity levels.

Frequently Asked Questions — Topotecan HS Codes

Common questions about Topotecan trade classification, answered with data from Indian Customs records.

What is the HS code for Topotecan exports from India?

The most commonly used HS code for Topotecan exports from India is 30049049 (Other gastrointestinal preparations (retail)), which accounts for 98.1% of all Topotecan trade valued at $3.7M. In total, India exports Topotecan under 7 distinct HS code classifications.

How many HS codes are used for Topotecan trade?

Topotecan is exported from India under 7 different HS code classifications, covering a total trade value of $3.8M across 558 shipments. The top 5 HS codes account for 100.0% of total trade.

What is HS code 30049049?

HS code 30049049 refers to "Other gastrointestinal preparations (retail)" under Chapter 30 (Pharmaceutical Products) of the Harmonized System. For Topotecan, this code covers $3.7M in trade value with 504 transactions, 31 suppliers, and 121 buyers across 68 countries. The average unit price under this code is $11.06.

What is the difference between HS 30049049 and 30049099 for Topotecan?

HS 30049049 (Other gastrointestinal preparations (retail)) accounts for 98.1% of Topotecan trade ($3.7M) with an average unit price of $11.06, while HS 30049099 (Other medicaments, put up in measured doses or for retail sale) covers 1.3% ($50.3K) at $30.07 per unit. HS 30049049 involves 31 suppliers and 121 buyers, compared to 25 suppliers and 23 buyers for HS 30049099.

Official References & Regulatory Resources

HS code classifications follow the WCO Harmonized System. Verify tariff rates with your national customs authority.

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.

Topotecan

Topotecan

Top Topotecan HS Code Classifications

All Topotecan HS Code Classifications

HS 30049049

HS 30049099

HS 30049049

HS 30044990

HS 30049039

HS 30042049

HS 30049099

Top Suppliers

Related Analysis

Need HS Code Reports?

Where Topotecan is Exported — Geographic HS Code Analysis

Understanding Topotecan HS Codes

How Topotecan HS Codes Work

Regulatory & Compliance — Topotecan Export Classification

Import Duty Classification

DGFT & Indian Customs Requirements

WHO Prequalification

Country-Specific Registration

Related Advanced Oncology — Products Sharing Similar HS Codes

Tariff Schedule — Top Markets

1Tariff Schedule — Top Markets

Classification Disputes & Misclassification Risks

1Classification Disputes & Misclassification Risks

Pharmacopoeia & Quality Standards

1Pharmacopoeia & Quality Standards

Frequently Asked Questions — Topotecan HS Codes

What is the HS code for Topotecan exports from India?

How many HS codes are used for Topotecan trade?

What is HS code 30049049?

What is the difference between HS 30049049 and 30049099 for Topotecan?

Official References & Regulatory Resources

Research Methodology & Data Transparency

Suresh Sormare

Primary Data Source

How much Topotecan is exported under HS code 30049049?

Which countries import the most Topotecan from India?

Who are the top Topotecan exporters from India?

Which Topotecan HS code has the highest unit price?

Analysis Methodology