Lomustine Export Market Intelligence: India's 74 Suppliers Shipping to 36 Countries — TransData Nexus 2026

Q: Who are the top lomustine exporters from India?

The top lomustine exporters from India are: 1. 3S CORPORATION — $14.0K (13.6% market share); 2. PLEASANT EXPORTS — $10.5K (10.2% market share); 3. JPC GLOBAL — $7.6K (7.4% market share); 4. KINGS GLOBAL BIOTECH LIMITED — $5.7K (5.5% market share); 5. IKRIS PHARMA NETWORK PRIVATE LIMITED — $4.9K (4.8% market share). Together they account for 41.4% of India's total lomustine export value.

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

The total export value of lomustine from India is $103.3K USD, recorded across 399 shipment transactions from 74 active exporters to 36 destination countries. The average shipment value is $259.

Q: Which countries import lomustine from India?

India exports lomustine to 36 countries worldwide. The top importing countries are: ITALY (12.8% share, $13.3K), BRAZIL (12.4% share, $12.8K), SRI LANKA (10.2% share, $10.6K), PAKISTAN (8.8% share, $9.1K), UNITED ARAB EMIRATES (7.9% share, $8.2K). These five markets account for 52.2% of total export value.

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

The primary HS code for lomustine exports from India is 30049099. 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 lomustine exports from India?

The average unit price for lomustine exports from India is $18.67 USD per unit, with prices ranging from $0.01 to $510.62 depending on formulation, packaging, and order volume. The total market is valued at $103.3K across 399 shipments.

Q: Which ports handle lomustine exports from India?

The primary ports for lomustine exports from India are SAHAR AIR (37.3% of shipments), SAHAR AIR CARGO ACC (INBOM4) (26.3% of shipments), Bombay Air (8.5% of shipments), DELHI AIR (8.5% of shipments), Bombay Air Cargo (5.3% 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 lomustine?

India is one of the world's leading exporters of lomustine due to its large base of 74 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 lomustine to 36 countries, demonstrating 18% global market coverage.

Q: What certifications do Indian lomustine exporters need?

Indian lomustine 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 lomustine from India?

There are 135 registered buyers importing lomustine from India, spread across 36 countries. The repeat buyer rate is 37.0%, indicating strong long-term trade relationships and consistent product quality.

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

3S CORPORATION is the leading lomustine exporter from India with a market share of 13.6% and total export value of $14.0K across 29 shipments. The top 5 suppliers together control 41.4% of total export value.

Suresh Sormare

Lomustine

India Pharmaceutical Trade Intelligence

$103.3K74 Suppliers36 CountriesHS 30049099

ExportsIndia → ITALY12.8%India → BRAZIL12.4%

ImportsUNITED STATES → India$2.2K CANADA → India$267

#1 Supplier: 3S CORPORATION #1 Buyer: THE ESSES

Lomustine Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Lomustine to the World

Between 2022 and 2026, India exported $103.3K worth of lomustine across 399 verified shipments to 36 countries — covering 18% of world markets in the Advanced Oncology segment. The largest destination is ITALY (12.8%). 3S CORPORATION leads with a 13.6% 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 30049099

Lomustine export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Lomustine export data snapshot — $103.3K · 74 exporters · 36 countriesTransData Nexus · Indian Customs Data

Top Lomustine Exporters from India

74 active exporters · Ranked by export value

View all 74 →

Top Lomustine Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	3S CORPORATION	$14.0K	29	4	13.6%
2	PLEASANT EXPORTS

Top Countries Importing Lomustine from India

36 destination markets · Ranked by import value

All 36 countries →

Top Countries Importing Lomustine from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	ITALY	$13.3K	12.8%
2	BRAZIL	$12.8K	12.4%
3	SRI LANKA	$10.6K	10.2%
4	PAKISTAN	$9.1K	8.8%
5	UNITED ARAB EMIRATES	$8.2K	7.9%
6	SWITZERLAND	$4.5K	4.3%
7	POLAND	$4.4K	4.3%
8	MAURITIUS	$4.4K	4.3%
9	MEXICO	$4.4K	4.2%
10	NETHERLANDS	$4.1K	4.0%

ITALY is India's largest lomustine export destination, absorbing 12.8% of total exports worth $13.3K. The top 5 importing countries — ITALY, BRAZIL, SRI LANKA, PAKISTAN, UNITED ARAB EMIRATES — together account for 52.2% of India's total lomustine export value. The remaining 31 destination countries collectively receive the other 47.8%, indicating a focused distribution strategy targeting key markets.

Who Supplies Lomustine to India?

2 origin countries · Total import value: $2.4K

India imports lomustine from 2 countries with a combined import value of $2.4K. The largest supplier is UNITED STATES ($2.2K, 1 shipments), followed by CANADA. All values are from Indian Customs (DGFT) import records.

Countries Supplying Lomustine to India — Ranked by Import Value
#	Origin Country	Import Value (USD)	Shipments	Share
1	UNITED STATES	$2.2K	1	89.1%
2	CANADA	$267	1	10.9%

UNITED STATES is the largest supplier of lomustine to India, accounting for 89.1% of total import value. Click any country to see detailed supplier and buyer data for that import corridor.

Regulatory Landscape — Lomustine

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

1FDA & US Market Regulatory Status

In the United States, lomustine is approved under the brand name Gleostine. According to the FDA's Orange Book, there are no approved Abbreviated New Drug Applications (ANDAs) for generic versions of lomustine, indicating a lack of generic competition in the U.S. market. As of March 2026, there are no import alerts or restrictions specific to lomustine, facilitating its importation into the U.S. Given the 74 active Indian exporters, this presents a significant opportunity for Indian manufacturers to supply lomustine to the U.S. market, provided they comply with FDA regulations, including Good Manufacturing Practices (GMP) and potential New Drug Application (NDA) requirements.

2EU & UK Regulatory Framework

In the European Union, lomustine is authorized for marketing under various national procedures. The European Medicines Agency (EMA) conducted a Periodic Safety Update Report Single Assessment (PSUSA) for lomustine, concluding in November 2023, which resulted in a variation to the marketing authorization. (ema.europa.eu) This underscores the importance of ongoing pharmacovigilance and compliance with EU GMP standards for manufacturers. In the United Kingdom, post-Brexit, the Medicines and Healthcare products Regulatory Agency (MHRA) oversees the authorization of medicines, and lomustine remains subject to national regulatory requirements.

3WHO Essential Medicines & Global Standards

Lomustine is included in the World Health Organization's (WHO) Model List of Essential Medicines, highlighting its critical role in treating specific cancers. Manufacturers must ensure that lomustine formulations meet international pharmacopoeial standards, including those of the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), to ensure global acceptance and compliance.

4India Regulatory Classification

In India, lomustine is classified as a Schedule H drug under the Drugs and Cosmetics Act, requiring a prescription for dispensing. The National Pharmaceutical Pricing Authority (NPPA) has not set a ceiling price for lomustine, allowing market-driven pricing. For export purposes, manufacturers must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT), ensuring compliance with export regulations.

5Patent & Exclusivity Status

The primary patents for lomustine have expired, leading to the availability of generic versions in various markets. However, the absence of approved ANDAs in the U.S. suggests limited generic competition, potentially due to regulatory or market barriers.

6Recent Industry Developments

In November 2023, the EMA concluded a PSUSA for lomustine, resulting in a variation to its marketing authorization, emphasizing the need for continuous safety monitoring. (ema.europa.eu) In July 2023, the EMA reported the withdrawal of a marketing authorization application for Lutholaz (pegfilgrastim) due to GMP certification issues, highlighting the critical importance of compliance with EU GMP standards for market approval. (ema.europa.eu) In June 2025, the EMA granted orphan designation to a new compound for the treatment of acute myeloid leukemia, reflecting ongoing developments in oncology therapeutics. (ema.europa.eu) In September 2025, the EMA adopted a positive opinion for a variation to the marketing authorization of Lunsumio, introducing a new route of administration and pharmaceutical form, indicating advancements in treatment modalities. (ema.europa.eu) In August 2023, the EMA reported the withdrawal of the marketing authorization application for Lutholaz due to GMP certification issues, underscoring the importance of manufacturing compliance. (ema.europa.eu)

These developments underscore the dynamic nature of the pharmaceutical regulatory landscape and the necessity for manufacturers to stay abreast of regulatory changes, maintain stringent quality standards, and engage in continuous pharmacovigilance to ensure market access and compliance.

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

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Global Price Benchmark — Lomustine

Retail & reference prices across 9 markets vs. India FOB export price of $18.67/unit

Global Price Benchmark for Lomustine across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	$500	USD	According to the FDA's Orange Book, Lomustine is an approved chemotherapeutic agent.
United Kingdom	$455	GBP	As per the NHS Drug Tariff, Lomustine is listed for use in the treatment of certain cancers.
Germany	$440	EUR	The German Federal Institute for Drugs and Medical Devices (BfArM) includes Lomustine in its list of approved oncology medications.
Australia	$420	AUD

Supply Chain Risk Assessment — Lomustine

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

HIGH RISK

1API Sourcing & Raw Material Dependency

Lomustine, an antineoplastic agent, relies on Active Pharmaceutical Ingredients (APIs) that are predominantly manufactured in India. However, the production of these APIs is heavily dependent on Key Starting Materials (KSMs), many of which are sourced from China. According to the U.S. Pharmacopeia, 41% of KSMs used in U.S.-approved APIs are solely sourced from China, while 16% come exclusively from India. This concentration poses a significant risk, as any disruption in China's supply chain can directly impact the availability of essential KSMs, thereby affecting API production in India.

Recent events have underscored this vulnerability. In March 2026, the closure of the Strait of Hormuz following geopolitical tensions led to significant disruptions in the supply of raw materials to Asia's chemical industry. Facilities that rely 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 pharmaceutical ingredients like Lomustine.

2Supplier Concentration & Single-Source Risk

Our proprietary trade data indicates that the top five Indian exporters of Lomustine account for 41.4% of the total export value, with 3S Corporation leading at a 13.6% share. This level of supplier concentration introduces a single-source risk, where disruptions affecting a major exporter can have disproportionate impacts on the global supply chain.

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Frequently Asked Questions — Lomustine Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top lomustine exporters from India?

The leading lomustine exporters from India are 3S CORPORATION, PLEASANT EXPORTS, JPC GLOBAL, and 9 others. 3S CORPORATION leads with 13.6% market share ($14.0K). The top 5 suppliers together control 41.4% of total export value.

What is the total export value of lomustine from India?

The total export value of lomustine from India is $103.3K, recorded across 399 shipments from 74 active exporters to 36 countries. The average shipment value is $259.

Which countries import lomustine from India?

India exports lomustine to 36 countries. The top importing countries are ITALY (12.8%), BRAZIL (12.4%), SRI LANKA (10.2%), PAKISTAN (8.8%), UNITED ARAB EMIRATES (7.9%), which together account for 52.2% of total export value.

What is the HS code for lomustine exports from India?

The primary HS code for lomustine exports from India is 30049099. 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 Lomustine Exporters from India

Top Countries Importing Lomustine from India

Who Supplies Lomustine to India?

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Regulatory Landscape — Lomustine

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 — Lomustine

Supply Chain Risk Assessment — Lomustine

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Lomustine Trade Intelligence

Frequently Asked Questions — Lomustine Exports from India

Who are the top lomustine exporters from India?

What is the total export value of lomustine from India?

Which countries import lomustine from India?

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

Which ports handle lomustine exports from India?

Why is India a leading exporter of lomustine?

What certifications do Indian lomustine exporters need?

How many buyers import lomustine from India?

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

Analysis Methodology