Chlorambucil Export Market Intelligence: India's 109 Suppliers Shipping to 60 Countries — TransData Nexus 2026

Q: Who are the top chlorambucil exporters from India?

The top chlorambucil exporters from India are: 1. CELON LABORATORIES PRIVATE LIMITED — $87.5K (25.5% market share); 2. INFUGEN PHARMA PRIVATE LIMITED — $75.9K (22.1% market share); 3. SP ACCURE LABS PRIVATE LIMITED — $16.0K (4.7% market share); 4. GLS PHARMA LIMITED — $12.3K (3.6% market share); 5. DECINA PHARMA PRIVATE LIMITED — $6.8K (2.0% market share). Together they account for 57.8% of India's total chlorambucil export value.

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

The total export value of chlorambucil from India is $343.6K USD, recorded across 325 shipment transactions from 109 active exporters to 60 destination countries. The average shipment value is $1.1K.

Q: Which countries import chlorambucil from India?

India exports chlorambucil to 60 countries worldwide. The top importing countries are: MOZAMBIQUE (22.1% share, $75.9K), UNITED ARAB EMIRATES (19.4% share, $66.6K), CUBA (14.3% share, $49.2K), IRAN (6.7% share, $23.2K), COSTA RICA (3.8% share, $12.9K). These five markets account for 66.3% of total export value.

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

The primary HS code for chlorambucil 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 chlorambucil exports from India?

The average unit price for chlorambucil exports from India is $12.59 USD per unit, with prices ranging from $0.08 to $320.04 depending on formulation, packaging, and order volume. The total market is valued at $343.6K across 325 shipments.

Q: Which ports handle chlorambucil exports from India?

The primary ports for chlorambucil exports from India are SAHAR AIR CARGO ACC (INBOM4) (27.7% of shipments), SAHAR AIR (26.5% of shipments), Bombay Air (8.9% of shipments), DELHI AIR (5.2% of shipments), HYDERABAD ACC (INHYD4) (4.6% 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 chlorambucil?

India is one of the world's leading exporters of chlorambucil due to its large base of 109 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 chlorambucil to 60 countries, demonstrating 31% global market coverage.

Q: What certifications do Indian chlorambucil exporters need?

Indian chlorambucil 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 chlorambucil from India?

There are 137 registered buyers importing chlorambucil from India, spread across 60 countries. The repeat buyer rate is 38.0%, indicating strong long-term trade relationships and consistent product quality.

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

CELON LABORATORIES PRIVATE LIMITED is the leading chlorambucil exporter from India with a market share of 25.5% and total export value of $87.5K across 18 shipments. The top 5 suppliers together control 57.8% of total export value.

Suresh Sormare

Chlorambucil

India Pharmaceutical Trade Intelligence

$343.6K109 Suppliers60 CountriesHS 30049049

ExportsIndia → MOZAMBIQUE22.1%India → UNITED ARAB19.4%

#1 Supplier: CELON LABORATORIES

Chlorambucil Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Chlorambucil to the World

Between 2022 and 2026, India exported $343.6K worth of chlorambucil across 325 verified shipments to 60 countries — covering 31% of world markets in the Advanced Oncology segment. The largest destination is MOZAMBIQUE (22.1%). CELON LABORATORIES PRIVATE LIMITED leads with a 25.5% 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·

Chlorambucil export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Chlorambucil export data snapshot — $343.6K · 109 exporters · 60 countriesTransData Nexus · Indian Customs Data

Top Chlorambucil Exporters from India

109 active exporters · Ranked by export value

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Top Chlorambucil Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	CELON LABORATORIES PRIVATE LIMITED	$87.5K	18	6	25.5%
2	INFUGEN PHARMA PRIVATE LIMITED

Top Countries Importing Chlorambucil from India

60 destination markets · Ranked by import value

All 60 countries →

Top Countries Importing Chlorambucil from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	MOZAMBIQUE	$75.9K	22.1%
2	UNITED ARAB EMIRATES	$66.6K	19.4%
3	CUBA	$49.2K	14.3%
4	IRAN	$23.2K	6.7%
5	COSTA RICA	$12.9K	3.8%
6	KAZAKHSTAN	$11.8K	3.4%
7	MYANMAR	$8.4K	2.5%
8	GHANA	$7.8K	2.3%
9	TANZANIA	$5.9K	1.7%
10	KENYA	$5.5K	1.6%

MOZAMBIQUE is India's largest chlorambucil export destination, absorbing 22.1% of total exports worth $75.9K. The top 5 importing countries — MOZAMBIQUE, UNITED ARAB EMIRATES, CUBA, IRAN, COSTA RICA — together account for 66.3% of India's total chlorambucil export value. The remaining 55 destination countries collectively receive the other 33.7%, indicating a broadly diversified export footprint across multiple regions.

Regulatory Landscape — Chlorambucil

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

1FDA & US Market Regulatory Status

As of March 2026, the FDA's Orange Book lists multiple approved Abbreviated New Drug Applications (ANDAs) for chlorambucil tablets, indicating a competitive generic market. The most recent approval was granted in January 2026. Currently, there are no active import alerts or enforcement actions against chlorambucil products from India, suggesting compliance with FDA standards. Given the presence of 109 active Indian exporters, it is imperative for manufacturers to adhere strictly to FDA regulations to maintain market access.

2EU & UK Regulatory Framework

In the European Union, chlorambucil is authorized for marketing under centralized procedures, with the European Medicines Agency (EMA) overseeing approvals. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) continues to recognize EMA approvals post-Brexit, ensuring continuity in regulatory standards. Compliance with EU Good Manufacturing Practice (GMP) requirements is mandatory for exporters, necessitating regular audits and quality assessments.

3WHO Essential Medicines & Global Standards

Chlorambucil is included in the 24th edition of the WHO Model List of Essential Medicines, published in September 2025, underscoring its significance in global health. While not listed under the WHO Prequalification Programme, adherence to international pharmacopoeia standards such as the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP) is essential for ensuring product quality and acceptance in various markets.

4India Regulatory Classification

In India, chlorambucil is classified under Schedule H of the Drugs and Cosmetics Act, requiring a prescription for dispensing. The National Pharmaceutical Pricing Authority (NPPA) has not set a ceiling price for chlorambucil as of March 2026. For exports, obtaining a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT) is mandatory, ensuring compliance with national regulations.

5Patent & Exclusivity Status

The primary patents for chlorambucil have expired, leading to a robust generic market with multiple manufacturers. This competitive landscape has resulted in reduced prices and increased accessibility globally.

6Recent Industry Developments

In May 2025, the WHO updated its Model List of Essential Medicines, reaffirming chlorambucil's inclusion, highlighting its continued importance in cancer treatment. In August 2025, the EMA issued a revised guideline on the quality requirements for anticancer agents, emphasizing stricter impurity controls, directly impacting chlorambucil manufacturers. In November 2025, the NPPA conducted a review of anticancer drug prices, including chlorambucil, to assess market dynamics and ensure affordability. In January 2026, the FDA approved a new generic version of chlorambucil, increasing competition in the U.S. market. In February 2026, the CDSCO issued a circular mandating enhanced stability studies for exported pharmaceuticals, affecting chlorambucil exporters.

These developments underscore the dynamic regulatory environment surrounding chlorambucil, necessitating continuous monitoring and compliance by exporters to maintain market access and competitiveness.

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

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Global Price Benchmark — Chlorambucil

Retail & reference prices across 9 markets vs. India FOB export price of $12.59/unit

Global Price Benchmark for Chlorambucil across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	$564.49	USD	According to the FDA's Orange Book, Leukeran (chlorambucil) is approved in a 2 mg tablet formulation. As of January 2026, no generic version is available in the U.S. market.
United Kingdom	$55.75	GBP	The NHS Drug Tariff lists chlorambucil 2 mg tablets at £1,115 for a pack of 25 tablets, effective from February 2023. (dmd-browser.nhsbsa.nhs.uk)
Germany	$55.00	EUR	Pricing information is based on standard pharmacy retail prices in Germany.
Australia

Supply Chain Risk Assessment — Chlorambucil

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

MEDIUM RISK

1API Sourcing & Raw Material Dependency

Chlorambucil, an antineoplastic agent, is primarily manufactured in India. However, the production of its Active Pharmaceutical Ingredient (API) heavily relies on Key Starting Materials (KSMs) sourced from China. This dependency is significant, as China controls approximately 70–80% of the global KSM supply and 60–70% of the global intermediate supply, making it a dominant player in the pharmaceutical raw material market.

Recent disruptions in China's chemical manufacturing sector, including environmental regulatory crackdowns and factory shutdowns, have led to supply chain interruptions. For instance, in July 2018, the closure of several Chinese chemical plants resulted in increased prices and shortages of essential KSMs, directly impacting global API production. Such events underscore the vulnerability of relying on a single country for critical raw materials.

2Supplier Concentration & Single-Source Risk

Our proprietary trade data indicates that the top five Indian exporters of Chlorambucil account for 57.8% of total exports, with CELON LABORATORIES PRIVATE LIMITED leading at a 25.5% share. This concentration poses a risk, as any operational or compliance issues within these key suppliers could disrupt the supply chain.

To mitigate such risks, the Indian government has implemented the Production Linked Incentive (PLI) scheme aimed at promoting domestic manufacturing of critical APIs and KSMs. As of December 2025, the Department of Pharmaceuticals extended the application deadline for the PLI scheme to January 16, 2026, encouraging more firms to participate in domestic production initiatives. This initiative aims to reduce import dependence and enhance supply chain resilience.

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Shipment-level records, verified supplier contacts, buyer histories, and pricing analytics for all 325 transactions across 60 markets.

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Frequently Asked Questions — Chlorambucil Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top chlorambucil exporters from India?

The leading chlorambucil exporters from India are CELON LABORATORIES PRIVATE LIMITED, INFUGEN PHARMA PRIVATE LIMITED, SP ACCURE LABS PRIVATE LIMITED, and 9 others. CELON LABORATORIES PRIVATE LIMITED leads with 25.5% market share ($87.5K). The top 5 suppliers together control 57.8% of total export value.

What is the total export value of chlorambucil from India?

The total export value of chlorambucil from India is $343.6K, recorded across 325 shipments from 109 active exporters to 60 countries. The average shipment value is $1.1K.

Which countries import chlorambucil from India?

India exports chlorambucil to 60 countries. The top importing countries are MOZAMBIQUE (22.1%), UNITED ARAB EMIRATES (19.4%), CUBA (14.3%), IRAN (6.7%), COSTA RICA (3.8%), which together account for 66.3% of total export value.

What is the HS code for chlorambucil exports from India?

The primary HS code for chlorambucil 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.

Chlorambucil

Chlorambucil

How India Exports Chlorambucil to the World

Top Chlorambucil Exporters from India

Top Countries Importing Chlorambucil from India

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Regulatory Landscape — Chlorambucil

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 — Chlorambucil

Supply Chain Risk Assessment — Chlorambucil

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Chlorambucil Trade Intelligence

Frequently Asked Questions — Chlorambucil Exports from India

Who are the top chlorambucil exporters from India?

What is the total export value of chlorambucil from India?

Which countries import chlorambucil from India?

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

Which ports handle chlorambucil exports from India?

Why is India a leading exporter of chlorambucil?

What certifications do Indian chlorambucil exporters need?

How many buyers import chlorambucil from India?

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

Analysis Methodology