Ethambutol Export Market Intelligence: India's 97 Suppliers Shipping to 133 Countries — TransData Nexus 2026

Q: Who are the top ethambutol exporters from India?

The top ethambutol exporters from India are: 1. LUPIN LIMITED — $831.6M (72.6% market share); 2. MACLEODS PHARMACEUTICALS LTD — $271.5M (23.7% market share); 3. CADILA PHARMACEUTICALS LIMITED — $13.4M (1.2% market share); 4. MACLEODS PHARMACEUTICALS LIMITED — $7.8M (0.7% market share); 5. MICRO LABS LIMITED — $6.8M (0.6% market share). Together they account for 98.8% of India's total ethambutol export value.

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

The total export value of ethambutol from India is $1.1B USD, recorded across 1,410 shipment transactions from 97 active exporters to 133 destination countries. The average shipment value is $812.1K.

Q: Which countries import ethambutol from India?

India exports ethambutol to 133 countries worldwide. The top importing countries are: CONGO DR (46.8% share, $536.2M), NIGERIA (21.9% share, $250.6M), VIETNAM (11.8% share, $135.4M), TUNISIA (6.9% share, $78.5M), NETHERLANDS (2.0% share, $22.4M). These five markets account for 89.3% of total export value.

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

The primary HS code for ethambutol exports from India is 30049057. 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 ethambutol exports from India?

The average unit price for ethambutol exports from India is $10.65 USD per unit, with prices ranging from $0.01 to $88.31 depending on formulation, packaging, and order volume. The total market is valued at $1.1B across 1,410 shipments.

Q: Which ports handle ethambutol exports from India?

The primary ports for ethambutol exports from India are SAHAR AIR (21.6% of shipments), SAHAR AIR CARGO ACC (INBOM4) (17.4% of shipments), DELHI AIR CARGO ACC (INDEL4) (8.6% of shipments), DELHI AIR (8.0% of shipments), NHAVA SHEVA SEA (INNSA1) (6.7% 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 ethambutol?

India is one of the world's leading exporters of ethambutol due to its large base of 97 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 ethambutol to 133 countries, demonstrating 68% global market coverage.

Q: What certifications do Indian ethambutol exporters need?

Indian ethambutol 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 ethambutol from India?

There are 458 registered buyers importing ethambutol from India, spread across 133 countries. The repeat buyer rate is 52.8%, indicating strong long-term trade relationships and consistent product quality.

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

LUPIN LIMITED is the leading ethambutol exporter from India with a market share of 72.6% and total export value of $831.6M across 317 shipments. The top 5 suppliers together control 98.8% of total export value.

Suresh Sormare

Ethambutol

India Pharmaceutical Trade Intelligence

$1.1B97 Suppliers133 CountriesHS 30049057

ExportsIndia → CONGO DR46.8%India → NIGERIA21.9%

ImportsBULGARIA → India$2.5K UNITED KINGDOM → India$1.7K

#1 Supplier: LUPIN LIMITED #1 Buyer: CAMESKIN/CORDAID

Ethambutol Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Ethambutol to the World

Between 2022 and 2026, India exported $1.1B worth of ethambutol across 1,410 verified shipments to 133 countries — covering 68% of world markets in the Tuberculosis Medications segment. The largest destination is CONGO DR (46.8%). LUPIN LIMITED leads with a 72.6% 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·

Ethambutol export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Ethambutol export data snapshot — $1.1B · 97 exporters · 133 countriesTransData Nexus · Indian Customs Data

Top Ethambutol Exporters from India

97 active exporters · Ranked by export value

View all 97 →

Top Ethambutol Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	LUPIN LIMITED	$831.6M	317	52	72.6%
2	MACLEODS PHARMACEUTICALS LTD

Top Countries Importing Ethambutol from India

133 destination markets · Ranked by import value

All 133 countries →

Top Countries Importing Ethambutol from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	CONGO DR	$536.2M	46.8%
2	NIGERIA	$250.6M	21.9%
3	VIETNAM	$135.4M	11.8%
4	TUNISIA	$78.5M	6.9%
5	NETHERLANDS	$22.4M	2.0%
6	SOUTH AFRICA	$18.4M	1.6%
7	SRI LANKA	$16.5M	1.4%
8	ZAMBIA	$9.9M	0.9%
9	PHILIPPINES	$7.2M	0.6%
10	PAKISTAN	$6.7M	0.6%

CONGO DR is India's largest ethambutol export destination, absorbing 46.8% of total exports worth $536.2M. The top 5 importing countries — CONGO DR, NIGERIA, VIETNAM, TUNISIA, NETHERLANDS — together account for 89.3% of India's total ethambutol export value. The remaining 128 destination countries collectively receive the other 10.7%, indicating a well-diversified global distribution network spanning all major continents.

Who Supplies Ethambutol to India?

6 origin countries · Total import value: $6.9K

India imports ethambutol from 6 countries with a combined import value of $6.9K. The largest supplier is BULGARIA ($2.5K, 2 shipments), followed by UNITED KINGDOM and GERMANY. All values are from Indian Customs (DGFT) import records.

Countries Supplying Ethambutol to India — Ranked by Import Value
#	Origin Country	Import Value (USD)	Shipments	Share
1	BULGARIA	$2.5K	2	36.7%
2	UNITED KINGDOM	$1.7K	6	24.7%
3	GERMANY	$1.4K	1	20.9%
4	UNITED STATES	$892	3	13.0%
5	SWITZERLAND	$210	1	3.1%
6	PAKISTAN	$113	3	1.7%

BULGARIA is the largest supplier of ethambutol to India, accounting for 36.7% of total import value. The top 5 origin countries — BULGARIA, UNITED KINGDOM, GERMANY, UNITED STATES, SWITZERLAND — together supply 98.3% of India's ethambutol imports. Click any country to see detailed supplier and buyer data for that import corridor.

Ethambutol — Export Intelligence Video

Visual overview of India's ethambutol import and export market — top suppliers, destinations, pricing, and trade routes

This video covers India's ethambutol pharmaceutical import and export market — $1.1B in total trade, 97 verified manufacturers, and 133 destination countries. Data sourced from Indian Customs (DGFT) shipment records.

Regulatory Landscape — Ethambutol

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

1FDA & US Market Regulatory Status

Ethambutol, a critical antitubercular agent, has been approved in the United States through multiple Abbreviated New Drug Applications (ANDAs). According to the FDA's Orange Book, numerous generic versions of ethambutol have received approval, indicating a well-established market presence. The most recent approval was granted in January 2026, reflecting ongoing interest and investment in this essential medication.

The importation of ethambutol into the U.S. is subject to stringent FDA regulations. As per the FDA's guidelines on importing human drugs, all foreign manufacturers must ensure compliance with Current Good Manufacturing Practices (cGMP) and register their facilities with the FDA. Additionally, the FDA maintains an import alert system to identify and restrict products that violate U.S. laws. As of March 2026, there are no active import alerts concerning ethambutol, suggesting that current imports meet the requisite regulatory standards.

Given that 97 Indian exporters are actively involved in the global ethambutol market, it is imperative for these entities to adhere to FDA regulations to maintain and expand their presence in the U.S. market.

2EU & UK Regulatory Framework

In the European Union, ethambutol is subject to the European Medicines Agency's (EMA) centralized marketing authorization process or national procedures, depending on the specific product and applicant's strategy. The Medicines and Healthcare products Regulatory Agency (MHRA) oversees the authorization in the United Kingdom. Both agencies require comprehensive data on quality, safety, and efficacy for approval.

Compliance with EU Good Manufacturing Practice (GMP) standards is mandatory for manufacturers supplying ethambutol to these markets. These standards ensure that products are consistently produced and controlled according to quality standards appropriate for their intended use.

3WHO Essential Medicines & Global Standards

Ethambutol is listed in the 24th edition of the WHO Model List of Essential Medicines, published in September 2025, underscoring its critical role in treating tuberculosis. The WHO's inclusion of ethambutol highlights its importance in global health initiatives. Additionally, ethambutol is recognized in major pharmacopoeias, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), ensuring standardized quality benchmarks across different regions.

4India Regulatory Classification

In India, ethambutol is classified under Schedule H of the Drugs and Cosmetics Act, indicating that it is a prescription-only medication. The National Pharmaceutical Pricing Authority (NPPA) has set a ceiling price for ethambutol to ensure affordability; the latest revision was in December 2025. For exports, the Directorate General of Foreign Trade (DGFT) mandates a No Objection Certificate (NOC) to regulate and monitor the international trade of pharmaceuticals, including ethambutol.

5Patent & Exclusivity Status

The primary patents for ethambutol have expired, leading to a competitive generic market. This expiration has facilitated the entry of multiple manufacturers, contributing to the availability and affordability of the drug globally.

6Recent Industry Developments

In August 2025, the WHO updated its Model List of Essential Medicines, reaffirming ethambutol's inclusion and emphasizing its continued relevance in tuberculosis treatment. In October 2025, the NPPA revised the ceiling price for ethambutol, reflecting efforts to balance affordability with industry sustainability. In January 2026, the FDA approved a new generic version of ethambutol, enhancing market competition and accessibility. In February 2026, the EMA issued updated guidelines on the manufacturing of antitubercular drugs, including ethambutol, to ensure compliance with evolving GMP standards. In March 2026, the CDSCO introduced streamlined procedures for the export NOC of pharmaceuticals, aiming to facilitate international trade while maintaining regulatory oversight.

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

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Global Price Benchmark — Ethambutol

Retail & reference prices across 9 markets vs. India FOB export price of $10.65/unit

Global Price Benchmark for Ethambutol across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	$0.35	USD	According to the National Average Drug Acquisition Cost (NADAC) data effective December 17, 2025, the average price for Ethambutol Hydrochloride 500 mg tablets is $0.35 per unit.
United Kingdom	Data not available	GBP	Specific pricing data for Ethambutol 500 mg tablets in the UK is not readily available from government sources.
Germany	Data not available	EUR	Specific pricing data for Ethambutol 500 mg tablets in Germany is not readily available from government sources.
Australia

Supply Chain Risk Assessment — Ethambutol

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

HIGH RISK

1API Sourcing & Raw Material Dependency

India's pharmaceutical industry, often referred to as the "pharmacy of the world," heavily relies on imports for Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs). Approximately 70% of India's APIs are sourced from China, highlighting a significant dependency on Chinese suppliers. This reliance poses substantial risks, as any disruption in the supply chain from China can directly impact India's pharmaceutical production capabilities.

The COVID-19 pandemic underscored these vulnerabilities, with supply chain disruptions leading to shortages of essential medicines. In response, the Indian government launched the Production Linked Incentive (PLI) scheme in 2020, allocating ₹6,940 crore to boost domestic production of 53 critical APIs and KSMs. Despite these efforts, the industry continues to face challenges in reducing its dependence on Chinese imports.

2Supplier Concentration & Single-Source Risk

Our proprietary trade data from 2022 to 2026 reveals a high supplier concentration in the export of Ethambutol from India. The top five exporters account for 98.8% of total exports, with LUPIN LIMITED alone contributing 72.6% ($831.6M USD). This concentration indicates a significant single-source risk, as any operational or regulatory issues affecting these key suppliers could disrupt the global supply of Ethambutol.

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Frequently Asked Questions — Ethambutol Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top ethambutol exporters from India?

The leading ethambutol exporters from India are LUPIN LIMITED, MACLEODS PHARMACEUTICALS LTD, CADILA PHARMACEUTICALS LIMITED, and 11 others. LUPIN LIMITED leads with 72.6% market share ($831.6M). The top 5 suppliers together control 98.8% of total export value.

What is the total export value of ethambutol from India?

The total export value of ethambutol from India is $1.1B, recorded across 1,410 shipments from 97 active exporters to 133 countries. The average shipment value is $812.1K.

Which countries import ethambutol from India?

India exports ethambutol to 133 countries. The top importing countries are CONGO DR (46.8%), NIGERIA (21.9%), VIETNAM (11.8%), TUNISIA (6.9%), NETHERLANDS (2.0%), which together account for 89.3% of total export value.

What is the HS code for ethambutol exports from India?

The primary HS code for ethambutol exports from India is 30049057. 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.

Ethambutol

Ethambutol

Top Ethambutol Exporters from India

Top Countries Importing Ethambutol from India

Who Supplies Ethambutol to India?

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Ethambutol — Export Intelligence Video

Regulatory Landscape — Ethambutol

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 — Ethambutol

Supply Chain Risk Assessment — Ethambutol

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Ethambutol Trade Intelligence

Frequently Asked Questions — Ethambutol Exports from India

Who are the top ethambutol exporters from India?

What is the total export value of ethambutol from India?

Which countries import ethambutol from India?

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

Which ports handle ethambutol exports from India?

Why is India a leading exporter of ethambutol?

What certifications do Indian ethambutol exporters need?

How many buyers import ethambutol from India?

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

Analysis Methodology