Irbesartan Export Market Intelligence: India's 123 Suppliers Shipping to 68 Countries — TransData Nexus 2026

Q: Who are the top irbesartan exporters from India?

The top irbesartan exporters from India are: 1. MACLEODS PHARMACEUTICALS LTD — $35.8M (33.7% market share); 2. MYLAN LABORATORIES LIMITED — $15.9M (14.9% market share); 3. CAPLIN POINT LABORATORIES LIMITED — $13.2M (12.4% market share); 4. SUN PHARMACEUTICAL INDUSTRIES LIMITED — $8.3M (7.9% market share); 5. ALEMBIC PHARMACEUTICALS LIMITED — $7.6M (7.2% market share). Together they account for 76.1% of India's total irbesartan export value.

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

The total export value of irbesartan from India is $106.3M USD, recorded across 2,669 shipment transactions from 123 active exporters to 68 destination countries. The average shipment value is $39.8K.

Q: Which countries import irbesartan from India?

India exports irbesartan to 68 countries worldwide. The top importing countries are: UNITED STATES (37.2% share, $39.5M), FRANCE (15.4% share, $16.4M), AUSTRALIA (7.9% share, $8.4M), NICARAGUA (7.2% share, $7.6M), BELGIUM (5.1% share, $5.4M). These five markets account for 72.8% of total export value.

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

The primary HS code for irbesartan exports from India is 30049079. 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 irbesartan exports from India?

The average unit price for irbesartan exports from India is $18.72 USD per unit, with prices ranging from $0.00 to $4772.17 depending on formulation, packaging, and order volume. The total market is valued at $106.3M across 2,669 shipments.

Q: Which ports handle irbesartan exports from India?

The primary ports for irbesartan exports from India are NHAVA SHEVA SEA (INNSA1) (10.6% of shipments), SAHAR AIR (7.4% of shipments), SAHAR AIR CARGO ACC (INBOM4) (6.4% of shipments), JNPT/ NHAVA SHEVA SEA (5.5% of shipments), DELHI AIR (5.1% 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 irbesartan?

India is one of the world's leading exporters of irbesartan due to its large base of 123 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 irbesartan to 68 countries, demonstrating 35% global market coverage.

Q: What certifications do Indian irbesartan exporters need?

Indian irbesartan 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 irbesartan from India?

There are 366 registered buyers importing irbesartan from India, spread across 68 countries. The repeat buyer rate is 69.9%, indicating strong long-term trade relationships and consistent product quality.

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

MACLEODS PHARMACEUTICALS LTD is the leading irbesartan exporter from India with a market share of 33.7% and total export value of $35.8M across 178 shipments. The top 5 suppliers together control 76.1% of total export value.

Suresh Sormare

Irbesartan

India Pharmaceutical Trade Intelligence

$106.3M123 Suppliers68 CountriesHS 30049079

ExportsIndia → UNITED STATES37.2%India → FRANCE15.4%

ImportsSPAIN → India$149.9K UNITED STATES → India$19.2K

#1 Buyer: MACLEODS PHARMA

Irbesartan Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Irbesartan to the World

Between 2022 and 2026, India exported $106.3M worth of irbesartan across 2,669 verified shipments to 68 countries — covering 35% of world markets in the Cardiovascular segment. The largest destination is UNITED STATES (37.2%). MACLEODS PHARMACEUTICALS LTD leads with a 33.7% 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·

Irbesartan export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Irbesartan export data snapshot — $106.3M · 123 exporters · 68 countriesTransData Nexus · Indian Customs Data

Top Irbesartan Exporters from India

123 active exporters · Ranked by export value

View all 123 →

Top Irbesartan Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	MACLEODS PHARMACEUTICALS LTD	$35.8M	178	12	33.7%
2	MYLAN LABORATORIES LIMITED

Top Countries Importing Irbesartan from India

68 destination markets · Ranked by import value

All 68 countries →

Top Countries Importing Irbesartan from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	UNITED STATES	$39.5M	37.2%
2	FRANCE	$16.4M	15.4%
3	AUSTRALIA	$8.4M	7.9%
4	NICARAGUA	$7.6M	7.2%
5	BELGIUM	$5.4M	5.1%
6	GUATEMALA	$5.4M	5.1%
7	PHILIPPINES	$4.1M	3.8%
8	HUNGARY	$2.6M	2.4%
9	HONDURAS	$2.6M	2.4%
10	CANADA	$2.1M	2.0%

UNITED STATES is India's largest irbesartan export destination, absorbing 37.2% of total exports worth $39.5M. The top 5 importing countries — UNITED STATES, FRANCE, AUSTRALIA, NICARAGUA, BELGIUM — together account for 72.8% of India's total irbesartan export value. The remaining 63 destination countries collectively receive the other 27.2%, indicating a broadly diversified export footprint across multiple regions.

Who Supplies Irbesartan to India?

14 origin countries · Total import value: $178.0K

India imports irbesartan from 14 countries with a combined import value of $178.0K. The largest supplier is SPAIN ($149.9K, 5 shipments), followed by UNITED STATES and CANADA. All values are from Indian Customs (DGFT) import records.

Countries Supplying Irbesartan to India — Ranked by Import Value
#	Origin Country	Import Value (USD)	Shipments	Share
1	SPAIN	$149.9K	5	84.2%
2	UNITED STATES	$19.2K	15	10.8%
3	CANADA	$3.6K	17	2.0%
4	HUNGARY	$1.6K	7	0.9%
5	BULGARIA	$1.2K	5	0.7%
6	FRANCE	$1.0K	2	0.6%
7	IRELAND	$693	1	0.4%
8	MEXICO	$343	4	0.2%
9	GERMANY	$301	1	0.2%
10	PHILIPPINES	$100	1	0.1%

Showing top 10 of 14 origin countries

SPAIN is the largest supplier of irbesartan to India, accounting for 84.2% of total import value. The top 5 origin countries — SPAIN, UNITED STATES, CANADA, HUNGARY, BULGARIA — together supply 98.6% of India's irbesartan imports. Click any country to see detailed supplier and buyer data for that import corridor.

Regulatory Landscape — Irbesartan

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

1FDA & US Market Regulatory Status

In the United States, irbesartan is approved for the treatment of hypertension and diabetic nephropathy. The FDA's Orange Book lists multiple approved Abbreviated New Drug Applications (ANDAs) for irbesartan, indicating a competitive generic market. Notably, the FDA has not issued any import alerts specific to irbesartan, suggesting compliance with regulatory standards. The substantial export volume to the U.S. underscores the importance of maintaining stringent quality controls to meet FDA requirements.

2EU & UK Regulatory Framework

In the European Union, irbesartan has been authorized for the treatment of essential hypertension and renal disease in hypertensive type 2 diabetic patients. For instance, the European Commission granted marketing authorization for Irbesartan BMS on January 19, 2007. However, this authorization was voluntarily withdrawn on November 11, 2009, due to commercial reasons, and the product was never marketed in the EU. Despite such withdrawals, other generic versions of irbesartan remain available in the European market. Manufacturers exporting to the EU and UK must adhere to Good Manufacturing Practice (GMP) standards as outlined by the European Medicines Agency (EMA) and the UK's Medicines and Healthcare products Regulatory Agency (MHRA).

3WHO Essential Medicines & Global Standards

Irbesartan is included in the 24th edition of the WHO Model List of Essential Medicines, published in September 2025, highlighting its significance in global health. This inclusion emphasizes the need for consistent quality and accessibility worldwide. Compliance with pharmacopoeial standards such as the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP) is essential to ensure product quality and facilitate international trade.

4India Regulatory Classification

In India, irbesartan 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) regulates the pricing of essential medicines; however, as of March 2026, irbesartan is not listed under the Drugs (Prices Control) Order (DPCO), allowing market-driven pricing. Exporters must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT) to comply with export regulations.

5Patent & Exclusivity Status

The primary patents for irbesartan have expired, leading to a robust generic market. This expiration has facilitated increased competition among manufacturers, contributing to the widespread availability and affordability of the drug globally.

6Recent Industry Developments

In May 2025, the WHO updated its Model List of Essential Medicines, reaffirming the inclusion of irbesartan, which underscores its continued importance in treating hypertension and diabetic nephropathy. In January 2026, the FDA approved a new generic formulation of irbesartan, further enhancing market competition and accessibility. Additionally, in February 2026, the EMA issued updated guidelines on the manufacturing of angiotensin II receptor antagonists, including irbesartan, emphasizing the need for stringent impurity controls to ensure product safety.

These developments reflect the dynamic regulatory landscape surrounding irbesartan, highlighting the necessity for manufacturers and exporters to stay informed and compliant with evolving standards to maintain market access and ensure patient safety.

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

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Global Price Benchmark — Irbesartan

Retail & reference prices across 9 markets vs. India FOB export price of $18.72/unit

Global Price Benchmark for Irbesartan across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	$0.50	USD	According to the FDA's Orange Book, generic versions of Irbesartan have been approved, contributing to competitive pricing in the market.
United Kingdom	$0.40	GBP	The NHS Drug Tariff lists Irbesartan 300mg tablets, indicating regulated pricing within the National Health Service framework.
Germany	$0.38	EUR	The European Medicines Agency (EMA) has approved generic versions of Irbesartan, facilitating market competition and price regulation.
Australia

Supply Chain Risk Assessment — Irbesartan

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

MEDIUM RISK

1API Sourcing & Raw Material Dependency

India is a prominent manufacturer of Active Pharmaceutical Ingredients (APIs), including Irbesartan. However, the production of these APIs often relies on Key Starting Materials (KSMs) sourced from China. According to the U.S. Pharmacopeia, 41% of KSMs used in U.S.-approved APIs are solely sourced from China, highlighting a significant dependency on Chinese suppliers.

This reliance poses a risk to the supply chain, as any disruption in China's production or export of KSMs can directly impact India's ability to manufacture APIs like Irbesartan. For instance, in November 2025, global supply chain issues, including shortages of ingredients and manufacturing supplies, led to intermittent and unpredictable disruptions in the availability of certain pharmaceutical products.

2Supplier Concentration & Single-Source Risk

Our proprietary trade data indicates that the top five Indian exporters account for 76.1% of Irbesartan exports, with MACLEODS PHARMACEUTICALS LTD alone contributing 33.7% ($35.8M USD). This high concentration among a few suppliers increases the risk of supply disruptions if any of these key exporters face operational challenges.

To mitigate such risks, the Indian government has implemented the Production Linked Incentive (PLI) scheme, aiming to boost domestic production of critical pharmaceutical ingredients and reduce import dependence. In October 2024, two greenfield plants were inaugurated under this scheme to manufacture essential molecules used in common antibiotics, marking a significant step towards self-reliance in API production.

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Shipment-level records, verified supplier contacts, buyer histories, and pricing analytics for all 2,669 transactions across 68 markets.

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Frequently Asked Questions — Irbesartan Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top irbesartan exporters from India?

The leading irbesartan exporters from India are MACLEODS PHARMACEUTICALS LTD, MYLAN LABORATORIES LIMITED, CAPLIN POINT LABORATORIES LIMITED, and 12 others. MACLEODS PHARMACEUTICALS LTD leads with 33.7% market share ($35.8M). The top 5 suppliers together control 76.1% of total export value.

What is the total export value of irbesartan from India?

The total export value of irbesartan from India is $106.3M, recorded across 2,669 shipments from 123 active exporters to 68 countries. The average shipment value is $39.8K.

Which countries import irbesartan from India?

India exports irbesartan to 68 countries. The top importing countries are UNITED STATES (37.2%), FRANCE (15.4%), AUSTRALIA (7.9%), NICARAGUA (7.2%), BELGIUM (5.1%), which together account for 72.8% of total export value.

What is the HS code for irbesartan exports from India?

The primary HS code for irbesartan exports from India is 30049079. 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.

Irbesartan

Irbesartan

Top Irbesartan Exporters from India

Top Countries Importing Irbesartan from India

Who Supplies Irbesartan to India?

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Regulatory Landscape — Irbesartan

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 — Irbesartan

Supply Chain Risk Assessment — Irbesartan

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Irbesartan Trade Intelligence

Frequently Asked Questions — Irbesartan Exports from India

Who are the top irbesartan exporters from India?

What is the total export value of irbesartan from India?

Which countries import irbesartan from India?

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

Which ports handle irbesartan exports from India?

Why is India a leading exporter of irbesartan?

What certifications do Indian irbesartan exporters need?

How many buyers import irbesartan from India?

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

Analysis Methodology