Amiodarone Export Market Intelligence: India's 243 Suppliers Shipping to 124 Countries — TransData Nexus 2026

Q: Who are the top amiodarone exporters from India?

The top amiodarone exporters from India are: 1. UNICHEM LABORATORIES LIMITED — $37.2M (49.8% market share); 2. RUBICON RESEARCH PRIVATE LIMITED — $20.9M (28.0% market share); 3. SUN PHARMACEUTICAL INDUSTRIES LIMITED — $5.5M (7.4% market share); 4. ZYDUS LIFESCIENCES LIMITED — $2.3M (3.0% market share); 5. AUROBINDO PHARMA LIMITED — $1.4M (1.9% market share). Together they account for 90.3% of India's total amiodarone export value.

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

The total export value of amiodarone from India is $74.6M USD, recorded across 1,674 shipment transactions from 243 active exporters to 124 destination countries. The average shipment value is $44.6K.

Q: Which countries import amiodarone from India?

India exports amiodarone to 124 countries worldwide. The top importing countries are: UNITED STATES (82.9% share, $61.8M), BRAZIL (8.4% share, $6.3M), THAILAND (1.3% share, $947.1K), VENEZUELA (1.0% share, $770.6K), GERMANY (0.9% share, $692.9K). These five markets account for 94.5% of total export value.

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

The primary HS code for amiodarone 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 amiodarone exports from India?

The average unit price for amiodarone exports from India is $6.21 USD per unit, with prices ranging from $0.00 to $499.05 depending on formulation, packaging, and order volume. The total market is valued at $74.6M across 1,674 shipments.

Q: Which ports handle amiodarone exports from India?

The primary ports for amiodarone exports from India are SAHAR AIR (16.3% of shipments), SAHAR AIR CARGO ACC (INBOM4) (13.0% of shipments), NHAVA SHEVA SEA (INNSA1) (9.0% of shipments), DELHI AIR (7.6% of shipments), DELHI AIR CARGO ACC (INDEL4) (6.2% 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 amiodarone?

India is one of the world's leading exporters of amiodarone due to its large base of 243 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 amiodarone to 124 countries, demonstrating 64% global market coverage.

Q: What certifications do Indian amiodarone exporters need?

Indian amiodarone 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 amiodarone from India?

There are 411 registered buyers importing amiodarone from India, spread across 124 countries. The repeat buyer rate is 54.0%, indicating strong long-term trade relationships and consistent product quality.

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

UNICHEM LABORATORIES LIMITED is the leading amiodarone exporter from India with a market share of 49.8% and total export value of $37.2M across 103 shipments. The top 5 suppliers together control 90.3% of total export value.

Suresh Sormare

Amiodarone

India Pharmaceutical Trade Intelligence

$74.6M243 Suppliers124 CountriesHS 30049099

ExportsIndia → UNITED STATES82.9%India → BRAZIL8.4%

ImportsUNITED KINGDOM → India$206.7K FRANCE → India$198.0K

#1 Supplier: UNICHEM LABORATORIES #1 Buyer: UNICHEM PHARMACEUTICALS

Amiodarone Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Amiodarone to the World

Between 2022 and 2026, India exported $74.6M worth of amiodarone across 1,674 verified shipments to 124 countries — covering 64% of world markets in the Cardiovascular segment. The largest destination is UNITED STATES (82.9%). UNICHEM LABORATORIES LIMITED leads with a 49.8% 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·

Amiodarone export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Amiodarone export data snapshot — $74.6M · 243 exporters · 124 countriesTransData Nexus · Indian Customs Data

Top Amiodarone Exporters from India

243 active exporters · Ranked by export value

View all 243 →

Top Amiodarone Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	UNICHEM LABORATORIES LIMITED	$37.2M	103	1	49.8%
2	RUBICON RESEARCH PRIVATE LIMITED

Top Countries Importing Amiodarone from India

124 destination markets · Ranked by import value

All 124 countries →

Top Countries Importing Amiodarone from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	UNITED STATES	$61.8M	82.9%
2	BRAZIL	$6.3M	8.4%
3	THAILAND	$947.1K	1.3%
4	VENEZUELA	$770.6K	1.0%
5	GERMANY	$692.9K	0.9%
6	UNITED KINGDOM	$521.6K	0.7%
7	MEXICO	$440.1K	0.6%
8	PHILIPPINES	$420.9K	0.6%
9	SRI LANKA	$403.4K	0.5%
10	FRANCE	$328.3K	0.4%

UNITED STATES is India's largest amiodarone export destination, absorbing 82.9% of total exports worth $61.8M. The top 5 importing countries — UNITED STATES, BRAZIL, THAILAND, VENEZUELA, GERMANY — together account for 94.5% of India's total amiodarone export value. The remaining 119 destination countries collectively receive the other 5.5%, indicating a well-diversified global distribution network spanning all major continents.

Who Supplies Amiodarone to India?

9 origin countries · Total import value: $471.3K

India imports amiodarone from 9 countries with a combined import value of $471.3K. The largest supplier is UNITED KINGDOM ($206.7K, 2 shipments), followed by FRANCE and SINGAPORE. All values are from Indian Customs (DGFT) import records.

Countries Supplying Amiodarone to India — Ranked by Import Value
#	Origin Country	Import Value (USD)	Shipments	Share
1	UNITED KINGDOM	$206.7K	2	43.9%
2	FRANCE	$198.0K	9	42.0%
3	SINGAPORE	$52.2K	2	11.1%
4	UNITED STATES	$10.9K	12	2.3%
5	AUSTRALIA	$2.9K	1	0.6%
6	CANADA	$308	3	0.1%
7	GERMANY	$187	3	0.0%
8	MALTA	$13	1	0.0%
9	ITALY	$11	1	0.0%

UNITED KINGDOM is the largest supplier of amiodarone to India, accounting for 43.9% of total import value. The top 5 origin countries — UNITED KINGDOM, FRANCE, SINGAPORE, UNITED STATES, AUSTRALIA — together supply 99.9% of India's amiodarone imports. Click any country to see detailed supplier and buyer data for that import corridor.

Amiodarone — Export Intelligence Video

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

This video covers India's amiodarone pharmaceutical import and export market — $74.6M in total trade, 243 verified manufacturers, and 124 destination countries. Data sourced from Indian Customs (DGFT) shipment records.

Regulatory Landscape — Amiodarone

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

1FDA & US Market Regulatory Status

In the United States, amiodarone has been approved through multiple Abbreviated New Drug Applications (ANDAs). Notably, Upsher-Smith Laboratories, Inc. received approval for its generic version of amiodarone hydrochloride tablets (ANDA 75-135) on April 30, 1998. Similarly, Copley Pharmaceutical, Inc. secured approval for its formulation (ANDA 74-739) on November 30, 1998, and Par Pharmaceutical, Inc. followed with approval (ANDA 75-188) on February 24, 1999.

The FDA's regulatory pathway for amiodarone involves stringent evaluation of bioequivalence and manufacturing standards to ensure safety and efficacy. Given the substantial number of Indian exporters involved in supplying amiodarone to the U.S. market, compliance with FDA regulations, including Good Manufacturing Practices (GMP) and periodic inspections, is imperative to maintain market access.

2EU & UK Regulatory Framework

In the European Union, the European Medicines Agency (EMA) oversees the marketing authorization of medicinal products, including amiodarone. The authorization process requires comprehensive data on quality, safety, and efficacy. Manufacturers must adhere to the EU's Good Manufacturing Practice (GMP) guidelines, ensuring consistent product quality.

In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicinal products. Post-Brexit, the UK has established its own regulatory framework, though it remains aligned with EU standards in many aspects. Manufacturers exporting amiodarone to the UK must comply with MHRA's requirements, including obtaining marketing authorization and adhering to GMP standards.

3WHO Essential Medicines & Global Standards

Amiodarone is listed in the World Health Organization's (WHO) Model List of Essential Medicines, underscoring its significance in treating priority health conditions. The 2025 edition of the WHO Model List includes over 520 medicines, reflecting the organization's commitment to ensuring access to essential treatments. (who.int)

Regarding pharmacopoeial standards, amiodarone is included in major compendia such as the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP). These standards provide specifications for the drug's quality, ensuring consistency across different markets.

4India Regulatory Classification

In India, amiodarone is classified under Schedule H of the Drugs and Cosmetics Rules, indicating that it is a prescription-only medication. This classification mandates that amiodarone can only be sold by retail pharmacies upon the prescription of a registered medical practitioner.

The Drug Price Control Order (DPCO), enforced by the National Pharmaceutical Pricing Authority (NPPA), regulates the pricing of essential medicines in India. As of the latest available data, amiodarone is subject to price control measures to ensure affordability. Manufacturers intending to export amiodarone 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 amiodarone have expired, leading to the availability of multiple generic versions in the 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 amiodarone, highlighting its continued importance in global health. (who.int)

In January 2026, the FDA issued updated guidance on the manufacturing standards for antiarrhythmic drugs, including amiodarone, emphasizing the need for enhanced quality control measures to ensure patient safety.

In March 2026, the NPPA revised the ceiling price for amiodarone under the DPCO, reflecting changes in production costs and market dynamics to maintain affordability for patients.

These developments underscore the dynamic regulatory environment surrounding amiodarone, necessitating continuous monitoring by stakeholders to ensure compliance and market competitiveness.

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

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Global Price Benchmark — Amiodarone

Retail & reference prices across 9 markets vs. India FOB export price of $6.21/unit

Global Price Benchmark for Amiodarone across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	$0.23–$0.27	USD	According to the FDA Orange Book, amiodarone is an approved generic medication, which contributes to its relatively low cost in the U.S. market.
United Kingdom	Data not available	GBP	Amiodarone is listed in the NHS Drug Tariff, indicating its availability and reimbursement under the UK's National Health Service.
Germany	Data not available	EUR	Amiodarone is approved by the European Medicines Agency (EMA) and is available in the German market.
Australia

Supply Chain Risk Assessment — Amiodarone

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

HIGH RISK

1API Sourcing & Raw Material Dependency

India's pharmaceutical industry, including the production of Amiodarone, heavily relies on Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs) imported from China. According to the US Pharmacopeia, 58% of KSMs used for U.S.-approved APIs are sourced from a single country, predominantly China. This dependency exposes the supply chain to risks associated with geopolitical tensions, trade restrictions, and production disruptions in China.

Recent events have exacerbated these vulnerabilities. In March 2026, escalating conflicts in the Middle East, particularly the closure of the Strait of Hormuz, have disrupted global shipping routes. This has led to significant delays and increased costs in transporting raw materials, including KSMs, from China to India. The United Nations Conference on Trade and Development (UNCTAD) highlighted that the Strait carries around one-quarter of global seaborne oil trade, as well as significant volumes of liquefied natural gas and fertilizers, and its disruption has raised concerns about ripple effects across global markets.

2Supplier Concentration & Single-Source Risk

Our proprietary trade data indicates a high concentration in Amiodarone exports from India, with the top five exporters accounting for 90.3% of the total export value. UNICHEM LABORATORIES LIMITED alone holds a 49.8% share, amounting to $37.2 million USD. This concentration poses a significant single-source risk; any operational or regulatory issues affecting these key suppliers could severely disrupt the global supply of Amiodarone.

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Frequently Asked Questions — Amiodarone Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top amiodarone exporters from India?

The leading amiodarone exporters from India are UNICHEM LABORATORIES LIMITED, RUBICON RESEARCH PRIVATE LIMITED, SUN PHARMACEUTICAL INDUSTRIES LIMITED, and 12 others. UNICHEM LABORATORIES LIMITED leads with 49.8% market share ($37.2M). The top 5 suppliers together control 90.3% of total export value.

What is the total export value of amiodarone from India?

The total export value of amiodarone from India is $74.6M, recorded across 1,674 shipments from 243 active exporters to 124 countries. The average shipment value is $44.6K.

Which countries import amiodarone from India?

India exports amiodarone to 124 countries. The top importing countries are UNITED STATES (82.9%), BRAZIL (8.4%), THAILAND (1.3%), VENEZUELA (1.0%), GERMANY (0.9%), which together account for 94.5% of total export value.

What is the HS code for amiodarone exports from India?

The primary HS code for amiodarone 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.

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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.

Amiodarone

Amiodarone

Top Amiodarone Exporters from India

Top Countries Importing Amiodarone from India

Who Supplies Amiodarone to India?

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Amiodarone — Export Intelligence Video

Regulatory Landscape — Amiodarone

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 — Amiodarone

Supply Chain Risk Assessment — Amiodarone

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Amiodarone Trade Intelligence

Frequently Asked Questions — Amiodarone Exports from India

Who are the top amiodarone exporters from India?

What is the total export value of amiodarone from India?

Which countries import amiodarone from India?

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

Which ports handle amiodarone exports from India?

Why is India a leading exporter of amiodarone?

What certifications do Indian amiodarone exporters need?

How many buyers import amiodarone from India?

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

Analysis Methodology