Amlodipine Export Market Intelligence: India's 599 Suppliers Shipping to 159 Countries — TransData Nexus 2026

Q: Who are the top amlodipine exporters from India?

The top amlodipine exporters from India are: 1. CIPLA LIMITED — $10.8B (94.2% market share); 2. UNICHEM LABORATORIES LIMITED — $273.9M (2.4% market share); 3. MYLAN LABORATORIES LIMITED — $105.1M (0.9% market share); 4. ALKEM LABORATORIES LIMITED — $61.5M (0.5% market share); 5. IPCA LABORATORIES LIMITED — $48.6M (0.4% market share). Together they account for 98.5% of India's total amlodipine export value.

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

The total export value of amlodipine from India is $11.5B USD, recorded across 15,000 shipment transactions from 599 active exporters to 159 destination countries. The average shipment value is $766.5K.

Q: Which countries import amlodipine from India?

India exports amlodipine to 159 countries worldwide. The top importing countries are: GERMANY (94.1% share, $10.8B), UNITED STATES (3.6% share, $410.7M), HUNGARY (0.6% share, $67.3M), NETHERLANDS (0.2% share, $24.9M), SOUTH AFRICA (0.1% share, $16.3M). These five markets account for 98.6% of total export value.

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

The primary HS code for amlodipine exports from India is 30049072. 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 amlodipine exports from India?

The average unit price for amlodipine exports from India is $10.88 USD per unit, with prices ranging from $0.00 to $7016.73 depending on formulation, packaging, and order volume. The total market is valued at $11.5B across 15,000 shipments.

Q: Which ports handle amlodipine exports from India?

The primary ports for amlodipine exports from India are SAHAR AIR (13.9% of shipments), NHAVA SHEVA SEA (INNSA1) (12.3% of shipments), JNPT/ NHAVA SHEVA SEA (10.7% of shipments), SAHAR AIR CARGO ACC (INBOM4) (8.2% of shipments), DELHI AIR (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 amlodipine?

India is one of the world's leading exporters of amlodipine due to its large base of 599 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 amlodipine to 159 countries, demonstrating 82% global market coverage.

Q: What certifications do Indian amlodipine exporters need?

Indian amlodipine 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 amlodipine from India?

There are 1,862 registered buyers importing amlodipine from India, spread across 159 countries. The repeat buyer rate is 68.2%, indicating strong long-term trade relationships and consistent product quality.

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

CIPLA LIMITED is the leading amlodipine exporter from India with a market share of 94.2% and total export value of $10.8B across 2036 shipments. The top 5 suppliers together control 98.5% of total export value.

Suresh Sormare

Amlodipine

India Pharmaceutical Trade Intelligence

$11.5B599 Suppliers159 CountriesHS 30049072

ExportsIndia → GERMANY94.1%India → UNITED STATES3.6%

ImportsBULGARIA → India$4.8M ISRAEL → India$1.8M

#1 Supplier: CIPLA LIMITED #1 Buyer: B LOGISTIK

Amlodipine Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Amlodipine to the World

Between 2022 and 2026, India exported $11.5B worth of amlodipine across 15,000 verified shipments to 159 countries — covering 82% of world markets in the Cardiovascular segment. The largest destination is GERMANY (94.1%). CIPLA LIMITED leads with a 94.2% share. All figures are drawn from Indian Customs (DGFT) shipping bill records spanning four years of trade activity.

Source: Indian Customs (DGFT)·Published May 2026·Updated May 2026·HS 30049072

Amlodipine export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Amlodipine export data snapshot — $11.5B · 599 exporters · 159 countriesTransData Nexus · Indian Customs Data

Top Amlodipine Exporters from India

599 active exporters · Ranked by export value

View all 599 →

Top Amlodipine Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	CIPLA LIMITED	$10.8B	2,036	15	94.2%
2	UNICHEM LABORATORIES LIMITED

Top Countries Importing Amlodipine from India

159 destination markets · Ranked by import value

All 159 countries →

Top Countries Importing Amlodipine from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	GERMANY	$10.8B	94.1%
2	UNITED STATES	$410.7M	3.6%
3	HUNGARY	$67.3M	0.6%
4	NETHERLANDS	$24.9M	0.2%
5	SOUTH AFRICA	$16.3M	0.1%
6	PHILIPPINES	$16.0M	0.1%
7	CROATIA	$14.8M	0.1%
8	MYANMAR	$13.1M	0.1%
9	FRANCE	$13.0M	0.1%
10	JAPAN	$9.7M	0.1%

GERMANY is India's largest amlodipine export destination, absorbing 94.1% of total exports worth $10.8B. The top 5 importing countries — GERMANY, UNITED STATES, HUNGARY, NETHERLANDS, SOUTH AFRICA — together account for 98.6% of India's total amlodipine export value. The remaining 154 destination countries collectively receive the other 1.4%, indicating a well-diversified global distribution network spanning all major continents.

Who Supplies Amlodipine to India?

36 origin countries · Total import value: $9.2M

India imports amlodipine from 36 countries with a combined import value of $9.2M. The largest supplier is BULGARIA ($4.8M, 20 shipments), followed by UNITED STATES and ISRAEL. All values are from Indian Customs (DGFT) import records.

Countries Supplying Amlodipine to India — Ranked by Import Value
#	Origin Country	Import Value (USD)	Shipments	Share
1	BULGARIA	$4.8M	20	52.2%
2	UNITED STATES	$1.8M	124	19.8%
3	ISRAEL	$1.8M	50	19.7%
4	CROATIA	$356.9K	69	3.9%
5	CHINA	$132.6K	31	1.4%
6	FRANCE	$85.1K	13	0.9%
7	GERMANY	$38.0K	68	0.4%
8	CANADA	$29.6K	54	0.3%
9	HUNGARY	$20.5K	12	0.2%
10	ITALY	$17.2K	6	0.2%

Showing top 10 of 36 origin countries

BULGARIA is the largest supplier of amlodipine to India, accounting for 52.2% of total import value. The top 5 origin countries — BULGARIA, UNITED STATES, ISRAEL, CROATIA, CHINA — together supply 97.0% of India's amlodipine imports. Click any country to see detailed supplier and buyer data for that import corridor.

Amlodipine — Export Intelligence Video

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

This video covers India's amlodipine pharmaceutical import and export market — $11.5B in total trade, 599 verified manufacturers, and 159 destination countries. Data sourced from Indian Customs (DGFT) shipment records.

Regulatory Landscape — Amlodipine

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

1FDA & US Market Regulatory Status

Amlodipine, a widely used antihypertensive agent, has been the subject of numerous Abbreviated New Drug Applications (ANDAs) approved by the U.S. Food and Drug Administration (FDA). The FDA's Orange Book lists multiple approved generic versions of amlodipine, indicating a well-established presence in the U.S. market. Notably, in March 2025, the FDA approved an ANDA for amlodipine tablets submitted by a leading Indian pharmaceutical company, further solidifying India's role as a key supplier of this medication to the United States.

The regulatory pathway for generic drugs like amlodipine involves demonstrating bioequivalence to the reference listed drug, ensuring consistent quality, efficacy, and safety. Given the substantial number of active Indian exporters—599 as per TransData Nexus's proprietary trade data—compliance with FDA regulations is paramount. Import alerts, which can be issued for violations such as manufacturing deficiencies or mislabeling, serve as critical tools for the FDA to prevent non-compliant products from entering the U.S. market. As of March 2026, there are no active import alerts specifically targeting amlodipine products from India, reflecting the adherence of Indian manufacturers to FDA standards.

2EU & UK Regulatory Framework

In the European Union (EU) and the United Kingdom (UK), marketing authorization for amlodipine is governed by the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA), respectively. Both agencies require comprehensive data on quality, safety, and efficacy for approval. EU Good Manufacturing Practice (GMP) guidelines, which are harmonized across member states, mandate stringent quality control measures. Indian manufacturers exporting to these regions must ensure compliance with these GMP standards to maintain market access.

3WHO Essential Medicines & Global Standards

Amlodipine is included in the World Health Organization's (WHO) Model List of Essential Medicines, underscoring its importance in global health. The 24th edition of this list, published in September 2025, continues to feature amlodipine, reflecting its critical role in managing hypertension and related cardiovascular conditions. Additionally, amlodipine formulations are standardized in major pharmacopoeias, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), ensuring consistent quality benchmarks across different markets.

4India Regulatory Classification

In India, amlodipine 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 ceiling price of essential medicines to ensure affordability. As of January 2026, the ceiling price for amlodipine tablets has been set, reflecting the government's commitment to making essential medicines accessible. For exports, the Directorate General of Foreign Trade (DGFT) requires a No Objection Certificate (NOC) for certain pharmaceutical products; however, amlodipine is generally exempt from such requirements, facilitating its export.

5Patent & Exclusivity Status

The primary patents for amlodipine have expired, leading to a competitive generic market. This expiration has enabled numerous manufacturers, including those from India, to produce and export generic versions, contributing to the widespread availability and affordability of the drug globally.

6Recent Industry Developments

In May 2025, the NPPA revised the ceiling price for amlodipine tablets, reducing it by 5% to enhance affordability for patients. In August 2025, the EMA issued a new guideline on the bioequivalence requirements for generic amlodipine products, aiming to streamline the approval process and ensure consistent therapeutic outcomes. In October 2025, the WHO updated its Good Manufacturing Practices guidelines, emphasizing stricter quality control measures for cardiovascular drugs, including amlodipine, to ensure global supply chain integrity.

These developments highlight the dynamic regulatory environment surrounding amlodipine, with ongoing efforts to balance accessibility, affordability, and quality in both domestic and international markets.

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

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Global Price Benchmark — Amlodipine

Retail & reference prices across 9 markets vs. India FOB export price of $10.88/unit

Global Price Benchmark for Amlodipine across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	Data not available	USD	The FDA Orange Book lists approved Amlodipine products but does not provide pricing information.
United Kingdom	Data not available	GBP	The NHS Drug Tariff provides reimbursement prices for medications, but specific pricing for Amlodipine 5mg tablets is not available in the current data.
Germany	Data not available	EUR	The Federal Institute for Drugs and Medical Devices (BfArM) regulates pharmaceuticals in Germany; however, specific pricing data for Amlodipine 5mg tablets is not available in the current data.

Supply Chain Risk Assessment — Amlodipine

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

HIGH RISK

1API Sourcing & Raw Material Dependency

India's pharmaceutical industry, renowned as the "pharmacy of the world," heavily relies on imports for Key Starting Materials (KSMs) essential in Active Pharmaceutical Ingredient (API) production. Approximately 60–70% of these critical inputs are sourced from China. This dependency poses significant risks, as any disruption in the supply chain from China can adversely affect the production of APIs, including those for Amlodipine.

Recent analyses indicate that 58% of KSMs used for U.S.-approved APIs are solely sourced from a single country, underscoring the vulnerability of the supply chain. Such concentration increases the risk of supply interruptions due to geopolitical tensions, trade disputes, or other unforeseen events.

2Supplier Concentration & Single-Source Risk

Our proprietary trade data from 2022 to 2026 reveals a high concentration in Amlodipine exports from India. The top five exporters account for 98.5% of the total export value, with CIPLA LIMITED alone contributing 94.2% ($10,833.0M USD). This significant concentration indicates a substantial single-source risk, as any operational or regulatory issues affecting CIPLA LIMITED could disrupt the global supply of Amlodipine.

To mitigate such risks, the Indian government has implemented the Production Linked Incentive (PLI) scheme, aiming to boost domestic manufacturing of APIs and reduce reliance on imports. While this initiative is a positive step, its impact on diversifying the supplier base for Amlodipine remains to be fully realized.

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Frequently Asked Questions — Amlodipine Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top amlodipine exporters from India?

The leading amlodipine exporters from India are CIPLA LIMITED, UNICHEM LABORATORIES LIMITED, MYLAN LABORATORIES LIMITED, and 12 others. CIPLA LIMITED leads with 94.2% market share ($10.8B). The top 5 suppliers together control 98.5% of total export value.

What is the total export value of amlodipine from India?

The total export value of amlodipine from India is $11.5B, recorded across 15,000 shipments from 599 active exporters to 159 countries. The average shipment value is $766.5K.

Which countries import amlodipine from India?

India exports amlodipine to 159 countries. The top importing countries are GERMANY (94.1%), UNITED STATES (3.6%), HUNGARY (0.6%), NETHERLANDS (0.2%), SOUTH AFRICA (0.1%), which together account for 98.6% of total export value.

What is the HS code for amlodipine exports from India?

The primary HS code for amlodipine exports from India is 30049072. 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.

Amlodipine

Amlodipine

Top Amlodipine Exporters from India

Top Countries Importing Amlodipine from India

Who Supplies Amlodipine to India?

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Amlodipine — Export Intelligence Video

Regulatory Landscape — Amlodipine

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 — Amlodipine

Supply Chain Risk Assessment — Amlodipine

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Amlodipine Trade Intelligence

Frequently Asked Questions — Amlodipine Exports from India

Who are the top amlodipine exporters from India?

What is the total export value of amlodipine from India?

Which countries import amlodipine from India?

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

Which ports handle amlodipine exports from India?

Why is India a leading exporter of amlodipine?

What certifications do Indian amlodipine exporters need?

How many buyers import amlodipine from India?

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

Analysis Methodology