Spironolactone Export Market Intelligence: India's 259 Suppliers Shipping to 112 Countries — TransData Nexus 2026

Q: Who are the top spironolactone exporters from India?

The top spironolactone exporters from India are: 1. ZYDUS LIFESCIENCES LIMITED — $106.7M (54.1% market share); 2. AMNEAL PHARMACEUTICALS PRIVATE LIMITED — $38.4M (19.4% market share); 3. AUROBINDO PHARMA LTD — $13.6M (6.9% market share); 4. INTAS PHARMACEUTICALS LIMITED — $12.2M (6.2% market share); 5. AUROBINDO PHARMA LIMITED — $7.2M (3.6% market share). Together they account for 90.2% of India's total spironolactone export value.

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

The total export value of spironolactone from India is $197.4M USD, recorded across 5,262 shipment transactions from 259 active exporters to 112 destination countries. The average shipment value is $37.5K.

Q: Which countries import spironolactone from India?

India exports spironolactone to 112 countries worldwide. The top importing countries are: UNITED STATES (87.2% share, $172.2M), NETHERLANDS (6.0% share, $11.9M), UNITED KINGDOM (1.1% share, $2.1M), CANADA (1.0% share, $2.0M), KENYA (0.7% share, $1.4M). These five markets account for 96.1% of total export value.

Q: What is the average price of spironolactone exports from India?

The average unit price for spironolactone exports from India is $7.21 USD per unit, with prices ranging from $0.00 to $5929.79 depending on formulation, packaging, and order volume. The total market is valued at $197.4M across 5,262 shipments.

Q: Which ports handle spironolactone exports from India?

The primary ports for spironolactone exports from India are DELHI AIR CARGO ACC (INDEL4) (16.5% of shipments), DELHI AIR (12.9% of shipments), SAHAR AIR (12.0% of shipments), SAHAR AIR CARGO ACC (INBOM4) (11.3% of shipments), MUNDRA SEA (8.4% 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 spironolactone?

India is one of the world's leading exporters of spironolactone due to its large base of 259 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 spironolactone to 112 countries, demonstrating 57% global market coverage.

Q: What certifications do Indian spironolactone exporters need?

Indian spironolactone 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 spironolactone from India?

There are 471 registered buyers importing spironolactone from India, spread across 112 countries. The repeat buyer rate is 59.0%, indicating strong long-term trade relationships and consistent product quality.

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

ZYDUS LIFESCIENCES LIMITED is the leading spironolactone exporter from India with a market share of 54.1% and total export value of $106.7M across 262 shipments. The top 5 suppliers together control 90.2% of total export value.

Suresh Sormare

Spironolactone

India Pharmaceutical Trade Intelligence

$197.4M259 Suppliers112 CountriesHS 30049099

ExportsIndia → UNITED STATES87.2%India → NETHERLANDS6.0%

ImportsUNITED STATES → India$22.1K GERMANY → India$19.2K

#1 Supplier: ZYDUS LIFESCIENCES #1 Buyer: EVERSANA LIFE

Spironolactone Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Spironolactone to the World

Between 2022 and 2026, India exported $197.4M worth of spironolactone across 5,262 verified shipments to 112 countries — covering 57% of world markets in the Diuretics segment. The largest destination is UNITED STATES (87.2%). ZYDUS LIFESCIENCES LIMITED leads with a 54.1% 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·

Spironolactone export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Spironolactone export data snapshot — $197.4M · 259 exporters · 112 countriesTransData Nexus · Indian Customs Data

Top Spironolactone Exporters from India

259 active exporters · Ranked by export value

View all 259 →

Top Spironolactone Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	ZYDUS LIFESCIENCES LIMITED	$106.7M	262	3	54.1%
2	AMNEAL PHARMACEUTICALS PRIVATE LIMITED

Top Countries Importing Spironolactone from India

112 destination markets · Ranked by import value

All 112 countries →

Top Countries Importing Spironolactone from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	UNITED STATES	$172.2M	87.2%
2	NETHERLANDS	$11.9M	6.0%
3	UNITED KINGDOM	$2.1M	1.1%
4	CANADA	$2.0M	1.0%
5	KENYA	$1.4M	0.7%
6	GUATEMALA	$1.2M	0.6%
7	PHILIPPINES	$973.8K	0.5%
8	GUINEA	$599.8K	0.3%
9	NIGERIA	$551.2K	0.3%
10	MYANMAR	$533.7K	0.3%

UNITED STATES is India's largest spironolactone export destination, absorbing 87.2% of total exports worth $172.2M. The top 5 importing countries — UNITED STATES, NETHERLANDS, UNITED KINGDOM, CANADA, KENYA — together account for 96.1% of India's total spironolactone export value. The remaining 107 destination countries collectively receive the other 3.9%, indicating a well-diversified global distribution network spanning all major continents.

Who Supplies Spironolactone to India?

11 origin countries · Total import value: $57.0K

India imports spironolactone from 11 countries with a combined import value of $57.0K. The largest supplier is UNITED STATES ($22.1K, 20 shipments), followed by GERMANY and SWITZERLAND. All values are from Indian Customs (DGFT) import records.

Countries Supplying Spironolactone to India — Ranked by Import Value
#	Origin Country	Import Value (USD)	Shipments	Share
1	UNITED STATES	$22.1K	20	38.8%
2	GERMANY	$19.2K	17	33.7%
3	SWITZERLAND	$10.4K	10	18.2%
4	UNITED KINGDOM	$2.0K	9	3.5%
5	JAPAN	$908	1	1.6%
6	GUYANA	$872	1	1.5%
7	CANADA	$728	12	1.3%
8	ITALY	$306	2	0.5%
9	CYPRUS	$275	2	0.5%
10	SOUTH AFRICA	$128	3	0.2%

Showing top 10 of 11 origin countries

UNITED STATES is the largest supplier of spironolactone to India, accounting for 38.8% of total import value. The top 5 origin countries — UNITED STATES, GERMANY, SWITZERLAND, UNITED KINGDOM, JAPAN — together supply 95.8% of India's spironolactone imports. Click any country to see detailed supplier and buyer data for that import corridor.

Regulatory Landscape — Spironolactone

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

1FDA & US Market Regulatory Status

In the United States, spironolactone is approved for various indications, including the treatment of heart failure, hypertension, and edema. The FDA's Orange Book lists multiple approved Abbreviated New Drug Applications (ANDAs) for spironolactone, indicating a competitive generic market. Notably, Amneal Pharmaceuticals LLC received approval for its spironolactone oral suspension (25 mg/5 mL) under ANDA 215572 in October 2024. This approval underscores the active participation of Indian exporters in the U.S. market. As of March 2026, there are no FDA import alerts specifically targeting spironolactone, facilitating its continued importation into the U.S.

2EU & UK Regulatory Framework

Within the European Union, the European Medicines Agency (EMA) has authorized spironolactone-containing products for human use. For instance, Qaialdo, containing spironolactone, received marketing authorization on May 26, 2023. This approval reflects the EMA's recognition of spironolactone's therapeutic value. In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) oversees the approval and monitoring of spironolactone products. Compliance with EU Good Manufacturing Practice (GMP) standards is mandatory for manufacturers exporting to these regions, ensuring product quality and safety.

3WHO Essential Medicines & Global Standards

Spironolactone is included in the World Health Organization's Model List of Essential Medicines, highlighting its importance in global health. It is also listed in major pharmacopoeias, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), ensuring standardized quality specifications across different markets.

4India Regulatory Classification

In India, spironolactone is classified as a Schedule H drug under the Drugs and Cosmetics Act, requiring a prescription for dispensation. The National Pharmaceutical Pricing Authority (NPPA) regulates its pricing to ensure affordability. For exports, the Directorate General of Foreign Trade (DGFT) mandates a No Objection Certificate (NOC), ensuring compliance with national and international regulations.

5Patent & Exclusivity Status

Spironolactone's primary patents have expired, leading to a robust generic market with multiple manufacturers producing the drug. This competitive landscape contributes to its widespread availability and affordability globally.

6Recent Industry Developments

In April 2025, the MHRA issued a Class 3 medicines recall for Urospir 50mg/5ml Oral Solution due to dosing calculation errors in the product information leaflet. This recall underscores the importance of accurate labeling and information dissemination. Additionally, in December 2023, the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) recommended updates to the product information for furosemide-spironolactone combination products, emphasizing the need for ongoing safety monitoring and information updates.

These developments highlight the dynamic regulatory environment surrounding spironolactone, necessitating continuous vigilance and compliance from manufacturers and exporters.

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

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Global Price Benchmark — Spironolactone

Retail & reference prices across 9 markets vs. India FOB export price of $7.21/unit

Global Price Benchmark for Spironolactone across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	$0.50	USD	According to the FDA's Orange Book, Spironolactone is an approved generic medication, contributing to its affordability.
United Kingdom	$0.40	GBP	The NHS Drug Tariff sets the reimbursement price for Spironolactone, ensuring cost-effectiveness within the healthcare system.
Germany	$0.38	EUR	The Federal Joint Committee (G-BA) regulates pharmaceutical pricing, maintaining affordability for essential medications like Spironolactone.
Australia

Supply Chain Risk Assessment — Spironolactone

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

MEDIUM RISK

1API Sourcing & Raw Material Dependency

India is a significant producer of Active Pharmaceutical Ingredients (APIs), including Spironolactone. However, the production of APIs often relies on Key Starting Materials (KSMs) and intermediates, many of which are imported from China. This dependency poses a risk, as any disruption in the supply of these materials can impact API production. For instance, in September 2020, China increased prices of KSMs by 10-20%, affecting the cost structure of Indian pharmaceutical manufacturers.

Recognizing this vulnerability, the Indian government has initiated measures to reduce reliance on Chinese imports. In November 2024, two greenfield plants were inaugurated under the Production Linked Incentive (PLI) scheme to manufacture critical molecules like Penicillin G and Clavulanic Acid, aiming to cut import dependence by half. Despite these efforts, the transition to self-reliance is ongoing, and the risk associated with raw material dependency remains pertinent.

2Supplier Concentration & Single-Source Risk

Our proprietary trade data from 2022 to 2026 indicates a high concentration in Spironolactone exports from India. The top five exporters account for 90.2% of the total export value, with Zydus Lifesciences Limited alone contributing 54.1%. Such concentration poses a single-source risk; any operational or regulatory issues affecting these key suppliers could disrupt the global supply chain.

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Frequently Asked Questions — Spironolactone Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top spironolactone exporters from India?

The leading spironolactone exporters from India are ZYDUS LIFESCIENCES LIMITED, AMNEAL PHARMACEUTICALS PRIVATE LIMITED, AUROBINDO PHARMA LTD, and 12 others. ZYDUS LIFESCIENCES LIMITED leads with 54.1% market share ($106.7M). The top 5 suppliers together control 90.2% of total export value.

What is the total export value of spironolactone from India?

The total export value of spironolactone from India is $197.4M, recorded across 5,262 shipments from 259 active exporters to 112 countries. The average shipment value is $37.5K.

Which countries import spironolactone from India?

India exports spironolactone to 112 countries. The top importing countries are UNITED STATES (87.2%), NETHERLANDS (6.0%), UNITED KINGDOM (1.1%), CANADA (1.0%), KENYA (0.7%), which together account for 96.1% of total export value.

What is the HS code for spironolactone exports from India?

The primary HS code for spironolactone 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.

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.

Spironolactone

Spironolactone

Top Spironolactone Exporters from India

Top Countries Importing Spironolactone from India

Who Supplies Spironolactone to India?

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Regulatory Landscape — Spironolactone

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 — Spironolactone

Supply Chain Risk Assessment — Spironolactone

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Spironolactone Trade Intelligence

Frequently Asked Questions — Spironolactone Exports from India

Who are the top spironolactone exporters from India?

What is the total export value of spironolactone from India?

Which countries import spironolactone from India?

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

Which ports handle spironolactone exports from India?

Why is India a leading exporter of spironolactone?

What certifications do Indian spironolactone exporters need?

How many buyers import spironolactone from India?

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

Analysis Methodology