Nystatin Export Market Intelligence: India's 223 Suppliers Shipping to 96 Countries — TransData Nexus 2026

Q: Who are the top nystatin exporters from India?

The top nystatin exporters from India are: 1. AGOG PHARMA LIMITED — $10.7M (20.4% market share); 2. ZYDUS LIFESCIENCES LIMITED — $6.4M (12.2% market share); 3. LINCOLN PHARMACEUTICALS LTD — $5.7M (10.9% market share); 4. MEDLEY PHARMACEUTICALS LIMITED — $4.5M (8.6% market share); 5. TORRENT PHARMACEUTICALS LTD — $4.2M (8.0% market share). Together they account for 60.1% of India's total nystatin export value.

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

The total export value of nystatin from India is $52.3M USD, recorded across 2,442 shipment transactions from 223 active exporters to 96 destination countries. The average shipment value is $21.4K.

Q: Which countries import nystatin from India?

India exports nystatin to 96 countries worldwide. The top importing countries are: UNITED STATES (40.9% share, $21.4M), UGANDA (20.4% share, $10.6M), MOZAMBIQUE (9.5% share, $5.0M), NIGERIA (2.6% share, $1.4M), DOMINICAN REPUBLIC (2.4% share, $1.3M). These five markets account for 75.8% of total export value.

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

The primary HS code for nystatin exports from India is 30049029. 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 nystatin exports from India?

The average unit price for nystatin exports from India is $26.10 USD per unit, with prices ranging from $0.01 to $1563.41 depending on formulation, packaging, and order volume. The total market is valued at $52.3M across 2,442 shipments.

Q: Which ports handle nystatin exports from India?

The primary ports for nystatin exports from India are NHAVA SHEVA SEA (INNSA1) (19.9% of shipments), JNPT/ NHAVA SHEVA SEA (11.3% of shipments), JNPT (8.5% of shipments), MUNDRA SEA (4.9% of shipments), DELHI AIR (4.3% 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 nystatin?

India is one of the world's leading exporters of nystatin due to its large base of 223 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 nystatin to 96 countries, demonstrating 49% global market coverage.

Q: What certifications do Indian nystatin exporters need?

Indian nystatin 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 nystatin from India?

There are 458 registered buyers importing nystatin from India, spread across 96 countries. The repeat buyer rate is 55.5%, indicating strong long-term trade relationships and consistent product quality.

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

AGOG PHARMA LIMITED is the leading nystatin exporter from India with a market share of 20.4% and total export value of $10.7M across 29 shipments. The top 5 suppliers together control 60.1% of total export value.

Suresh Sormare

Nystatin

India Pharmaceutical Trade Intelligence

$52.3M223 Suppliers96 CountriesHS 30049029

ExportsIndia → UNITED STATES40.9%India → UGANDA20.4%

ImportsCANADA → India$19.7K UNITED STATES → India$1.8K

#1 Supplier: AGOG PHARMA #1 Buyer: M/S. GITTOES

Nystatin Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Nystatin to the World

Between 2022 and 2026, India exported $52.3M worth of nystatin across 2,442 verified shipments to 96 countries — covering 49% of world markets in the Antifungals segment. The largest destination is UNITED STATES (40.9%). AGOG PHARMA LIMITED leads with a 20.4% 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·HS 30049029

Nystatin export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Nystatin export data snapshot — $52.3M · 223 exporters · 96 countriesTransData Nexus · Indian Customs Data

Top Nystatin Exporters from India

223 active exporters · Ranked by export value

View all 223 →

Top Nystatin Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	AGOG PHARMA LIMITED	$10.7M	29	2	20.4%
2	ZYDUS LIFESCIENCES LIMITED

Top Countries Importing Nystatin from India

96 destination markets · Ranked by import value

All 96 countries →

Top Countries Importing Nystatin from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	UNITED STATES	$21.4M	40.9%
2	UGANDA	$10.6M	20.4%
3	MOZAMBIQUE	$5.0M	9.5%
4	NIGERIA	$1.4M	2.6%
5	DOMINICAN REPUBLIC	$1.3M	2.4%
6	TANZANIA	$1.2M	2.3%
7	MYANMAR	$1.1M	2.1%
8	CAMEROON	$970.6K	1.9%
9	UNITED ARAB EMIRATES	$603.2K	1.2%
10	FRANCE	$540.1K	1.0%

UNITED STATES is India's largest nystatin export destination, absorbing 40.9% of total exports worth $21.4M. The top 5 importing countries — UNITED STATES, UGANDA, MOZAMBIQUE, NIGERIA, DOMINICAN REPUBLIC — together account for 75.8% of India's total nystatin export value. The remaining 91 destination countries collectively receive the other 24.2%, indicating a broadly diversified export footprint across multiple regions.

Who Supplies Nystatin to India?

6 origin countries · Total import value: $22.6K

India imports nystatin from 6 countries with a combined import value of $22.6K. The largest supplier is CANADA ($19.7K, 14 shipments), followed by UNITED STATES and SINGAPORE. All values are from Indian Customs (DGFT) import records.

Countries Supplying Nystatin to India — Ranked by Import Value
#	Origin Country	Import Value (USD)	Shipments	Share
1	CANADA	$19.7K	14	87.0%
2	UNITED STATES	$1.8K	20	8.0%
3	SINGAPORE	$994	1	4.4%
4	UNITED KINGDOM	$78	1	0.3%
5	SENEGAL	$36	1	0.2%
6	ITALY	$26	1	0.1%

CANADA is the largest supplier of nystatin to India, accounting for 87.0% of total import value. The top 5 origin countries — CANADA, UNITED STATES, SINGAPORE, UNITED KINGDOM, SENEGAL — together supply 99.9% of India's nystatin imports. Click any country to see detailed supplier and buyer data for that import corridor.

Regulatory Landscape — Nystatin

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

1FDA & US Market Regulatory Status

In the United States, nystatin is approved for various formulations, including oral suspensions and topical powders. For instance, UDL Laboratories, Inc. received approval for Nystatin Oral Suspension USP under ANDA 64-142 on June 25, 1998. Additionally, the FDA has issued product-specific guidance for generic nystatin topical powders, emphasizing the need for comparative physicochemical and structural characterization to establish pharmaceutical equivalence.

The substantial number of Indian exporters (223) supplying nystatin to the U.S. underscores the competitive landscape and the importance of adhering to FDA regulations to maintain market access.

2EU & UK Regulatory Framework

In the European Union, marketing authorization for nystatin requires compliance with the European Medicines Agency (EMA) standards, including Good Manufacturing Practice (GMP) guidelines. Similarly, in the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) oversees the approval process, ensuring that products meet safety, quality, and efficacy standards. Manufacturers must obtain the necessary marketing authorizations and demonstrate adherence to EU GMP requirements to distribute nystatin within these markets.

3WHO Essential Medicines & Global Standards

Nystatin is included in the World Health Organization's (WHO) Model List of Essential Medicines, highlighting its significance in treating fungal infections. The drug is also recognized in various pharmacopoeias, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), ensuring standardized quality and efficacy across different regions.

4India Regulatory Classification

In India, nystatin 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, nystatin is not listed under the Drug Price Control Order (DPCO), allowing manufacturers to set prices based on market dynamics. For exports, the Directorate General of Foreign Trade (DGFT) mandates a No Objection Certificate (NOC) to ensure compliance with international standards and regulations.

5Patent & Exclusivity Status

Nystatin, first discovered in the 1950s, is no longer under patent protection, facilitating the production and export of generic versions by multiple manufacturers. This has led to a competitive market with numerous Indian exporters supplying nystatin globally.

6Recent Industry Developments

In August 2021, the FDA issued revised draft guidance for generic nystatin topical powders, emphasizing the need for comparative physicochemical and structural characterization to establish pharmaceutical equivalence.

In June 2023, the WHO updated its Model List of Essential Medicines, reaffirming the inclusion of nystatin for the treatment of fungal infections, underscoring its continued global importance.

In January 2024, the Indian Ministry of Health and Family Welfare announced plans to streamline the export NOC process for pharmaceuticals, aiming to reduce approval times and enhance the competitiveness of Indian exporters in the global market.

In March 2024, the EMA released updated GMP guidelines, affecting the manufacturing standards for nystatin and other pharmaceuticals intended for the European market.

In December 2024, the NPPA conducted a review of essential medicines pricing, though nystatin remained outside the purview of price controls, allowing market-driven pricing to continue.

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

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Global Price Benchmark — Nystatin

Retail & reference prices across 9 markets vs. India FOB export price of $26.10/unit

Global Price Benchmark for Nystatin across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	Data not available	USD	The FDA Orange Book lists Nystatin 500,000 IU tablets as an approved formulation; however, specific pricing data is not publicly disclosed.
United Kingdom	Data not available	GBP	The NHS Drug Tariff includes Nystatin 500,000 IU tablets; specific pricing details are not publicly disclosed.
Germany	Data not available	EUR	The Federal Institute for Drugs and Medical Devices (BfArM) lists Nystatin 500,000 IU tablets; specific pricing details are not publicly disclosed.
Australia

Supply Chain Risk Assessment — Nystatin

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

HIGH RISK

1API Sourcing & Raw Material Dependency

India is a leading producer of Active Pharmaceutical Ingredients (APIs), including Nystatin. However, the production of APIs often relies on Key Starting Materials (KSMs), which are predominantly 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. This reliance poses a risk, as any disruption in the supply of KSMs from China can directly impact API production in India.

Recent geopolitical tensions have exacerbated these risks. In February 2026, military strikes in the Middle East led to the closure of the Strait of Hormuz, a critical maritime chokepoint. This disruption has significantly affected global shipping routes, including those essential for transporting raw materials necessary for pharmaceutical manufacturing. The United Nations Conference on Trade and Development (UNCTAD) reported that the closure has led to a sharp decline in maritime transit, affecting about 20% of the world's daily oil supply and significant volumes of liquefied natural gas (LNG). Such disruptions can delay the delivery of essential KSMs to India, thereby impacting the production and export of Nystatin.

2Supplier Concentration & Single-Source Risk

The export market for Nystatin from India is notably concentrated. The top five exporters—AGOG PHARMA LIMITED, ZYDUS LIFESCIENCES LIMITED, LINCOLN PHARMACEUTICALS LTD, MEDLEY PHARMACEUTICALS LIMITED, and TORRENT PHARMACEUTICALS LTD—collectively account for 60.1% of total exports. AGOG PHARMA LIMITED alone holds a 20.4% share. This high level of supplier concentration increases the risk of supply chain disruptions, as issues affecting any of these key players could significantly impact the availability of Nystatin in international markets.

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Frequently Asked Questions — Nystatin Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top nystatin exporters from India?

The leading nystatin exporters from India are AGOG PHARMA LIMITED, ZYDUS LIFESCIENCES LIMITED, LINCOLN PHARMACEUTICALS LTD, and 12 others. AGOG PHARMA LIMITED leads with 20.4% market share ($10.7M). The top 5 suppliers together control 60.1% of total export value.

What is the total export value of nystatin from India?

The total export value of nystatin from India is $52.3M, recorded across 2,442 shipments from 223 active exporters to 96 countries. The average shipment value is $21.4K.

Which countries import nystatin from India?

India exports nystatin to 96 countries. The top importing countries are UNITED STATES (40.9%), UGANDA (20.4%), MOZAMBIQUE (9.5%), NIGERIA (2.6%), DOMINICAN REPUBLIC (2.4%), which together account for 75.8% of total export value.

What is the HS code for nystatin exports from India?

The primary HS code for nystatin exports from India is 30049029. 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.

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Top Nystatin Exporters from India

Top Countries Importing Nystatin from India

Who Supplies Nystatin to India?

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Regulatory Landscape — Nystatin

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 — Nystatin

Supply Chain Risk Assessment — Nystatin

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Nystatin Trade Intelligence

Frequently Asked Questions — Nystatin Exports from India

Who are the top nystatin exporters from India?

What is the total export value of nystatin from India?

Which countries import nystatin from India?

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

Which ports handle nystatin exports from India?

Why is India a leading exporter of nystatin?

What certifications do Indian nystatin exporters need?

How many buyers import nystatin from India?

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

Analysis Methodology