Proguanil Export Market Intelligence: India's 38 Suppliers Shipping to 41 Countries — TransData Nexus 2026

Q: Who are the top proguanil exporters from India?

The top proguanil exporters from India are: 1. MYLAN LABORATORIES LIMITED — $931.0M (99.8% market share); 2. GLENMARK PHARMACEUTICALS LIMITED — $993.6K (0.1% market share); 3. HETERO LABS LIMITED — $378.4K (0.0% market share); 4. MANCARE PHARMACEUTICALS PRIVATE LIMITED — $354.1K (0.0% market share); 5. BDH INDUSTRIES LIMITED — $123.2K (0.0% market share). Together they account for 100.0% of India's total proguanil export value.

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

The total export value of proguanil from India is $933.3M USD, recorded across 382 shipment transactions from 38 active exporters to 41 destination countries. The average shipment value is $2.4M.

Q: Which countries import proguanil from India?

India exports proguanil to 41 countries worldwide. The top importing countries are: HUNGARY (99.4% share, $927.3M), UNITED STATES (0.4% share, $3.4M), GERMANY (0.1% share, $741.0K), NIGERIA (0.1% share, $639.2K), CANADA (0.0% share, $387.5K). These five markets account for 99.9% of total export value.

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

The primary HS code for proguanil 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 proguanil exports from India?

The average unit price for proguanil exports from India is $5.70 USD per unit, with prices ranging from $0.04 to $551.15 depending on formulation, packaging, and order volume. The total market is valued at $933.3M across 382 shipments.

Q: Which ports handle proguanil exports from India?

The primary ports for proguanil exports from India are SAHAR AIR (40.3% of shipments), SAHAR AIR CARGO ACC (INBOM4) (26.2% of shipments), Bombay Air (6.5% of shipments), JNPT (5.5% of shipments), NHAVA SHEVA SEA (INNSA1) (5.2% 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 proguanil?

India is one of the world's leading exporters of proguanil due to its large base of 38 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 proguanil to 41 countries, demonstrating 21% global market coverage.

Q: What certifications do Indian proguanil exporters need?

Indian proguanil 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 proguanil from India?

There are 197 registered buyers importing proguanil from India, spread across 41 countries. The repeat buyer rate is 33.0%, indicating strong long-term trade relationships and consistent product quality.

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

MYLAN LABORATORIES LIMITED is the leading proguanil exporter from India with a market share of 99.8% and total export value of $931.0M across 47 shipments. The top 5 suppliers together control 100.0% of total export value.

Suresh Sormare

Proguanil

India Pharmaceutical Trade Intelligence

$933.3M38 Suppliers41 CountriesHS 30049099

ExportsIndia → HUNGARY99.4%India → UNITED STATES0.4%

ImportsUNITED STATES → India$15.0K IRELAND → India$2.3K

#1 Supplier: MYLAN LABORATORIES #1 Buyer: MYLAN HUNGARY

Proguanil Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Proguanil to the World

Between 2022 and 2026, India exported $933.3M worth of proguanil across 382 verified shipments to 41 countries — covering 21% of world markets in the Antimalarial & Antiparasitic segment. The largest destination is HUNGARY (99.4%). MYLAN LABORATORIES LIMITED leads with a 99.8% 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·

Proguanil export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Proguanil export data snapshot — $933.3M · 38 exporters · 41 countriesTransData Nexus · Indian Customs Data

Top Proguanil Exporters from India

38 active exporters · Ranked by export value

View all 38 →

Top Proguanil Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	MYLAN LABORATORIES LIMITED	$931.0M	47	4	99.8%
2	GLENMARK PHARMACEUTICALS LIMITED

Top Countries Importing Proguanil from India

41 destination markets · Ranked by import value

All 41 countries →

Top Countries Importing Proguanil from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	HUNGARY	$927.3M	99.4%
2	UNITED STATES	$3.4M	0.4%
3	GERMANY	$741.0K	0.1%
4	NIGERIA	$639.2K	0.1%
5	CANADA	$387.5K	0.0%
6	NETHERLANDS	$237.5K	0.0%
7	UNITED KINGDOM	$223.0K	0.0%
8	SOUTH AFRICA	$121.1K	0.0%
9	UNITED ARAB EMIRATES	$100.9K	0.0%
10	TURKEY	$99.7K	0.0%

HUNGARY is India's largest proguanil export destination, absorbing 99.4% of total exports worth $927.3M. The top 5 importing countries — HUNGARY, UNITED STATES, GERMANY, NIGERIA, CANADA — together account for 99.9% of India's total proguanil export value. The remaining 36 destination countries collectively receive the other 0.1%, indicating a focused distribution strategy targeting key markets.

Who Supplies Proguanil to India?

3 origin countries · Total import value: $17.3K

India imports proguanil from 3 countries with a combined import value of $17.3K. The largest supplier is UNITED STATES ($15.0K, 4 shipments), followed by IRELAND and CHINA. All values are from Indian Customs (DGFT) import records.

Countries Supplying Proguanil to India — Ranked by Import Value
#	Origin Country	Import Value (USD)	Shipments	Share
1	UNITED STATES	$15.0K	4	86.4%
2	IRELAND	$2.3K	2	13.2%
3	CHINA	$79	1	0.5%

UNITED STATES is the largest supplier of proguanil to India, accounting for 86.4% of total import value. Click any country to see detailed supplier and buyer data for that import corridor.

Regulatory Landscape — Proguanil

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

1FDA & US Market Regulatory Status

Proguanil is primarily available in the United States as part of the combination therapy atovaquone/proguanil, marketed under the brand name Malarone. According to the FDA's Orange Book, there are multiple approved Abbreviated New Drug Applications (ANDAs) for generic versions of this combination, indicating a competitive market landscape. Notably, the FDA has not issued any import alerts specific to proguanil or its combination products, suggesting compliance with regulatory standards. Given that only 0.4% of India's proguanil exports are directed to the United States, the market presence of Indian exporters in this segment appears limited.

2EU & UK Regulatory Framework

In the European Union, proguanil is authorized for use both as a monotherapy and in combination with atovaquone. The European Medicines Agency (EMA) oversees the approval and monitoring of these medicines, ensuring they meet stringent safety and efficacy standards. Similarly, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) regulates proguanil-containing products. Compliance with EU Good Manufacturing Practice (GMP) requirements is mandatory for manufacturers exporting to these regions, ensuring product quality and safety.

3WHO Essential Medicines & Global Standards

Proguanil was included in the WHO Model List of Essential Medicines until September 2025, when it was removed during the 24th list update. This removal reflects evolving treatment guidelines and the availability of alternative therapies. Proguanil is recognized in various pharmacopoeias, including the British Pharmacopoeia (BP) and the European Pharmacopoeia (EP), which set quality standards for medicinal substances.

4India Regulatory Classification

In India, proguanil 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) has not set a ceiling price for proguanil, allowing market-driven pricing. For exports, the Directorate General of Foreign Trade (DGFT) requires a No Objection Certificate (NOC) to ensure compliance with national regulations and to monitor the export of pharmaceutical products.

5Patent & Exclusivity Status

The primary patents for proguanil have expired, leading to the availability of generic versions and increased market competition. This patent expiration has facilitated the entry of multiple manufacturers into the market, contributing to the widespread availability of the drug.

6Recent Industry Developments

In May 2025, the WHO's 25th Expert Committee on Selection and Use of Essential Medicines convened to update the Model List of Essential Medicines. During this meeting, proguanil was removed from the list, reflecting changes in global treatment protocols and the availability of more effective antimalarial therapies. (who.int)

In September 2025, the WHO published the 24th edition of the Model List of Essential Medicines, which no longer includes proguanil. This update underscores the shift in global health priorities and the adoption of newer antimalarial treatments. (who.int)

These developments highlight the dynamic nature of the pharmaceutical landscape and the importance of staying informed about regulatory changes and market trends.

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

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Global Price Benchmark — Proguanil

Retail & reference prices across 9 markets vs. India FOB export price of $5.70/unit

Global Price Benchmark for Proguanil across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	$5.48	USD	According to the FDA, atovaquone/proguanil hydrochloride is approved for malaria prophylaxis and treatment.
United Kingdom	$7.08	GBP	The UK's Medicines and Healthcare products Regulatory Agency (MHRA) lists atovaquone/proguanil hydrochloride as a licensed medication for malaria prevention.
Germany	$6.50	EUR	The European Medicines Agency (EMA) has authorized atovaquone/proguanil hydrochloride for use in malaria prophylaxis.
Australia	$5.60

Supply Chain Risk Assessment — Proguanil

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

HIGH RISK

1API Sourcing & Raw Material Dependency

Proguanil's active pharmaceutical ingredient (API) production in India is heavily reliant on key starting materials (KSMs) sourced from China. This dependency is part of a broader trend where approximately 41% of KSMs used in U.S.-approved APIs are solely sourced from China, and 16% from India. Such concentration exposes the supply chain to risks associated with geopolitical tensions, trade disputes, and regulatory changes in these countries.

In recent years, environmental regulations in China have led to the shutdown of several chemical manufacturing plants, causing disruptions in the supply of KSMs. For instance, in July 2018, the closure of Chinese companies impacted Indian pharmaceutical players, leading to increased prices and supply uncertainties. These events underscore the vulnerability of the supply chain due to over-reliance on a limited number of sources for critical raw materials.

2Supplier Concentration & Single-Source Risk

Our proprietary trade data indicates that Mylan Laboratories Limited dominates Proguanil exports from India, accounting for 99.8% of the total export value between 2022 and 2026. This extreme supplier concentration poses significant risks, as any operational or compliance issues within Mylan could severely disrupt the global supply of Proguanil.

To mitigate such risks, the Indian government has implemented the Production Linked Incentive (PLI) scheme aimed at reducing dependency on imports for critical APIs and KSMs. In November 2024, two greenfield plants were inaugurated under this scheme to manufacture essential molecules like Penicillin G and 6-APA, marking a significant step towards self-reliance. However, the effectiveness of these initiatives in diversifying the supplier base for Proguanil remains to be seen.

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Frequently Asked Questions — Proguanil Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top proguanil exporters from India?

The leading proguanil exporters from India are MYLAN LABORATORIES LIMITED, GLENMARK PHARMACEUTICALS LIMITED, HETERO LABS LIMITED, and 7 others. MYLAN LABORATORIES LIMITED leads with 99.8% market share ($931.0M). The top 5 suppliers together control 100.0% of total export value.

What is the total export value of proguanil from India?

The total export value of proguanil from India is $933.3M, recorded across 382 shipments from 38 active exporters to 41 countries. The average shipment value is $2.4M.

Which countries import proguanil from India?

India exports proguanil to 41 countries. The top importing countries are HUNGARY (99.4%), UNITED STATES (0.4%), GERMANY (0.1%), NIGERIA (0.1%), CANADA (0.0%), which together account for 99.9% of total export value.

What is the HS code for proguanil exports from India?

The primary HS code for proguanil 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.

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Proguanil

Top Proguanil Exporters from India

Top Countries Importing Proguanil from India

Who Supplies Proguanil to India?

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Regulatory Landscape — Proguanil

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 — Proguanil

Supply Chain Risk Assessment — Proguanil

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Proguanil Trade Intelligence

Frequently Asked Questions — Proguanil Exports from India

Who are the top proguanil exporters from India?

What is the total export value of proguanil from India?

Which countries import proguanil from India?

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

Which ports handle proguanil exports from India?

Why is India a leading exporter of proguanil?

What certifications do Indian proguanil exporters need?

How many buyers import proguanil from India?

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

Analysis Methodology