Montelukast Export Market Intelligence: India's 510 Suppliers Shipping to 138 Countries — TransData Nexus 2026

Q: Who are the top montelukast exporters from India?

The top montelukast exporters from India are: 1. MACLEODS PHARMACEUTICALS LTD — $64.3M (38.2% market share); 2. UNICHEM LABORATORIES LIMITED — $14.8M (8.8% market share); 3. AJANTA PHARMA LIMITED — $12.2M (7.3% market share); 4. DR.REDDY'S LABORATORIES LTD — $9.4M (5.6% market share); 5. CIPLA LIMITED — $8.2M (4.9% market share). Together they account for 64.8% of India's total montelukast export value.

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

The total export value of montelukast from India is $168.3M USD, recorded across 6,431 shipment transactions from 510 active exporters to 138 destination countries. The average shipment value is $26.2K.

Q: Which countries import montelukast from India?

India exports montelukast to 138 countries worldwide. The top importing countries are: UNITED STATES (58.1% share, $97.8M), PHILIPPINES (7.9% share, $13.3M), SRI LANKA (5.1% share, $8.5M), UNITED KINGDOM (4.8% share, $8.1M), SOUTH AFRICA (4.0% share, $6.7M). These five markets account for 79.9% of total export value.

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

The primary HS code for montelukast 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 montelukast exports from India?

The average unit price for montelukast exports from India is $10.60 USD per unit, with prices ranging from $0.00 to $17964.27 depending on formulation, packaging, and order volume. The total market is valued at $168.3M across 6,431 shipments.

Q: Which ports handle montelukast exports from India?

The primary ports for montelukast exports from India are DELHI AIR CARGO ACC (INDEL4) (8.4% of shipments), NHAVA SHEVA SEA (INNSA1) (8.2% of shipments), SAHAR AIR (7.4% of shipments), SAHAR AIR CARGO ACC (INBOM4) (7.2% of shipments), DELHI AIR (7.0% 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 montelukast?

India is one of the world's leading exporters of montelukast due to its large base of 510 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 montelukast to 138 countries, demonstrating 71% global market coverage.

Q: What certifications do Indian montelukast exporters need?

Indian montelukast 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 montelukast from India?

There are 1,324 registered buyers importing montelukast from India, spread across 138 countries. The repeat buyer rate is 58.0%, indicating strong long-term trade relationships and consistent product quality.

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

MACLEODS PHARMACEUTICALS LTD is the leading montelukast exporter from India with a market share of 38.2% and total export value of $64.3M across 231 shipments. The top 5 suppliers together control 64.8% of total export value.

Suresh Sormare

Montelukast

India Pharmaceutical Trade Intelligence

$168.3M510 Suppliers138 CountriesHS 30049099

ExportsIndia → UNITED STATES58.1%India → PHILIPPINES7.9%

ImportsUNITED STATES → India$7.2K MALTA → India$6.9K

#1 Buyer: AMERISOURCE HEALTH

Montelukast Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Montelukast to the World

Between 2022 and 2026, India exported $168.3M worth of montelukast across 6,431 verified shipments to 138 countries — covering 71% of world markets in the Respiratory segment. The largest destination is UNITED STATES (58.1%). MACLEODS PHARMACEUTICALS LTD leads with a 38.2% 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 30049099

Montelukast export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Montelukast export data snapshot — $168.3M · 510 exporters · 138 countriesTransData Nexus · Indian Customs Data

Top Montelukast Exporters from India

510 active exporters · Ranked by export value

View all 510 →

Top Montelukast Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	MACLEODS PHARMACEUTICALS LTD	$64.3M	231	16	38.2%
2	UNICHEM LABORATORIES LIMITED

Top Countries Importing Montelukast from India

138 destination markets · Ranked by import value

All 138 countries →

Top Countries Importing Montelukast from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	UNITED STATES	$97.8M	58.1%
2	PHILIPPINES	$13.3M	7.9%
3	SRI LANKA	$8.5M	5.1%
4	UNITED KINGDOM	$8.1M	4.8%
5	SOUTH AFRICA	$6.7M	4.0%
6	UZBEKISTAN	$2.4M	1.4%
7	IRAQ	$2.3M	1.4%
8	CHINA	$2.1M	1.2%
9	JAMAICA	$1.8M	1.0%
10	AUSTRALIA	$1.5M	0.9%

UNITED STATES is India's largest montelukast export destination, absorbing 58.1% of total exports worth $97.8M. The top 5 importing countries — UNITED STATES, PHILIPPINES, SRI LANKA, UNITED KINGDOM, SOUTH AFRICA — together account for 79.9% of India's total montelukast export value. The remaining 133 destination countries collectively receive the other 20.1%, indicating a well-diversified global distribution network spanning all major continents.

Who Supplies Montelukast to India?

16 origin countries · Total import value: $22.5K

India imports montelukast from 16 countries with a combined import value of $22.5K. The largest supplier is UNITED STATES ($7.2K, 16 shipments), followed by MALTA and BRAZIL. All values are from Indian Customs (DGFT) import records.

Countries Supplying Montelukast to India — Ranked by Import Value
#	Origin Country	Import Value (USD)	Shipments	Share
1	UNITED STATES	$7.2K	16	32.1%
2	MALTA	$6.9K	15	30.7%
3	BRAZIL	$1.8K	2	8.1%
4	IRELAND	$1.4K	1	6.4%
5	UNITED KINGDOM	$1.1K	2	4.7%
6	PORTUGAL	$1.0K	1	4.6%
7	BULGARIA	$806	1	3.6%
8	GERMANY	$743	4	3.3%
9	NETHERLANDS	$466	2	2.1%
10	SOUTH AFRICA	$371	3	1.6%

Showing top 10 of 16 origin countries

UNITED STATES is the largest supplier of montelukast to India, accounting for 32.1% of total import value. The top 5 origin countries — UNITED STATES, MALTA, BRAZIL, IRELAND, UNITED KINGDOM — together supply 82.1% of India's montelukast imports. Click any country to see detailed supplier and buyer data for that import corridor.

Regulatory Landscape — Montelukast

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

1FDA & US Market Regulatory Status

In the United States, Montelukast is approved under the brand name Singulair, with numerous generic versions available. The FDA's Orange Book lists multiple approved Abbreviated New Drug Applications (ANDAs) for Montelukast Sodium Tablets, 10 mg. For instance, Sandoz Inc. received approval for its generic version on July 11, 2012. The regulatory pathway for Montelukast involves demonstrating bioequivalence to the reference listed drug, Singulair. Given the substantial number of active Indian exporters (510) supplying Montelukast to the U.S., it is imperative for these entities to adhere strictly to FDA regulations to maintain market access.

2EU & UK Regulatory Framework

In the European Union, Montelukast has been subject to regulatory scrutiny to ensure harmonized safety and efficacy standards. The European Medicines Agency (EMA) conducted a Periodic Safety Update Report Single Assessment (PSUSA) for Montelukast, resulting in a variation to its marketing authorization in May 2019. (ema.europa.eu) Additionally, in April 2008, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended harmonizing the Summary of Product Characteristics (SPC), labeling, and package leaflet for Singulair and associated names. (ema.europa.eu) Compliance with EU Good Manufacturing Practice (GMP) requirements is mandatory for Indian exporters targeting the EU and UK markets.

3WHO Essential Medicines & Global Standards

Montelukast is included in the World Health Organization's Model List of Essential Medicines, underscoring its importance in global health. The drug is also subject to international pharmacopoeia standards, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP). Adherence to these standards is crucial for ensuring the quality and efficacy of Montelukast in international markets.

4India Regulatory Classification

In India, Montelukast 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 Montelukast, allowing market-driven pricing. For export purposes, Indian manufacturers must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT), ensuring compliance with national regulations.

5Patent & Exclusivity Status

The primary patents for Montelukast have expired, leading to a competitive generic market. This has facilitated the entry of multiple generic manufacturers, including those from India, into global markets. The absence of patent restrictions has contributed to the significant export volume of Montelukast from India.

6Recent Industry Developments

In March 2025, the EMA published a list of nationally authorized medicinal products containing Montelukast, reflecting ongoing regulatory oversight. (ema.europa.eu) Additionally, in December 2025, the EMA's CHMP adopted a positive opinion recommending a new indication for Nucala (mepolizumab) in the treatment of chronic obstructive pulmonary disease (COPD), indicating evolving treatment landscapes in respiratory conditions. (ema.europa.eu) These developments highlight the dynamic nature of the pharmaceutical industry and the importance of staying abreast of regulatory changes.

In conclusion, the regulatory landscape for Montelukast is multifaceted, encompassing stringent requirements across major markets. Indian exporters must navigate these regulations diligently to maintain and expand their global market presence.

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

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Global Price Benchmark — Montelukast

Retail & reference prices across 9 markets vs. India FOB export price of $10.60/unit

Global Price Benchmark for Montelukast across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	$0.50	USD	According to the FDA's Orange Book, Montelukast is available as a generic medication, contributing to its affordability.
United Kingdom	$0.40	GBP	The NHS Drug Tariff lists Montelukast as a reimbursable item, ensuring standardized pricing across the UK.
Germany	$0.38	EUR	The Federal Institute for Drugs and Medical Devices (BfArM) regulates pharmaceutical pricing, maintaining consistent costs for medications like Montelukast.
Australia

Supply Chain Risk Assessment — Montelukast

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

MEDIUM RISK

1API Sourcing & Raw Material Dependency

Montelukast, a widely used leukotriene receptor antagonist, is primarily manufactured in India. However, the production of its Active Pharmaceutical Ingredient (API) heavily relies on Key Starting Materials (KSMs) sourced from China. China controls approximately 70–80% of the global KSM supply and 60–70% of the global intermediate supply, making it a dominant player in this sector. This dependency exposes the Montelukast supply chain to potential disruptions stemming from geopolitical tensions, trade policies, and environmental regulations in China.

Recent disruptions have underscored these vulnerabilities. Between 2022 and 2024, several major Montelukast API suppliers received FDA warning letters due to deficiencies in data integrity, contamination control, and batch release procedures. These regulatory actions temporarily constrained market supply and elevated compliance costs across the industry. Such incidents highlight the critical importance of maintaining robust quality management systems and the risks associated with over-reliance on a single source for raw materials.

2Supplier Concentration & Single-Source Risk

The export data from TransData Nexus indicates a significant concentration among Indian exporters of Montelukast. The top five exporters account for 64.8% of the total export value, with MACLEODS PHARMACEUTICALS LTD alone contributing 38.2%. This high supplier concentration poses a single-source risk, where disruptions affecting a major exporter can have cascading effects on the global supply chain.

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Frequently Asked Questions — Montelukast Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top montelukast exporters from India?

The leading montelukast exporters from India are MACLEODS PHARMACEUTICALS LTD, UNICHEM LABORATORIES LIMITED, AJANTA PHARMA LIMITED, and 12 others. MACLEODS PHARMACEUTICALS LTD leads with 38.2% market share ($64.3M). The top 5 suppliers together control 64.8% of total export value.

What is the total export value of montelukast from India?

The total export value of montelukast from India is $168.3M, recorded across 6,431 shipments from 510 active exporters to 138 countries. The average shipment value is $26.2K.

Which countries import montelukast from India?

India exports montelukast to 138 countries. The top importing countries are UNITED STATES (58.1%), PHILIPPINES (7.9%), SRI LANKA (5.1%), UNITED KINGDOM (4.8%), SOUTH AFRICA (4.0%), which together account for 79.9% of total export value.

What is the HS code for montelukast exports from India?

The primary HS code for montelukast 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.

Montelukast

Montelukast

Top Montelukast Exporters from India

Top Countries Importing Montelukast from India

Who Supplies Montelukast to India?

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Regulatory Landscape — Montelukast

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 — Montelukast

Supply Chain Risk Assessment — Montelukast

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Montelukast Trade Intelligence

Frequently Asked Questions — Montelukast Exports from India

Who are the top montelukast exporters from India?

What is the total export value of montelukast from India?

Which countries import montelukast from India?

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

Which ports handle montelukast exports from India?

Why is India a leading exporter of montelukast?

What certifications do Indian montelukast exporters need?

How many buyers import montelukast from India?

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

Analysis Methodology