Who Exports Montelukast from India — 510 Suppliers Behind a $168.3M Market
India's montelukast export market is supplied by 510 active exporters who collectively shipped $168.3M across 6,431 shipments. MACLEODS PHARMACEUTICALS LTD leads with a 38.2% market share, followed by UNICHEM LABORATORIES LIMITED and AJANTA PHARMA LIMITED. The top 5 suppliers together control 64.8% of total export value, reflecting a concentrated market structure.

Top Montelukast Exporters from India — Ranked by Export Value
MACLEODS PHARMACEUTICALS LTD is the leading montelukast exporter from India, holding a 38.2% share of the $168.3M market across 6,431 shipments from 510 exporters. The top 5 suppliers — MACLEODS PHARMACEUTICALS LTD, UNICHEM LABORATORIES LIMITED, AJANTA PHARMA LIMITED, DR.REDDY'S LABORATORIES LTD, CIPLA LIMITED — collectively control 64.8% of total export value, indicating a moderately concentrated market. Individual shares are: MACLEODS PHARMACEUTICALS LTD (38.2%), UNICHEM LABORATORIES LIMITED (8.8%), AJANTA PHARMA LIMITED (7.3%), DR.REDDY'S LABORATORIES LTD (5.6%), CIPLA LIMITED (4.9%).
Top Montelukast Exporters from India
Ranked by export value · 510 active suppliers · Indian Customs (DGFT) data
| # | Supplier & Formulations | Value | Ctry. | Share |
|---|---|---|---|---|
| 1 | MACLEODS PHARMACEUTICALS LTD MONTELUKAST SODIUM 10MG TABLETS-NDC NO.NO.68001-0361-03,MONTELUKAST SODIUM 10MG TABLETSSINTAIR 10MG TABLET | $64.3M | 16 | 38.2% |
| 2 | UNICHEM LABORATORIES LIMITED MONTELUKAST SODIUM 10MG TABLETS-NDC NO.NO.68001-0361-03,MONTELUKAST SODIUM 10MG TABLETS | $14.8M | 3 | 8.8% |
| 3 | AJANTA PHARMA LIMITED MONTELUKAST SODIUM 10MG TABLETS-NDC NO.NO.68001-0361-03,MONTELUKAST SODIUM 10MG TABLETS | $12.2M | 5 | 7.3% |
| 4 | DR.REDDY'S LABORATORIES LTD MONTELUKAST SODIUM 10MG TABLETS-NDC NO.NO.68001-0361-03,MONTELUKAST SODIUM 10MG TABLETSMONTELUKAST 10MG TABLETS PACK OF 2 X14 | $9.4M | 4 | 5.6% |
| 5 | CIPLA LIMITED MONTAIR 5 MG TABS ..MONTAIR 4 TABLETSMONTAIR 10 TABLETS . | $8.2M | 5 | 4.9% |
| 6 | TORRENT PHARMACEUTICALS LTD MONTELUKAST SODIUM 10MG TABLETS-NDC NO.NO.68001-0361-03,MONTELUKAST SODIUM 10MG TABLETSMONTELUKAST 10MG TABLETS PACK OF 2 X14 | $5.4M | 14 | 3.2% |
| 7 | HETERO LABS LIMITED MONTELUKAST SODIUM 10MG TABLETS-NDC NO.NO.68001-0361-03,MONTELUKAST SODIUM 10MG TABLETS | $4.3M | 8 | 2.5% |
| 8 | INTAS PHARMACEUTICALS LIMITED MONTELUKAST 10MG TABLETS PACK OF 2 X14PHARM.DRUGS&MEDICINE.MONTELUKAST SANDOZMONTELUKAST 10MG FILMCOATED TAB 28S GPEL | $3.8M | 10 | 2.2% |
| 9 | INDOCO REMEDIES LIMITED MONTELUKAST 10MG TABLETS PACK OF 2 X14MONTELUKAST 10MG FILMCOATED TAB 28S GPEL | $3.6M | 2 | 2.1% |
| 10 | MSN LABORATORIES PRIVATE LIMITED MONTAIR 5 MG TABS ..MONTAIR 4 TABLETSMONTAIR 10 TABLETS . | $3.2M | 18 | 1.9% |
| 11 | TORRENT PHARMACEUTICALS LIMITED MONTELUKAST SODIUM 10MG TABLETS-NDC NO.NO.68001-0361-03,MONTELUKAST SODIUM 10MG TABLETSMONTELUKAST 10MG TABLETS PACK OF 2 X14 | $3.1M | 13 | 1.8% |
| 12 | DR REDDYS LABORATORIES LIMITED MONTELUKAST SODIUM 10MG TABLETS-NDC NO.NO.68001-0361-03,MONTELUKAST SODIUM 10MG TABLETSMONTELUKAST 10MG TABLETS PACK OF 2 X14 | $2.7M | 3 | 1.6% |
| 13 | SANDOZ PRIVATE LIMITED MATERIAL NO- 44087978 MONTELUKAST SOD 10MG 30FCT BO CNMATERIAL NO. - 44087978 - MONTELUKAST SOD 10MG 30FCT BO CNMATERIAL NO 44087978 MONTELUKAST SOD 10MG 30FCT BO CN | $2.1M | 1 | 1.2% |
| 14 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | $1.9M | 6 | 1.1% |
| 15 | MICRO LABS LIMITED MONTAIR 5 MG TABS ..MONTAIR 4 TABLETSMONTAIR 10 TABLETS . | $1.8M | 7 | 1.1% |
Related Analysis
Supplier Certification & Compliance Matrix
FDA, WHO-GMP, and EU GMP status for top Montelukast exporters
| Supplier | US FDA | WHO-GMP | EU GMP | ANDAs | Notes |
|---|---|---|---|---|---|
| Dr. Reddy's Laboratories Ltd. | Approved | Yes | Yes | Over 190 | Dr. Reddy's Laboratories Ltd. has received FDA approval, holds WHO-GMP and EU GM |
| Unichem Laboratories Limited | Approved | Yes | Yes | Over 70 | Unichem Laboratories Limited has received FDA approval, holds WHO-GMP and EU GMP |
| Intas Pharmaceuticals Limited | Approved | Yes | Yes | Over 89 | Intas Pharmaceuticals Limited has received FDA approval, holds WHO-GMP and EU GM |
| Ajanta Pharma Limited | Approved | Yes | Yes | Over 27 | Ajanta Pharma Limited has received FDA approval, holds WHO-GMP and EU GMP certif |
| Torrent Pharmaceuticals Limited | Approved | Yes | Yes | Over 200 | Torrent Pharmaceuticals Limited has received FDA approval, holds WHO-GMP and EU |
| Cipla Limited | Approved | Yes | Yes | Over 150 | Cipla Limited has received FDA approval, holds WHO-GMP and EU GMP certifications |
| Sun Pharmaceutical Industries Limited | Approved | Yes | Yes | Over 400 | Sun Pharmaceutical Industries Limited has received FDA approval, holds WHO-GMP a |
| Micro Labs Limited | Approved | Yes | Yes | Over 50 | Micro Labs Limited has received FDA approval, holds WHO-GMP and EU GMP certifica |
TransData Nexus reviewed the regulatory standing of 8 leading Montelukast exporters from India. 8 hold US FDA facility approvals, 8 maintain WHO-GMP certification, and 8 are EU GMP compliant. For regulated markets (US, EU, Australia), prioritise suppliers with active FDA or EU GMP approvals. For semi-regulated markets (Africa, ASEAN, Latin America), WHO-GMP certification is the minimum recommended standard.
Certification status compiled from publicly available regulatory databases including FDA Orange Book, WHO Prequalification database, and EMA GMP registry. Buyers should independently verify compliance status with the relevant regulatory authority before placing orders.
TransData Nexus Research · Mar 2026
Manufacturing Hub Analysis — Vendor Proximity
India's pharmaceutical clusters relevant to Montelukast sourcing
1Hyderabad — Bulk Drug Capital
Hyderabad, often referred to as the "Bulk Drug Capital of India," is a pivotal hub for the production of active pharmaceutical ingredients (APIs), including Montelukast. The city's pharmaceutical landscape is characterized by a robust infrastructure, a skilled workforce, and a favorable regulatory environment. Companies such as Granules India, headquartered in Hyderabad, exemplify the region's capacity for large-scale API manufacturing. This concentration of API producers ensures a steady supply of Montelukast's raw materials, facilitating both domestic formulation and international export.
2Ahmedabad-Vadodara — Formulations Hub
The Ahmedabad-Vadodara corridor in Gujarat is renowned for its focus on pharmaceutical formulations. This region hosts numerous companies specializing in the development and production of finished dosage forms of Montelukast. Alembic Pharmaceuticals, based in Vadodara, is a notable example, contributing significantly to the formulation and export of Montelukast products. The area's emphasis on formulations complements the API production in Hyderabad, creating a seamless supply chain from raw material to finished product.
3Mumbai-Thane-Raigad — Export Gateway
The Mumbai-Thane-Raigad belt serves as a critical export gateway for pharmaceutical products, including Montelukast. This region's well-developed port infrastructure, particularly the Nhava Sheva Sea Port, facilitates efficient international distribution. Companies operating in this area leverage the logistical advantages to export Montelukast formulations to key markets such as the United States, which accounted for 58.1% of India's Montelukast exports between 2022 and 2026.
4Baddi-Nalagarh — Tax Incentive Zone
The Baddi-Nalagarh region in Himachal Pradesh has emerged as a significant pharmaceutical manufacturing zone, largely due to favorable tax incentives. This area attracts numerous pharmaceutical companies, contributing to the production of various drugs, including Montelukast. The fiscal benefits and supportive infrastructure make Baddi-Nalagarh an attractive location for cost-effective manufacturing, enhancing the competitiveness of Indian Montelukast in global markets.
5Sourcing Recommendations
- Diversify Supplier Base: Engage with multiple API manufacturers in Hyderabad to mitigate supply chain risks and ensure a consistent supply of Montelukast raw materials.
- Leverage Formulation Expertise: Collaborate with formulation specialists in the Ahmedabad-Vadodara region to develop high-quality Montelukast products tailored to target markets.
- Optimize Export Logistics: Utilize the Mumbai-Thane-Raigad corridor's port facilities to streamline export processes and reduce lead times for international shipments.
- Explore Cost Advantages: Consider manufacturing partnerships in the Baddi-Nalagarh region to benefit from tax incentives and cost efficiencies in Montelukast production.
By strategically engaging with these pharmaceutical clusters, companies can enhance their Montelukast supply chain resilience and capitalize on India's robust pharmaceutical infrastructure.
Recent M&A, Collaborations & Capacity Expansions
Industry developments among top Montelukast exporters from India
Unichem Laboratories Limited — Torrent Pharmaceuticals acquires Unichem Laboratories
In December 2017, Torrent Pharmaceuticals completed the acquisition of Unichem Laboratories Limited. This strategic move aimed to enhance Torrent's market presence and product portfolio. IMPACT: The acquisition may have influenced Unichem's Montelukast export operations, potentially affecting market dynamics.
Impact: The acquisition may have influenced Unichem's Montelukast export operations, potentially affecting market dynamics.
Dr. Reddy's Laboratories Ltd — Dr. Reddy's partners for Sputnik V vaccine trials in India
In September 2020, Dr. Reddy's Laboratories partnered with the Russian Direct Investment Fund to conduct phase 3 trials of the Sputnik V COVID-19 vaccine in India. This collaboration also included manufacturing and distribution rights for up to 100 million doses. IMPACT: While not directly related to Montelukast, this partnership may have impacted Dr. Reddy's resource allocation and focus.
Impact: While not directly related to Montelukast, this partnership may have impacted Dr. Reddy's resource allocation and focus.
Dr. Reddy's Laboratories Ltd — Dr. Reddy's acquires Germany's Betapharm for €480 million
In March 2006, Dr. Reddy's Laboratories acquired Betapharm Arzneimittel GmbH, Germany's fourth-largest generics pharmaceutical company, for €480 million. This acquisition aimed to strengthen Dr. Reddy's presence in the European market. IMPACT: The acquisition expanded Dr. Reddy's market reach, potentially influencing its Montelukast export strategy.
Impact: The acquisition expanded Dr. Reddy's market reach, potentially influencing its Montelukast export strategy.
Common Questions — Montelukast Suppliers from India
Answers based on Indian Customs (DGFT) shipment records compiled by TransData Nexus
Q Which montelukast supplier from India is the most reliable for bulk orders?
Based on shipment frequency and export consistency, MACLEODS PHARMACEUTICALS LTD leads with 231 recorded shipments worth $64.3M. UNICHEM LABORATORIES LIMITED (262 shipments) and AJANTA PHARMA LIMITED (128 shipments) are also established high-volume exporters.
Q How many montelukast manufacturers are there in India?
India has 510 active montelukast exporters with a combined export market of $168.3M across 6,431 shipments to 138 countries. The top 5 suppliers hold 64.8% of total export value.
Q What certifications should I verify?
Verify: WHO-GMP certification (most markets), US FDA approval (United States), EU GMP certificate (EU/EEA), and Free Sale Certificate from CDSCO. Always request a Certificate of Analysis (CoA) and Certificate of Origin (CoO).
Q What is the typical price range for montelukast from India?
Average FOB unit price: $10.60 per unit, ranging from $0.00 to $17964.27. Average shipment value: $26.2K.
Official References & Regulatory Resources
- CDSCO India
- Pharmexcil
- IBEF — India Pharma Industry
- Ministry of Commerce — Pharma Exports
- India Trade Statistics (DGFT)
Verify manufacturer licensing and export certifications with the official agencies above.
Research Methodology & Data Transparency
Suresh Sormare
Verified AuthorPharmaceutical 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/sureshsormarePrimary 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.
Analysis Methodology
- 1.Supplier Ranking: 510 verified Indian exporters of Montelukast ranked by capped export value from DGFT shipping bill records.
- 2.Export Value Analysis: Total export value aggregated from 6,431 individual shipping bill records. Values are FOB in USD.
- 3.Statistical Normalization: Shipment values are statistically normalized to ensure accurate market share representation.
- 4.Market Concentration: Supplier market share and geographic reach analyzed across 138 destination countries.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
6,431 Verified Shipments
510 exporters tracked
Expert-Reviewed
By pharmaceutical trade specialists