The Global Montelukast Sodium Market was valued at USD 62.10 Million in 2025 and is projected to reach USD 145 Million by 2034, growing at a Compound Annual Growth Rate (CAGR) of 14.1% during the forecast period (2024–2034). This robust growth is fueled by a large and persistent global patient base for asthma and allergic rhinitis, the convenience of oral administration, and its established role as an add-on therapy when inhaled medications alone are insufficient for symptom control.

As the pharmaceutical industry navigates competitive pricing, stringent regulatory standards, and the drive for high-purity Active Pharmaceutical Ingredients (APIs), the focus intensifies on the key manufacturers who ensure a reliable, high-quality supply of this critical medication. In this blog, we profile the Top 10 Companies in the Montelukast Sodium Industry—a group of established pharmaceutical giants and specialized API producers shaping the accessibility and future of respiratory care worldwide.

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🔟 1. Morepen Laboratories

Headquarters: New Delhi, India
Key Offering: Montelukast Sodium API (Amorphous & Crystalline)

Morepen Laboratories is a leading Indian manufacturer of Active Pharmaceutical Ingredients (APIs) and a significant global supplier of Montelukast Sodium. The company has established robust manufacturing capabilities and holds approvals from major regulatory bodies, including the US FDA, making it a key player in both domestic and international markets.

Strategic Initiatives:

• Significant investment in API manufacturing capacity expansion

• Focus on cost-efficient production to compete in the generic market

• Strong portfolio of APIs for chronic disease management

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Montelukast Sodium Market – View in Detailed Research Report

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9️⃣ 2. Mylan (now part of Viatris)

Headquarters: Canonsburg, Pennsylvania, USA
Key Offering: Montelukast Sodium Tablets & Chewables

Mylan, now operating under the global brand Viatris following a merger, is a powerhouse in generic pharmaceuticals. The company is a major marketer of finished-dose Montelukast Sodium products globally, leveraging its extensive distribution network to supply affordable asthma and allergy medications to millions of patients.

Strategic Initiatives:

• Global supply chain optimization for wide accessibility

• Commitment to expanding access to essential medicines in emerging markets

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8️⃣ 3. Teva Active Pharmaceutical Industries (TAPI)

Headquarters: Petach Tikva, Israel
Key Offering: Montelukast Sodium API

TAPI, the API division of Teva Pharmaceutical Industries, is one of the world’s largest API manufacturers. With a vast portfolio and a strong focus on quality and compliance, TAPI is a critical supplier of Montelukast Sodium API to pharmaceutical companies worldwide, supporting the production of generic versions of the drug.

Strategic Initiatives:

• Leadership in complex generic API development and manufacturing

• Continuous process optimization to ensure supply reliability and cost-effectiveness

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7️⃣ 4. Aurobindo Pharma

Headquarters: Hyderabad, India
Key Offering: Montelukast Sodium API and Formulations

Aurobindo Pharma is a vertically integrated Indian pharmaceutical company with a formidable presence in the API space. It manufactures and supplies Montelukast Sodium API and also produces a range of finished formulations, allowing it to capture value across the supply chain.

Strategic Initiatives:

• Vertical integration strategy from APIs to finished dosages

• Aggressive expansion in regulated markets like the US and Europe

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Montelukast Sodium Market – View in Detailed Research Report

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6️⃣ 5. Hetero Labs

Headquarters: Hyderabad, India
Key Offering: Montelukast Sodium API

Hetero Labs is another major Indian API manufacturer with a strong global footprint. The company is known for its expertise in reverse engineering and producing high-quality generic APIs, including Montelukast Sodium, and holds numerous approvals from international regulatory agencies.

Strategic Initiatives:

• Strong R&D focus on developing efficient and scalable synthesis processes

• Strategic partnerships with global pharmaceutical companies for API supply

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5️⃣ 6. Lunan Pharmaceutical Group

Headquarters: Linshu, Shandong, China
Key Offering: Montelukast Sodium API and Formulations

Lunan Pharmaceutical is a leading Chinese pharmaceutical company with a comprehensive product portfolio. It is a significant producer of Montelukast Sodium both as an API and in various finished dosage forms, catering primarily to the vast domestic market and expanding internationally.

Strategic Initiatives:

• Dominant position in the high-volume Chinese pharmaceutical market

• Investment in modernizing manufacturing facilities to meet international GMP standards

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4️⃣ 7. Unimark Remedies

Headquarters: Mumbai, Maharashtra, India
Key Offering: Montelukast Sodium API

Unimark Remedies specializes in the manufacture of APIs and intermediates, with a focus on niche molecules. The company has carved out a space in the Montelukast Sodium market through its dedicated manufacturing capabilities and consistent quality, supplying to formulation companies globally.

Strategic Initiatives:

• Specialization in complex API synthesis

• Focus on building long-term supply agreements with key customers

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3️⃣ 8. Ortin Laboratories

Headquarters: Hyderabad, Telangana, India
Key Offering: Montelukast Sodium API

Ortin Laboratories is an emerging player in the API sector, focusing on the development and manufacturing of a select portfolio of products, including Montelukast Sodium. The company emphasizes research-driven processes to ensure competitive production.

Strategic Initiatives:

• Investment in process chemistry to improve yield and purity

• Targeting growth through exports to semi-regulated and regulated markets

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2️⃣ 9. Arromax Pharmaceutical Technology

Headquarters: Wuhan, Hubei, China
Key Offering: Montelukast Sodium API

Arromax is a Chinese pharmaceutical company engaged in the R&D, production, and sale of APIs and pharmaceutical intermediates. It contributes to the global Montelukast Sodium supply chain with its manufacturing expertise and cost-competitive offerings.

Strategic Initiatives:

• Leveraging China’s strong chemical manufacturing base for cost advantages

• Expanding its international customer base for API exports

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1️⃣ 10. Dongyue Group

Headquarters: Zibo, Shandong, China
Key Offering: Key Chemical Intermediates for Montelukast Sodium

While not a direct manufacturer of the final API, Dongyue Group is a critical upstream player. As a major chemical company, it supplies key fluorochemical and other specialty intermediates that are essential for the synthesis of Montelukast Sodium, influencing the supply chain’s stability and cost structure.

Strategic Initiatives:

• Leading producer of fluorochemicals used in pharmaceutical synthesis

• Vertical integration within the chemical supply chain to ensure raw material security

Get Full Report Here:
Montelukast Sodium Market – View in Detailed Research Report

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🌍 Outlook: The Future of Montelukast Sodium Is Driven by Accessibility and Innovation

The Montelukast Sodium market is characterized by intense competition and price pressure, yet it remains a vital component of global respiratory therapy. The industry’s trajectory is being shaped by the strategic moves of API manufacturers to optimize costs, ensure quality, and navigate a complex regulatory landscape.

📈 Key Trends Shaping the Market:

• Increasing API production capacity in Asia, particularly India and China, to meet global generic demand

• Stricter regulatory scrutiny on impurity profiles (e.g., nitrosamines) requiring advanced purification technologies

• Growing demand in emerging markets due to rising prevalence of asthma and allergic rhinitis

• Competition from alternative therapies, including inhaled corticosteroids and biologics, pushing manufacturers to maintain cost-effectiveness

Get Full Report Here:
Montelukast Sodium Market – View in Detailed Research Report

The companies listed above are not only supplying a critical respiratory medication—they are upholding the standards of quality and affordability that make chronic disease management accessible to patients around the world.