Suppliers and packagers for singulair

singulair

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Organon	SINGULAIR	montelukast sodium	GRANULE;ORAL	021409	NDA	Organon LLC	78206-171-01	30 PACKET in 1 CARTON (78206-171-01) / 1 GRANULE in 1 PACKET	2021-06-01
Organon	SINGULAIR	montelukast sodium	TABLET, CHEWABLE;ORAL	020830	NDA	Organon LLC	78206-170-01	30 TABLET, CHEWABLE in 1 BOTTLE (78206-170-01)	2021-06-01
Organon	SINGULAIR	montelukast sodium	TABLET, CHEWABLE;ORAL	020830	NDA	Organon LLC	78206-173-01	30 TABLET, CHEWABLE in 1 BOTTLE (78206-173-01)	2021-06-01
Organon	SINGULAIR	montelukast sodium	TABLET;ORAL	020829	NDA	Organon LLC	78206-172-01	30 TABLET, FILM COATED in 1 BOTTLE (78206-172-01)	2021-06-01

Suppliers for the Pharmaceutical Drug: Singulair

Last updated: July 31, 2025

Introduction

Singulair (montelukast) is a widely prescribed medication used primarily to manage asthma, allergic rhinitis, and other respiratory conditions. Developed by Merck & Co., Singulair is a leukotriene receptor antagonist that helps reduce airway inflammation. Its global demand has led to a complex supply chain involving multiple manufacturers, active pharmaceutical ingredient (API) suppliers, and distributors. Understanding the landscape of Singulair suppliers is pivotal for stakeholders—ranging from pharmaceutical companies, healthcare providers, to investors—aiming to ensure drug availability, assess supply chain risks, or explore potential licensing opportunities.

Active Pharmaceutical Ingredient (API) Suppliers

The core component of Singulair is montelukast sodium, the API that imparts its therapeutic effects. API sourcing is critical to maintaining manufacturing quality, regulatory compliance, and cost efficiency. Several companies globally supply montelukast API, either through direct manufacturing partnerships or API licensing agreements.

Main API Producers

1. MS) (Manufacturing Sources)

   Historically, Merck was the prime manufacturer of montelukast API, leveraging in-house production facilities to ensure control over the supply chain. However, recent years have seen a diversification of API manufacturing via third-party suppliers, partly driven by patent expirations and cost considerations.

2. Teva Pharmaceutical Industries

   Teva is a significant API supplier of montelukast sodium, offering the API to generic manufacturers worldwide. Their manufacturing plants in Israel and India produce APIs compliant with regulatory standards such as GMP.

3. Hetero Labs (India)

   As a prominent generic pharmaceutical company, Hetero manufactures the montelukast API at scale, serving both domestic and international markets. Their manufacturing processes adhere to stringent quality controls, enabling them to supply to multiple generics manufacturers.

4. Cipla Ltd.

   Cipla supplies montelukast API produced through its GMP-compliant facilities, primarily catering to markets in Asia and Africa. Their API manufacturing capacity supports the production of generic Singulair equivalents.

5. Mingda Pharmaceutical (China)

   This Chinese API manufacturer has expanded its portfolio to include montelukast sodium, targeting both domestic and export markets. The company has achieved certifications such as EUGMP and USFDA approval for some facilities.

API Supply Chain Dynamics

The supply of montelukast API has faced challenges related to quality standards, regulatory approvals, and geopolitical factors affecting manufacturing locations. For example, regulatory scrutiny on Chinese and Indian API producers can impact supply continuity. Nonetheless, companies like Teva and Hetero have maintained steady supply chains through diversified production sites and compliance with international standards.

Formulation and Final Product Manufacturers

Post-API procurement, formulation and tablet manufacturing are carried out by various pharmaceutical firms. While Merck originally manufactured the brand-name Singulair, the patent expiration in 2012 catalyzed a surge of generic manufacturers.

1. Mylan (now part of Viatris)

   One of the leading producers of generic montelukast tablets, Mylan licensed the rights from Merck to manufacture generic versions post-patent expiry. Their manufacturing facilities in India and the US are major suppliers of generic Singulair.

2. Sun Pharmaceutical Industries

   As a global generics leader, Sun Pharma produces both finished formulations of montelukast and APIs, supplying numerous markets, especially in Asia, Africa, and emerging economies.

3. Alkem Laboratories

   Alkem manufactures and distributes generic montelukast tablets across multiple regions, benefiting from operational GMP compliance and extensive distribution networks.

4. Dr. Reddy's Laboratories

   Dr. Reddy’s produces both the API and finished formulations, providing competitive pricing and manufacturing flexibility.

5. Aurobindo Pharma

   Leveraging its robust API and formulation manufacturing capabilities, Aurobindo supplies montelukast-based medicines globally, including in the U.S. and Europe.

Market and Regulatory Influences

The supply landscape for Singulair is intricately linked with patent expirations, regulatory hurdles, and geopolitical shifts. With Merck’s patent expiry in 2012, the subsequent proliferation of generics intensified market competition, leading to a broad supplier base for API and finished drugs. Regulatory authorities like the USFDA and EMA rigorously inspect manufacturing practices ensuring API and formulations meet quality standards—impacting supply continuity and product credibility.

Emerging Trends in Supplier Landscape

• Diversification of API sources: To mitigate supply risk, pharmaceutical companies are increasingly engaging multiple API suppliers from various geographies.
• Regulatory compliance: Suppliers investing in GMP certifications, USFDA approvals, and EUGMP standards enhance credibility.
• Vertical integration: Companies like Sun Pharma and Aurobindo are expanding their manufacturing footprint to encompass both API and finished formulations.

Conclusion

The supply chain for Singulair is characterized by a diversified pool of API manufacturers, predominantly from India and China, and a robust network of finished product manufacturers globally. While Merck initially dominated production, the patent expiry catalyzed the growth of multiple generics players, improving access and reducing costs. Nevertheless, supply chain resilience depends on maintaining GMP standards, regulatory compliance, and sourcing diversification.

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Key Takeaways

• API market diversification: The API for Singulair is supplied by multiple players, reducing dependency on any single source and enhancing supply security.
• Regulatory compliance is critical: Suppliers maintaining GMP and obtaining approvals from agencies like USFDA or EMA are better positioned to serve global markets reliably.
• Patent expiry spurred competition: Generics companies rapidly increased their production capacity post-2012, expanding the supplier ecosystem.
• Geopolitical factors impact supply: US-China and India’s regulatory environments significantly influence API and finished drug manufacturing capacities.
• Supply chain resilience is essential: Companies should develop diversified sourcing strategies, monitor regulatory changes, and consider vertical integration for stability.

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FAQs

1. Who are the main API suppliers for Singulair?
Major API suppliers include Teva Pharmaceutical Industries, Hetero Labs (India), Cipla Ltd., and Mingda Pharmaceutical (China), all of whom produce GMP-compliant montelukast sodium.

2. How has patent expiration affected Singulair’s supply chain?
Patent expiration in 2012 led to increased manufacturing by multiple generic companies, diversifying the supplier base and reducing dependency on Merck.

3. What regulatory challenges influence Singulair’s supply?
Regulatory scrutiny from USFDA and EMA impacts API manufacturing facilities, affecting approval status, manufacturing continuity, and ultimately, drug availability.

4. Are there any risks associated with Singulair’s API sourcing?
Yes, reliance on suppliers from China and India introduces risks such as regulatory compliance issues, geopolitical tensions, and supply disruptions.

5. How do finished formulation manufacturers ensure supply stability?
By engaging multiple API suppliers, maintaining regulatory approvals, and expanding manufacturing capacity, companies improve stability and meet global demand.

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References

1. [1] Merck & Co. Official Website. (2022). Singulair: Drug Overview and Manufacturer Details.
2. [2] USFDA Drug Approvals Database. API manufacturing facilities for montelukast sodium.
3. [3] Market research reports on API supply chain dynamics for respiratory drugs.
4. [4] Indian Pharmaceutical Market Data (IQVIA).
5. [5] Chinese GMP-certified API manufacturers listing (CDE China).