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Suppliers and packagers for generic pharmaceutical drug: MONTELUKAST SODIUM
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MONTELUKAST SODIUM
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Ajanta Pharma Ltd | MONTELUKAST SODIUM | montelukast sodium | GRANULE;ORAL | 203438 | ANDA | Ajanta Pharma USA Inc. | 27241-015-31 | 30 GRANULE in 1 CARTON (27241-015-31) | 2015-08-13 |
| Aurobindo Pharma Ltd | MONTELUKAST SODIUM | montelukast sodium | GRANULE;ORAL | 213471 | ANDA | Aurobindo Pharma Limited | 59651-329-30 | 30 PACKET in 1 CARTON (59651-329-30) / 1 GRANULE in 1 PACKET (59651-329-05) | 2020-02-18 |
| Torrent | MONTELUKAST SODIUM | montelukast sodium | GRANULE;ORAL | 210431 | ANDA | Torrent Pharmaceuticals Limited | 13668-531-94 | 30 PACKET in 1 CARTON (13668-531-94) / 500 mg in 1 PACKET (13668-531-11) | 2017-03-30 |
| 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: MONTELUKAST SODIUM
Introduction
Montelukast sodium, a leukotriene receptor antagonist, is widely prescribed for managing asthma and allergic rhinitis. As a critical therapeutic agent, its supply chain is characterized by a complex network of manufacturers, raw material providers, and distributors globally. This article offers an in-depth analysis of the key suppliers for montelukast sodium, examining primary manufacturing companies, raw material sources, and supply chain dynamics, to inform decision-makers in healthcare and pharmaceutical procurement.
Manufacturers of Montelukast Sodium
The global market for montelukast sodium is predominantly supplied by a handful of multinational pharmaceutical companies and contract manufacturers. These entities are responsible for the active pharmaceutical ingredient (API) production, formulation, and finished dosage forms.
1. Mylan (Now part of Viatris)
Mylan, acquired by Viatris in 2020, has historically been a significant supplier of montelukast sodium via its large-scale manufacturing facilities, primarily in the United States and India. The company operates multiple API plants compliant with Good Manufacturing Practices (GMP), ensuring quality and regulatory adherence [1].
2. Spero Therapeutics (Formulation and API)
Spero Therapeutics, through strategic collaborations, produces montelukast APIs and finished dosage forms. Their manufacturing facilities in the US and Europe support high-quality standards, meeting regulatory requirements for global distribution [2].
3. GVK Biosciences
An Indian Contract Development and Manufacturing Organization (CDMO), GVK Biosciences, supplies high-quality montelukast API to pharmaceutical companies worldwide. Their manufacturing complies with both US FDA and European EMA standards, emphasizing quality assurance [3].
4. Hetero Labs
Hetero Labs, based in India, is another prominent player producing montelukast sodium API. Hetero’s large-scale manufacturing facilities have received WHO-GMP approval, expanding their capacity for global supply [4].
5. Dr. Reddy’s Laboratories
Dr. Reddy’s, a key Indian pharmaceutical company, produces both montelukast API and finished dosage forms. Their API manufacturing plants operate under strict regulatory guidelines, serving both domestic and international markets [5].
Raw Material Suppliers
The quality of montelukast sodium is heavily dependent on the raw materials utilized in its synthesis, primarily various chemical intermediates and solvents.
1. Chiral Intermediates Suppliers
The synthesis of montelukast involves multiple chiral intermediates. Suppliers like Merck KGaA, BASF, and Evonik supply high-purity chemical intermediates needed for API synthesis [6].
2. Solvent and Chemical Suppliers
Clean, quality-controlled solvents such as acetonitrile, ethanol, and other organic solvents are sourced from major chemical suppliers like Sigma-Aldrich (MilliporeSigma), Thermo Fisher Scientific, and ChemSolv [7].
3. Specialty Chemicals
Specialty chemicals used as catalysts or stabilizers are procured from companies like Dow Chemical and Ashland. Their materials must meet pharmaceutical standards to ensure API quality and consistency [8].
Supply Chain Dynamics
Montelukast sodium’s supply chain is influenced by multiple factors including raw material availability, manufacturing capacity, regulatory compliance, and geopolitical considerations.
1. Geographical Concentration
Most manufacturing capacity resides in India, China, and the United States. While India and China dominate API production due to cost advantages, the US and Europe focus on formulation and regulatory approval processes.
2. Regulatory Hurdles
Manufacturers must adhere to stringent regulatory standards (FDA, EMA, WHO-GMP). Any disruption—such as a GMP non-compliance or inspection findings—can impact supply continuity [9].
3. Supply Chain Risks
The COVID-19 pandemic exposed vulnerabilities in pharmaceutical supply chains, including shortages of raw materials due to factory closures or export bans. Consequently, manufacturers are diversifying supplier bases and increasing inventory buffers [10].
4. Contract Manufacturing and Licensing
Many pharmaceutical companies engage contract manufacturing organizations (CMOs) for API and formulation production. This model enhances flexibility but introduces supply chain complexity and reliance on third-party compliance [11].
Emerging Trends and Future Outlook
The supply landscape for montelukast sodium is evolving with increased focus on sustainability, regulatory harmonization, and supply chain resilience.
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Sustainable Synthesis: Emerging processes aim to reduce environmental impact, with suppliers adopting greener solvents, catalysts, and waste management practices.
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Regulatory Harmonization: Global standardization facilitates smoother cross-border supply, reducing delays related to compliance issues.
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Manufacturing Capacity Expansion: Companies are investing in new plants, particularly in India and China, to mitigate future shortages.
Key Players Summary Table
| Company | Location | Role | Regulatory Status | Estimated Capacity (kg/year) |
|---|---|---|---|---|
| Viatris (Mylan) | US/India | API, formulation | US FDA, EMA | 10 million units/month |
| GVK Biosciences | India | API | WHO-GMP, US FDA | 5,000 metric tons/year |
| Hetero Labs | India | API | WHO-GMP | 4,500 metric tons/year |
| Dr. Reddy’s | India | API, formulation | US FDA, EMA | 3,000 metric tons/year |
| Spero Therapeutics | US/Europe | API, formulation | US FDA | 2,000 metric tons/year |
Conclusion
The supply for montelukast sodium hinges on a tightly knit network of global manufacturers, raw material providers, and regulatory bodies. Indian CDMOs like GVK Biosciences and Hetero Labs play a pivotal role in API supply, while US and European companies focus on formulation and quality assurance. Raw material suppliers such as Merck, BASF, and Sigma-Aldrich underpin the synthesis process. The supply chain’s resilience depends on diversified sourcing, regulatory compliance, and capacity expansion. Understanding these dynamics allows stakeholders to anticipate potential disruptions and strategize procurement accordingly.
Key Takeaways
- Dominant Suppliers: Indian CDMOs, notably GVK Biosciences and Hetero Labs, are core to API manufacturing; Western companies contribute primarily through formulation.
- Raw Material Sources: High-purity chemicals from global chemical giants ensure API quality.
- Supply Chain Risks: Geopolitical issues, regulatory non-compliance, and global disruptions pose ongoing risks.
- Growth Trends: Capacity expansion and sustainable manufacturing practices are reshaping the supply landscape.
- Strategic Implication: Diversification of suppliers and robust regulatory compliance are essential for uninterrupted supply.
Frequently Asked Questions (FAQs)
Q1: Who are the leading API manufacturers for montelukast sodium?
A1: Indian CDMOs such as GVK Biosciences and Hetero Labs are prominent, alongside global firms like Merck and BASF that supply intermediates used in synthesis.
Q2: Are there any notable supply chain disruptions for montelukast sodium?
A2: Yes. The COVID-19 pandemic caused raw material shortages and factory closures, underscoring supply chain vulnerabilities.
Q3: What regulatory standards govern montelukast sodium manufacturing?
A3: Manufacturers must comply with US FDA, EMA, WHO-GMP, and other regional standards to ensure safety, efficacy, and quality.
Q4: How is sustainability impacting suppliers of montelukast sodium?
A4: Suppliers are adopting greener synthesis methods and reducing environmental footprints to meet regulatory and societal expectations.
Q5: What is the future outlook for montelukast sodium supply?
A5: Increased production capacity, diversification of raw material sourcing, and sustainable manufacturing practices are expected to improve supply reliability.
Sources
[1] Viatris Official Website. (2023). Company profile and manufacturing facilities.
[2] Spero Therapeutics. (2023). Manufacturing capabilities overview.
[3] GVK Biosciences. (2023). API manufacturing and quality standards.
[4] Hetero Labs. (2023). Production capacity and compliance details.
[5] Dr. Reddy’s Laboratories. (2023). API and finished product supply.
[6] Pharmaceutical Intermediates Suppliers – Chemical Weekly, 2023.
[7] Sigma-Aldrich. (2023). Chemical product catalog.
[8] Dow Chemical and Ashland. (2023). Specialty chemicals for pharmaceuticals.
[9] WHO. (2022). Pharmaceutical manufacturing standards.
[10] IMF Report on Supply Chain Disruptions. (2022).
[11] Contract Manufacturing Organizations in Pharma. (2023). Industry analysis.
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