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Suppliers and packagers for LOSARTAN POTASSIUM
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LOSARTAN POTASSIUM
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Alembic Pharms Ltd | LOSARTAN POTASSIUM | losartan potassium | TABLET;ORAL | 090428 | ANDA | Alembic Pharmaceuticals Limited | 46708-445-30 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-445-30) | 2016-05-23 |
| Alembic Pharms Ltd | LOSARTAN POTASSIUM | losartan potassium | TABLET;ORAL | 090428 | ANDA | Alembic Pharmaceuticals Limited | 46708-445-31 | 100 TABLET, FILM COATED in 1 BOTTLE (46708-445-31) | 2016-05-23 |
| Alembic Pharms Ltd | LOSARTAN POTASSIUM | losartan potassium | TABLET;ORAL | 090428 | ANDA | Alembic Pharmaceuticals Limited | 46708-445-90 | 90 TABLET, FILM COATED in 1 BOTTLE (46708-445-90) | 2016-05-23 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Losartan Potassium
Introduction
Losartan potassium is a widely prescribed angiotensin II receptor blocker (ARB) primarily utilized in managing hypertension and reducing the risk of stroke in patients with hypertension and left ventricular hypertrophy. Its global demand stems from its efficacy, safety profile, and its role in cardiovascular risk mitigation. The drug's manufacturing relies on complex chemical synthesis and robust supply chains encompassing raw material providers, active pharmaceutical ingredient (API) manufacturers, and finished formulators. Understanding the key suppliers within this ecosystem is essential for stakeholders, including pharmaceutical companies, healthcare providers, and investors, aiming to navigate the market’s competitive landscape and ensure supply chain resilience.
Market Overview
The global losartan potassium market is driven by increasing prevalence of hypertension, evolving regulatory environments, and patent expirations encouraging generic manufacturers. Market estimates suggest a compound annual growth rate (CAGR) of approximately 3-5% over the past five years, fueled by cost-effective generics from multiple manufacturers. Major regions include North America, Europe, and Asia-Pacific, with significant contributions from countries such as India, China, and the US.
Key Raw Material Suppliers
The synthesis of losartan potassium involves specialized organic intermediates derived from controlled chemical reactions, requiring high-purity raw materials. The primary raw materials include:
- Aromatic Amines and Carboxylic Acids: Utilized in the initial synthesis steps.
- Chlorinated Intermediates: Chemicals such as chlorobenzenes crucial for final compound assembly.
- Lithium and Lithium Salts: Used in certain synthesis pathways for the formation of specific intermediates.
Major raw material suppliers are predominantly located in China, India, and Europe, supplying either bulk chemicals or fine intermediates. Companies like Shandong Baling Pharmaceutical Co., Sinopharm Chemical Reagent Co., and Thermo Fisher Scientific provide some of these essential chemicals, often with certifications compliant with Good Manufacturing Practice (GMP).
Active Pharmaceutical Ingredient (API) Manufacturers
The core of losartan potassium supply hinges on API producers capable of large-scale synthesis, validation, and regulatory compliance. Leading API suppliers include:
- Macleods Pharmaceuticals (India): One of the largest producers of losartan API, with multiple manufacturing sites adhering to global standards.
- Torrent Pharmaceuticals (India): A significant API manufacturer with extensive experience and a broad product portfolio.
- Hetero Labs (India): Recognized for its robust API production capacity, including losartan.
- Sino Biopharmaceutical (China): Provides API with competitive pricing and extensive distribution capabilities.
- Jubilant Life Sciences (India): Supplies high-quality APIs with a focus on quality assurance and regulatory compliance.
These manufacturers typically possess WHO GMP certifications, with many exporting globally, especially to North America and Europe, via authorized distributors or directly to pharmaceutical companies.
Generics and Finished Dosage Suppliers
Post patent expiration, the market has seen a proliferation of generic formulations. Major finished drug suppliers include:
- Mylan (now part of Viatris): A major player in generic antihypertensive drugs, including losartan tablets.
- Teva Pharmaceutical Industries: Offers affordable losartan formulations worldwide.
- Sun Pharmaceutical Industries: Provides a broad portfolio of generic cardiovascular drugs.
- Cipla Limited: A key supplier in emerging markets with extensive distribution networks.
- Aurobindo Pharma: Delivers competitively priced losartan brands across diverse regions.
These companies leverage their API sources to produce finished tablets, capsules, and combination therapies.
Regulatory and Certification Landscape
Suppliers must adhere to stringent regulatory standards to participate in global markets:
- FDA (United States Food and Drug Administration): Certification necessary for API export to the US.
- EMA (European Medicines Agency): Compliance for European markets.
- WHO GMP Certification: Recognized internationally, facilitating exports to developing regions.
- ISO Certifications: Ensuring quality management systems and process consistency.
Many Indian and Chinese API manufacturers hold multiple certifications, enabling them to supply global markets reliably.
Supply Chain Dynamics and Risks
The losartan potassium supply chain is subject to geopolitical, regulatory, and operational risks:
- Regulatory Changes: Stringent quality controls, especially regarding product registration and compliance, can disrupt supply.
- Manufacturing Disruptions: Facility downtime, capacity constraints, or raw material shortages affect delivery timelines.
- Trade Tariffs and Import Restrictions: Geopolitical tensions can influence the flow of raw materials and finished products.
- Quality Assurance: Continuous compliance with evolving standards is necessary to avoid market withdrawals or regulatory penalties.
Emerging Trends
- Vertical Integration: Some pharmaceutical companies are integrating upstream by acquiring API manufacturing capabilities to ensure supply chain security.
- Diversification of Suppliers: To mitigate risks, companies are sourcing from multiple manufacturers across different regions.
- Focus on Quality and Regulatory Alignment: Suppliers investing in advanced quality management systems enhance credibility.
- Sustainable Practices: Increasing emphasis on environmentally friendly synthesis methods affects supplier choice.
Key Players Summary
- India: Macleods, Torrent, Hetero, Sun Pharma, Aurobindo
- China: Sino Biopharmaceutical, Huzhou Zhenyu Pharmaceutical
- Europe/Other: TEVA (Israel), Mylan (global)
Recognizing these suppliers’ geographic distribution and certifications aids companies in establishing resilient procurement strategies.
Conclusion
The pharmaceutical supply chain for losartan potassium involves a complex web of raw material suppliers, API manufacturers, and finished drug producers spanning multiple continents. India remains a dominant hub for API production, with stringent regulatory compliance and competitive costs bolstering its position. Chinese firms also contribute significantly, offering cost advantages and substantial production capacity. Globalized sourcing, regulatory adherence, and quality assurance are critical in maintaining a reliable supply. The market’s future stability hinges on diversifying supplier bases, investing in supply chain transparency, and fostering continuous compliance with evolving standards.
Key Takeaways
- India dominates losartan potassium API manufacturing, supported by key players like Macleods, Torrent, and Hetero.
- Chinese suppliers provide cost-effective raw materials and APIs, though regulatory compliance remains vital.
- Finished drug formulation providers include Mylan, Teva, and Sun Pharma, offering widespread access to generics.
- Supply chain resilience depends on diversification, regulatory adherence, and quality certifications.
- Emerging trends favor vertical integration and environmentally sustainable manufacturing practices to ensure long-term stability.
FAQs
1. Who are the leading API suppliers for losartan potassium globally?
Major API producers include Indian companies like Macleods Pharmaceuticals, Torrent Pharmaceuticals, and Hetero Labs, alongside Chinese firms such as Sino Biopharmaceutical. These manufacturers comply with international standards like WHO GMP and export worldwide.
2. What regions are the primary sources of losartan potassium raw materials?
India and China are the predominant sources for raw materials and APIs, owing to their significant manufacturing infrastructure and cost advantages. Europe also contributes high-quality intermediates and specialty chemicals.
3. How do regulatory standards impact losartan potassium suppliers?
Compliance with standards such as FDA, EMA, and WHO GMP certifications ensures suppliers can access key global markets. Non-compliance jeopardizes market approval, leads to recalls, and disrupts supply chains.
4. What risks are associated with the losartan potassium supply chain?
Risks include regulatory changes, manufacturing disruptions, raw material shortages, geopolitical trade tensions, and quality lapses. Diversification and rigorous quality assessments mitigate these risks.
5. Are there emerging players disrupting traditional supply dynamics?
Yes, some companies invest in vertically integrated operations, sustainable manufacturing, and regional diversification to enhance supply resilience and compliance, influencing the competitive landscape.
Sources
- Pharmaceutical Technology: Losartan API Manufacturing
- IQVIA: Global Pharmaceutical Market Reports
- WHO GMP Certification Directory
- Frost & Sullivan: Trends in the Generic Drug Industry
- European Medicines Agency: Active Substance Manufacturing Standards
(Note: The above sources are illustrative; specific up-to-date details should be verified through authoritative industry reports and official certification directories.)
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