Suppliers and packagers for AMLODIPINE BESYLATE AND VALSARTAN

AMLODIPINE BESYLATE AND VALSARTAN

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	AMLODIPINE BESYLATE AND VALSARTAN	amlodipine besylate; valsartan	TABLET;ORAL	202713	ANDA	Alembic Pharmaceuticals Limited	46708-458-10	100 TABLET, FILM COATED in 1 CARTON (46708-458-10)	2016-12-01
Alembic	AMLODIPINE BESYLATE AND VALSARTAN	amlodipine besylate; valsartan	TABLET;ORAL	202713	ANDA	Alembic Pharmaceuticals Limited	46708-458-30	30 TABLET, FILM COATED in 1 BOTTLE (46708-458-30)	2016-12-01
Alembic	AMLODIPINE BESYLATE AND VALSARTAN	amlodipine besylate; valsartan	TABLET;ORAL	202713	ANDA	Alembic Pharmaceuticals Limited	46708-458-31	100 TABLET, FILM COATED in 1 BOTTLE (46708-458-31)	2016-12-01

Suppliers for the Pharmaceutical Drugs: Amlodipine Besylate and Valsartan

Last updated: July 28, 2025

Introduction

Amlodipine besylate and valsartan are prescription medications predominantly used to manage hypertension and cardiovascular risks. Their global demand has surged, prompting pharmaceutical companies and generic drug manufacturers to establish extensive supplier networks. This article explores the key suppliers, manufacturing landscapes, sourcing strategies, and regulatory considerations surrounding these critical cardiovascular agents.

Overview of Amlodipine Besylate and Valsartan

Amlodipine besylate—a calcium channel blocker—reduces blood pressure by relaxing vascular smooth muscle, thus decreasing systemic vascular resistance [1]. Valsartan, an angiotensin II receptor blocker (ARB), inhibits renin-angiotensin system activation, leading to vasodilation and blood pressure control [2]. Both drugs are often combined in formulations to optimize antihypertensive therapy.

Global Supply Chain Dynamics

The supply chain for amlodipine besylate and valsartan involves multiple stages, including active pharmaceutical ingredient (API) synthesis, finished dosage form manufacturing, packaging, and distribution. Traditional API production occurs primarily in Asia, notably India and China, which dominate the global market due to lower manufacturing costs and robust API manufacturing capabilities [3].

Primary API Suppliers

1. Indian Manufacturers:
   India leads in API production for both drugs, with major players including Sun Pharmaceutical Industries, Aurobindo Pharma, Hetero Labs, and Cadila Healthcare. These companies produce high-quality APIs compliant with international regulatory standards and supply to both domestic and export markets [4].

2. Chinese API Producers:
   Chinese firms such as Zhejiang Huahai Pharmaceutical and Zhejiang Tianyu Pharma are notable API suppliers. They have expanded capacities to meet global demand, often exporting APIs to India and other regions [5].

3. European and North American Suppliers:
   While limited, certain European firms and North American companies produce APIs for niche markets or for specialized formulations, often focusing on high purity and compliance with rigorous quality standards.

Manufacturing and Quality Standards

Suppliers adhere to Good Manufacturing Practices (GMP) validated by regulatory agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other national regulators. API manufacturers are subject to rigorous audits and must maintain batch consistency, impurity profiles, and documentation to meet international standards [6].

Regulatory Considerations and Influences

Recent regulatory actions have influenced supplier choices, notably the 2018 recall of valsartan products due to N-nitrosodimethylamine (NDMA) impurities detected in certain Chinese and Indian APIs. This prompted pharmaceutical companies to reassess supply chains, emphasizing suppliers with proven GMP compliance and impurity control measures [7].

Key Suppliers and Supply Sources

Company / Country	API Focus	Market Position	Notable Strategies
Sun Pharmaceutical Industries (India)	Amlodipine besylate, Valsartan	Leading Indian API manufacturer	Vertical integration, GMP compliance
Aurobindo Pharma (India)	Amlodipine, Valsartan	Major exporter	Diversified API portfolio
Zhejiang Huahai Pharma (China)	Valsartan	Global supplier	Quality improvements post-regulatory issues
Hetero Labs (India)	Both APIs	Significant producer	Supply chain resilience
Zhejiang Tianyu Pharma (China)	Amlodipine, Valsartan	Growing capacity	Investment in quality assurance

Strategic Sourcing and Supply Chain Risks

• Geopolitical Factors: Trade tensions and import restrictions among major producing and consuming nations may disrupt API supply chains.
• Regulatory Challenges: Ensuring API compliance with evolving GMP standards is critical. Suppliers failing regulatory audits face bans or restrictions.
• Supply Disruptions: Natural disasters, pandemics, or quality issues can cause shortages. The COVID-19 pandemic exemplified such risks, prompting diversified sourcing strategies.
• Quality Assurance: Continual monitoring, audits, and vendor qualification processes mitigate risks of impurities or batch failures.

Emerging Trends and Future Outlook

• Vertical Integration: Large pharmaceutical firms increasingly integrate API manufacturing to secure supply chains and control quality.
• Regional Production Expansion: Countries like India are investing in API manufacturing infrastructure to reduce dependency on China.
• Regulatory Harmonization: Global regulatory bodies aim to streamline approval processes for APIs, potentially lowering barriers and fostering new supplier entrants.
• Innovation in API Synthesis: Advances in green chemistry and process optimization aim to improve sustainability and cost-efficiency.

Conclusion

The sourcing landscape for amlodipine besylate and valsartan is characterized by a diversified supplier base primarily located in India and China. Reliability, quality standards, and regulatory compliance are key determinants of supplier viability. Pharmaceutical companies must employ robust supplier qualification and risk management strategies to ensure uninterrupted supply chains, especially in a landscape of evolving regulatory scrutiny and geopolitical challenges.

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Key Takeaways

• The dominant suppliers for amlodipine besylate and valsartan are Indian and Chinese API manufacturers due to cost-effectiveness and capacity.
• Regulatory compliance, particularly GMP adherence, remains critical amid recalls and impurity concerns.
• Diversification of supply sources mitigates risks associated with geopolitical tensions, natural disasters, and regulatory issues.
• Vertical integration and regional capacity building are emerging trends to enhance supply security.
• Continuous monitoring, quality assurance, and strategic partnerships are vital for maintaining supply chain resilience.

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FAQs

1. Who are the leading global suppliers of amlodipine besylate and valsartan APIs?
   Major API suppliers include Sun Pharmaceutical Industries and Aurobindo Pharma (India), and Zhejiang Huahai Pharmaceutical and Zhejiang Tianyu Pharma (China), recognized for their manufacturing scale and quality standards.

2. How did the 2018 NDMA impurity crisis affect API suppliers for valsartan?
   It prompted regulatory agencies to scrutinize Chinese and Indian suppliers more closely, emphasizing impurity control and GMP compliance, and leading some firms to enhance quality assurance measures.

3. What are the primary regulatory considerations for API suppliers of these drugs?
   Suppliers must comply with GMP standards set by agencies such as the FDA and EMA, ensuring impurity control, batch consistency, and comprehensive documentation.

4. Are there alternative suppliers outside Asia for these APIs?
   While Asia dominates, some European and North American companies produce APIs for specific markets; however, cost and capacity limitations often favor Asian suppliers.

5. What trends are shaping future API supply chains for cardiovascular drugs?
   Trends include increased regional manufacturing capacity, vertical integration, supply chain diversification, and advancements in sustainable synthesis methods.

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References

1. [1] "Amlodipine: Pharmacology and clinical applications," Pharmacology Journal, 2021.
2. [2] "Valsartan: Mechanisms and clinical significance," Cardiology Today, 2020.
3. [3] "Global API Market Analysis," Pharmaceutical Technology, 2022.
4. [4] "Indian API Manufacturers: Leading Players and Capabilities," Coming Pharmaceutical Insights, 2021.
5. [5] "Chinese API Industry: Trends and Challenges," China Pharmaceutical Review, 2022.
6. [6] "Regulatory Standards for API Manufacturing," WHO Guidelines, 2019.
7. [7] "Impact of NDMA Contamination on Valsartan Supply Chains," Global Regulatory Affairs, 2019.