Suppliers and packagers for generic pharmaceutical drug: AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN

AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Azurity	WIDAPLIK	amlodipine besylate; indapamide; telmisartan	TABLET;ORAL	219423	NDA	Azurity Pharmaceuticals, Inc.	24338-001-30	30 TABLET in 1 BOTTLE (24338-001-30)	2025-10-20
Azurity	WIDAPLIK	amlodipine besylate; indapamide; telmisartan	TABLET;ORAL	219423	NDA	Azurity Pharmaceuticals, Inc.	24338-002-30	30 TABLET in 1 BOTTLE (24338-002-30)	2025-10-20
Azurity	WIDAPLIK	amlodipine besylate; indapamide; telmisartan	TABLET;ORAL	219423	NDA	Azurity Pharmaceuticals, Inc.	24338-003-30	30 TABLET in 1 BOTTLE (24338-003-30)	2025-10-20

Last updated: November 13, 2025

ppliers for the Pharmaceutical Drugs: Amlodipine Besylate, Indapamide, Telmisartan

Introduction

The global pharmaceutical landscape relies heavily on a diverse and reliable network of suppliers for vital antihypertensive medications, including Amlodipine Besylate, Indapamide, and Telmisartan. These drugs, integral in managing hypertension and cardiovascular risk, are produced by numerous manufacturers spanning developed and emerging economies. Access to a comprehensive supplier network is critical for pharmaceutical companies, healthcare providers, and governments to ensure drug availability, affordability, and regulatory compliance. This analysis examines the leading suppliers, manufacturing hubs, and supply chain dynamics for these key medications.

Amlodipine Besylate Suppliers

Overview of Amlodipine Besylate

Amlodipine Besylate is a widely prescribed calcium channel blocker used for hypertension and angina. Its production involves complex chemical synthesis, necessitating high-quality manufacturing standards.

Major Suppliers and Manufacturers

Leading global suppliers include established pharmaceutical companies from India, China, and the European Union, often operating through both proprietary and generic formulations:

• Dr. Reddy's Laboratories (India): One of the largest producers of amlodipine, with extensive API manufacturing facilities compliant with WHO-GMP standards. Reddy’s supplies to over 150 countries globally.
• Sun Pharmaceutical Industries (India): A major player with vertically integrated manufacturing, Sun Pharma produces both API and finished dosages, with approvals from multiple regulatory authorities.
• Cipla Ltd. (India): Known for robust API production, Cipla’s manufacturing standards meet stringent international regulatory requirements.
• China-based Manufacturers: Companies like Zhejiang Huahai Pharmaceutical and Zhejiang Huahai produce APIs for export markets, leveraging low-cost manufacturing advantages.
• European Suppliers: Motilal Oswal and Teva Pharmaceuticals manufacture amlodipine in Europe, primarily serving developed markets with strict quality controls.

Supply Chain Considerations

The API supply for amlodipine is heavily concentrated in India and China, accounting for a significant portion of global production. Supply chain resilience is impacted by geopolitical factors, patent statuses, and regulatory harmonization efforts.

Indapamide Suppliers

Overview of Indapamide

Indapamide, a thiazide-like diuretic, forms part of class I compounded antihypertensive regimens. Its chemical synthesis demands precise control of manufacturing processes.

Leading Manufacturers

• Krka (Slovenia): A European pharmaceutical firm with a strong portfolio of cardiovascular drugs, supplying both APIs and finished products worldwide.
• Sun Pharmaceutical Industries: Also supplies Indapamide as part of its comprehensive antihypertensive portfolio, leveraging its global manufacturing footprint.
• Taiwan-based Vendors: Many local manufacturers serve Asian markets, often producing under generics or contract manufacturing arrangements.
• Indian API Makers: Several Indian manufacturers such as AV Life Sciences and Hetero Labs produce high-quality APIs for export to Europe and North America, adhering to global regulatory standards.

Regulatory and Supply Dynamics

The API market for Indapamide remains relatively stable, with supply concentrated in India and Europe. High-quality manufacturing practices and patent expirations have enhanced market competition, lowering prices and increasing supplier options.

Telmisartan Suppliers

Overview of Telmisartan

Telmisartan, an angiotensin II receptor blocker (ARB), is utilized for hypertension and cardiovascular risk reduction. Its complex synthesis involves advanced chemical processes, often requiring sophisticated facilities.

Prominent Suppliers

• Zhejiang Hisun Pharmaceuticals (China): A key supplier providing both APIs and finished formulations to global markets, leveraging modern manufacturing facilities.
• Mitsubishi Tanabe Pharma (Japan): Supplies high-purity Telmisartan APIs primarily for developed markets, emphasizing strict quality controls.
• Hetero Labs (India): A notable producer of ARBs, including Telmisartan, with robust API manufacturing capabilities meeting regulatory standards worldwide.
• TEVA Pharmaceuticals: With manufacturing sites in Israel and other countries, TEVA produces both APIs and finished products, guaranteeing quality and supply.
• LiShen Pharmaceutical (China): Emerging as a significant supplier, expanding its reach through competitive pricing and manufacturing scale efficiencies.

Market and Supply Chain Outlook

The supply chain for Telmisartan has been characterized by diversification, with increasing Chinese and Indian API manufacturers challenging traditional European and Japanese suppliers. Regulatory considerations, notably FDA and EMA approvals, influence supplier selection.

Supply Dynamics and Challenges

Global Manufacturing Hubs

India and China dominate API manufacturing for these antihypertensive drugs due to cost advantages and scale of production. European and North American suppliers tend to focus on finished formulations and high-regulatory-compliance markets.

Market Trends

• Patent Expirations: Several key patents for these drugs have expired or are nearing expiration, creating a surge in generic manufacturers and increased supplier options.
• Regulatory Harmonization: ICH guidelines and local regulatory bodies influence supplier qualification and API approval, impacting global supply consistency.
• Supply Chain Risks: Geopolitical tensions, pandemics, and trade restrictions present persistent risks to API supply stability. diversification of sources remains a strategic priority for pharmaceutical companies.

Regulatory and Quality Considerations

High-quality API production aligned with WHO-GMP, US FDA, and EMA standards is crucial for global supply security. Suppliers often undergo stringent qualification processes, including audits and validation, before supply contracts are established. Quality assurance encompasses raw material sourcing, process validation, and stability testing.

Strategic Implications for Stakeholders

• Pharmaceutical Companies: Should diversify supplier bases and establish contingency plans to mitigate supply disruptions. Investment in supplier qualification and ongoing quality audits enhances supply chain resilience.
• Governments and Regulators: Need to monitor API manufacturing trends, promote technology transfer, and support diversification to reduce dependency on specific regions.
• Investors and Market Analysts: Should track supplier capacity expansions, regulatory approvals, and geopolitical developments influencing supply chains.

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Key Takeaways

• The primary suppliers of Amlodipine Besylate, Indapamide, and Telmisartan are concentrated mainly in India, China, Europe, and North America.
• India and China dominate API manufacturing, offering cost-effective production but posing supply chain diversification challenges.
• Regulatory compliance, particularly WHO-GMP, FDA, and EMA standards, remains a critical factor for supplier qualification.
• Patent expirations are increasing the number of generic suppliers, enhancing competition but requiring vigilance over quality and supply reliability.
• Geopolitical and logistical risks necessitate strategic partnership management, including diversification and contingency planning.

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FAQs

1. Who are the leading global suppliers of Amlodipine Besylate?
Major suppliers include Dr. Reddy’s Laboratories and Sun Pharmaceutical Industries in India; Zhejiang Huahai Pharmaceutical in China; and established European manufacturers like Teva and Motilal Oswal.

2. Are there regional differences in API quality standards?
Yes. While API manufacturing in India and China is regulated by local authorities and increasingly aligned with international standards, European and North American suppliers typically adhere to more stringent regulatory compliance, impacting market access and trust.

3. How has patent expiration affected supplier competition?
Patent expirations for drugs like Amlodipine and Telmisartan have led to a surge in generic manufacturers, expanding supplier options and reducing prices but emphasizing the need for quality oversight.

4. What supply chain risks exist for these antihypertensive drugs?
Risks include geopolitical tensions, pandemics, trade restrictions, raw material shortages, and regulatory delays. Diversification of source countries and manufacturers mitigates these risks.

5. How do regulatory approvals influence supplier selection?
Regulatory approval, particularly from the FDA and EMA, is essential for market access in developed countries. Suppliers must meet strict quality and manufacturing standards, influencing their eligibility and competitiveness.

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Sources

[1] World Health Organization (WHO). "Good Manufacturing Practices (GMP) for Pharmaceuticals."
[2] US Food and Drug Administration (FDA). "Drug Master Files and API Registration."
[3] IMS Health. "Global API Manufacturing and Supply Report."
[4] Pharmaceutical Technology. "API Supply Chain & Regulatory Challenges."
[5] European Medicines Agency (EMA). "Guidelines on Quality of Medicine."