AMLODIPINE BESYLATE; TELMISARTAN: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alembic	TELMISARTAN AND AMLODIPINE	amlodipine besylate; telmisartan	TABLET;ORAL	205234	ANDA	Alembic Pharmaceuticals Limited	46708-184-08	80 BLISTER PACK in 1 CARTON (46708-184-08) / 8 TABLET in 1 BLISTER PACK	2016-11-22
Alembic	TELMISARTAN AND AMLODIPINE	amlodipine besylate; telmisartan	TABLET;ORAL	205234	ANDA	Alembic Pharmaceuticals Limited	46708-185-08	80 BLISTER PACK in 1 CARTON (46708-185-08) / 8 TABLET in 1 BLISTER PACK	2016-11-22
Alembic	TELMISARTAN AND AMLODIPINE	amlodipine besylate; telmisartan	TABLET;ORAL	205234	ANDA	Alembic Pharmaceuticals Limited	46708-186-06	60 BLISTER PACK in 1 CARTON (46708-186-06) / 6 TABLET in 1 BLISTER PACK	2016-11-22
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

The pharmaceutical market for antihypertensive medications such as Amlodipine Besylate and Telmisartan involves a complex global supply chain encompassing raw material providers, active pharmaceutical ingredient (API) manufacturers, formulators, and distributors. These drugs are widely prescribed for managing hypertension and cardiovascular risks, making their supply chains critical to healthcare infrastructure worldwide. Understanding the landscape of key suppliers for these medications is vital for stakeholders—including pharmaceutical companies, healthcare providers, and policymakers—aiming to secure reliable, quality-assured sources.

Global Overview of Suppliers

1. Active Pharmaceutical Ingredient (API) Manufacturers

Amlodipine Besylate and Telmisartan are synthesized from chemically distinct APIs. The procurement of high-purity APIs is central to ensuring the efficacy and safety of finished pharmaceutical products. API manufacturers are often located in regions with established chemical manufacturing hubs, notably in India, China, and certain European regions.

2. Leading Suppliers for Amlodipine Besylate

Amlodipine Besylate is a calcium channel blocker widely used in hypertension management. Its API production is primarily dominated by Asian generic pharmaceutical firms. Notable suppliers include:

Hetero Labs (India): A leading player supplying Amlodipine Besylate API known for reliable quality standards and large-scale manufacturing capacity. Hetero invests heavily in cGMP-compliant facilities, ensuring consistency across batches (Source: [1]).
Mylan (India): Mylan, now part of Viatris, provides high-quality APIs for global markets, with a significant share in Amlodipine Besylate production. They maintain rigorous quality control aligned with international standards like USFDA and EMA (Source: [2]).
Lupin Limited (India): Another major manufacturer with extensive API portfolio, including Amlodipine Besylate, catering to both generic and branded formulations globally.
Jiangsu Hengrui Medicine (China): A prominent Chinese API producer with increasing global presence due to competitive pricing and comparable quality standards.

Proprietary and Contract Manufacturing Operations: Several multinational pharmaceutical companies leverage contract manufacturing organizations (CMOs) based in India and China for their API requirements, underscoring the importance of these regions in the supply chain.

3. Leading Suppliers for Telmisartan

Telmisartan is an angiotensin receptor blocker (ARB) used predominantly in hypertension and cardiovascular risk management. Its API manufacturing landscape is similar, with key suppliers predominantly based in Asia.

Lupin Limited (India): A leading supplier of Telmisartan API offering high-quality production and regulatory compliance, serving global markets including North America and Europe.
Zhejiang Huahai Pharmaceutical (China): Known for its comprehensive portfolio of ARBs, including Telmisartan, this company supplies APIs to both regional and international pharmaceutical firms, with adherence to global regulatory standards.
Macleods Pharmaceuticals (India): An established API manufacturer with competitive pricing, supplying Telmisartan for global markets. Their manufacturing facilities are certified by USFDA, EMA, and other regulatory agencies.
Teva Pharmaceutical Industries (Israel): Although more renowned for finished formulations, Teva engages in API procurement and has been active in sourcing Telmisartan from Asian suppliers.

Innovations in Manufacturing: Companies are increasingly adopting continuous manufacturing and process optimization to enhance API yields, which benefits supply chain resilience.

4. Geographical and Regulatory Dynamics

India remains the largest API producer for both drugs, driven by cost advantages and a robust manufacturing infrastructure aligned with cGMP standards. Indian API manufacturers like Aurobindo Pharma, Cadila Healthcare, and Biocon also supply these APIs, emphasizing quality and compliance to meet global regulatory demands.

China has seen increased API production capacity, with companies such as Hengdian Group and Zhejiang Huahai expanding their offerings. Chinese suppliers often provide cost-effective options but may face regulatory scrutiny in certain markets (e.g., US and EU).

Regulatory environment plays a pivotal role. Suppliers with registration and approval by agencies like the USFDA, EMA, and PMDA are highly sought after by global pharmaceutical firms seeking regulatory compliance and market access.

5. Supply Chain Challenges and Considerations

Quality Assurance: Ensuring API suppliers meet Good Manufacturing Practices (GMP) and possess requisite regulatory approvals is critical to prevent supply disruptions and maintain product safety.
Regulatory Compliance: Increasing scrutiny by regulatory agencies necessitates transparency and documentation from suppliers regarding manufacturing practices, source materials, and quality control measures.
Supply Chain Resilience: geopolitical tensions, trade restrictions, and disruptions like the COVID-19 pandemic have underscored the importance of diversified sourcing strategies, including dual sourcing from multiple regions.
Cost vs. Quality: While cost-effective APIs from China and India dominate, pharmaceutical companies must balance pricing with quality assurance standards and regulatory compliance.

6. Future Outlook

The ongoing trend toward local manufacturing and API vertical integration may reshape supplier landscapes for both Amlodipine Besylate and Telmisartan. Governments in the US and Europe are incentivizing local API production to reduce dependency on imports, which could alter the global supplier dynamics. Additionally, advancements in green chemistry and sustainable manufacturing practices are influencing supplier capabilities and standards.

Key Takeaways

Indian and Chinese API producers are primary suppliers for Amlodipine Besylate and Telmisartan, offering competitive pricing and extensive capabilities.
Major suppliers include Hetero Labs, Lupin, Macleods, and Zhejiang Huahai, among others, with regulatory approval playing a crucial role.
Ensuring supplier compliance with international GMP standards remains critical to securing a reliable supply chain and maintaining product integrity.
Diversification and strategic sourcing are vital amid geopolitical and global health uncertainties to sustain stable medication supply.
Future shifts toward localized manufacturing and sustainable practices could redefine supplier relationships and market dynamics.

FAQs

Q1: Why is India a dominant supplier of APIs for Amlodipine Besylate and Telmisartan?
India's established chemical manufacturing infrastructure, cost-effective production, and compliance with international GMP standards make it a global hub for APIs, supported by government policies favoring pharmaceutical exports.

Q2: How do regulatory standards impact API suppliers?
Suppliers with approvals from agencies like USFDA and EMA demonstrate adherence to strict quality control, influencing their eligibility to supply to global markets and ensuring product safety and efficacy.

Q3: Are Chinese API manufacturers reliable for pharmaceutical supply?
While Chinese APIs often offer cost advantages, reliability depends on compliance with GMP standards, regulatory approvals, and consistent quality management. Many Chinese suppliers have achieved regulatory certifications, making them viable sources.

Q4: What are the risks associated with a concentrated API supply chain?
Dependence on limited suppliers or regions increases vulnerability to supply disruptions due to geopolitical issues, trade restrictions, or pandemics. Diversification minimizes such risks.

Q5: How could future policies impact API supplier choices?
Regulatory initiatives promoting local API production and sustainable manufacturing practices could shift supplier preferences, emphasizing domestic sourcing and environmentally friendly processes.

Sources

GlobalData. (2022). API Manufacturing Landscape Report.
U.S. Food and Drug Administration (FDA). (2021). Approved API List.
Indian Pharmaceutical Alliance Reports. (2022). API Production and Export Data.
European Medicines Agency (EMA). (2022). GMP Inspections and Compliance Reports.
Industry Analysis. (2023). Trends in Global API Manufacturing.

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