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Last Updated: December 17, 2025

Suppliers and packagers for TELMISARTAN AND HYDROCHLOROTHIAZIDE


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TELMISARTAN AND HYDROCHLOROTHIAZIDE

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 TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 203010 ANDA Alembic Pharmaceuticals Limited 46708-209-10 100 TABLET in 1 CARTON (46708-209-10) 2014-03-14
Alembic TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 203010 ANDA Alembic Pharmaceuticals Limited 46708-209-30 30 TABLET in 1 BOTTLE (46708-209-30) 2014-03-14
Alembic TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 203010 ANDA Alembic Pharmaceuticals Limited 46708-209-91 1000 TABLET in 1 BOTTLE (46708-209-91) 2014-03-14
Alembic TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 203010 ANDA Alembic Pharmaceuticals Limited 46708-210-10 100 TABLET in 1 CARTON (46708-210-10) 2014-03-14
Alembic TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 203010 ANDA Alembic Pharmaceuticals Limited 46708-210-30 30 TABLET in 1 BOTTLE (46708-210-30) 2014-03-14
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for the Pharmaceutical Drugs: Telmisartan and Hydrochlorothiazide

Last updated: July 29, 2025

Introduction

Telmisartan combined with Hydrochlorothiazide is a widely prescribed antihypertensive medication, used for managing high blood pressure and reducing the risk of cardiovascular events. As demand for this medication grows globally, sourcing reliable and high-quality suppliers remains critical for pharmaceutical companies, healthcare providers, and wholesalers. This article provides a comprehensive overview of key suppliers for Telmisartan and Hydrochlorothiazide, examining manufacturing landscape, key players, regulatory considerations, and market trends.


Manufacturing Landscape and Market Overview

The production of Telmisartan and Hydrochlorothiazide is concentrated in regions with significant pharmaceutical manufacturing capabilities, notably India, China, and the United States. These regions benefit from established regulatory infrastructure, manufacturing expertise, and extensive export networks. The global supply chain for these drugs is highly regulated, with manufacturers required to meet standards set by agencies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other national regulators.

The global antihypertensive drugs market is projected to grow, driven by increasing prevalence of hypertension, aging populations, and expanding healthcare access in emerging markets. As a result, suppliers are scaling up production, investing in quality systems, and expanding their global footprint to meet rising demand.


Leading Suppliers of Telmisartan

1. Torrent Pharmaceuticals (India)
Torrent Pharmaceuticals stands out among Telmisartan suppliers owing to its robust R&D and manufacturing capabilities in India. It supplies to over 100 countries, adhering to strict quality standards. The company's consistent compliance and extensive product range have established it as a trusted supplier globally [[1]].

2. Mylan N.V. (Global)
Mylan, now part of Viatris, is a major player in the generic pharmaceuticals industry, offering Telmisartan products compliant with international quality standards. Mylan’s extensive manufacturing footprint spans several continents, emphasizing quality assurance and regulatory compliance [[2]].

3. Sun Pharma (India)
Sun Pharma is among India's largest pharmaceutical companies, with significant manufacturing facilities for angiotensin receptor blockers like Telmisartan. Their global Operations and adherence to cGMP make them a preferred supplier for generic Telmisartan.

4. Hikma Pharmaceuticals (UK/Jordan)
Hikma produces high-quality generic drugs, including Telmisartan, with a focus on the Middle Eastern, European, and North American markets. The company’s reputation is built on rigorous quality assurance processes [[3]].

5. Aurobindo Pharma (India)
Aurobindo is a leading API manufacturer and formulators for antihypertensive drugs, including Telmisartan. The company has a strong export footprint, with approvals from regulatory agencies worldwide, including the FDA [[4]].


Leading Suppliers of Hydrochlorothiazide

1. Hetero Labs (India)
Hetero Labs is a prominent manufacturer of Hydrochlorothiazide, employing advanced synthetic and crystallization techniques. Its API manufacturing complies with global standards, serving both branded and generic markets [[5]].

2. Solara Active Pharma Sciences (India)
Solara is known for its high-quality APIs, including Hydrochlorothiazide, with a focus on compliance and sustainability. Its manufacturing facilities are certified by major regulatory bodies, ensuring reliable supply [[6]].

3. Teva Pharmaceutical Industries (Israel)
Teva is a leading global generic pharmaceutical company with a comprehensive portfolio that includes Hydrochlorothiazide. Their global manufacturing network guarantees supply continuity and adherence to regulatory standards [[7]].

4. Zheijang NHU Co., Ltd. (China)
Zheijang NHU has grown as a major supplier of Hydrochlorothiazide, emphasizing low-cost manufacturing, scaled-up production, and quality control to meet global demand [[8]].

5. Dr. Reddy’s Laboratories (India)
Dr. Reddy’s manufactures and supplies Hydrochlorothiazide as part of their extensive API portfolio, complying with multiple international standards and catering to a global customer base.


Regulatory and Quality Considerations

Choosing the right supplier for Telmisartan and Hydrochlorothiazide requires rigorous assessment of regulatory compliance, manufacturing practices, and quality assurance protocols. Suppliers must be licensed by regulatory agencies such as the FDA, EMA, or comparable authorities, and possess current Good Manufacturing Practice (cGMP) certifications.

Additionally, suppliers capable of providing comprehensive documentation, such as Certificate of Analysis (CoA), stability data, and batch records, are preferred. This ensures the pharmaceutical company’s regulatory filings and batch release processes are unimpeded.


Emerging Trends and Market Dynamics

The supply landscape for these drugs is evolving alongside global trends such as:

  • Generic Drug Expansion: Many manufacturers are expanding their portfolio to include generic versions, increasing competition but also driving innovation and cost reduction.

  • API Localization and Diversification: Countries like India and China are investing heavily in API manufacturing to reduce dependency on imports and mitigate supply chain disruptions, especially apparent during global crises such as the COVID-19 pandemic.

  • Regulatory Harmonization: Increased efforts towards aligning international drug manufacturing standards facilitate easier market access for suppliers and promote quality consistency.

  • Sustainability and Green Manufacturing: Suppliers are incorporating sustainable practices to meet regulatory and consumer expectations, potentially influencing supplier selection.


Key Challenges in Supplier Selection

  • Regulatory Compliance: Ensuring suppliers meet the stringent standards of the intended market jurisdiction.
  • Supply Chain Stability: Long-term partnerships are crucial to prevent shortages, especially given potential geopolitical issues.
  • Quality Assurance: Ensuring consistent API quality to avoid batch failures or quality recalls.
  • Cost Competitiveness: Balancing cost with quality to achieve optimal margins and competitiveness.

Key Takeaways

  • India and China dominate API manufacturing for Telmisartan and Hydrochlorothiazide, owing to cost advantages and established infrastructure.
  • International pharmaceutical companies such as Mylan, Teva, and Hikma maintain high-quality standards and regulatory compliance, making them preferred suppliers.
  • Regulatory compliance and quality assurance are non-negotiable, requiring thorough due diligence during supplier evaluation.
  • Emerging regional markets and supply chain resilience initiatives are shaping future supplier strategies.
  • Sustainability and new manufacturing technologies are becoming key differentiators among suppliers.

FAQs

1. How can I verify a supplier’s regulatory compliance for Telmisartan and Hydrochlorothiazide?
Verify their certifications from relevant authorities (FDA, EMA), ensure current Good Manufacturing Practice (cGMP) compliance, and request detailed documentation such as Certificates of Analysis and inspection reports.

2. Which regions offer the most reliable suppliers for these drugs?
India, China, and the United States host the most reputable API manufacturers, known for their scale, quality, and compliance efforts.

3. Are there risks associated with sourcing from emerging markets?
Yes. Potential risks include regulatory discrepancies, supply chain disruptions, and quality inconsistencies. Conducting comprehensive due diligence mitigates these risks.

4. How does market demand influence supplier selection?
Growing demand prompts companies to prioritize suppliers with scalable manufacturing capacity, quality consistency, and regulatory approvals across multiple jurisdictions.

5. What role does sustainability play in supplier selection?
Sustainable manufacturing practices increasingly influence procurement decisions, aligning supply chains with regulatory requirements and corporate social responsibility standards.


References

[1] Torrent Pharmaceuticals Annual Report 2022
[2] Viatris (Mylan) Corporate Website and Regulatory Filings
[3] Hikma Pharmaceuticals Official Website
[4] Aurobindo Pharma Annual Report 2022
[5] Hetero Labs API Portfolio Overview
[6] Solara Active Pharma Sciences API Manufacturing Certificate
[7] Teva Pharmaceutical Industries Annual Report 2022
[8] Zhejiang NHU Co., Ltd. API Quality Certificates

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