Suppliers and packagers for generic pharmaceutical drug: HYDROCHLOROTHIAZIDE; LISINOPRIL

HYDROCHLOROTHIAZIDE; LISINOPRIL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aurobindo	LISINOPRIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	077606	ANDA	Aurobindo Pharma Limited	65862-043-00	100 TABLET in 1 BOTTLE (65862-043-00)	2006-03-14
Aurobindo	LISINOPRIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	077606	ANDA	Aurobindo Pharma Limited	65862-043-01	100 TABLET in 1 BOTTLE (65862-043-01)	2006-03-14
Aurobindo	LISINOPRIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	077606	ANDA	Aurobindo Pharma Limited	65862-043-05	500 TABLET in 1 BOTTLE (65862-043-05)	2006-03-14

Suppliers for the Pharmaceutical Drugs: Hydrochlorothiazide and Lisinopril

Last updated: July 29, 2025

Introduction

Hydrochlorothiazide and lisinopril are critical medications widely prescribed for hypertension and heart failure management. Hydrochlorothiazide, a thiazide diuretic, enhances sodium and water excretion, while lisinopril, an angiotensin-converting enzyme (ACE) inhibitor, reduces blood pressure and alleviates cardiac workload. As demand for these drugs remains robust, identifying reliable suppliers is paramount for manufacturers, healthcare providers, and policymakers. This report evaluates the leading suppliers, sourcing trends, regulatory considerations, and market dynamics shaping the supply chain for hydrochlorothiazide and lisinopril.

Manufacturers and Suppliers: An Overview

Global Leaders in Active Pharmaceutical Ingredient (API) Production

The pharmaceutical supply chain for hydrochlorothiazide and lisinopril relies heavily on multinational API manufacturers primarily based in China, India, and Europe. These regions dominate the production of raw materials and final APIs due to cost efficiencies, manufacturing capacity, and technological advances.

• China: As of 2022, China remains the largest producer of APIs globally, with companies like Zhejiang Huahai Pharmaceutical and Wuchang Kunpeng Pharmaceutical leading in hypertension drug APIs. Chinese manufacturers benefit from extensive experience, significant scale, and low manufacturing costs. However, geopolitical tensions and quality control concerns have prompted some buyers to diversify sources.

• India: Indian pharmaceutical firms, such as Sun Pharmaceutical Industries, Aurobindo Pharma, and Lupin Ltd., occupy a prominent role in API production and formulation. India’s robust regulatory framework and proven track record make Indian APIs a preferred alternative to Chinese products, especially amid increasing scrutiny over quality standards.

• Europe: European API manufacturers, like Sandoz and Teva Pharmaceutical Industries, emphasize high-quality standards and regulatory compliance. While more expensive, their products are often preferred in markets with strict quality and regulatory requirements.

Key API Suppliers for Hydrochlorothiazide

Hydrochlorothiazide APIs are widely produced by Indian and Chinese manufacturers, with several companies holding approvals from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Notable suppliers include:

• Zhejiang Huahai Pharmaceutical (China)
• Wuchang Kunpeng Pharmaceutical (China)
• Aarti Industries (India)
• Hetero Labs (India)

Key API Suppliers for Lisinopril

Lisinopril APIs are primarily sourced from Indian and Chinese companies that have invested in fermentation and synthesis technologies. Major suppliers include:

• Biocon Ltd. (India)
• Zhejiang Hisun Pharmaceutical (China)
• Wockhardt Ltd. (India)
• Hetero Labs (India)

Formulation and Finished Dosage Form Suppliers

Beyond raw API manufacturing, companies specializing in formulation and finished dosage forms distribute hydrochlorothiazide and lisinopril globally. Notable players include:

• Teva Pharmaceuticals (Israel)
• Mylan (now part of Viatris)
• Sandoz (Switzerland)
• Sun Pharma (India)

These firms often source APIs from international suppliers and handle formulation, packaging, and distribution.

Supply Chain Dynamics and Market Trends

Regulatory and Quality Control Challenges

Regulatory agencies like the FDA and EMA enforce rigorous standards for API manufacturing. Recent crackdowns, especially in China, have led to quality concerns, causing supply disruptions. Consequently, many manufacturers seek diversified sourcing strategies, including sourcing from multiple countries or establishing local manufacturing facilities.

Impact of Geopolitical Factors

Trade tensions, tariffs, and export restrictions have affected supply chain stability. The COVID-19 pandemic accentuated vulnerabilities, leading to shortages and increased costs. These factors have accelerated efforts toward regional API production and stockpiling.

Market Consolidation and Strategic Partnerships

Major pharmaceutical companies often establish strategic partnerships with API suppliers to secure supply continuity. Vertical integration, mergers, and acquisitions, such as Teva's acquisition of API manufacturing plants, aim to bolster supply security.

Innovation and Custom Synthesis

Advancements in synthesis technology have enabled more efficient production of lisinopril and hydrochlorothiazide. Custom synthesis services cater to specific formulation needs, ensuring better stability and bioavailability.

Regulatory Considerations

Healthcare authorities increasingly scrutinize API suppliers' quality standards. Suppliers must possess current Good Manufacturing Practice (cGMP) certifications. The presence of multiple suppliers with FDA or EMA approval provides relative flexibility but demands vigilance concerning documentation, batch consistency, and compliance updates.

Market Challenges and Opportunities

• Supply Chain Disruptions: Ongoing global disruptions underscore risks related to single-source dependency; diversification remains vital.
• Quality Assurance: Suppliers adhering to strict quality controls secure longer-term contracts and regulatory approvals.
• Emerging Markets: Growing demand in low- and middle-income countries offers opportunities for suppliers with cost-effective manufacturing.
• Environmental Sustainability: Increasing emphasis on greener manufacturing processes influences supplier selection.

Conclusion

Hydrochlorothiazide and lisinopril supply chains are characterized by a diverse array of global suppliers, predominantly from China and India, with European firms emphasizing quality and regulatory compliance. Market dynamics hinge on quality assurance, geopolitical stability, regulatory adherence, and technological innovation. Securing reliable suppliers involves multi-sourcing strategies, continuous quality monitoring, and understanding regional regulatory landscapes.

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Key Takeaways

• The primary API suppliers for hydrochlorothiazide and lisinopril are based in China and India, with European firms emphasizing high-quality standards.
• Supply chain vulnerabilities heightened by geopolitical tensions and pandemic-related disruptions have prompted diversification efforts.
• Regulatory compliance and quality assurance are critical factors influencing supplier selection and ongoing market stability.
• Strategic partnerships, vertical integration, and technological innovation enhance supply reliability.
• Industry trends favor sustainable manufacturing practices, regional production, and improved supply chain transparency.

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FAQs

1. Who are the leading global suppliers for hydrochlorothiazide and lisinopril?
   Major suppliers include Chinese companies like Zhejiang Huahai Pharmaceutical, Indian firms such as Sun Pharma and Hetero Labs, and European producers like Sandoz, with manufacturing capacity across continents.

2. How do regulatory standards influence supplier choices?
   Suppliers must meet cGMP standards set by agencies like the FDA and EMA. Approved suppliers with validated quality systems are preferred to mitigate risks of regulatory non-compliance and product recalls.

3. What recent market trends have affected API supply chains?
   Cracks down on quality standards in China, geopolitical tensions, the COVID-19 pandemic, and increased demand in emerging markets are reshaping sourcing strategies and encouraging regional manufacturing.

4. Are there risks associated with depending on Asian API suppliers?
   Yes. Over-reliance on single-source regions like China or India can lead to supply disruptions, especially during geopolitical or health crises. Diversification and regional manufacturing are solutions.

5. What future developments could impact the supply of hydrochlorothiazide and lisinopril?
   Innovations in synthesis, stricter regulatory oversight, environmental sustainability initiatives, and political stability will influence supply stability and cost dynamics in the coming years.

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Sources:

1. [1] "Global API Market Outlook," IQVIA, 2022.
2. [2] "The State of Pharmaceutical Manufacturing in China," UK Department for International Trade, 2021.
3. [3] "Indian Pharmaceutical Industry: Trends and Opportunities," PhRMA Reports, 2022.
4. [4] "Regulatory Standards for APIs," FDA Guidance, 2022.
5. [5] "Supply Chain Resilience in Pharma," McKinsey & Company, 2022.