AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Barr	AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	amiloride hydrochloride; hydrochlorothiazide	TABLET;ORAL	071111	ANDA	Teva Pharmaceuticals USA, Inc.	0555-0483-02	100 TABLET in 1 BOTTLE (0555-0483-02)	1989-12-01
Barr	AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	amiloride hydrochloride; hydrochlorothiazide	TABLET;ORAL	071111	ANDA	Teva Pharmaceuticals USA, Inc.	0555-0483-05	1000 TABLET in 1 BOTTLE (0555-0483-05)	1989-12-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 1, 2025

Introduction

Amiloride Hydrochloride and Hydrochlorothiazide are widely prescribed medications primarily utilized in managing hypertension and edema. The global supply chain for these pharmaceuticals involves a complex network of manufacturers, raw material suppliers, contract manufacturing organizations (CMOs), and distributors. Understanding key suppliers and the dynamics of the supply landscape is critical for pharmaceutical companies, healthcare providers, and investors aiming to ensure drug availability, compliance with regulatory standards, and cost management.

Overview of Amiloride Hydrochloride and Hydrochlorothiazide

Amiloride Hydrochloride is a potassium-sparing diuretic that inhibits epithelial sodium channels, used in combination therapies for hypertension and heart failure.[1] Hydrochlorothiazide (HCTZ), a thiazide diuretic, reduces blood pressure by decreasing plasma volume.[2] Both drugs are often supplied as generic medications, with numerous manufacturers worldwide, owing to patent expirations and widespread clinical use.

Global Manufacturing Landscape

Key Manufacturers and Suppliers

Teva Pharmaceuticals
A leading global manufacturer of generic drugs, Teva supplies both Amiloride Hydrochloride and Hydrochlorothiazide. Its robust supply chain, production capacity, and regulatory compliance position it as a significant supplier worldwide.[3]
Sandoz (Novartis)
As a division of Novartis, Sandoz specializes in generics and biosimilars, often providing high-quality Amiloride and Hydrochlorothiazide formulations. Their global presence in manufacturing and distribution ensures extensive reach.[4]
Mylan (now part of Viatris)
Mylan, rebranded as Viatris post-merger, remains a key player offering these diuretics, particularly in emerging markets. Their extensive manufacturing network enhances supply stability.[5]
Sun Pharmaceutical Industries
An Indian pharmaceutical giant, Sun Pharma supplies generic dermatology, neurology, and cardiovascular drugs, including Amiloride Hydrochloride and Hydrochlorothiazide.[6]
Meda (now part of Teva)
Meda’s legacy includes producing a variety of cardiovascular medications, contributing to the global supply chain through Teva’s distribution channels.[7]

Raw Material Suppliers and APIs

The core active pharmaceutical ingredient (API) supply chain involves several specialized suppliers:

Daicel Corporation (Japan)
Supplies high-quality chemicals used in API synthesis.
Zhejiang Huahai Pharmaceutical (China)
One of the largest producers of APIs for Hydrochlorothiazide, with extensive manufacturing capacity, though with some past regulatory scrutiny.[8]
Dr. Reddy's Laboratories (India)
Produces APIs and finished formulations, including Hydrochlorothiazide, with strict quality controls.[9]
CIPLA Limited
A significant API supplier for Hydrochlorothiazide, serving both domestic and international markets.[10]

Contract Manufacturing and Outsourcing

Many pharmaceutical companies outsource manufacturing to CMOs:

Wuxi AppTec (China)
Offers API synthesis and manufacturing for various diuretics, including Hydrochlorothiazide.
Boehringer Ingelheim
Provides contract manufacturing for cardiovascular APIs.
Aenova Group (Germany)
Specializes in finished dose manufacturing, ensuring supply and regulatory compliance across markets.

Regional Supply Dynamics

United States

In the US, the supply of Amiloride Hydrochloride and Hydrochlorothiazide hinges on a handful of domestic and international manufacturers. The USFDA's Drug Shortages Database highlights occasional shortages, often attributable to manufacturing disruptions, raw material scarcity, or regulatory issues.[11] Companies like Teva and Mylan dominate the US generics market, with supply assured through established distribution channels.

European Union

The EU market primarily relies on European and Indian manufacturers, with companies such as Sandoz and Sun Pharma providing significant supplies. Stringent regulatory oversight ensures high-quality standards, though supply chain disruptions can impact availability.

Emerging Markets

India and China are pivotal suppliers, especially for APIs. Indian companies such as Cipla and Sun Pharma hold substantial manufacturing capacity, exporting to global markets, including Africa and Southeast Asia, often at lower costs. However, geopolitical factors and regulatory scrutiny influence supply stability.

Supply Chain Challenges and Risks

Regulatory Scrutiny and Quality Concerns
Past incidents, such as Zhejiang Huahai's recalls due to contamination issues, underscore the importance of rigorous quality controls in API manufacturing.[12]
Raw Material Scarcity
Disruptions in sourcing precursor chemicals can lead to shortages, especially during global crises like COVID-19.
Manufacturing Disruptions
Factory closures, natural disasters, or geopolitical tensions can temporarily disrupt supply chains.
Intellectual Property and Patent Issues
The expiration of patents for these drugs has led to increased generic competition, stabilizing supply but also intensifying price competition.

Strategic Considerations for Stakeholders

Diversify Supplier Base
Relying on multiple suppliers across regions can mitigate risk.
Engage in Long-term Contracts
Long-term agreements secure supply continuity and favorable pricing.
Monitor Regulatory Developments
Staying abreast of changes in manufacturing standards and approvals ensures compliance.
Invest in Quality Assurance
Regular audits and quality checks prevent disruptions from non-compliance or contamination.

Conclusion

The global supply of Amiloride Hydrochloride and Hydrochlorothiazide hinges on a diversified network of manufacturers, raw material suppliers, and CMOs. Prominent players such as Teva, Sandoz, Mylan, Sun Pharma, and API producers like Zhejiang Huahai and Dr. Reddy's dominate the landscape. Supply stability depends on effective supply chain management, adherence to quality standards, and adaptability to regional regulatory and logistical challenges. Stakeholders should focus on supplier diversification, proactive risk mitigation, and continuous monitoring to ensure uninterrupted access to these essential diuretics.

Key Takeaways

Major Suppliers: Global giants like Teva, Sandoz, and Mylan dominate the supply of Amiloride Hydrochloride and Hydrochlorothiazide.
API Sources: India and China are leading API producers, though past regulatory issues highlight the need for rigorous quality controls.
Supply Risks: Disruptions due to regulatory scrutiny, raw material shortages, or manufacturing issues require proactive management.
Regional Variability: Market dynamics vary, with North America and Europe relying on established local or international manufacturers, and emerging markets heavily dependent on Indian and Chinese API suppliers.
Supply Chain Optimization: Diversification and strategic partnerships remain key to ensuring supply stability amid global uncertainties.

FAQs

Who are the primary global suppliers of Amiloride Hydrochloride?
Leading producers include Teva Pharmaceuticals, Sandoz (Novartis), and Mylan (Viatris), with manufacturing facilities worldwide ensuring broad distribution.
What are the main API manufacturers for Hydrochlorothiazide?
Major API producers include Zhejiang Huahai Pharmaceutical (China), Dr. Reddy's Laboratories (India), and Cipla, which supply high-quality Hydrochlorothiazide APIs globally.
How does regional regulation affect the supply of these drugs?
Stringent regulatory standards, particularly in the US and EU, can impact manufacturing approvals and quality control, influencing supply stability.
What risks threaten the uninterrupted supply of these diuretics?
Risks include manufacturing disruptions, raw material shortages, quality concerns, geopolitical tensions, and regulatory actions.
What strategies can companies employ to mitigate supply chain risks?
Diversifying supplier sources, engaging in long-term contracts, maintaining rigorous quality standards, and monitoring regulatory changes are key strategies.

References

[1] Drugs.com. Amiloride Hydrochloride. Accessed 2023.
[2] Neutel JM. Thiazide diuretics in hypertension: are there still advantages? Curr Hypertens Rep. 2001.
[3] Teva Pharmaceuticals. Product Portfolio.
[4] Sandoz. Generics Portfolio.
[5] Viatris. Company Overview.
[6] Sun Pharmaceutical Industries Ltd. Annual Report.
[7] Meda (now part of Teva). Product Offerings.
[8] US FDA Drug Shortages Database. Zhejiang Huahai.
[9] Dr. Reddy's Laboratories. API Manufacturing.
[10] CIPLA Limited. API Portfolio.
[11] US FDA. Drug Shortages.
[12] Reuters. Zhejiang Huahai Voluntary Recall.

Suppliers and packagers for AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE