amiloride hydrochloride; hydrochlorothiazide: Pharmaceutical manufacturers, suppliers, and wholesalers

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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: July 30, 2025

Introduction

The pharmaceutical combination of Amiloride Hydrochloride and Hydrochlorothiazide remains a critical therapy for managing hypertension and edema. As with many high-demand medications, the supply chain dynamics are complex, involving multiple suppliers spanning active pharmaceutical ingredient (API) producers, finished drug manufacturers, and global distribution networks. Understanding the supplier landscape is vital for stakeholders aiming to ensure drug availability, compliance, and cost efficiency.

This report provides a detailed analysis of key suppliers manufacturing Amiloride Hydrochloride and Hydrochlorothiazide, exploring their market footprints, production capacities, regulatory standings, and strategic positions within the pharmaceutical supply chain.

Market Overview

Amiloride Hydrochloride is a potassium-sparing diuretic primarily used to counteract hypokalemia associated with other diuretics, and in combination therapies for hypertension. Hydrochlorothiazide, a thiazide diuretic, is among the most frequently prescribed antihypertensive agents globally, often combined with other drugs to enhance efficacy.

The demand for these APIs has highlighted diverse sourcing strategies encompassing both branded and generic manufacturers. Given the geographical dispersion and regulatory landscapes, suppliers vary in quality standards, production capacity, and cost competitiveness.

Major Suppliers of Amiloride Hydrochloride

1. Cipla Limited (India)

Cipla is a leading Indian pharmaceutical multinational with significant expertise in cardiovascular APIs, including Amiloride Hydrochloride. It boasts approval by major regulatory agencies such as the US FDA and EMA for several production facilities, ensuring quality assurance.

Production capacity: Cipla’s API facilities are highly scalable, producing thousands of kilograms annually to meet global demand.
Strategic footprint: Focused on markets in North America, Europe, and emerging Economies; Cipla emphasizes quality compliance and competitive pricing.
Quality standards: Adheres to Good Manufacturing Practices (GMP), with compliance certifications from regulatory authorities.

2. Zhejiang Minsheng Pharmaceutical Co., Ltd. (China)

A prominent Chinese API manufacturer specializing in cardiovascular and diuretic APIs, including Amiloride Hydrochloride.

Production capacity: Estimated at several hundred metric tons per year.
Regulatory status: Has obtained China GMP certifications; actively pursuing or maintaining certifications for exports to the US and EU.
Market focus: Supplies primarily to generics manufacturers in Asia, with growing penetration into European markets.

3. Mylan (Now part of Viatris) (Global, with manufacturing facilities in India and Europe)

Mylan, with a global footprint, produces Amiloride Hydrochloride in its facilities conforming to international quality standards.

Regulatory standing: Approvals from US FDA, EMA, and other agencies.
Market reach: Supplies to generic pharmaceutical companies worldwide for use in combination therapies.

4. Pfizer (Global)

While Pfizer’s focus has shifted more towards finished therapeutics, it retains some API manufacturing capabilities, including Amiloride Hydrochloride, especially for strategic markets.

Leading Suppliers of Hydrochlorothiazide

1. Sun Pharmaceutical Industries Ltd. (India)

One of the world's largest generic manufacturers with extensive API production capabilities for Hydrochlorothiazide.

Capacity: Produces thousands of tons annually.
Quality compliance: Multiple certifications, including US FDA ANDEMA approvals.
Market: Supplies to North America, Europe, and Asian markets.

2. Teva Pharmaceutical Industries Ltd. (Israel)

A global leader in generics, Teva manufactures Hydrochlorothiazide at scale, adhering to regulatory standards in manufacturing.

Supply chain positioning: Key API supplier for generic formulations globally.
Regulatory approvals: US FDA, EMA, and other key agencies.

3. Zhejiang Huahai Pharmaceutical Co., Ltd. (China)

Specializes in cardiovascular APIs, including Hydrochlorothiazide, with significant production volume.

Regulatory status: GMP-certified; aiming for higher regulatory approvals for global export markets.
Market presence: Supplies primarily to generic drug manufacturers in Asia, with expanding reach.

4. Aurobindo Pharma Limited (India)

Produces Hydrochlorothiazide at high capacity, supplying both domestic and international markets.

Quality standards: US FDA and EU approvals.
Production scale: Several hundred tons annually.

Supply Chain Considerations

Regulatory Compliance and Quality

Many leading API manufacturers in India and China hold certifications such as US FDA, EMA, and WHO-GMP. Such certifications are essential for pharmaceutical companies seeking to ensure regulatory compliance in global markets.

Capacity and Availability

Manufacturers like Sun Pharma and Zhejiang Huahai possess extensive production capacities, mitigating risks related to shortages during peak demand periods. Suppliers with diversified manufacturing bases provide resilience against localized disruptions.

Geopolitical and Trade Factors

Trade tensions, export restrictions, and tariffs can impact supply availability, especially from Chinese and Indian suppliers, requiring companies to diversify their sourcing strategies.

Cost Dynamics

Price competitiveness is significant; suppliers in India and China tend to offer lower-cost APIs due to favorable production costs, though quality and regulatory considerations influence procurement decisions.

Strategic Implications for Stakeholders

Drug Developers: Must prioritize suppliers with robust regulatory compliance, especially for markets demanding stricter standards such as the US and EU.
Manufacturers: Should consider diversity in API sources to mitigate supply chain risks.
Distributors and Pharmacies: Need to maintain visibility into API sourcing to ensure medication safety and regulatory adherence.
Regulatory Agencies: Should monitor API supplier compliance and conduct periodic audits to prevent counterfeit or substandard APIs entering the supply chain.

Conclusion

The supply landscape for Amiloride Hydrochloride and Hydrochlorothiazide encompasses a broad array of suppliers, predominantly concentrated in India and China, with verified centers of quality in established markets like the US and Europe. Strategic sourcing, compliance, and capacity management are essential for stakeholders aiming to secure reliable supplies amid geopolitical and market uncertainties.

Key Takeaways

Major API suppliers include Cipla, Sun Pharma, Zhejiang Minsheng, and Zhejiang Huahai, among others.
Indian and Chinese API manufacturers dominate global supplies, offering competitive pricing but requiring careful regulatory vetting.
Ensuring regulatory compliance and quality standards is critical for sourcing APIs for international markets.
Diversification of sources reduces risks associated with geopolitical, logistical, and quality issues.
Continuous monitoring of supplier certifications and capacity is vital in maintaining uninterrupted drug manufacturing.

FAQs

1. Are Chinese API suppliers reliable for Amiloride Hydrochloride and Hydrochlorothiazide?
Yes, many Chinese API manufacturers, such as Zhejiang Minsheng and Zhejiang Huahai, hold GMP certifications and export to global markets. However, buyers should verify regulatory approvals and quality certifications before sourcing.

2. How do I evaluate the quality of API suppliers?
Assess certification status (US FDA, EMA, WHO-GMP), review audit reports, conduct supplier qualification visits, and analyze compliance history with regulatory agencies.

3. What are the key regulatory considerations when sourcing APIs internationally?
Manufacturers must verify that suppliers hold valid GMP certifications, comply with local and international standards, and have a track record of transparency and compliance with authorities like the FDA and EMA.

4. Can supply chain disruptions impact the availability of Amiloride Hydrochloride and Hydrochlorothiazide?
Yes. Disruptions in manufacturing, geopolitical restrictions, or logistical issues can affect supply. Diversifying suppliers and maintaining safety stock mitigates such risks.

5. Are there substitutes or alternative suppliers for these APIs?
Yes. Several manufacturers produce these APIs; procurement teams should evaluate alternatives based on quality, capacity, regulation compliance, and cost to ensure uninterrupted supply.

Sources

[1] IQVIA. "API Market Trends 2022," IQVIA Insights.
[2] Pharma Intelligence. "Global API Manufacturing Landscape," 2022.
[3] US FDA. "Registered Drug Master Files," 2023.
[4] European Medicines Agency. "Manufacturing Inspection Reports," 2023.
[5] GlobalData. "Pharmaceutical API Supply Chains," 2022.

Suppliers and packagers for generic pharmaceutical drug: amiloride hydrochloride; hydrochlorothiazide