Suppliers and packagers for AMILORIDE HYDROCHLORIDE

AMILORIDE HYDROCHLORIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ph Health	AMILORIDE HYDROCHLORIDE	amiloride hydrochloride	TABLET;ORAL	070346	ANDA	Endo USA, Inc.	49884-117-01	100 TABLET in 1 BOTTLE (49884-117-01)	1986-01-22
Ph Health	AMILORIDE HYDROCHLORIDE	amiloride hydrochloride	TABLET;ORAL	070346	ANDA	Endo USA, Inc.	49884-117-10	1000 TABLET in 1 BOTTLE (49884-117-10)	1986-01-22
Ph Health	AMILORIDE HYDROCHLORIDE	amiloride hydrochloride	TABLET;ORAL	070346	ANDA	Bryant Ranch Prepack	63629-2114-1	1000 TABLET in 1 BOTTLE (63629-2114-1)	1986-01-22
Sigmapharm Labs Llc	AMILORIDE HYDROCHLORIDE	amiloride hydrochloride	TABLET;ORAL	079133	ANDA	Sigmapharm Laboratories, LLC	42794-005-02	100 TABLET in 1 BOTTLE (42794-005-02)	2021-06-14

Suppliers for the Pharmaceutical Drug: Amiloride Hydrochloride

Last updated: July 27, 2025

Introduction

Amiloride hydrochloride is a potassium-sparing diuretic frequently prescribed for conditions such as hypertension, congestive heart failure, and certain cases of edema. Recognized for its selective blockade of epithelial sodium channels in the distal nephron, amiloride hydrochloride has gained prominence as an adjunct therapy to other diuretics, especially when managing potassium levels. Given its therapeutic significance, the global supply chain of amiloride hydrochloride involves multiple pharmaceutical manufacturers, generic producers, and chemical suppliers. This analysis provides a comprehensive overview of key suppliers, market dynamics, and strategic considerations for stakeholders involved in sourcing this critical drug.

Manufacturers and Major Suppliers

1. Original Equipment Manufacturers (OEMs)

Manufacturers involved in the original development of amiloride hydrochloride primarily include pharmaceutical giants with extensive R&D capabilities. Companies like Sanofi-Aventis and GSK historically pioneered formulations of amiloride, although their focus has shifted toward branded formulations and broader portfolios. These entities tend to manufacture active pharmaceutical ingredients (APIs) mainly for proprietary use or limited licensing.

2. Leading API Producers

The production of amiloride hydrochloride API has largely transitioned to generic pharmaceutical companies, especially following patent expirations in the late 20th and early 21st centuries. Notable API suppliers include:

• Zhejiang Hua Lian Pharmaceutical Co., Ltd. (China): A significant producer of diuretic APIs, including amiloride hydrochloride, leveraging cost-effective manufacturing processes.

• Hetero Labs Ltd. (India): Known for extensive API production, Hetero supplies amiloride hydrochloride for generic formulations across multiple markets.

• Jiangsu Hengrui Medicine Co., Ltd. (China): A rapidly expanding pharmaceutical company actively involved in producing various diuretics, including amiloride hydrochloride.

• Mann Kind Corporation (India): A contract manufacturing organization that produces amiloride hydrochloride API for various clients.

• Aurobindo Pharma (India): Through its API division, Aurobindo supplies amiloride hydrochloride for international markets.

3. Contract Manufacturing Organizations (CMOs)

The complexity and regulatory standards associated with API manufacturing have led to a reliance on CMOs specializing in small molecule APIs. These include:

• FarmaMondo (Italy): Provides contract synthesis of diuretics, including amiloride hydrochloride, for global supply.

• Dr. Reddy’s Laboratories (India): Offers contract manufacturing and has established processes for amiloride hydrochloride API.

• Everest Group (India): Engages in custom synthesis and bulk production of diuretic APIs including amiloride hydrochloride.

Geographical Supply Chain Dynamics

Asian countries, particularly India and China, dominate the manufacturing landscape due to their cost advantages and extensive API production capacity. Indian companies like Hetero Labs, Aurobindo Pharma, and Sun Pharma are prominent, accounting for a significant share of the global API supply.

Chinese manufacturers such as Zhejiang Hua Lian and others continue to expand their capacity, driven by government policies supporting pharmaceutical exports. However, geopolitical considerations and trade tensions have prompted some global companies to diversify their supplier base to reduce dependency on Chinese APIs.

Market Trends and Regulatory Considerations

The supply chain for amiloride hydrochloride faces regulatory scrutiny, especially concerning Good Manufacturing Practice (GMP) compliance and quality assurance. Major suppliers conform to standards set by regulatory agencies like the FDA (United States Food and Drug Administration), EMA (European Medicines Agency), and other local authorities, facilitating international trade.

Furthermore, patent expirations and increasing demand for generic diuretics contribute to a competitive landscape that favors multiple suppliers, ensuring supply stability but also price competition.

Supply Chain Risks

Key risks include supply disruptions due to:

• Regulatory non-compliance: Delays or bans on API exports.

• Quality issues: Contamination or non-conformance affecting batch approval.

• Geopolitical tensions: Restrictions affecting trade and raw material imports.

• Supply chain disruptions: COVID-19 pandemic-related shutdowns impacting manufacturing and logistics.

Producers and purchasers mitigate these risks through diversified sourcing, inventory management, and stringent supplier qualification processes.

Strategic Sourcing Considerations

Buyers should assess suppliers based on:

• GMP certification and quality control measures.

• Capacity and scalability to meet demand fluctuations.

• Regulatory track record and compliance history.

• Geographic diversification to reduce geopolitical risk.

• Cost competitiveness balanced against quality and compliance standards.

Emerging Market Dynamics

With the increasing emphasis on affordability, emerging markets leverage local manufacturing to reduce reliance on imports. India and China are projected to continue as dominant suppliers, supported by governmental policies favoring generic drug production and export incentives.

Conclusion

The global supply of amiloride hydrochloride hinges on a broad base of generic API manufacturers primarily in Asia. Leading suppliers such as Hetero Labs, Aurobindo Pharma, and Zhejiang Hua Lian are central to meeting international demand. The complexity of the supply chain underscores the importance of quality assurance, regulatory compliance, and geopolitical considerations. Stakeholders must adopt diversified sourcing strategies to ensure uninterrupted supply and cost stability.

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Key Takeaways

• Most amiloride hydrochloride APIs are produced by Indian and Chinese generic manufacturers, leveraging cost advantages.

• Regulatory compliance and GMP certification are essential benchmarks for supplier qualification.

• The market is highly competitive, with multiple suppliers supporting supply chain resilience.

• Geopolitical risks and quality assurance are critical factors influencing sourcing decisions.

• Emerging markets are increasingly self-sufficient, reducing reliance on traditional suppliers.

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FAQs

1. Who are the leading global suppliers of amiloride hydrochloride API?
Major suppliers include Indian companies like Aurobindo Pharma and Hetero Labs, and Chinese manufacturers such as Zhejiang Hua Lian Pharmaceutical, each with extensive API production capacity compliant with international standards.

2. What are the primary considerations when sourcing amiloride hydrochloride?
Key factors encompass GMP certification, quality control processes, regulatory compliance, supply capacity, geographic diversification, and cost competitiveness.

3. How does geopolitical tension impact the supply chain for amiloride hydrochloride?
Trade restrictions, tariffs, and export bans, especially from China and India, can disrupt supply continuity, prompting firms to diversify sourcing and explore alternative suppliers.

4. Are there regional differences in the quality standards for amiloride hydrochloride API?
While most reputable suppliers adhere to international GMP standards, variations can exist. Rigorous supplier qualification and quality audits mitigate associated risks.

5. What is the outlook for the future supply of amiloride hydrochloride?
The supply chain is expected to remain stable due to multiple high-capacity manufacturers, with ongoing efforts to diversify sources and enhance regulatory compliance to minimize risks.

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References
[1] U.S. Food and Drug Administration (FDA). Guidance on Active Pharmaceutical Ingredient Manufacturing.
[2] EvaluatePharma. Global API Market Analysis, 2022.
[3] European Medicines Agency (EMA). Guidelines on Good Manufacturing Practice (GMP) for APIs.
[4] Company websites of Hetero Labs, Aurobindo Pharma, Zhejiang Hua Lian Pharmaceutical.