AMILORIDE HYDROCHLORIDE: Pharmaceutical manufacturers, suppliers, and distributors

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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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: February 19, 2026

WHAT IS AMILORIDE HYDROCHLORIDE?

Amiloride hydrochloride is a potassium-sparing diuretic. It is primarily used in the management of hypertension, congestive heart failure, and edema associated with renal disease. The active pharmaceutical ingredient (API) functions by inhibiting sodium reabsorption in the distal tubule and collecting duct of the nephron, thereby reducing water and sodium retention without significant potassium loss [1]. Its chemical formula is C6H11ClN7O • HCl, and its CAS number is 2016-88-8.

PATENT LANDSCAPE FOR AMILORIDE HYDROCHLORIDE

The original patent for amiloride hydrochloride has long expired. However, patents related to its manufacturing processes, formulations, and specific therapeutic uses may still be active. Analysis of patent databases indicates a focus on improved synthesis routes and novel drug delivery systems for amiloride hydrochloride.

Patent Type	Description	Status	Expiration Date
Composition of Matter	Original amiloride hydrochloride molecule	Expired	N/A
Manufacturing Process	Novel synthesis pathways, purification methods	Varies; some active	Varies
Formulation	Modified-release tablets, combination therapies	Varies; some active	Varies
Method of Use	Specific treatment protocols, dosages	Varies; some active	Varies

Companies that have historically held or currently hold patents related to amiloride hydrochloride and its applications include Merck & Co., Inc., and other generic drug manufacturers. The expiration of foundational patents has paved the way for generic competition.

KEY GLOBAL AMILORIDE HYDROCHLORIDE SUPPLIERS

The supply chain for amiloride hydrochloride API is characterized by a mix of established pharmaceutical manufacturers and specialized API producers. Suppliers are located across various regions, with a significant concentration in Asia.

Major API Manufacturers

These companies are known for their large-scale production capabilities and adherence to stringent regulatory standards.

Teva Pharmaceutical Industries Ltd. (Israel): A leading generic drug manufacturer with a broad API portfolio, including amiloride hydrochloride. Teva operates global manufacturing facilities and adheres to cGMP standards.
Sun Pharmaceutical Industries Ltd. (India): One of the largest pharmaceutical companies globally, Sun Pharma is a significant producer of APIs. They have a strong presence in regulated markets, including the U.S. and Europe.
Dr. Reddy's Laboratories (India): Another major Indian pharmaceutical company involved in API manufacturing. Dr. Reddy's supplies amiloride hydrochloride to numerous global markets and maintains a robust quality control system.
Wockhardt Ltd. (India): Wockhardt is a global pharmaceutical and biotechnology company with API manufacturing facilities that produce amiloride hydrochloride. They focus on quality and regulatory compliance.
Hetero Drugs Ltd. (India): A prominent Indian API manufacturer known for its extensive product range. Hetero supplies amiloride hydrochloride to pharmaceutical companies worldwide.

Specialized API Producers and Contract Manufacturers

These entities often focus on specific APIs or provide contract manufacturing services, offering flexibility and specialized expertise.

Amneal Pharmaceuticals (U.S.): While primarily known for finished dosage forms, Amneal also has API development and manufacturing capabilities. They may produce amiloride hydrochloride for internal use or external sales.
Lupin Ltd. (India): Lupin is a research-based pharmaceutical company with significant API manufacturing operations. They are a potential supplier for amiloride hydrochloride.
Aarti Industries Limited (India): Aarti Industries is a leading Indian manufacturer of specialty chemicals and pharmaceuticals, including APIs. They have the capacity to produce amiloride hydrochloride.
Jubilant Life Sciences (India): Jubilant offers a wide range of pharmaceutical products, including APIs. Their manufacturing sites are equipped to produce amiloride hydrochloride under strict quality guidelines.

REGULATORY CONSIDERATIONS FOR AMILORIDE HYDROCHLORIDE SUPPLY

Suppliers of amiloride hydrochloride API must meet rigorous regulatory requirements to ensure product safety, efficacy, and quality. Key regulatory bodies and their requirements include:

U.S. Food and Drug Administration (FDA): Manufacturers must comply with Current Good Manufacturing Practices (cGMP). Facilities are subject to FDA inspection. Drug Master Files (DMFs) are often submitted to support new drug applications (NDAs) and abbreviated new drug applications (ANDAs) that utilize the API.
European Medicines Agency (EMA): Compliance with EU GMP standards is mandatory. Certificates of Suitability to the European Pharmacopoeia (CEP) may be required for APIs marketed in Europe.
Other National Regulatory Authorities: Agencies in Japan (PMDA), Canada (Health Canada), and Australia (TGA) have their own specific requirements, often harmonized with FDA and EMA standards.

Key Quality Standards and Certifications

cGMP Compliance: Essential for all API manufacturers supplying regulated markets.
ISO Certifications: While not always mandatory for API, ISO 9001 (Quality Management) and ISO 14001 (Environmental Management) are common.
Pharmacopoeial Standards: The API must meet specifications outlined in major pharmacopoeias, such as the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and Japanese Pharmacopoeia (JP).

PRICING AND AVAILABILITY TRENDS

The pricing of amiloride hydrochloride API is influenced by several factors:

Manufacturing Costs: Raw material prices, labor, energy, and regulatory compliance expenses.
Production Scale: Larger production runs generally lead to lower per-unit costs.
Market Demand: The volume of amiloride hydrochloride required by finished dosage form manufacturers.
Competition: The number of suppliers in the market impacts pricing dynamics.
Geopolitical Factors: Trade policies, shipping costs, and regional stability can affect availability and price.

Currently, amiloride hydrochloride is a well-established generic drug. As such, its pricing is generally stable and competitive. The availability is considered good, with multiple suppliers capable of meeting global demand. However, disruptions in raw material supply chains or unforeseen regulatory changes could impact short-term availability or pricing.

SUPPLY CHAIN RISKS AND MITIGATION STRATEGIES

Suppliers and purchasers of amiloride hydrochloride must consider potential risks within the supply chain.

Identified Risks

Quality Control Failures: Batch failures due to contamination, impurities, or manufacturing deviations can lead to product recalls and supply interruptions.
Regulatory Non-Compliance: Failure to meet cGMP or other regulatory standards can result in import bans or facility shutdowns.
Geographic Concentration: Over-reliance on suppliers from a single region can create vulnerabilities to local disruptions (e.g., natural disasters, political instability, pandemics).
Raw Material Shortages: Dependence on specific upstream raw material providers can lead to supply chain bottlenecks.
Intellectual Property Disputes: Although foundational patents are expired, disputes over process patents or trademarks can arise.

Mitigation Strategies

Supplier Audits and Qualification: Conduct thorough due diligence and regular audits of API manufacturers to ensure adherence to quality and regulatory standards.
Diversification of Suppliers: Establish relationships with multiple qualified suppliers from different geographic regions to reduce reliance on any single source.
Inventory Management: Maintain adequate safety stock of critical APIs to buffer against short-term supply disruptions.
Supply Chain Transparency: Gain visibility into the upstream supply chain to identify potential raw material vulnerabilities.
Contingency Planning: Develop robust business continuity plans to address potential disruptions, including alternative sourcing strategies and communication protocols.
Contractual Safeguards: Include clear quality, delivery, and compliance clauses in supplier agreements.

FUTURE OUTLOOK

The market for amiloride hydrochloride is expected to remain stable, driven by its established therapeutic uses and its role in combination therapies. Generic competition will continue to ensure competitive pricing. Innovation may focus on more efficient and environmentally friendly manufacturing processes. Companies that can consistently demonstrate high-quality production, robust regulatory compliance, and reliable supply chain management will be best positioned in this market.

KEY TAKEAWAYS

Amiloride hydrochloride is a mature, well-established generic API with stable market demand.
The global supply base is diversified, with a significant presence of Indian manufacturers, alongside established players from Israel and the U.S.
Regulatory compliance, particularly cGMP, is a critical factor for suppliers serving regulated markets like the U.S. and Europe.
Supply chain risks include quality control failures, regulatory non-compliance, and geographic concentration of manufacturing.
Mitigation strategies involve supplier diversification, rigorous auditing, and robust inventory management.

FREQUENTLY ASKED QUESTIONS

What are the primary regulatory hurdles for a new amiloride hydrochloride supplier?

New suppliers must demonstrate full compliance with cGMP guidelines as enforced by target market regulatory bodies such as the FDA and EMA. This includes successful facility inspections, submission of comprehensive Drug Master Files (DMFs) or equivalent documentation, and adherence to pharmacopoeial standards.

How does the patent expiration impact the supplier landscape for amiloride hydrochloride?

The expiration of the original composition of matter patent has led to widespread generic manufacturing. This has intensified competition among API suppliers, driving down prices and emphasizing cost-efficiency and reliable quality as key differentiators.

What are the typical lead times for amiloride hydrochloride API orders?

Lead times can vary significantly based on the supplier’s current production schedule, order volume, and shipping logistics. Standard lead times for established, high-volume suppliers typically range from 8 to 16 weeks. Rush orders may be accommodated at a premium.

Are there specific quality control tests that are critical for amiloride hydrochloride API?

Critical quality control tests include assay for potency, identification tests (e.g., IR spectroscopy, HPLC), impurity profiling (related substances), residual solvents, heavy metals, water content (Karl Fischer), and microbial limits. Compliance with USP and Ph. Eur. monographs is essential.

What are the main raw materials used in the synthesis of amiloride hydrochloride, and are there any known supply chain vulnerabilities for these materials?

Key raw materials can include guanidine derivatives and dichloracetic acid derivatives, among others, depending on the specific synthesis route employed. Supply chain vulnerabilities for these precursors can arise from their own manufacturing complexity, geographic concentration of their producers, or dependence on petrochemical feedstocks.

Citations

[1] National Center for Biotechnology Information. (2023). Amiloride hydrochloride. PubChem Compound Summary for CID 2361. https://pubchem.ncbi.nlm.nih.gov/compound/Amiloride-hydrochloride

Suppliers and packagers for AMILORIDE HYDROCHLORIDE