Amiloride HCl

In the realm of cardiovascular and renal medicine, maintaining the delicate balance of electrolytes and fluid retention is critical for effective management of hypertension, congestive heart failure, and edema. Amiloride Hydrochloride (HCl), a well-established potassium-sparing diuretic, plays a vital role in optimizing diuretic therapy by preventing excessive potassium loss often caused by thiazide or loop diuretics. With its unique pharmacological profile and clinical efficacy, Amiloride HCl is a staple in modern cardiovascular pharmacotherapy.

At BluepillExpress, we are proud to offer comprehensive third-party manufacturing solutions for Amiloride Hydrochloride, serving pharmaceutical companies, exporters, hospital networks, and government tenders. With WHO-GMP-certified production units, a skilled formulation team, and decades of experience in producing quality diuretics and cardiovascular drugs, BluepillExpress is your ideal contract manufacturing partner.

About Amiloride HCl

Amiloride Hydrochloride is a potassium-sparing diuretic that acts on the distal convoluted tubule and collecting duct of the nephron to inhibit sodium reabsorption without promoting potassium excretion. Unlike other diuretics that may deplete potassium and magnesium levels, Amiloride offers a balanced diuretic effect, making it a preferred choice in combination with other natriuretic agents.

Mechanism of Action:

Amiloride inhibits epithelial sodium channels (ENaC) in the distal nephron, reducing sodium uptake and the electrochemical gradient that drives potassium excretion. This mechanism helps retain potassium and prevent hypokalemia.

Primary Therapeutic Uses:

• Edema associated with congestive heart failure
• Hypertension (particularly with hypokalemia)
• Hepatic cirrhosis-related ascites
• Renal disorders requiring potassium conservation
• Combination therapy with thiazide or loop diuretics
• Off-label use in certain electrolyte disturbances

Its safety profile and ability to complement other diuretics make it a core drug in long-term cardiovascular and renal care.

Why Choose BluepillExpress for Amiloride HCl Manufacturing?

1. WHO-GMP Certified Production Facilities
Our manufacturing facilities adhere strictly to WHO-GMP, Good Manufacturing Practices, and ISO 9001:2015 certifications. These globally accepted quality frameworks ensure that every batch of Amiloride HCl manufactured meets international safety, purity, and efficacy standards.

2. Complete Third-Party Manufacturing Support
BluepillExpress offers end-to-end third-party manufacturing services tailored to your business needs, including:

• Formulation development
• Product packaging design
• Labeling and branding
• Regulatory documentation
• Custom formulation based on IP/BP/USP/EP standards
• Batch documentation: BMR, CoA, MOA, Stability reports

We support startups, established brands, and institutional buyers with flexible MOQs and scalable production capacity.

3. Regulatory-Ready Formulations
We manufacture Amiloride HCl formulations that comply with Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), United States Pharmacopeia (USP), and European Pharmacopoeia (EP) standards, making them suitable for both domestic distribution and international exports.

Available Formulations

We manufacture Amiloride HCl in its most widely accepted dosage form:

Amiloride Hydrochloride Tablets

• 5 mg – the standard therapeutic dose for adult patients.
• 2.5 mg – for dose titration and pediatric applications (available upon request).

Available as:

• Uncoated or film-coated tablets, depending on client requirements.
• Single formulation or in combination with other diuretics such as Hydrochlorothiazide.

We also offer co-formulations (e.g., Amiloride 5 mg + Hydrochlorothiazide 50 mg) used commonly in antihypertensive therapy.

Technical Product Specifications

Product Name	Amiloride Hydrochloride
Dosage Form	Oral Tablets
Strengths Available	5 mg, 2.5 mg
Pharmacopoeial Standards	IP / BP / USP / EP
Route of Administration	Oral
Packing Options	Blister packs, strip packs, bottle packs
Shelf Life	24 to 36 months
Storage Conditions	Store below 30°C; protect from moisture and light

All raw materials are sourced from GMP-approved vendors and each lot undergoes strict quality control checks during production and packaging.

Therapeutic Applications and Indications

Amiloride HCl is widely used in the treatment and management of conditions such as:

1. Hypertension (High Blood Pressure)
As an adjunct to thiazide or loop diuretics to prevent potassium loss in hypertensive patients.

2. Congestive Heart Failure
Amiloride helps manage fluid overload while preserving serum potassium levels.

3. Hepatic Cirrhosis and Ascites
Reduces fluid retention in liver disease patients without exacerbating hypokalemia.

4. Edematous States from Renal Dysfunction
Supports electrolyte management in nephrotic syndrome and chronic renal insufficiency.

5. Hypokalemia Prevention
Used prophylactically to prevent or treat potassium deficiency caused by other diuretics.

6. Combination Therapy
Combined with hydrochlorothiazide or furosemide for synergistic effects with potassium conservation.

Manufacturing Process Overview

We follow validated standard operating procedures for the production of Amiloride HCl tablets, including:

1. Dispensing and Weighing of API & Excipients
2. Granulation Process (Dry or Wet Granulation)
3. Compression using high-speed tablet press
4. Coating (optional)
5. Primary and Secondary Packaging
6. Final Quality Control and Release

Our manufacturing lines are equipped with modern technology, including:

• Rapid mixer granulators (RMG)
• High-speed compression machines
• Tablet coating machines
• Blister and strip packing units
• Stability chambers for ICH-compliant testing

Each batch is produced under controlled environmental conditions to avoid cross-contamination and ensure uniformity.

Quality Assurance and Quality Control

BluepillExpress enforces a multi-tier quality assurance system encompassing:

• Raw material verification
• In-process quality checks
• Finished product analysis
• Stability testing
• Microbial limit testing
• Assay and dissolution profile studies
• Packaging integrity tests

Our documentation includes:

• Certificate of Analysis (CoA)
• Batch Manufacturing Record (BMR)
• Method of Analysis (MOA)
• Stability Data (Zone II & IV available)

All testing is conducted in-house by trained chemists and microbiologists using validated analytical methods and calibrated instruments.

Packaging and Customization Options

We offer customizable packaging solutions suited for:

• Retail Distribution
  • 10×10 strip/blister in cartons
  • Multilingual printed inserts (optional)
• Institutional and Tender Supply
  • Bulk packs
  • Bottle packaging with tamper-evident seals

Packaging is designed to be light-resistant, moisture-proof, and transport-safe, ensuring product integrity throughout the supply chain.

Regulatory and Export Compliance

As a global pharmaceutical manufacturer, BluepillExpress provides all necessary documentation to support international product registration and importation:

• Certificate of Pharmaceutical Product (CoPP)
• Certificate of Origin (COO)
• Free Sale Certificate
• GMP and Manufacturing License
• Full CTD/eCTD Dossier
• BE/Bioavailability Data (if applicable)
• Third-party test reports upon request

We export to more than 40 countries, including markets in Africa, Asia, Latin America, Middle East, and CIS regions.

Client Segments We Serve

Our third-party Amiloride HCl manufacturing caters to:

• Generic drug marketers
• Government and hospital procurement agencies
• Institutional health programs
• NGOs and public health bodies
• Distributors and wholesalers
• International importers requiring private labeling

Whether for local distribution or export purposes, our clients benefit from tailored manufacturing, transparent pricing, and timely delivery.

Research & Development Support

Our R&D team is equipped to help clients with:

• New product development and fixed-dose combinations
• Taste-masking and stability-enhancing formulations
• Regulatory documentation for new markets
• Analytical method validation
• BE studies and clinical dossier preparation (in collaboration)

We also provide pilot batches, tech transfer assistance, and customized formulations upon request.

Ethical Manufacturing and Sustainability

At BluepillExpress, ethical compliance and sustainability are fundamental principles:

• Zero Liquid Discharge (ZLD) effluent treatment
• Use of eco-friendly solvents and packaging
• Ethical labor practices and workplace safety
• No child labor or animal testing
• Sustainable sourcing from certified vendors

Our practices align with UN Sustainable Development Goals (SDGs) and WHO standards for ethical pharma manufacturing.

Client Support and Confidentiality

BluepillExpress provides:

• Non-disclosure agreements (NDAs)
• Dedicated project management
• Real-time production tracking
• Transparent billing and quotations
• Flexible logistics and shipping
• Regulatory guidance for dossier submissions

We aim to be more than a manufacturer—we are your strategic partner in building a credible and competitive product portfolio.

Conclusion

Amiloride HCl is an essential component in cardiovascular and renal medicine. With rising demand for diuretics that preserve potassium and minimize electrolyte imbalances, this product holds strong clinical value and market potential.

At BluepillExpress, we deliver best-in-class third-party manufacturing for Amiloride Hydrochloride, supported by regulatory compliance, scalable infrastructure, and scientific integrity. Whether you are a growing domestic brand or a global distributor seeking WHO-standard formulations, our services are built to empower your success.