Active Pharmaceutical Ingredient

Amiloride API Manufacturer & Supplier in India

Also known as: Midamor

CAS: 2016-88-8 Potassium-Sparing Diuretic USP / BP / IP Bulk Supply Available
Amiloride API Manufacturer India | Mediocon Inc
Amiloride — Pharmaceutical Grade API

Product Overview

CAS No: 2016-88-8  |  MF: C₆H₈ClN₇O  |  MW: 229.63 g/mol

Amiloride hydrochloride is a potassium-sparing diuretic that blocks epithelial sodium channels (ENaC) in the distal nephron. It is used in the treatment of hypertension and oedema, often combined with thiazide diuretics. Mediocon Inc supplies pharmaceutical-grade Amiloride meeting USP, BP, and IP standards.

Key Features

  • Potassium-sparing ENaC blocker
  • USP/BP/IP compliant quality
  • Reduces risk of hypokalaemia in diuretic therapy
  • Widely used in combination diuretics

Applications

  • Hypertension combination tablets
  • Congestive heart failure oedema
  • Combination diuretic formulations
  • Ascites management in liver disease

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameAmiloride
Also Known AsMidamor
CAS Number2016-88-8
Molecular FormulaC₆H₈ClN₇O
Molecular Weight229.63 g/mol
CategoryPotassium-Sparing Diuretic
AppearanceYellow to Greenish-yellow Crystalline Powder
GradeUSP / BP / IP

Analytical Specifications

ParameterSpecification
Assay98.5% – 101.5%
Loss on DryingNMT 1.0%
Melting Point293°C – 296°C (decomp)
Heavy MetalsNMT 10 ppm
pH3.5 – 5.0 (1% solution)
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing25 kg HDPE drums / as per requirement

Sourcing, Regulatory & Export Information

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Amiloride (CAS 2016-88-8) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Amiloride is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing — identity (IR/HPLC), assay, related substances, residual solvents (ICH Q3C), heavy metals, and microbial limits — before release with a Certificate of Analysis.

Export Markets

  • USA — FDA-registered facility; DMF support available for ANDA/NDA filings
  • Europe — EMA-compliant documentation; CEP/EDMF support on request
  • Africa & Middle East — WHO-GMP certified; competitive pricing for emerging markets
  • Southeast Asia — established logistics network; temperature-controlled shipments
  • India domestic — schedule H/X compliance; all state licensing documentation provided

Quality & Compliance

  • ISO 9001:2015 certified quality management system
  • GMP-certified manufacturing facility, Aurangabad, Maharashtra
  • Full batch traceability from raw material to finished API
  • Stability data available (ICH Q1A guidelines) for regulatory submissions
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Amiloride API

What is the minimum order quantity for Amiloride API?
Mediocon Inc supplies Amiloride with a minimum order quantity of 1 kg (sample packs available for R&D). We accommodate both small R&D quantities and large commercial-scale orders. Contact our sales team at akshay@mediocon.com or +91 9309999757 for a tailored quote.
What pharmacopoeial grades of Amiloride does Mediocon supply?
We supply Amiloride conforming to USP / BP / IP pharmacopoeial standards. Each batch is tested against full pharmacopoeial specifications and released with a Certificate of Analysis. Custom specifications can be accommodated for regulated markets.
What documentation is provided with Amiloride API?
Every shipment of Amiloride comes with: Certificate of Analysis (CoA), MSDS/SDS, Certificate of Origin (COO), and Drug Master File (DMF) support on request. We also provide GMP certification, ISO 9001:2015 compliance documentation, and full regulatory support for filings in USA (FDA), Europe (EMA), and other markets.
What is the lead time and shipping for Amiloride bulk orders?
Standard lead time for Amiloride is 2–4 weeks for standard orders; expedited shipments possible for urgent requirements. We ship to 40+ countries worldwide using approved pharmaceutical-grade packaging (25 kg HDPE drums / aluminium foil bags). All shipments include temperature-controlled logistics options where required by the product's storage conditions.
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