Active Pharmaceutical Ingredient

Hydrochlorothiazide API Manufacturer & Supplier in India

Also known as: HCTZ / HydroDiuril

CAS: 58-93-5 Thiazide Diuretic / Antihypertensive IP / BP / EP / USP Bulk Supply Available
Hydrochlorothiazide API Manufacturer India | Mediocon Inc
Hydrochlorothiazide — Pharmaceutical Grade API

Product Overview

CAS No: 58-93-5  |  MF: C₇H₈ClN₃O₄S₂  |  MW: 297.74 g/mol

Hydrochlorothiazide (HCTZ) is a thiazide diuretic used to treat hypertension and edema associated with heart failure, renal disorders, and hepatic cirrhosis. Mediocon Inc supplies IP/BP/EP/USP compliant Hydrochlorothiazide API for solid and liquid dosage formulations.

Key Features

  • Thiazide diuretic with antihypertensive effect
  • IP/BP/EP/USP compliant quality
  • Consistent particle size distribution
  • Suitable for tablet and capsule formulations

Applications

  • Hypertension management
  • Edema (heart failure, renal, hepatic)
  • Combination antihypertensive therapy
  • Nephrolithiasis prevention

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 NameHydrochlorothiazide
Also Known AsHCTZ / HydroDiuril
CAS Number58-93-5
Molecular FormulaC₇H₈ClN₃O₄S₂
Molecular Weight297.74 g/mol
CategoryThiazide Diuretic / Antihypertensive
AppearanceWhite or Practically White Crystalline Powder
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
Assay98.0% – 102.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
pHN/A
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 Hydrochlorothiazide (CAS 58-93-5) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Hydrochlorothiazide 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 — Hydrochlorothiazide API

What is the minimum order quantity for Hydrochlorothiazide API?
Mediocon Inc supplies Hydrochlorothiazide 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 Hydrochlorothiazide does Mediocon supply?
We supply Hydrochlorothiazide conforming to IP / BP / EP / USP 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 Hydrochlorothiazide API?
Every shipment of Hydrochlorothiazide 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 Hydrochlorothiazide bulk orders?
Standard lead time for Hydrochlorothiazide 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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