Diuretics — commonly known as "water pills" — help the kidneys remove extra salt and water from the body through urine. They are often used to reduce swelling or lower blood pressure. Hydrochlorothiazide API produced with consistent particle characteristics and impurity profiles aligned to pharmacopoeial monographs for export-quality finished dosage forms.
Kodel Life is one of the leading Hydrochlorothiazide API manufacturers in India, producing CAS 58-93-5 to IP, BP, USP, and EP pharmacopoeial standards from its ISO 9001:2015 certified facility in Morbi, Gujarat. This thiazide diuretic active pharmaceutical ingredient is supplied as a bulk API for antihypertensive monotherapy tablets, fixed-dose combination formulations, and adjunct cardiovascular therapies.
With 10 MT per month production capacity and a complete export documentation package, Kodel Life is a trusted Hydrochlorothiazide API bulk supplier and exporter serving pharmaceutical manufacturers across 21 countries.
Request COA & DMF TodayISO 9001:2015 CertifiedShips to 21 Countries
Hydrochlorothiazide (HCTZ) is a thiazide diuretic that acts on the distal convoluted tubule of the nephron. It inhibits the sodium-chloride symporter, reducing reabsorption of sodium and chloride ions and promoting their excretion in urine. The resulting increase in water excretion reduces blood volume, lowering systemic vascular resistance and blood pressure. HCTZ is one of the most widely prescribed antihypertensive agents globally, endorsed as a first-line therapy in major clinical guidelines from the WHO, JNC 8, and ESC/ESH.
As an Active Pharmaceutical Ingredient, Hydrochlorothiazide must meet precise assay, particle size distribution, related substance, and polymorphic purity specifications to ensure consistent bioavailability across both monotherapy and combination tablet formulations. Kodel Life manufactures HCTZ API to all four major pharmacopoeia standards in a single cGMP-compliant facility, giving Hydrochlorothiazide API bulk suppliers and buyers a fully characterised, batch-documented starting material from one qualified source.
Clinical Context
Hydrochlorothiazide is included on the WHO Model List of Essential Medicines. It is prescribed in over 100 countries as either a monotherapy antihypertensive or as the diuretic component in fixed-dose combination products paired with ACE inhibitors, ARBs, beta blockers, and calcium channel blockers. This breadth of clinical use drives consistent global demand for high-quality HCTZ API from qualified bulk suppliers.
Hydrochlorothiazide API for Tablet Formulations
HCTZ API is used primarily in oral solid dosage forms. The most common commercial products are immediate-release tablets, but the API also appears in extended-release and modified-release combination tablets. Kodel Life supplies HCTZ API with specifications matched to both monotherapy tablet manufacturing and the more demanding fixed-dose combination formulation environment.
HCTZ monotherapy tablets represent a high-volume generic product globally, particularly in regulated and semi-regulated markets. API for direct compression or wet granulation manufacture requires consistent particle properties.
Defined particle size distribution (D50 and D90 control) for blend uniformity and content uniformity
Tight polymorphic form control: Form I (more soluble, preferred for tablet dissolution performance)
Low residual solvent content per ICH Q3C
Assay of 98.0% to 102.0% per IP, USP, and BP monograph limits
Impurity profile aligned to pharmacopoeial limits for related substances and heavy metals
Fixed-Dose Combination (FDC) Tablets
HCTZ is the diuretic component in dozens of globally marketed fixed-dose combination antihypertensive products. FDC formulation demands more stringent API uniformity to avoid inter-ingredient interactions.
HCTZ paired with ACE inhibitors: Lisinopril/HCTZ, Enalapril/HCTZ, Ramipril/HCTZ
HCTZ paired with ARBs: Valsartan/HCTZ, Losartan/HCTZ, Telmisartan/HCTZ, Olmesartan/HCTZ
HCTZ paired with beta blockers: Bisoprolol/HCTZ, Atenolol/HCTZ, Metoprolol/HCTZ
HCTZ paired with calcium channel blockers: Amlodipine/HCTZ combinations
API compatibility testing data and co-processing suitability information available on request
Capsule and Powder Sachets (Emerging Market Formats)
In select emerging markets, HCTZ is dispensed as hard gelatin capsules or powder sachets. These formats require specific flow and particle size characteristics for uniform fill.
Fine particle size grade available for capsule fill and powder sachet dispensing
Low hygroscopicity documentation available to support open-pack stability in humid climates
Certificate of Analysis adapted to local pharmacopoeia if required (IP, BP, EP, USP)
Formulators and product development teams receive a Technical Data Package on request. This includes the COA, impurity profile, method validation data, particle size report, polymorphic form confirmation, and compatibility data for the relevant co-formulated APIs.
Why Choose Kodel Life as Your Hydrochlorothiazide API Supplier
Pharmaceutical procurement teams selecting Hydrochlorothiazide API suppliers evaluate three factors above price: documentation quality, supply chain consistency, and regulatory compliance. Kodel Life addresses all three from a single ISO-certified facility in Morbi, Gujarat.
Quality and Compliance Credentials
ISO 9001:2015 certified facility — Morbi, Gujarat, India
FDA-compliant cGMP manufacturing practices applied across all API production
In-house analytical lab: HPLC assay, related substances by TLC/HPLC, PSD by laser diffraction, moisture by KF
Compendial testing to IP, BP, USP, and EP: full monograph compliance per batch
Batch-specific COA issued with every shipment; impurity profile, residual solvent data included
DMF documentation package available for Type II (US) and ASMF (EU) submissions
Supply Consistency You Can Plan Around
10 MT per month dedicated production capacity for Hydrochlorothiazide API
Validated synthesis process with documented batch-to-batch consistency across particle size, assay, and purity
Dedicated export documentation team managing shipping, customs, and import compliance for 21 country markets
Development samples dispatched within one to two business days of confirmed request
Long-term commercial supply contracts accommodated with agreed volume scheduling
Supplier Qualification Note
Kodel Life provides a complete supplier qualification package on request: facility overview document, QMS summary, ISO certificate, product-specific DMF, three recent COAs, and a reference letter for regulatory authority filing. This package is designed to reduce the buyer's qualification timeline to a single audit cycle.
Hydrochlorothiazide API Bulk Suppliers and Exporters: Kodel Life's Global Reach
Kodel Life is an established Hydrochlorothiazide API bulk exporter from India, with active supply relationships across 21 countries on five continents. The combination of Gujarat's established pharmaceutical manufacturing infrastructure, India's competitive API synthesis cost base, and Kodel Life's ISO-certified quality systems positions this facility among the preferred Hydrochlorothiazide API bulk manufacturers for regulated and semi-regulated market buyers.
Active Export Markets
Southeast Asia
Thailand, Vietnam, Myanmar, Malaysia, Philippines
South Asia
Sri Lanka, Bangladesh, Nepal, Pakistan
Middle East
UAE, Saudi Arabia, Jordan
Africa
Kenya, Tanzania, Nigeria, Ethiopia, South Africa
Europe and CIS
Germany, Russia, Ukraine
Americas
USA, Brazil, Canada
Export Documentation Package
Every Hydrochlorothiazide API bulk shipment from Kodel Life includes:
Batch-specific Certificate of Analysis (COA) to the pharmacopoeial standard specified by the buyer
Drug Master File (DMF) reference letter or open DMF for regulatory submissions in the destination market
Stability data per ICH Q1A: six-month accelerated and 12-month long-term conditions
Impurity profile per ICH Q3A: identification and qualification thresholds documented
Residual solvent data per ICH Q3C: Class 2 and Class 3 solvents profiled
Shipping and customs documentation for destination market import compliance
Material Safety Data Sheet (MSDS/SDS) compliant with GHS/UN hazardous material standards
Bulk Order Lead Time
Sample quantities are dispatched within one to two business days of confirmed request. Commercial bulk orders are processed with a committed lead time agreed at the time of order confirmation. Contact the team via the enquiry form or WhatsApp (+91 75023 33335) to discuss your volume, timeline, and documentation requirements.
Hydrochlorothiazide vs Chlorthalidone: Which Thiazide API Do You Need?
Hydrochlorothiazide and Chlorthalidone are the two most widely used thiazide-type diuretics in antihypertensive formulation. They share a mechanism of action but differ meaningfully in pharmacokinetics, evidence base, and market penetration. The comparison below helps procurement and formulation teams select the right API for their product.
Parameter
Hydrochlorothiazide (HCTZ)
Chlorthalidone
CAS Number
58-93-5
77-36-1
Drug Class
Thiazide diuretic
Thiazide-like diuretic
Half-Life
6-15 hours
45-60 hours (longer duration)
Dosing Frequency
Once or twice daily
Once daily
Primary Dosage Forms
Tablets: monotherapy and FDC
Tablets: monotherapy
Key FDC Partners
ARBs, ACE inhibitors, beta blockers, CCBs
ARBs, beta blockers
Market Availability
Established generic: very broad global market
Narrower but growing, particularly US and EU
Guideline Preference
WHO EML, JNC 8, ESC/ESH endorsed
ALLHAT trial preferred; gaining guideline support
Generic Competition
High: many manufacturers globally
Moderate: fewer manufacturers
Kodel Life Supply
Yes: IP/BP/USP/EP, 10 MT/Month
Not in current portfolio
For pharmaceutical manufacturers building antihypertensive portfolios, HCTZ remains the dominant global choice due to its FDC versatility, established generic infrastructure, and WHO Essential Medicines status. Chlorthalidone has a stronger evidence base for cardiovascular outcomes but a smaller global supply base.
Hydrochlorothiazide API in Fixed-Dose Combination Antihypertensives
The largest commercial opportunity for Hydrochlorothiazide API is in fixed-dose combination antihypertensive tablets. Major global antihypertensive guidelines recommend combination therapy as a first-line treatment for most patients with Stage 2 hypertension, and HCTZ is the diuretic of choice in the majority of these regimens. Kodel Life's HCTZ API is supplied with the particle size, purity, and compatibility documentation needed to support FDC tablet registration in regulated and semi-regulated markets.
FDC Product
Partner API
Key Market Regions
HCTZ Strength
Losartan/HCTZ
Losartan Potassium
US, EU, Asia, LatAm
12.5 mg / 25 mg
Valsartan/HCTZ
Valsartan
EU, Asia, LatAm
12.5 mg / 25 mg
Telmisartan/HCTZ
Telmisartan
EU, Asia, Africa
12.5 mg / 25 mg
Lisinopril/HCTZ
Lisinopril
US, LatAm, Africa
12.5 mg / 25 mg
Enalapril/HCTZ
Enalapril Maleate
EU, LatAm, Asia
12.5 mg / 25 mg
Bisoprolol/HCTZ
Bisoprolol Fumarate
EU, Middle East, Asia
12.5 mg / 25 mg
Olmesartan/HCTZ
Olmesartan Medoxomil
US, EU, Japan
12.5 mg / 25 mg
Amlodipine/Valsartan/HCTZ
Amlodipine + Valsartan
US, EU, Asia
12.5 mg / 25 mg
Buyers developing FDC products receive API compatibility data and stability data at relevant storage conditions alongside the standard documentation package. Contact the team to discuss product-specific requirements.
Where Hydrochlorothiazide API Is Used
Hydrochlorothiazide API is sourced by generic pharmaceutical manufacturers, FDC product developers, branded generics companies, and CDMOs across the antihypertensive and cardiovascular therapeutic segment. Applications include:
Fixed-dose combination antihypertensive tablets paired with ARBs, ACE inhibitors, beta blockers, and CCBs
Hard gelatin capsules for select emerging market formats
Oedema management tablets for heart failure and hepatic cirrhosis indications
Adjunct therapy products for calcium oxalate nephrolithiasis (kidney stone prevention)
OTC antihypertensive products in markets where HCTZ holds OTC approval
Paediatric antihypertensive formulations where weight-based HCTZ dosing is appropriate
How to Order Hydrochlorothiazide API from Kodel Life
Kodel Life works with pharmaceutical manufacturers, generic drug companies, CDMOs, and trading houses sourcing HCTZ API from India. The procurement process runs in five steps:
1
Submit an enquiry via the contact form or WhatsApp (+91 75023 33335). Specify your formulation type (monotherapy tablet, FDC, capsule) and the target pharmacopoeial standard.
2
Receive COA, full specification sheet, and pricing within one to two business days.
3
Request a development sample or Technical Data Package for in-house testing and formulation compatibility work.
4
Confirm order quantity, packaging specification, and export documentation requirements for your destination market.
5
Shipment dispatched with the complete documentation package: COA, DMF reference letter, stability data, impurity profile, and SDS.
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Contact our team to discuss
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Quality Certifications
ISO 9001:2015
Quality Management System
FDA Compliant
Regulatory Compliance
Why Buyers Choose Kodel Life
10 MT/month manufacturing capacity
IP, BP, USP & EP grades available
ISO 9001:2015 certified QMS
Supplied for monotherapy and fixed-dose combination tablets
Batch-specific COA with every shipment
Export to 21 countries across 5 continents
DMF reference letter support for regulated markets
Kodel Life manufactures Hydrochlorothiazide API to IP, BP, USP, and EP pharmacopoeial grades. Buyers specify the required standard at enquiry stage, and the batch COA confirms compliance with the applicable monograph, covering assay, related substances, particle size distribution, residual solvents, and heavy metals.
Kodel Life has 10 MT per month production capacity for Hydrochlorothiazide API, supporting both development-scale sample requests and long-term commercial bulk supply contracts. Contact the team to discuss volume availability and delivery scheduling for your specific requirement.
Yes. Kodel Life's Hydrochlorothiazide API is supplied for both monotherapy and FDC antihypertensive tablet manufacture. API compatibility data, particle size reports, and co-processing suitability documentation are available on request to support FDC product development and regulatory filing.
Standard documentation includes the batch COA to the specified pharmacopoeial standard, DMF or ASMF support for regulatory submissions, impurity profiles per ICH Q3A, residual solvent data per ICH Q3C, stability data per ICH Q1A, and method validation certificates per ICH Q2R1. A complete supplier qualification package with ISO certificate, QMS summary, and facility overview is also available on request.
Kodel Life exports HCTZ API to 21 countries across Asia, Africa, Europe, and the Americas. Active export markets include Thailand, Bangladesh, UAE, Saudi Arabia, Germany, USA, Canada, Brazil, Kenya, South Africa, Sri Lanka, Vietnam, and the Philippines, among others. Each shipment includes country-specific export documentation and import compliance support.
Both are thiazide-type diuretics used in antihypertensive formulations. Hydrochlorothiazide has a shorter half-life of six to 15 hours and is the dominant global choice, particularly in fixed-dose combination products with ARBs, ACE inhibitors, and beta blockers. Chlorthalidone has a longer half-life of 45 to 60 hours and is preferred in some cardiovascular outcome trials. Kodel Life manufactures Hydrochlorothiazide API and does not currently supply Chlorthalidone.
Yes. Kodel Life is a multi-product pharmaceutical API manufacturing company. The same ISO-certified facility in Morbi, Gujarat produces Furosemide API (loop diuretic, 20 MT/month), Metoprolol Succinate API (beta blocker ER, 20 MT/month), Metoprolol Tartrate API (beta blocker IR, 62 MT/month), and Piroxicam API (NSAID, 10 MT/month). Buyers sourcing multiple cardiovascular APIs can consolidate procurement to a single qualified supplier.
Development samples are dispatched within one to two business days of a confirmed sample request. Submit your sample request via the contact form on this page or through WhatsApp (+91 75023 33335). The team will confirm availability, quantity, and the accompanying documentation package before dispatch.
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