Furosemide API Manufacturer & Bulk Supplier in India
Molecular Formula
C12H11ClN2O5S
Molecular Weight
330.74 g/mol
CAS Number
54-31-9
Drug Class
Diuretics
Potent loop diuretic API for edema and hypertension formulations.
Key Product Information
Generic Name
Furosemide
CAS Number
54-31-9
Molecular Formula
C12H11ClN2O5S
Molecular Weight
330.74 g/mol
Drug Class
Diuretics
Use Case
Loop Diuretic
Production Capacity
20 MT/Month
Grade
IPBPUSPEP
Applications & Use Cases
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. Furosemide is a high-purity loop diuretic manufactured under ISO 9001:2015 controls, suitable for global pharmaceutical formulations with documented process validation and batch traceability.
Furosemide is one of the most prescribed loop diuretics worldwide. Behind every tablet, injection, or oral solution that reaches a patient is an Active Pharmaceutical Ingredient (API) that must be manufactured, tested, and documented to meet strict standards.
At Kodel Life, we produce Furosemide API in IP, BP, USP, and EP grades with a monthly output of 20 MT. Our manufacturing plant operates under ISO 9001:2015 certification and supplies to pharmaceutical companies in 21 countries across 5 continents.
This page covers everything a pharma buyer, formulator, or procurement head needs to know before choosing a Furosemide API supplier.
What Is Furosemide API?
Chemical Profile & Drug Class
Furosemide is a sulfonamide-derived loop diuretic. It acts on the ascending limb of the Loop of Henle in the kidneys, blocking the sodium-potassium-chloride cotransporter (NKCC2). This causes rapid excretion of water, sodium, and chloride through urine.
Parameter
Value
Generic Name
Furosemide
CAS Number
54-31-9
Molecular Formula
C12H11ClN2O5S
Molecular Weight
330.74 g/mol
Drug Class
Diuretic
Pharmacopoeial Grades
IP, BP, USP, EP
Physical Form
White to off-white crystalline powder
How It Works as a Loop Diuretic
Unlike thiazide diuretics, Furosemide works specifically at the thick ascending limb of the Loop of Henle. The result is a potent natriuretic and diuretic effect that can increase urine output significantly within 30 to 60 minutes of oral administration and within 5 minutes of intravenous use.
This fast-acting profile makes it the go-to API for acute heart failure, pulmonary edema, and hypertension management, particularly in hospitalized patients. Formulations using Furosemide API must account for its pH-dependent solubility and its sensitivity to light during storage.
Global Market Overview for Furosemide
Furosemide has been on the WHO Essential Medicines List for decades. Demand continues to grow as the global population ages and cardiovascular disease prevalence rises.
Rising incidence of congestive heart failure (CHF) worldwide
According to WHO estimates, approximately 1.28 billion adults aged 30–79 years live with hypertension worldwide
Increasing use of generic formulations in emerging markets
Expansion of hospital-based care in Africa, Southeast Asia, and South America
India manufactures over 20% of the world's generic APIs by volume. Several of the largest Furosemide API bulk manufacturers operate out of Gujarat and Maharashtra, benefiting from established chemical supply chains and skilled pharma workforces.
Furosemide API Technical Specifications
Grades Available: IP, BP, USP, EP
Procurement teams sourcing Furosemide API for regulated markets need the right pharmacopoeial grade. Here is what each covers:
IP
Indian Pharmacopoeia
Required for products marketed in India and several South Asian and African markets.
BP
British Pharmacopoeia
Accepted across the UK, the Commonwealth, and many EU countries.
USP
United States Pharmacopeia
Mandatory for products entering the US market and many Latin American regulators.
EP
European Pharmacopoeia
Required for EU market access; often accepted alongside BP.
Kodel Life supplies all four grades from a single manufacturing facility, which reduces sourcing complexity for exporters managing multi-market compliance.
Pharmacopoeial Standards & Purity
Every batch of Furosemide API we release undergoes testing per pharmacopoeial specifications, including:
Assay (HPLC) – typically 99.0% to 101.0% as per USP/EP
Related substances and impurity profiling
Residual solvents (ICH Q3C Class 2 and 3)
Heavy metals and elemental impurities (ICH Q3D)
Particle size distribution
Water content by Karl Fischer titration
Certificate of Analysis (COA), technical specifications, and regulatory documentation support are available upon request. Documentation availability may vary depending on the destination market and regulatory requirements.
Packaging, Storage & Shelf Life
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Packaging
Double-lined HDPE drums with moisture-proof inner lining. Available in 25 kg net fills. Custom packaging on request.
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Storage
Cool, dry place away from direct light. Recommended temperature below 25°C.
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Shelf Life
36 months from manufacturing date under recommended storage conditions.
Transport classification: Non-hazardous under standard pharmaceutical freight guidelines. Export documentation, including COO, COA, and MSDS, is supplied with every shipment.
Why Buyers Choose Kodel Life for Furosemide API
Pharmaceutical companies sourcing Furosemide API require more than competitive pricing. They need consistent quality, reliable documentation, and dependable supply continuity.
Manufacturing capacity of 20 MT per month
Available in IP, BP, USP, and EP grades
ISO 9001:2015 certified quality management system
Batch-specific Certificate of Analysis (COA)
Export supply experience across multiple international markets
Technical support for formulation and procurement teams
Consistent batch-to-batch quality control procedures
Documentation support available for qualified buyers
Why Source Furosemide API from India?
India accounts for a significant share of global API exports, and the reasons are structural rather than coincidental.
Regulatory Infrastructure
India has the second-highest number of US FDA-approved manufacturing sites outside the US.
Cost Advantage
Labor, raw material, and utility costs in India remain significantly lower than in Europe or North America without compromising output quality.
Scale
Large Indian manufacturers can handle multi-tonne monthly orders with consistent batch-to-batch quality.
Speed to Market
Established logistics corridors from JNPT, Mundra, and Chennai ports reduce lead times for global buyers.
Documentation Readiness
Leading API manufacturers often maintain regulatory documentation such as DMFs, ASMFs, CEPs, or market-specific dossiers depending on their target export markets and regulatory strategy.
For buyers in the US, EU, Southeast Asia, or Africa sourcing a Furosemide API supplier for export, India-based manufacturers offer the most practical combination of price, scale, and compliance.
Applications in Pharmaceutical Formulations
Tablet & Injection Formulations
Furosemide API sees widespread use in two primary dosage forms:
Oral Tablets
20 mg, 40 mg, 80 mg, and 500 mg tablet formulations. Most common retail and hospital-use format.
IV/IM Injections
10 mg/mL solution used in acute care and ICU settings.
Oral Solution
10 mg/mL liquid formulations for pediatric and geriatric patients.
Formulators should note that Furosemide has low aqueous solubility at acidic pH. Film-coating and pH-adjusted solubilization are common formulation strategies for improving bioavailability in solid dosage forms.
Therapeutic Areas
Furosemide is a first-line agent in several high-prevalence conditions:
Congestive heart failure (CHF) — for acute and chronic fluid management
Pulmonary edema — rapid diuresis to reduce fluid in the lungs
Hypertension — particularly in combination with other antihypertensives
Renal impairment-related edema — used across nephrology and ICU settings
Nephrotic syndrome and hepatic cirrhosis-related ascites
This breadth of clinical use means stable, long-term demand for Furosemide API across formulation companies of all sizes.
Explore Related Manufacturing Capabilities
In addition to Furosemide API manufacturing, Kodel Life supports pharmaceutical companies through a broad range of manufacturing and documentation services.
API Manufacturing Services
Bulk Drug Manufacturing
Quality Control & Testing
Export Documentation Support
Pharmaceutical Contract Manufacturing
Comparing Furosemide API Suppliers: What Actually Matters
Not every API supplier will fit every buyer's situation. Here is a practical comparison of the key variables:
Factor
What to Check
Why It Matters
Certifications
ISO 9001, FDA compliance, EDQM CEP
Determines which regulated markets you can sell into
DMF Availability
USDMF, ASMF, JDMF
Required for regulatory submissions in US, EU, Japan
Production Capacity
MT per month, surge capacity
Avoids supply disruptions during peak demand
Grades Offered
IP / BP / USP / EP
Must match your target market's pharmacopoeial requirements
Lead Time
Standard and expedited timelines
Affects planning cycles and inventory management
COA & Documentation
Full analytical reports, MSDS, COO
Required by customs, QA teams, and regulators
Export Track Record
Countries served, logistics partners
Reduces risk of first-shipment compliance issues
Kodel Life checks every box in this table. We have been exporting to 21 countries and maintain active documentation for all four pharmacopoeial grades.
What to Look for When Choosing a Furosemide API Manufacturer
Certifications: ISO, FDA, EDQM
A certificate is only as good as the audit trail behind it. When evaluating any Furosemide API manufacturer, ask specifically for:
ISO 9001:2015 scope certificate covering API manufacturing
FDA establishment registration number (verifiable on FDA.gov)
EDQM CEP (Certificate of Suitability) if you target European markets
Kodel Life holds ISO 9001:2015 certification and follows documented quality management systems designed to support pharmaceutical manufacturing requirements. Product documentation, including COA and technical specifications, is available to qualified buyers upon request. Our COA is traceable to in-house testing carried out by qualified analytical chemists.
DMF Filing & COA Availability
A Drug Master File (DMF) is a submission to a regulatory authority (USFDA, EMA, PMDA) that contains confidential details about the manufacturing process, facilities, and controls for an API. Buyers planning US or EU market launches need to confirm that their API supplier has an active, open DMF on file. Without this, the formulator cannot reference the API in their New Drug Application or Abbreviated New Drug Application.
At Kodel Life, COA and DMF documentation is available upon request for qualified buyers. Our team supports the technical transfer process from the first enquiry.
Production Capacity & Lead Times
20 MT/Month
Furosemide API production capacity
62 MT/Month
Total API capacity across all products
2–4 Weeks
Standard lead time for stocked material
Custom batch orders take 6 to 8 weeks depending on specifications.
Common Mistakes Pharma Buyers Make When Sourcing APIs
1
Choosing based on price alone
A lower price per kg means nothing if the supplier cannot provide a valid COA or if impurity profiles fail incoming QC. Always verify the analytical data first.
2
Not confirming the grade before ordering
Furosemide in IP grade cannot be used for a US NDA submission. Always map the grade to your regulatory target market.
3
Skipping supplier audits
Even for small initial orders, request a supplier self-audit questionnaire or arrange a remote audit. Regulatory agencies expect documented supplier qualification.
4
Overlooking shelf life vs. your manufacturing cycle
If your API has a 36-month shelf life but your production cycle runs 18 months, you need fresh stock, not warehouse clearance.
5
Not asking for DMF reference letters upfront
If your API supplier refuses to issue a DMF authorization letter, your regulatory submission will stall. Clarify this before placing the first order.
Get Furosemide API Samples & Pricing
If you are sourcing Furosemide API in bulk for formulation or export, our team can walk you through grade options, documentation packages, and dispatch timelines. We work with formulation companies, contract manufacturers, and pharmaceutical distributors globally. Whether you need one tonne or twenty, the process starts the same way: a conversation with our technical sales team.
Samples
Available for pre-qualified buyers
COA / DMF
Available upon formal inquiry
20 MT/Month
Furosemide API capacity
21 Countries
USA, UK, EU, Africa, SEA
Reach out through the enquiry form or contact us directly. We respond within 1 to 2 business days.
Interested in This Product?
Contact our team to discuss
pricing, availability, and custom requirements.
Quality Certifications
ISO 9001:2015
Quality Management System
FDA Compliant
Regulatory Compliance
Why Buyers Choose Kodel Life
Manufacturing capacity of 20 MT per month
Available in IP, BP, USP, and EP grades
ISO 9001:2015 certified quality management system
Batch-specific Certificate of Analysis (COA)
Export supply experience across multiple international markets
Technical support for formulation and procurement teams
Consistent batch-to-batch quality control procedures
Documentation support available for qualified buyers
Several ISO and FDA-compliant manufacturers produce Furosemide API in India. Kodel Life is one such manufacturer, exporting to 21 countries with active COA and DMF support. Other notable names in the Indian market include manufacturers from Gujarat and Maharashtra with EDQM approvals.
Furosemide API is available in IP (Indian Pharmacopoeia), BP (British Pharmacopoeia), USP (United States Pharmacopeia), and EP (European Pharmacopoeia) grades. The grade required depends entirely on the target market's regulatory authority.
Reputable manufacturers like Kodel Life supply a Certificate of Analysis with every batch. Drug Master File documents (USDMF, ASMF) are provided through a formal authorization process to qualified buyers who plan to make regulated market submissions. Contact us to initiate the documentation process.
As per USP and EP monographs, Furosemide API assay should be between 99.0% and 101.0% on a dried basis. All batches from Kodel Life are tested by HPLC to confirm compliance before release.
Yes. Kodel Life provides samples to pre-qualified buyers for evaluation purposes. Submit your inquiry through our contact page and specify your target grade, quantity requirement, and intended formulation type.
The CAS number of Furosemide API is 54-31-9. This unique identifier is used globally for regulatory, procurement, and product documentation purposes.
Furosemide API is typically supplied in double-lined HDPE drums with moisture-protective inner liners. Standard packaging is generally available in 25 kg quantities, with custom packaging options available based on customer requirements.
Under recommended storage conditions, Furosemide API generally has a shelf life of up to 36 months from the manufacturing date. Storage recommendations should always be followed as specified in the product documentation.
Market Insights
