Bumetanide API Manufacturers and Suppliers in India
Bumetanide API (CAS 28395-03-1) is a loop diuretic active pharmaceutical ingredient. It is a white or almost white powder, practically insoluble in water, and is formulated into tablets and injections for the treatment of oedema in congestive heart failure, hepatic disease and renal disease, including nephrotic syndrome. We manufacture Bumetanide API at our Balanagar site in Hyderabad and supply it to formulation companies in India and abroad against a batch-specific Certificate of Analysis.
Product Description
Product Description
Product Description
Generic name: Bumetanide
Chemical name: 3-(Butylamino)-4-phenoxy-5-sulfamoylbenzoic acid
CAS number: 28395-03-1
Molecular formula: C17H20N2O5S
Molecular weight: 364.42 g/mol
Category: Loop diuretic
Therapeutic use: Oedema associated with congestive heart failure, hepatic disease and renal disease, including nephrotic syndrome
Form: Powder
Colour: White or almost white
Solubility: Practically insoluble in water; soluble in acetone and in ethanol (96%); slightly soluble in methylene chloride
Packing: As per customer requirement
Synonyms: IHS
The formula above is the free acid, which is the form the pharmacopoeial monographs describe, so quotes from different suppliers should be for the same substance. What does vary is the pharmacopoeial grade tested against, and that should be fixed in writing before an order is placed.
Bumetanide API Specification
Every batch of Bumetanide API leaves the site with a Certificate of Analysis written to the monograph for the grade ordered. A Bumetanide CoA typically covers appearance, solubility, identification by infrared absorption, related substances by HPLC, assay by HPLC, and the general tests the monograph calls for, such as loss on drying and residual solvents.
The limits we publish today:
Test | Limit |
Assay by HPLC | Not less than 98.0% and not more than 102.0% w/w |
Any unspecified impurity | Not more than 0.1% w/w |
Total impurities | Not more than 0.2% w/w |
Two points matter to formulators. Bumetanide is practically insoluble in water, so dissolution of a tablet depends on the particle size of the API. Ask for the particle size distribution with the sample if your formulation needs it. Second, the molecule carries a sulfonamide and a carboxylic acid group, so related-substance control at the 0.1% level depends on how the final purification step is run and monitored, not just on the release test.
Bumetanide API Manufacturers in India
We are registered as Biochemical and Synthetic Products Private Limited and have manufactured active pharmaceutical ingredients since 1943. The plant sits at Plot No. 11/6/2029, Phase-2, SVCIE, Balanagar, Hyderabad 500037, and operates under Form 25 manufacturing licence 118/HD/AP/96/B/R. The company history is on the our story page.
Bumetanide is made by multi-step organic synthesis. The sulfamoyl group, the phenoxy ether and the butylamino side chain are introduced in separate stages, and each stage produces intermediates that must be isolated and tested before the next step. We make the Bumetanide intermediates in-house. Where a stage is run in-house, the manufacturer controls the impurity profile of the material entering the final step, and a change in that stage goes through the manufacturer’s own change control rather than a supplier’s. That is what shortens the investigation when a related-substance result drifts.
ICH Q7 sets the expectations for API manufacture: defined critical steps, validated cleaning between products, in-process controls, and a documented batch record for every lot. We declare that our API operations are run in line with ICH Q7 principles. The chemistry the site handles is summarised on the reaction capabilities page.
Bumetanide API Suppliers in India
We supply Bumetanide API directly from the manufacturing site. There is no trading layer between the plant and the buyer, so the batch on the Certificate of Analysis is the batch that ships.
Pack sizes are set to the order. Each container is labelled in line with ICH Q7: product name, batch number, quantity, manufacturing and retest dates, and storage condition. The document set that travels with an order is the Certificate of Analysis for the shipped batch, the Safety Data Sheet, and the standard specification. A method of analysis, a stability summary and a Site Master File extract can be discussed under a confidentiality agreement for regulatory filings.
A first order usually runs in this sequence: enquiry with grade, quantity and destination market; specification and a sample against your tests; agreement on the specification; purchase order; batch manufacture or allocation from stock; pre-shipment CoA; dispatch. Lead time depends on whether material is in stock or made to order.
Bumetanide API Price in India
Bumetanide API is quoted per kilogram against a written specification. We do not publish a list price because the number moves with four things.
The pharmacopoeial grade and any additional tests you require, such as particle size or a tighter impurity limit, set the base. Order volume comes next: a single development quantity is priced differently from a recurring commercial order. Packing and shipping terms follow, since drum size, export documentation and Incoterms all change the landed cost. Lead time is last. Material allocated from stock and material scheduled into a production campaign are not the same price.
There is no reliable published benchmark for Bumetanide API price in India that states both grade and quantity, so treat any marketplace figure as a starting point for a conversation rather than a comparison. Send your grade, quantity and destination through the contact page and a written quotation follows.
Quality and Compliance
Our quality management system is certified to ISO 9001:2015 by DNV Business Assurance UK Limited under UKAS accreditation, certificate number 156792-2014-AQ-IND-UKAS, first certified on 20 August 2002. The certificate scope reads “Development, manufacture and sale of active pharmaceutical ingredients (APIs), drug intermediates, biological products & liver injectable”.
The Balanagar site holds a WHO-GMP certificate issued by the Drugs Control Administration, Government of Telangana, L.Dis.No. 150458/TS/2024, dated 6 June 2024 and valid until 5 June 2027.
Bumetanide API is manufactured in line with ICH Q7 principles under our own GMP declaration. Buyers in regulated markets should plan on their own audit or a questionnaire-based qualification. More on the site’s systems is on the pharmaceutical quality assurance page.
How Bumetanide Works and Where It Is Used
Bumetanide inhibits sodium reabsorption in the ascending limb of the loop of Henle. Sodium, chloride and water are excreted, which produces diuresis. The US prescribing information gives an onset of diuresis 30 to 60 minutes after an oral dose, with diuresis largely complete within 4 hours at usual doses.
The approved indication in the US prescribing information is oedema associated with congestive heart failure, hepatic disease and renal disease, including nephrotic syndrome. On a milligram basis, the same label states that 1 mg of bumetanide has a diuretic potency equivalent to approximately 40 mg of furosemide. Tablets are marketed at 0.5 mg, 1 mg and 2 mg, and the usual total daily dose is 0.5 mg to 2 mg given as a single dose. Strengths this low make content uniformity a live issue, which brings the discussion back to particle size and blend homogeneity. A general primer on what an API is and how it fits into a finished product is in our post on the role of active pharmaceutical ingredients.
Bumetanide API FAQs
We are listening.
We believe that the heart of dialogue is listening.Please write in your queries and we will get back to you.
1. What type of drug is bumetanide?
Bumetanide is a loop diuretic. It acts on the ascending limb of the loop of Henle to block sodium reabsorption, which increases the excretion of sodium, chloride and water. It belongs to the same class as furosemide and torsemide.
2. Is bumetanide the same as Lasix?
No. Lasix is a brand of furosemide. Bumetanide and furosemide are both loop diuretics with the same mechanism, but they are different molecules with different potencies and pharmacokinetics. They are not interchangeable milligram for milligram.
3. How does bumetanide compare with furosemide?
The US prescribing information for bumetanide states that 1 mg of bumetanide has a diuretic potency equivalent to approximately 40 mg of furosemide. The same label notes an almost equal diuretic response after oral and parenteral dosing. Clinical selection between the two is a prescriber’s decision; for an API buyer the practical difference is that bumetanide tablets are low-strength, so blend uniformity and particle size matter more.
4. What is Bumetanide API used for?
Bumetanide API is used to manufacture tablets and injections for the treatment of oedema associated with congestive heart failure, hepatic disease and renal disease, including nephrotic syndrome.
5. Which pharmacopoeial grade of Bumetanide API does Bio-Synth supply?
Bumetanide has monographs in the major pharmacopoeias. We supply the grade agreed in the specification, and the Certificate of Analysis for each batch states the tests and limits applied. Confirm the grade you need when you enquire.
6. What documents come with a Bumetanide API order?
Each shipment carries the Certificate of Analysis for the batch supplied, the Safety Data Sheet and the agreed specification. Further technical documents for regulatory filings can be discussed under a confidentiality agreement.
7. What is the price of Bumetanide API in India?
Bumetanide API is quoted per kilogram against grade, quantity, packing and lead time. There is no list price. Send your requirement and a written quotation is issued.
Request a Quotation
Send the pharmacopoeial grade, the quantity, the destination market and whether you need a sample first. Include any tests beyond the monograph, such as particle size, so they can be priced in. Use the contact page to reach the sales team.
You will receive the specification, a written quotation with lead time and pack size, and, where a sample is agreed, a sample with its Certificate of Analysis. Bumetanide is one of the products in our API portfolio.