Empagliflozin API Manufacturers and Suppliers in India
Empagliflozin is a C-aryl glucoside that inhibits sodium-glucose co-transporter 2 in the proximal renal tubule, lowering the kidney’s reabsorption of filtered glucose. Bio-Synth manufactures it as a bulk active pharmaceutical ingredient in Hyderabad for oral antidiabetic formulations. Everything a formulator needs from the datasheet sits below.
Product Description
Product Description
Product Description
Product: Empagliflozin API
CAS Number: 864070-44-0
Chemical Name: (2S,3R,4R,5S,6R)-2-[4-chloro-3-[[4-[(3S)-oxolan-3-yl]oxyphenyl]methyl]phenyl]-6-(hydroxymethyl)oxane-3,4,5-triol
Molecular Formula: C23H27ClO7
Molecular Weight: 450.91 g/mol
Category: SGLT2 inhibitor, oral antidiabetic
Therapeutic Use: Glycaemic control in type 2 diabetes mellitus
Physical Form: Crystalline solid
Colour: White to yellow
Solubility: Sparingly soluble in methanol; soluble in acetonitrile and in water/acetonitrile (1:1)
Storage: [CONFIRM: the live page publishes no storage condition. Confirm container, temperature and any light-protection requirement with QA]
Pharmacopoeial Grade: [CONFIRM: no grade is stated on the live page. Confirm with RA whether Bio-Synth releases against IP, BP/Ph.Eur, USP or an in-house monograph]
Packing: As per requirement
Synonyms: BI-10773; (1S)-1,5-anhydro-1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3-furanyl]oxy]phenyl]methyl]phenyl]-D-glucitol
Worth noting when you line up quotations across the flozin class. Empagliflozin is supplied as the free molecule, anhydrous, with no salt former and no water of crystallisation. Dapagliflozin is not: it is normally supplied as the propanediol monohydrate, which carries additional mass and a water specification of its own. Comparing a per-kilogram empagliflozin price against a per-kilogram dapagliflozin price without accounting for that is comparing two different things, and the same trap catches buyers who assume a hydrated empagliflozin grade exists. It does not.
Empagliflozin API Specification
Four limits are published against this product.
Test | Limit |
Any unspecified impurity | Not more than 0.1% |
Total impurities | Not more than 1.0% |
Loss on drying (105 degrees C, 3 hours) | Not more than 0.5% w/w |
Residue on ignition | Not more than 0.1% w/w |
The 0.1% ceiling on any single unidentified impurity is the tight one, and it is tighter than the equivalent limit Bio-Synth publishes on several of its other APIs. Loss on drying and residue on ignition together police the two things that go wrong with an anhydrous crystalline glucoside: retained solvent or moisture from the final crystallisation, and inorganic carry-over from the catalyst and reagent train.
Two further controls a formulator will ask about: the anomeric impurity, meaning the alpha-configured C-glycoside that can survive the reduction step, and particle size.
A certificate of analysis is issued for every batch. Tests typically reported against a pharmacopoeial or in-house monograph include description, identification by infrared and HPLC, specific optical rotation, water content, related substances, residual solvents to ICH Q3C class limits, and heavy metals.
Empagliflozin API Manufacturers in India
Bio-Synth is the trading name of Biochemical and Synthetic Products Private Limited, in continuous operation since 1943 from Plot No. 11/6/2029, Phase-2, SVCIE, Balanagar, Medchal-Malkajgiri district, Hyderabad. The site operates under manufacturing licence 118/HD/AP/96/B/R, issued under Form 25 and valid to 31 December 2026.
Empagliflozin is a C-glycoside, and that single structural fact shapes the whole process. The sugar ring is joined to the aromatic system by a carbon-carbon bond rather than the carbon-oxygen bond of an ordinary glycoside, which makes the finished molecule robust but makes the bond hard to form. The commercial routes go through addition of an aryl metal species to a protected gluconolactone, followed by reduction of the resulting anomeric hemiketal. Two stereochemical checkpoints then decide the batch: the anomeric centre has to end up beta, and the tetrahydrofuran-3-yl ether has to carry the (3S) configuration it was built with. Failures at either point show up as related substances that are chemically very close to the product and correspondingly awkward to purge by crystallisation alone.
For a buyer the practical consequence is that impurity profile, not assay, is the thing to compare between suppliers. Two batches can both assay at 99.5% and carry completely different related-substance fingerprints depending on how each manufacturer runs the coupling and reduction. Ask for a representative impurity profile, not just a headline purity number, and ask whether the route has been revalidated since your last qualification. Bio-Synth’s reaction capabilities describe the chemistry the plant is set up to run.
Empagliflozin API Suppliers in India
Pack configuration is set per order rather than offered from a fixed list. Fix the pack size, the inner liner and the label format with Bio-Synth in writing before the first commercial shipment, since these are the details that a receiving QA group tends to reject a delivery over.
Each consignment travels with a batch certificate of analysis and a safety data sheet. Where the destination regulator asks for one, a certificate of pharmaceutical product can be applied for through the Telangana Drugs Control Administration. **[CONFIRM: standard lead time, minimum order quantity, and the retention sample policy.]**
Buyers exporting into the European Union should note one thing early. An imported API destined for an EU medicinal product normally requires a written confirmation from the exporting country’s competent authority under Article 46b(2)(b) of Directive 2001/83/EC. Bio-Synth holds two such confirmations from CDSCO, and both are product-specific to other molecules. Neither extends to empagliflozin. If the EU is your market, raise this at the enquiry stage rather than after qualification. The export regulatory guidelines post covers the wider documentation picture.
Empagliflozin API Price in India
Public listings for this molecule are not a usable guide. A search on the Indian marketplaces returns per-kilogram figures spanning more than an order of magnitude, because some sellers are quoting research quantities, some are quoting for a different grade, and some are traders rather than producers. The number that matters is the one against your specification and your volume.
Four inputs move it. The grade and impurity specification you release against, since a tighter unspecified-impurity or particle-size requirement costs yield. The annual volume and call-off pattern, because a quantity that slots into a scheduled campaign is cheaper than one that needs a dedicated run. The packing and documentation set, which for a regulated export market can be a meaningful share of the landed cost. And the route economics, which on a C-glycoside are dominated by the coupling and reduction steps rather than by raw material cost.
Bio-Synth quotes against a specification, not from a price list. Send yours. If you are still deciding between molecules in this class, the empagliflozin and dapagliflozin comparison sets out where the two differ for a buyer.
How Empagliflozin API Works (Mechanism of Action)Quality and Compliance
Document | Reference | Status and scope |
ISO 9001:2015 | 156792-2014-AQ-IND-UKAS, DNV Business Assurance UK Limited, UKAS accredited | Management system certificate for the site. Initial certification 20 August 2002. Scope reads “Development, manufacture and sale of active pharmaceutical ingredients (APIs), drug intermediates, biological products & liver injectable”. [CONFIRM: the certificate on file expired on 19 August 2026. Obtain the renewal from DNV and update the number and validity dates before publishing this page] |
ICH Q7 | Company declaration on letterhead | Manufacturing follows ICH Q7 principles, the international GMP guideline for APIs. This is a self-declaration, not a third-party certificate, and must never be described as “ICH Q7 certified” |
WHO-GMP | L.Dis.No. 150458/TS/2024, Drugs Control Administration, Government of Telangana, valid to 5 June 2027 | Site certificate issued under the export scheme for the two products named in the joint inspection report. Empagliflozin is not one of them. No empagliflozin claim may rest on this certificate |
Manufacturing licence | 118/HD/AP/96/B/R, Form 25 | Valid to 31 December 2026 |
Three things Bio-Synth does not have, stated plainly because the current page implies otherwise. There is no CEP or EDQM certificate of suitability, and the “Regulatory status: CEP in process” line on the live page has no supporting document behind it. There is no USFDA approval or FDA-registered status. There is no drug master file filed for empagliflozin in any jurisdiction. If your market requires any of these, Bio-Synth is not currently a qualified source for it, and it is better for both sides to establish that in the first email.
For the general framework of GMP and pharmacopoeial standards that governs API manufacture, see API regulations and standards.
Bio-Synth’s own quality systems page describes how batches are controlled and released at the site.
How Empagliflozin Works and Where It Is Used
Sodium-glucose co-transporter 2 sits in the proximal convoluted tubule and does most of the work of reclaiming glucose from the glomerular filtrate. Empagliflozin inhibits it, so less filtered glucose is returned to the blood and more is excreted in urine. The mechanism is insulin-independent, which is why it behaves differently from the older oral antidiabetic classes.
Finished products containing empagliflozin are used to improve glycaemic control in type 2 diabetes alongside diet and exercise, and the class has been studied extensively in cardiovascular and renal outcomes as well. Prescribing indications vary by market and by product licence, so formulators should work from the approved labelling in their own territory rather than from a supplier page.
Empagliflozin API FAQs
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1. Who manufactures empagliflozin API in India?
A number of Indian producers supply it. Public directories including PharmaCompass and Pharmaoffer list them, and Google’s AI Overview for this query names several alongside Bio-Synth, which manufactures at Balanagar, Hyderabad.
2. What is the CAS number and molecular formula of empagliflozin?
CAS 864070-44-0, molecular formula C23H27ClO7, molecular weight 450.91 g/mol.
3. Does empagliflozin come as a salt or a hydrate?
No. It is supplied as the anhydrous free molecule. Dapagliflozin, by contrast, is normally supplied as the propanediol monohydrate.
4. Is Bio-Synth's empagliflozin covered by WHO-GMP?
No. The WHO-GMP certificate is a site certificate issued for two specified products under the export scheme, and empagliflozin is not among them. Bio-Synth holds ISO 9001:2015 for the site and manufactures to ICH Q7 principles.
5.Is there a DMF or CEP for this product?
No drug master file and no CEP is recorded in Bio-Synth’s documentation for empagliflozin.
6. Can I get a sample to qualify?
Yes. Send the specification you intend to qualify against, with your target volume and destination market.
Request a Quotation
Send the grade, the annual quantity, the pack size and the country the material is going to. Where you already have an internal specification, attach it. A limit that Bio-Synth cannot meet is worth knowing about on day one.
What comes back is a written quotation, the current specification sheet, and an honest list of which regulatory documents exist for this product and which do not. Enquiries go through the contact page.
Running a new-supplier assessment? The company history covers the site’s background.
The full API portfolio shows the rest of the range.