Dapagliflozin API Manufacturers and Suppliers in India

Dapagliflozin API

Dapagliflozin was the first sodium-glucose co-transporter 2 (SGLT2) inhibitor to reach the market for type 2 diabetes. We manufacture the form used in most finished formulations: dapagliflozin propanediol monohydrate, CAS 960404-48-2, molecular formula C21H25ClO6·C3H8O2·H2O, molecular weight 502.98 g/mol. It is supplied as a white to off-white powder for oral solid dose work from our Balanagar plant in Hyderabad.

Check Price

Product Description

Product Description

Product name: Dapagliflozin Propanediol Monohydrate

CAS number: 960404-48-2

Molecular formula: C21H25ClO6·C3H8O2·H2O

Molecular weight: 502.98 g/mol

Chemical name: (2S)-Propane-1,2-diol (2S,3R,4R,5S,6R)-2-{4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl}-6-(hydroxymethyl)oxane-3,4,5-triol hydrate

Category: Sodium-glucose co-transporter 2 (SGLT2) inhibitor

Therapeutic use: Type 2 diabetes; heart failure; chronic kidney disease

Form: Powder

Colour: White to off-white

Solubility: Soluble in DMF, DMSO and ethanol; insoluble in water and cyclohexane

Packing: As per requirement

Synonym: Dapagliflozin (S)-propylene glycol monohydrate, BMS 512148 propanediol hydrate

Note the form: this is the propanediol monohydrate co-crystal at 502.98 g/mol, not dapagliflozin free base, which is CAS 461432-26-8 at 408.87 g/mol. One kilogram of the monohydrate carries about 813 g of dapagliflozin. Most dossiers reference the monohydrate; check yours before comparing quotations.

Dapagliflozin API Specification

The limits for Dapagliflozin API:

Test

Limit

Total impurities

Not more than 0.5

Any single unspecified impurity

Not more than 0.1

Residue on ignition

Not more than 0.1

Water content by KF

Between 2.5% and 4.5% w/w

The water window is worth reading twice. Stoichiometric water for the monohydrate is about 3.6%, so a Karl Fischer result inside 2.5-4.5% is your confirmation that the hydrate is intact; drift outside it signals form change during storage or transit. Each batch ships with a Certificate of Analysis, which for this product typically covers description, identification by IR and HPLC, assay, related substances, residual solvents against ICH Q3C limits, water content, and residue on ignition.

Dapagliflozin API Manufacturers in India

We are Biochemical and Synthetic Products Private Limited, and we have manufactured active pharmaceutical ingredients at Balanagar, Hyderabad since 1943, under manufacturing licence 118/HD/AP/96/B/R.

Dapagliflozin is a C-aryl glucoside: the glucose ring is carbon-bonded to the aglycone, which is what makes the synthesis harder than an O-glycoside and puts the stereochemistry of five contiguous centres at the heart of quality. We run the route through to the propanediol-water co-crystallisation that fixes the final form. Owning that last step matters: the co-crystal is the product, and the supplier who controls crystallisation controls water content, polymorphic purity and particle size directly rather than inheriting them. The full sequence is described step by step in how Dapagliflozin API is manufactured. Manufacturing follows ICH Q7 principles: process validation, change control, validated cleaning between campaigns, complete batch records.

Dapagliflozin API Suppliers in India

Pack size is agreed per order. The usual configuration for a solid API of this class is HDPE drums with double liners, tamper-evident sealing, and labelling with product name, batch number, manufacturing and retest dates and net quantity. Because the product is a hydrate, keep it sealed against moisture exchange in both directions.

The document set that travels with a consignment: Certificate of Analysis and safety data sheet, with a Certificate of Pharmaceutical Product arranged where the destination requires one. ] Dossier and filing requirements by market are covered in our note on DMF filing and regulatory requirements for Dapagliflozin export.

A first order normally runs: specification and representative CoA, then a sample for your own identity, assay, water content and impurity checks, then a quotation with Incoterms, lead time and minimum order quantity in writing, then vendor qualification.

Dapagliflozin API Price in India

We quote Dapagliflozin per kilogram against a specific specification and volume. Four things move the number: the form quoted (propanediol monohydrate versus amorphous or free base, which are different products), order volume against campaign economics, packing configuration, and lead time. Confirm the form first; a cheaper quote for a different form is not a cheaper quote.

Send your specification, quantity and destination market and you will get a firm quotation rather than a range.

Quality and Compliance

Our Balanagar site holds ISO 9001:2015 certification issued by DNV Business Assurance UK Limited under UKAS accreditation, certificate number 156792-2014-AQ-IND-UKAS, initially certified on 20 August 2002, scoped to “Development, manufacture and sale of active pharmaceutical ingredients (APIs), drug intermediates, biological products & liver injectable”. Manufacturing follows ICH Q7 principles, and ICH Q3A and Q3C are the frameworks a reviewer will read our impurity and residual solvent limits against. More sits on the quality management system page.

The site also holds a WHO-GMP certificate issued by the Drugs Control Administration, Government of Telangana, L.Dis.No. 150458/TS/2024 dated 6 June 2024, valid until 5 June 2027.

How Dapagliflozin Works and Where It Is Used

Dapagliflozin inhibits SGLT2 in the proximal tubule of the kidney, the transporter responsible for about 90% of renal glucose reabsorption. Blocking it sends excess glucose out in the urine, which lowers blood glucose independently of insulin, and brings the modest weight and blood pressure reductions characteristic of the class.

The indications have widened well beyond diabetes: reducing hospitalisation risk in heart failure, including heart failure with reduced ejection fraction, and slowing progression of chronic kidney disease. That expansion is what has kept API demand growing, a pattern covered in our review of SGLT2 inhibitor APIs in India

For how the molecule compares with its closest class rival, see Dapagliflozin vs Empagliflozin.

Dapagliflozin 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.


    The propanediol monohydrate form we manufacture is CAS 960404-48-2, molecular weight 502.98 g/mol. Dapagliflozin free base is CAS 461432-26-8 at 408.87 g/mol. Confirm which form your dossier references before comparing quotes.

    Several Indian makers offer it in more than one form. We manufacture the propanediol monohydrate at Balanagar, Hyderabad, against a published specification that includes water content of 2.5-4.5% by KF.

    Quoted per kilogram against your specification and volume, not sold at a list price. Form, grade, order quantity, packing and lead time all move the figure, and quotes for different forms are not comparable.

    Because the product is a defined monohydrate co-crystal. Water by Karl Fischer inside the 2.5-4.5% window confirms the hydrate is intact; a result outside it means the form has shifted and dissolution behaviour may follow.

    Certificate of Analysis and safety data sheet, with a Certificate of Pharmaceutical Product arranged where the destination requires one. The specification sheet and a representative CoA are available before you order.

    Bio-Synth offers premium-quality Dapagliflozin API at competitive prices, tailored to meet your specific requirements. By handling all production stages internally, we maintain strict control over quality while optimizing pricing. For accurate pricing and to discuss your specific needs, we encourage you to reach out with your inquiry. Our team is dedicated to providing timely responses and ensuring your complete satisfaction.

    Bio-synth is one of the top manufacturers of Dapagliflozin API in India, offering top quality, competitive prices, and short lead time.

    The chemical composition of Dapagliflozin API is C₂₁H₂₅ClO₆·C₃H₈O₂·H₂O, which stands for (2S)-propane-1,2-diol (2S,3R,4R,5S,6R)-2-{4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl}-6-(hydroxymethyl)oxane-3,4,5-triol hydrate

    Yes, Dapagliflozin API is available for purchase in India. Bio-synth is one of the leading manufacturers and suppliers of the product. Please reach out via the enquiry form with your requirement and we will be happy to assist you.

    Bio-synth has almost 8 decades of experience manufacturing high-quality APIs, with Dapagliflozin API as one of the key products in its product portfolio, making Bio-Synth one of the trusted manufacturers in India.

    Bio-Synth offers high-quality Dapagliflozin API that meets global standards like WHO-GMP and ISO 9000:2015 certification. Our rigorous quality control ensures consistent and reliable Dapagliflozin supply, making us a top choice for Dapagliflozin API suppliers in India.

    Our facilities are equipped with cutting-edge technology and maintain strict adherence to GLP (Good Laboratory Practices), GDP (Good Documentation Practices), and cGMP (Current Good Manufacturing Practices). This results in consistent product quality, reinforcing Bio-Synth’s reputation for excellence.

    To place an order for Dapagliflozin API, contact Bio-Synth through our customer service team or by filling out the contact form on our website. We provide comprehensive support to guide you through the order process and ensure timely delivery to meet your specific needs.

    Request a Quotation

    Send your specification, required quantity, pack size, and destination market. You will get the specification sheet, a representative Certificate of Analysis, and a quotation with Incoterms and lead time. Contact us with the details.

    Dapagliflozin sits in our full API product portfolio.