Empagliflozin Tablets, 10 mg
Empagliflozin is an oral sodium-glucose co-transporter 2 (SGLT2) inhibitor that lowers blood glucose by reducing renal glucose reabsorption. Film-coated tablets are supplied at 10 mg and 25 mg for once-daily dosing. Bulk and private-label supply, with registration documentation and batch traceability from API to finished tablet.
Dosage form: Film-coated tablet
Strength: 10 mg,
Indications: Type 2 diabetes; heart failure to reduce cardiovascular death; chronic kidney disease and reduce risk of end-stage kidney disease.
Documentation: CoA, DMF, GMP certificate, ICH stability data, MSDS
FAQ
Which strengths are available? 10 mg film-coated tablets, once daily.
Is this the same as Jardiance? Same active ingredient; generic availability and patent status differ by market — confirm before quoting.
Do you supply both API and finished tablets? Yes, subject to MOQ.
Can you support registration? DMF/CTD modules and GMP evidence on request.
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Empagliflozin tablets are supplied in two strengths, 10 mg and 25 mg, and sit in three approved indications rather than one. For a buyer, the specification is straightforward and the risk is not. The molecule carries six fixed chiral centres and a lactose-containing formulation, and the parameters that decide whether a batch travels well are assay trend, chiral purity, dissolution in the fed and fasted states, and the completeness of the registration file. Eight questions buyers ask most often are answered at the end.
Empagliflozin is an orally active, reversible competitive inhibitor of sodium-glucose co-transporter 2. It was developed jointly by Boehringer Ingelheim and Eli Lilly and first approved in the United States in 2014 under the brand name Jardiance.
The mechanism is insulin-independent. SGLT2 is the predominant transporter responsible for reabsorbing glucose from the glomerular filtrate back into the circulation, and it is expressed almost exclusively in the kidney. Inhibiting it lowers the renal threshold for glucose and increases urinary glucose excretion. In patients with type 2 diabetes, urinary glucose excretion rises immediately after the first dose and continues across the 24-hour dosing interval, averaging roughly 64 g per day at 10 mg and 78 g per day at 25 mg once daily.
Selectivity matters clinically. Empagliflozin inhibits SGLT2 with an IC50 of about 1.3 nM and shows roughly 5,000-fold selectivity over SGLT1, the gut transporter responsible for glucose absorption. That separation is why gastrointestinal glucose absorption is largely preserved.
In China the molecule entered the market in 2017 for type 2 diabetes, was added to the national reimbursement list at the end of 2019, and gained heart failure and adult chronic kidney disease indications in 2022 and 2023 respectively. The tablet now sits in three therapeutic areas, which changes how buyers forecast demand and how they position the product in tender markets.
Chemical name: (1S)-1,5-anhydro-1-(4-chloro-3-{4-[(3S)-tetrahydrofuran-3-yloxy]benzyl}phenyl)-D-glucitol
CAS number: 864070-44-0
Molecular formula: C23H27ClO7
Molecular weight: 450.91
Strengths: 10 mg and 25 mg, expressed as empagliflozin free base
Dosage form: film-coated tablet
Appearance: pale yellow film-coated tablet; white to off-white core
Drug substance: white to yellowish powder, very slightly soluble in water, sparingly soluble in methanol, not hygroscopic, and no polymorphism has been observed
Crystal form: neither a hydrate nor a solvate
Chiral centres: six, all fixed by synthesis
Pharmacological class: SGLT2 inhibitor
Legal status: prescription only
Dosing: 10 mg once daily in the morning, with or without food; may be increased to 25 mg once daily in patients who tolerate 10 mg
Renal eligibility: depends on the indication. The glycaemic control indication has a higher eGFR threshold than the heart failure and chronic kidney disease indications, which extend to lower filtration rates. Confirm the current local label rather than relying on an older version
An SGLT2 inhibitor tablet looks simple on paper. Three parameters separate a batch that registers smoothly from one that generates questions.
Chiral purity. Empagliflozin has six stereocentres, all fixed as (2S,3R,4R,5S,6R) on the glucitol backbone with the tetrahydrofuran ring at (3S). A supplier that does not control the diastereomeric profile will pass assay and still fail on related substances. Ask for the chromatographic method that resolves the diastereomers, and ask for representative data, not a statement that the limit is met.
Dissolution. Empagliflozin is very slightly soluble in water, so dissolution is the discriminating test and the basis of any biowaiver argument. Request the full profile at multiple pH values and at the paddle speed specified in the relevant guidance, plus comparative data against the reference product. A single-point result at 30 minutes tells you almost nothing about whether a bridging study will hold.
Assay trend over shelf life. The tablet is hygroscopic only at the formulation level, not the drug substance level, but a 25 mg strength with a lactose-based filler still picks up moisture through a poor seal. A batch released at 99.5 percent with a falling trend will be out of specification before expiry in a Zone IVb warehouse.
The reference formulation contains lactose monohydrate. That is a labelling obligation in markets that require lactose declaration, and a genuine issue for patients with severe lactose intolerance. Generic developers sometimes substitute the filler, which changes the dissolution profile and forces a fresh bioequivalence study. Ask what the filler is before you compare prices.
The film coat contains hypromellose, titanium dioxide, talc, macrogol and yellow ferric oxide. Colour matching against the reference product is a common cause of sample rejection even when the batch is fully compliant.
The tablet has no score line. Splitting is not supported by the label, and patients or caregivers who need intermediate doses should be switched to a different strength rather than breaking a tablet. This comes up in tender questionnaires more often than manufacturers expect.
Batch certificate of analysis for the specific batch, including chiral purity and dissolution data rather than a summary sheet.
GMP certificate with scope wording that covers oral solid dosage forms, from an authority your target market recognises.
Drug master file or certificate of suitability where required, plus CTD module 3 content covering process validation, method validation and specification justification.
Stability data matched to your climatic zone. For Zone IVb, ask specifically for 30 degrees Celsius at 75 percent relative humidity at the long-term condition.
Bioequivalence study report or the Chinese consistency evaluation outcome, since most export markets will require a bridging argument rather than accepting a foreign approval at face value.
Elemental impurity assessment per ICH Q3D and a nitrosamine risk evaluation. The molecule itself carries no nitrosamine risk motif, but the statement is expected as a matter of routine.
Packaging specification, minimum order quantity and lead time in writing. Blister material and foil composition matter for moisture protection on a lactose-based tablet.
【To be confirmed before publication: whether Loncom holds a registration or filing for empagliflozin tablets, approved strengths and pack sizes, oral solid dosage capacity, GMP certificate scope, and whether bioequivalence and stability packages are available to licensing partners. No manufacturing or supply claim should be published in this section until these points are verified.】
The recommended starting dose is 10 mg once daily, taken in the morning with or without food. In patients who tolerate 10 mg, the dose can be increased to 25 mg once daily. Both strengths use the same formulation and process, differing only in the amount of active substance, but they are separate registrations and separate dissolution specifications. Buyers normally order both together because prescribers titrate between them.
Jardiance is the originator brand name, developed by Boehringer Ingelheim and Eli Lilly. Empagliflozin is the international nonproprietary name of the active substance. A generic empagliflozin tablet contains the same molecule and must demonstrate bioequivalence to the reference product, but it is not the same registered product and cannot be substituted without reference to your market's rules.
CAS 864070-44-0, molecular formula C23H27ClO7, molecular weight 450.91. The substance is the (1S)-glucitol derivative and is supplied as the free base, not as a salt, so there is no salt conversion factor to apply when calculating label claim.
No polymorphism has been observed. The substance is neither a hydrate nor a solvate and is not hygroscopic. This simplifies crystallinity control, but it does not remove the need to confirm that the supplier's drug substance matches the form used in your bioequivalence batch.
The tablet has no score line and splitting is not supported by the label. Splitting a film-coated tablet exposes the core to moisture and produces halves of unequal content, which matters for a 10 mg strength. Patients needing intermediate doses should be prescribed a different strength.
The reference formulation contains lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, colloidal silicon dioxide and magnesium stearate, with a film coat of hypromellose, titanium dioxide, talc, macrogol and yellow ferric oxide. Lactose is the one that triggers labelling obligations and matters for lactose-intolerant patients. If a supplier has replaced the filler, expect a different dissolution profile.
Batch certificate of analysis with chiral purity and multi-point dissolution, GMP certificate covering oral solid dosage forms, drug master file or certificate of suitability where applicable, CTD module 3, stability data for your climatic zone, ICH Q3D elemental impurity assessment, a nitrosamine risk statement, and a bioequivalence report or consistency evaluation outcome.
Store below 30 degrees Celsius in the original packaging, protected from moisture. Shelf life is set by the approved registration and should be confirmed on the certificate of analysis and the outer carton rather than assumed from another manufacturer's product.
Empagliflozin is not indicated for type 1 diabetes and must not be used to treat diabetic ketoacidosis. It is not a substitute for metformin in first-line therapy in most guidelines, and it is not appropriate below the renal cut-off specified in the label. Volume status should be assessed before initiation in patients at risk of depletion.
A molecule with no polymorph and a well-known synthesis is not a difficult molecule to make. It is a difficult molecule to make consistently, batch after batch, in a tablet that still dissolves the same way in year three as it did in the validation batch.
