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Empagliflozin | CAS No: 864070-44-0 | GMP-certified suppliers
A medication that supports glycemic control in type 2 diabetes and helps lower cardiorenal risks in adults with cardiovascular disease, heart failure, or chronic kidney disease.
Therapeutic categories
Primary indications
- Empagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in patients aged 10 years and older with type 2 diabetes
- It is used either alone or in combination with [metformin] or [linagliptin]
- It is also indicated to reduce the risk of cardiovascular death in adult patients with both type 2 diabetes mellitus and established cardiovascular disease, either alone or as a combination product with metformin
Product Snapshot
- Oral small‑molecule API supplied for film‑coated and extended‑release tablet formulations
- Primary uses include type 2 diabetes glycemic control and risk reduction for cardiovascular death, heart failure hospitalization, and chronic kidney disease progression
- Approved in the US, Canada, and EU
Clinical Overview
Empagliflozin selectively inhibits the renal sodium‑glucose co‑transporter 2 located in the proximal tubule, reducing glucose reabsorption and increasing urinary glucose excretion. This mechanism lowers plasma glucose independently of insulin and supports once‑daily administration. Cardiovascular and renal benefits observed in clinical practice appear to extend beyond glycemic effects, although the precise pathways remain incompletely defined.
Pharmacokinetic characteristics include oral absorption with high selectivity for SGLT2 over SGLT1, minimal metabolic transformation via glucuronidation pathways, and predominant renal elimination. The compound belongs to the phenolic glycoside class, containing a phenolic structure linked to a glycosyl moiety.
Safety considerations include the risk of diabetic ketoacidosis, which may occur even with near‑normal glucose levels. Treatment interruption may be appropriate in acute kidney injury or marked renal function decline. Increased urinary glucose concentration elevates the risk of genital and urinary tract infections. Volume depletion, hypotension, and electrolyte disturbances may occur, particularly in patients receiving diuretics or with impaired renal reserve.
Empagliflozin is marketed in various regions as single‑agent tablets and in fixed‑dose combinations with metformin or linagliptin, including extended‑release formulations.
For API procurement, suppliers should provide evidence of compliance with regional GMP standards, validated impurity control strategies, and consistent solid‑state quality attributes to support formulation robustness and regulatory submissions.
Identification & chemistry
| Generic name | Empagliflozin |
|---|---|
| Molecule type | Small molecule |
| CAS | 864070-44-0 |
| UNII | HDC1R2M35U |
| DrugBank ID | DB09038 |
Pharmacology
| Summary | Empagliflozin is an SGLT2 inhibitor that reduces renal glucose reabsorption in the proximal tubule, leading to increased urinary glucose excretion and lower circulating glucose levels. Its pharmacologic effects also include osmotic diuresis and natriuresis, which may contribute to observed cardiovascular and renal benefits through mechanisms that are not fully defined. Proposed pathways include modulation of sodium–hydrogen exchangers, hemodynamic effects, and reductions in pro‑fibrotic and inflammatory signaling. |
|---|---|
| Mechanism of action | The vast majority of glucose filtered through the glomerulus is reabsorbed within the proximal tubule, primarily via SGLT2 (sodium-glucose linked co-transporter-2) which is responsible for ~90% of the total glucose reabsorption within the kidneys. Na<sup>+</sup>/K<sup>+</sup>-ATPase on the basolateral membrane of proximal tubular cells utilize ATP to actively pump Na+ ions into the interstitium surrounding the tubule, establishing a Na<sup>+</sup> gradient within the tubular cell. SGLT2 on the apical membrane of these cells then utilize this gradient to facilitate secondary active co-transport of both Na+ and glucose out of the filtrate, thereby reabsorbing glucose back into the blood – inhibiting this co-transport, then, allows for a marked increase in glucosuria and decrease in blood glucose levels.Empagliflozin is a potent inhibitor of renal SGLT2 transporters located in the proximal tubules of the kidneys and works to lower blood glucose levels via an increase in glucosuria. Empagliflozin also appears to exert cardiovascular benefits - specifically in the prevention of heart failure - independent of its blood glucose-lowering effects, though the exact mechanism of this benefit is not precisely understood. Several theories have been posited, including the potential inhibition of Na<sup>+</sup>/H<sup>+</sup> exchanger (NHE) 1 in the myocardium and NHE3 in the proximal tubule, reduction of pre-load via diuretic/natriuretic effects and reduction of blood pressure, prevention of cardiac fibrosis via suppression of pro-fibrotic markers, and reduction of pro-inflammatory adipokines. |
| Pharmacodynamics | Empagliflozin lowers blood glucose levels by preventing glucose reabsorption in the kidneys, thereby increasing the amount of glucose excreted in the urine.It has a relatively long duration of action requiring only once-daily dosing. Patients should be monitored closely for signs and symptoms of ketoacidosis regardless of blood glucose level as empagliflozin may precipitate diabetic ketoacidosis in the absence of hyperglycemia.As its mechanism of action is contingent on the renal excretion of glucose, empagliflozin may be held in cases of acute kidney injury and/or discontinued in patients who develop chronic renal disease. The overexcretion of glucose creates a sugar-rich urogenital environment which increases the risk of urogenital infections in both male and female patients - monitor closely for signs and symptoms of developing infection. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Sodium/glucose cotransporter 2 | Humans | inhibitor |
ADME / PK
| Absorption | Following oral administration, peak plasma concentrations are reached in approximately 1.5 hours (T<sub>max</sub>). At steady-state, plasma AUC and C<sub>max</sub> were 1870 nmol·h/L and 259 nmol/L, respectively, following therapy with empagliflozin 10mg daily and 4740 nmol·h/L and 687 nmol/L, respectively, following therapy with empagliflozin 25mg daily.Administration with food does not significantly affect the absorption of empagliflozin. |
|---|---|
| Half-life | The apparent terminal elimination half-life was found to be 12.4 h based on population pharmacokinetic analysis. |
| Protein binding | Empagliflozin is approximately 86.2% protein-bound in plasma. |
| Metabolism | Empagliflozin undergoes minimal metabolism. It is primarily metabolized via glucuronidation by 5'-diphospho-glucuronosyltransferases 2B7, 1A3, 1A8, and 1A9 to yield three glucuronide metabolites: 2-O-, 3-O-, and 6-O-glucuronide.No metabolite represented more than 10% of total drug-related material. |
| Route of elimination | After oral administration of radiolabeled empagliflozin approximately 41.2% of the administered dose was found eliminated in feces and 54.4% eliminated in urine. The majority of radioactivity in the feces was due to unchanged parent drug while approximately half of the radioactivity in urine was due to unchanged parent drug. |
| Volume of distribution | The estimated apparent steady-state volume of distribution is 73.8 L. |
| Clearance | Apparent oral clearance was found to be 10.6 L/h based on a population pharmacokinetic analysis. |
Formulation & handling
- Oral small‑molecule API with low aqueous solubility, requiring solubility‑enhancing strategies for consistent tablet performance.
- Solid-state stability is generally good, but moisture control is recommended due to glycosidic functionality.
- Food has minimal impact on absorption, allowing flexible administration without special formulation adjustments.
Regulatory status
| Lifecycle | The API is in a mature stage in most markets, with key U.S. patents already expired and one remaining protection extending to 2034. With availability across the US, Canada, and the EU, the market is largely open to competition except where the later-expiring patent still applies. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | Empagliflozin is supplied by a single originator set of manufacturers, with branded products marketed across the US, Canada, and EU. Multiple US patents have already expired, and the remaining key protection extends into 2034, indicating that some territories may already allow generic development while others remain protected. This mixed patent status suggests a transition period in which generic competition is emerging or expected as remaining exclusivities lapse. |
|---|
Safety
| Toxicity | Experience with empagliflozin overdose is limited - employ standard symptomatic and supportive measures, as well as gastric decontamination when appropriate. The use of hemodialysis in empagliflozin overdose has not been studied but is unlikely to be of benefit given the drug's relatively high protein-binding. |
|---|
- Limited overdose data
- Management relies on standard symptomatic and supportive measures, with gastric decontamination considered when clinically appropriate
- High protein binding reduces the likelihood that hemodialysis will enhance clearance in overdose scenarios
US Drug Master File (USDMF)
A US Drug Master File (USDMF) is a confidential document submitted to the U.S. Food and Drug Administration (FDA) that provides detailed information about the manufacturing process of an Active Pharmaceutical Ingredient (API) or a finished pharmaceutical product. This document includes comprehensive details such as chemical properties, manufacturing facilities, production processes, packaging specifications, storage conditions, and more.
The USDMF ensures that proprietary information remains protected while allowing the FDA to review the data as part of drug approval processes. Unlike other types of DMFs used in different regions, the USDMF is specifically designed to meet the regulatory requirements set by the FDA, ensuring compliance with U.S. standards.
Empagliflozin is a type of SGLT2-inhibitors
SGLT2 inhibitors, short for Sodium-Glucose Co-Transporter 2 inhibitors, belong to the pharmaceutical API subcategory utilized in the treatment of type 2 diabetes mellitus (T2DM). These innovative drugs target the SGLT2 protein responsible for reabsorbing glucose in the kidneys, resulting in increased urinary glucose excretion.
By inhibiting SGLT2, these drugs effectively lower blood glucose levels and improve glycemic control in patients with T2DM. This mechanism of action is independent of insulin secretion or sensitivity, making SGLT2 inhibitors an attractive option for individuals who are resistant to or cannot tolerate other diabetes medications.
Some commonly prescribed SGLT2 inhibitors include canagliflozin, dapagliflozin, and empagliflozin. These pharmaceutical APIs are typically formulated into oral tablets, making them convenient for patient administration.
Clinical studies have demonstrated the effectiveness of SGLT2 inhibitors in reducing HbA1c levels, body weight, and blood pressure in patients with T2DM. Additionally, these medications have shown potential cardiovascular benefits, including a decreased risk of cardiovascular events.
However, it is important to note that SGLT2 inhibitors are not suitable for everyone, and their use should be carefully considered in patients with renal impairment or a history of ketoacidosis. Adverse effects may include genitourinary infections and increased risk of dehydration.
Overall, SGLT2 inhibitors are a promising class of pharmaceutical APIs that offer an innovative approach to managing T2DM by targeting renal glucose reabsorption. Ongoing research and development in this field aim to further optimize the therapeutic potential of SGLT2 inhibitors and improve patient outcomes.
Empagliflozin (SGLT2-inhibitors), classified under Anti-diabetics
Anti-diabetics, belonging to the pharmaceutical API (Active Pharmaceutical Ingredient) category, are a group of compounds designed to manage and treat diabetes mellitus, a chronic metabolic disorder characterized by high blood sugar levels. These medications play a vital role in controlling diabetes and preventing complications associated with the disease.
Anti-diabetics encompass a wide range of drug classes, including biguanides, sulfonylureas, thiazolidinediones, dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium-glucose cotransporter-2 (SGLT2) inhibitors, and glucagon-like peptide-1 (GLP-1) receptor agonists. Each class works through different mechanisms to regulate blood sugar levels and improve insulin sensitivity.
Biguanides, such as metformin, reduce glucose production by the liver and enhance insulin sensitivity in peripheral tissues. Sulfonylureas, like glipizide, stimulate insulin secretion from pancreatic beta cells. Thiazolidinediones, including pioglitazone, improve insulin sensitivity in muscle and adipose tissues. DPP-4 inhibitors, such as sitagliptin, increase insulin release and inhibit glucagon secretion. SGLT2 inhibitors, like dapagliflozin, decrease renal glucose reabsorption, leading to increased urinary glucose excretion. GLP-1 receptor agonists, such as exenatide, enhance insulin secretion, suppress glucagon release, slow gastric emptying, and promote satiety.
These anti-diabetic APIs serve as the foundational ingredients for the formulation of various oral tablets, capsules, and injectable medications used in the treatment of diabetes. By targeting different aspects of glucose regulation, they help patients achieve and maintain optimal blood sugar levels, thus reducing the risk of diabetic complications, such as cardiovascular disease, neuropathy, and nephropathy.
It is crucial for healthcare professionals to prescribe and administer these anti-diabetic medications appropriately, considering factors like the patient's medical history, co-existing conditions, and potential drug interactions. Regular monitoring of blood glucose levels and close medical supervision are necessary to ensure effective diabetes management.
In conclusion, anti-diabetics form a critical category of pharmaceutical APIs used for the treatment of diabetes. These compounds, encompassing various drug classes, work through distinct mechanisms to regulate blood sugar levels and improve insulin sensitivity. By facilitating glucose control, anti-diabetic APIs help mitigate the risk of complications associated with diabetes mellitus, ultimately promoting better health outcomes for patients.
Empagliflozin API manufacturers & distributors
Compare qualified Empagliflozin API suppliers worldwide. We currently have 35 companies offering Empagliflozin API, with manufacturing taking place in 10 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| ACE Japan | Producer | Japan | Japan | CoA | 76 products |
| ALP PHARM | Producer | China | China | CoA, USDMF | 33 products |
| Amino Chemicals | Producer | Malta | Malta | CoA, GMP | 20 products |
| Apino Pharma Co., Ltd. | Producer | China | China | BSE/TSE, CoA, GMP, MSDS, USDMF | 229 products |
| Arshine Pharmaceutical Co... | Distributor | China | China | CoA | 176 products |
| AXXO GmbH | Distributor | Germany | World | CoA, GMP, GDP, MSDS, USDMF | 243 products |
| Bakul Pharma Private Limi... | Producer | India | India | BSE/TSE, CoA, EDMF/ASMF, FDA, GMP, MSDS | 52 products |
| Beijing Huikang Boyuan | Producer | China | China | CoA, USDMF | 10 products |
| Bidachem | Producer | Italy | Italy | CoA, GMP | 14 products |
| Boehringer Ingelheim | Producer | Germany | Germany | CoA, GMP | 35 products |
| Cipla | Producer | India | India | CoA, USDMF | 164 products |
| Dr. Reddy's | Producer | India | India | BSE/TSE, CoA, FDA, GMP, KDMF, MSDS, USDMF, WC | 170 products |
| Emeishan Hongsen Biopharm... | Producer | China | China | CoA, MSDS | 107 products |
| Fuxing Long Rui Pharma | Producer | China | China | CoA, USDMF | 10 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Hikal | Producer | India | India | CoA, USDMF | 26 products |
| Honour Lab | Producer | India | India | CoA, USDMF | 30 products |
| Jiangxi Aifeimu Technolog... | Producer | China | China | CoA | 7 products |
| Laurus Labs | Producer | India | India | CoA, USDMF | 50 products |
| Lupin | Producer | India | India | CoA, USDMF | 155 products |
| Morepen Laboratories Ltd. | Producer | India | India | BSE/TSE, CoA, EDMF/ASMF, FDA, GMP, ISO9001, MSDS, USDMF, WC | 22 products |
| MSN Life Sciences | Producer | India | India | CoA, USDMF | 46 products |
| Mylan | Producer | India | India | CoA, USDMF | 201 products |
| Polpharma | Producer | Poland | Poland | BSE/TSE, CoA, FDA, GMP, KDMF, MSDS, USDMF | 64 products |
| Rochem International, Inc... | Distributor | United States | United States | BSE/TSE, CoA, GMP, ISO9001, MSDS | 144 products |
| Senova Technology Co., Lt... | Producer | China | China | CEP, CoA, GMP, ISO9001, USDMF, WC | 157 products |
| Shandong Boyuan | Producer | China | China | BSE/TSE, CoA, MSDS, USDMF | 55 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, GMP, ISO9001, MSDS, USDMF | 764 products |
| Solfyn International LLP | Distributor | India | China | BSE/TSE, CoA, GMP, ISO9001, MSDS, USDMF, WHO-GMP | 24 products |
| Sun Pharma | Producer | India | India | CoA, USDMF | 219 products |
| Tianjin Pharmacn Medical ... | Producer | China | China | CoA, GMP | 66 products |
| Vonage Pharma (Former Plu... | Producer | Turkey | Turkey | CoA, GMP, MSDS, USDMF, WC | 28 products |
| ZCL Chemicals | Producer | India | India | CoA, Other, FDA, ISO9001 | 30 products |
| Zhejiang Hongyuan | Producer | China | China | CoA | 7 products |
When sending a request, specify which Empagliflozin API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Empagliflozin API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
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