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Empagliflozin API from Indian Manufacturers & Suppliers

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Employees: 500

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Employees: 455+

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Employees: 25+

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Distributor
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Employees: 50+

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Produced in  Turkey
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Employees: 100+

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Producer
Produced in  China
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Employees: 300+

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CoA

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CoA
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Employees: 250+

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Employees: 10+

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Employees: 25

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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

Alimentary Tract and MetabolismBCRP/ABCG2 SubstratesBenzene DerivativesBlood Glucose Lowering AgentsDiureticsDrugs that are Mainly Renally Excreted
Generic name
Empagliflozin
Molecule type
small molecule
CAS number
864070-44-0
DrugBank ID
DB09038
Approval status
Approved drug
ATC code
A10BD19

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 (CAS 864070-44-0) is an orally administered SGLT2 inhibitor used for glycemic management in type 2 diabetes and for cardiorenal risk reduction in adults with established cardiovascular disease, heart failure, or chronic kidney disease. It is also approved for glycemic control in patients aged 10 years and older with type 2 diabetes, either as monotherapy or in combination with metformin or linagliptin. It is not indicated for type 1 diabetes.

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

SummaryEmpagliflozin 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 actionThe 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.
PharmacodynamicsEmpagliflozin 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
TargetOrganismActions
Sodium/glucose cotransporter 2Humansinhibitor

ADME / PK

AbsorptionFollowing 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-lifeThe apparent terminal elimination half-life was found to be 12.4 h based on population pharmacokinetic analysis.
Protein bindingEmpagliflozin is approximately 86.2% protein-bound in plasma.
MetabolismEmpagliflozin 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 eliminationAfter 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 distributionThe estimated apparent steady-state volume of distribution is 73.8 L.
ClearanceApparent 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

LifecycleThe 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.
MarketsUS, Canada, EU
Supply Chain
Supply chain summaryEmpagliflozin 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

ToxicityExperience 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.
High Level Warnings:
  • 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

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.

SupplierTypeCountryProduct originCertificationsPortfolio
Producer
Japan Japan CoA76 products
Producer
China China CoA, USDMF33 products
Producer
Malta Malta CoA, GMP20 products
Producer
China China BSE/TSE, CoA, GMP, MSDS, USDMF229 products
Distributor
China China CoA176 products
Distributor
Germany World CoA, GMP, GDP, MSDS, USDMF243 products
Producer
India India BSE/TSE, CoA, EDMF/ASMF, FDA, GMP, MSDS52 products
Producer
China China CoA, USDMF10 products
Producer
Italy Italy CoA, GMP14 products
Producer
Germany Germany CoA, GMP35 products
Producer
India India CoA, USDMF164 products
Producer
India India BSE/TSE, CoA, FDA, GMP, KDMF, MSDS, USDMF, WC170 products
Producer
China China CoA, MSDS107 products
Producer
China China CoA, USDMF10 products
Distributor
India India BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS484 products
Producer
India India CoA, USDMF26 products
Producer
India India CoA, USDMF30 products
Producer
China China CoA7 products
Producer
India India CoA, USDMF50 products
Producer
India India CoA, USDMF155 products
Producer
India India BSE/TSE, CoA, EDMF/ASMF, FDA, GMP, ISO9001, MSDS, USDMF, WC22 products
Producer
India India CoA, USDMF46 products
Producer
India India CoA, USDMF201 products
Producer
Poland Poland BSE/TSE, CoA, FDA, GMP, KDMF, MSDS, USDMF64 products
Distributor
United States United States BSE/TSE, CoA, GMP, ISO9001, MSDS144 products
Producer
China China CEP, CoA, GMP, ISO9001, USDMF, WC157 products
Producer
China China BSE/TSE, CoA, MSDS, USDMF55 products
Distributor
China China CoA162 products
Distributor
China China CoA, GMP, ISO9001, MSDS, USDMF764 products
Distributor
India China BSE/TSE, CoA, GMP, ISO9001, MSDS, USDMF, WHO-GMP24 products
Producer
India India CoA, USDMF219 products
Producer
China China CoA, GMP66 products
Producer
Turkey Turkey CoA, GMP, MSDS, USDMF, WC28 products
Producer
India India CoA, Other, FDA, ISO900130 products
Producer
China China CoA7 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.

Frequently asked questions about Empagliflozin API


Sourcing

What matters most when sourcing GMP-grade Empagliflozin?
Key factors include verifying GMP compliance and ensuring the manufacturer meets US, Canadian, and EU regulatory expectations. Confirming reliable supply from the originator source is important given the limited number of approved producers. Patent status should be reviewed by territory, as mixed protections through 2034 may affect where the ingredient can be sourced and used.
Which documents are typically required when sourcing Empagliflozin API?
Request the core API documentation set: CoA (35 companies), USDMF (21 companies), GMP (16 companies), MSDS (13 companies), BSE/TSE (9 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Empagliflozin API?
How can I request quotes for Empagliflozin API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Empagliflozin manufacturers?
Audit reports may be requested for Empagliflozin: 13 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Empagliflozin API on Pharmaoffer?
Reported supplier count for Empagliflozin: 35 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Empagliflozin API?
Production countries reported for Empagliflozin: China (14 producers), India (13 producers), Poland (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Empagliflozin usually hold?
Common certifications for Empagliflozin suppliers: CoA (35 companies), USDMF (21 companies), GMP (16 companies), MSDS (13 companies), BSE/TSE (9 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.

Technical

What is Empagliflozin (CAS 864070-44-0) used for?
Empagliflozin is used to improve glycemic control in adults and in patients aged 10 years and older with type 2 diabetes, either alone or with agents such as metformin or linagliptin. It is also used to reduce cardiovascular and renal risk in adults with established cardiovascular disease, heart failure, or chronic kidney disease. It is not indicated for type 1 diabetes.
Which therapeutic class does Empagliflozin fall into?
Empagliflozin belongs to the following therapeutic categories: Alimentary Tract and Metabolism, BCRP/ABCG2 Substrates, Benzene Derivatives, Blood Glucose Lowering Agents, Diuretics. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Empagliflozin mainly prescribed for?
The primary indications for Empagliflozin: 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. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Empagliflozin work?
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+/K+-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+ 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+/H+ 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.
What should someone know about the safety or toxicity profile of Empagliflozin?
Empagliflozin’s safety profile includes risks related to its mechanism, such as increased genital and urinary tract infections and potential volume depletion, hypotension, or electrolyte disturbances. Diabetic ketoacidosis can occur, sometimes with near‑normal glucose levels, and treatment interruption may be warranted in acute kidney injury or significant renal function decline. Overdose experience is limited; management is supportive, and high protein binding makes hemodialysis unlikely to enhance clearance.
What are important formulation and handling considerations for Empagliflozin as an API?
Empagliflozin has low aqueous solubility, so formulations typically require solubility‑enhancing approaches to ensure consistent dissolution and exposure. The API shows generally good solid‑state stability, but moisture control during manufacturing and storage is recommended because of its glycosidic functionality. Its absorption is not significantly affected by food, allowing standard oral tablet design without food‑dependent release strategies.
Is Empagliflozin a small molecule?
Empagliflozin is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Empagliflozin?
Oral Empagliflozin shows generally good solid‑state stability, but moisture control is recommended due to its glycosidic functionality. Its low aqueous solubility can affect consistent tablet performance, so formulations typically incorporate solubility‑enhancing strategies. No additional stability concerns are noted beyond managing moisture exposure and ensuring adequate solubility in the final dosage form.

Regulatory

Where is Empagliflozin approved or in use globally?
Empagliflozin is reported as approved in the following major regions: US, Canada, EU. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Empagliflozin right now?
Empagliflozin is regulated for use in the United States, Canada, and the European Union, where it is approved as an active pharmaceutical ingredient. Patent protections for the compound follow the standard pharmaceutical patent systems in these regions, with coverage governed by each jurisdiction’s established frameworks.

Pharmaoffer

How does Pharmaoffer’s Smart Sourcing Service help with Empagliflozin procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Empagliflozin. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Empagliflozin included in the PRO Data Insights coverage?
PRO Data Insights coverage for Empagliflozin: 3988 verified transactions across 1038 suppliers and 605 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Empagliflozin?
Market report availability for Empagliflozin: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.