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Chemistry

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Also known as: 864070-44-0, Jardiance, Bi 10773, Bi-10773, Bi10773, Empagliflozin (bi 10773)
Molecular Formula
C23H27ClO7
Molecular Weight
450.9  g/mol
InChI Key
OBWASQILIWPZMG-QZMOQZSNSA-N
FDA UNII
HDC1R2M35U

Empagliflozin
Empagliflozin is an orally available competitive inhibitor of sodium-glucose co-transporter 2 (SGLT2; SLC5A2) with antihyperglycemic activity. Upon oral administration, empagliflozin selectively and potently inhibits SGLT2 in the kidneys, thereby suppressing the reabsorption of glucose in the proximal tubule. Inhibition of SGLT2 increases urinary glucose excretion by the kidneys, resulting in a reduction of plasma glucose levels in an insulin-independent manner. Inhibition of SGLT2 in the kidneys also suppresses the renal reabsorption of 1,5-anhydroglucitol (1,5AG). This lowers serum 1,5AG and neutrophil 1,5-anhydroglucitol-6-phosphate (1,5AG6P) levels, which may improve neutropenia and neutrophil dysfunction in patients with glycogen storage disease type Ib (GSD Ib). SGLT2, a transport protein exclusively expressed in the proximal renal tubules, mediates approximately 90% of renal glucose reabsorption from tubular fluid.
Empagliflozin is a Sodium-Glucose Cotransporter 2 Inhibitor. The mechanism of action of empagliflozin is as a Sodium-Glucose Transporter 2 Inhibitor.
1 2D Structure

Empagliflozin

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC 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
2.1.2 InChI
InChI=1S/C23H27ClO7/c24-18-6-3-14(23-22(28)21(27)20(26)19(11-25)31-23)10-15(18)9-13-1-4-16(5-2-13)30-17-7-8-29-12-17/h1-6,10,17,19-23,25-28H,7-9,11-12H2/t17-,19+,20+,21-,22+,23-/m0/s1
2.1.3 InChI Key
OBWASQILIWPZMG-QZMOQZSNSA-N
2.1.4 Canonical SMILES
C1COCC1OC2=CC=C(C=C2)CC3=C(C=CC(=C3)C4C(C(C(C(O4)CO)O)O)O)Cl
2.1.5 Isomeric SMILES
C1COC[C@H]1OC2=CC=C(C=C2)CC3=C(C=CC(=C3)[C@H]4[C@@H]([C@H]([C@@H]([C@H](O4)CO)O)O)O)Cl
2.2 Other Identifiers
2.2.1 UNII
HDC1R2M35U
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 1-chloro-4-(glucopyranos-1-yl)-2-(4-(tetrahydrofuran-3-yloxy)benzyl)benzene

2. Bi 10773

3. Bi-10773

4. Bi10773

5. Jardiance

2.3.2 Depositor-Supplied Synonyms

1. 864070-44-0

2. Jardiance

3. Bi 10773

4. Bi-10773

5. Bi10773

6. Empagliflozin (bi 10773)

7. (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-(((s)-tetrahydrofuran-3-yl)oxy)benzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol

8. Hdc1r2m35u

9. 1-chloro-4-(glucopyranos-1-yl)-2-(4-(tetrahydrofuran-3-yloxy)benzyl)benzene

10. Chebi:82720

11. (1s)-1,5-anhydro-1-(4-chloro-3-{4-[(3s)-tetrahydrofuran-3-yloxy]benzyl}phenyl)-d-glucitol

12. (2s,3r,4r,5s,6r)-2-[4-chloro-3-({4-[(3s)-oxolan-3-yloxy]phenyl}methyl)phenyl]-6-(hydroxymethyl)oxane-3,4,5-triol

13. (2s,3r,4r,5s,6r)-2-[4-chloro-3-[[4-[(3s)-oxolan-3-yl]oxyphenyl]methyl]phenyl]-6-(hydroxymethyl)oxane-3,4,5-triol

14. (1s)-1,5-anhydro-1-c-{4-chloro-3-((4-{((3s)-oxolan-3-yl)oxy}phenyl)methyl)phenyl}-d-glucitol

15. (2s,3r,4r,5s,6r)-2-[4-chloranyl-3-[[4-[(3s)-oxolan-3-yl]oxyphenyl]methyl]phenyl]-6-(hydroxymethyl)oxane-3,4,5-triol

16. D-glucitol, 1,5-anhydro-1-c-(4-chloro-3-((4-(((3s)-tetrahydro-3-furanyl)oxy)phenyl)methyl)phenyl)-, (1s)-

17. Empagliflozin [inn]

18. Unii-hdc1r2m35u

19. Empagliflozin [usan:inn]

20. Mfcd22566222

21. Jardiance (tn)

22. (s)-empagliflozin D4

23. Empagliflozin [mi]

24. Bi-10773;empagliflozin

25. Empagliflozin [jan]

26. Empagliflozin [usan]

27. Empagliflozin (bi10773)

28. Empagliflozin [vandf]

29. Schembl899986

30. Empagliflozin [who-dd]

31. Gtpl4754

32. Chembl2107830

33. Empagliflozin (jan/usan/inn)

34. Amy1858

35. Ex-a414

36. Bdbm150162

37. Dtxsid601026093

38. Empagliflozin [orange Book]

39. Bbl104150

40. S8022

41. Stl557964

42. Us8980829, Empagliflozin

43. Zinc36520252

44. Akos024464680

45. Glyxambi Component Empagliflozin

46. Ccg-269242

47. Cs-0940

48. Db09038

49. Ds-9824

50. Pb23119

51. (1s)-1,5-anhydro-1-c-[4-chloro-3-[[4-[[(3s)-tetrahydro-3-furanyl]oxy]phenyl]methyl]phenyl]-d-glucitol

52. Ac-27643

53. Empagliflozin Component Of Glyxambi

54. Empagliflozin Component Of Synjardy

55. Hy-15409

56. Trijardy Xr Component Empagliflozin

57. Empagliflozin Component Of Trijardy Xr

58. Sw219120-1

59. C22194

60. D10459

61. A852380

62. Au-004/43508285

63. Q5373824

64. Empagliflozin (bi-10773;bi 10773;bi10773)

65. 1,5-anhydro-1-{4-chloro-3-[4-(tetrahydro-3-furanyloxy)benzyl]phenyl}hexitol

66. (1s)-1,5-anhydro-1-c-(4-chloro-3-((4-(((3s)-oxan-3-yl)oxy)phenyl)methyl)phenyl)-d-glucitol

67. (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-((s)-tetrahydrofuran-3-yloxy)benzyl)phenyl)-6-(hydroxymethyl)-tetrahydro-2h-pyran-3,4,5-triol

68. (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-((s)-tetrahydrofuran-3-yloxy)benzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol

69. (2s,3r,4r,5s,6r)-2-[4-chloro-3-[[4-[(3s)-tetrahydrofuran-3-yl]oxyphenyl]methyl]phenyl]-6-(hydroxymethyl)tetrahydropyran-3,4,5-triol

70. 7r3

2.4 Create Date
2006-11-20
3 Chemical and Physical Properties
Molecular Weight 450.9 g/mol
Molecular Formula C23H27ClO7
XLogP32
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count7
Rotatable Bond Count6
Exact Mass450.1445309 g/mol
Monoisotopic Mass450.1445309 g/mol
Topological Polar Surface Area109 Ų
Heavy Atom Count31
Formal Charge0
Complexity558
Isotope Atom Count0
Defined Atom Stereocenter Count6
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Empagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes. It is also indicated to reduce the risk of cardiovascular death in adult patients with both type 2 diabetes mellitus and established cardiovascular disease. Empagliflozin is also available as a combination product with either metformin and linagliptin as an adjunct to diet and exercise in the management of type 2 diabetes mellitus in adults. An extended-release combination product containing empagliflozin, metformin, and linagliptin was approved by the FDA in January 2020 for the improvement of glycemic control in adults with type 2 diabetes mellitus when used adjunctively with diet and exercise. Empagliflozin is also approved to reduce the risk of cardiovascular mortality and hospitalization in adults with heart failure with reduced ejection fraction regardless of whether or not the patient has concomitant diabetes. Empagliflozin is not approved for use in patients with type 1 diabetes.


Type 2 diabetes mellitus

Jardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise - as monotherapy when metformin is considered inappropriate due to intolerance - in addition to other medicinal products for the treatment of diabetes For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4. 4, 4. 5 and 5. 1.

Heart failure

Jardiance is indicated in adults for the treatment of symptomatic chronic heart failure.


Treatment of type I diabetes mellitus


Treatment of chronic kidney disease


Prevention of cardiovascular events in patients with chronic heart failure


Treatment of type II diabetes mellitus


5 Pharmacology and Biochemistry
5.1 Pharmacology

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 - including urosepsis, pyelonephritis, mycotic infections, and even Fournier's gangrene - in both male and female patients - monitor closely for signs and symptoms of developing infection.


5.2 MeSH Pharmacological Classification

Sodium-Glucose Transporter 2 Inhibitors

Compounds that inhibit SODIUM-GLUCOSE TRANSPORTER 2. They lower blood sugar by preventing the reabsorption of glucose by the kidney and are used in the treatment of TYPE 2 DIABETES MELLITUS. (See all compounds classified as Sodium-Glucose Transporter 2 Inhibitors.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
EMPAGLIFLOZIN
5.3.2 FDA UNII
HDC1R2M35U
5.3.3 Pharmacological Classes
Sodium-Glucose Transporter 2 Inhibitors [MoA]; Sodium-Glucose Cotransporter 2 Inhibitor [EPC]
5.4 ATC Code

A10BK03


A - Alimentary tract and metabolism

A10 - Drugs used in diabetes

A10B - Blood glucose lowering drugs, excl. insulins

A10BK - Sodium-glucose co-transporter 2 (sglt2) inhibitors

A10BK03 - Empagliflozin


5.5 Absorption, Distribution and Excretion

Absorption

Following oral administration, peak plasma concentrations are reached in approximately 1.5 hours (Tmax). At steady-state, plasma AUC and Cmax were 1870 nmolh/L and 259 nmol/L, respectively, following therapy with empagliflozin 10mg daily and 4740 nmolh/L and 687 nmol/L, respectively, following therapy with empagliflozin 25mg daily. Administration with food does not significantly affect the absorption of empagliflozin.


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.


5.6 Metabolism/Metabolites

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.


5.7 Biological Half-Life

The apparent terminal elimination half-life was found to be 12.4 h based on population pharmacokinetic analysis.


5.8 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+/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.


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Empagliflozin

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Registration Date : 2024-09-09

Registration Number : Thu21-13-ND(3)

Manufacturer Name : Honour Lab Limited Unit III

Manufacturer Address : Plot No.4, Hetero Infrastructure SEZ Ltd., N.Narsapuram Nakkapalli Mandal, Anakapalli...

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Virtual BoothHonour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.

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Empagliflozin 2L-Proline

Registrant Name : Kyungbo Pharmaceutical Co., Ltd.

Registration Date : 2024-09-02

Registration Number : 1673-56-ND

Manufacturer Name : Honour Lab Limited (Unit-III...

Manufacturer Address : Plot No.4, Hetero Infrastructure SEZ Ltd, N. Narasapuram Village, Nakkapally Mandal, ...

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Virtual BoothHonour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.

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Empagliflozin

Registrant Name : Pampia Co., Ltd.

Registration Date : 2024-01-24

Registration Number : Su21-10-ND(5)

Manufacturer Name : Honour Lab Limited(Unit-III)

Manufacturer Address : Plot No.4, Hetero Infrastructure SEZ Ltd., N.Narsapuram Nakkapalli Mandal, Anakapalli...

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Virtual BoothHonour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.

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Empagliflozin (amorphous)

Registrant Name : Hoosung Bio Co., Ltd.

Registration Date : 2023-07-11

Registration Number : Su21-10-ND(4)

Manufacturer Name : Honour Lab Limited(Unit-III)

Manufacturer Address : Plot No.4, Hetero Infrastructure SEZ Ltd., N. Narasapuram Village, Nakkapalli Mandal,...

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Virtual BoothHonour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.

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Empagliflozin

Registrant Name : Pharmapia Co., Ltd.

Registration Date : 2022-04-04

Registration Number : Thu21-13-ND(1)

Manufacturer Name : Honour Lab Limited(Unit-III)

Manufacturer Address : Plot No.4, Hetero Infrastructure SEZ Ltd., N. Narasapuram Village, Nakkapalli Mandal,...

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NDC API

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01

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Virtual BoothHonour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.

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EMPAGLIFLOZIN

NDC Package Code : 69037-0033

Start Marketing Date : 2014-08-01

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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02

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Virtual BoothHonour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.

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EMPAGLIFLOZIN

NDC Package Code : 69037-0029

Start Marketing Date : 2014-08-01

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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03

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Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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EMPAGLIFLOZIN

NDC Package Code : 71796-001

Start Marketing Date : 2018-01-02

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

Dr Reddy Company Banner

04

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Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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EMPAGLIFLOZIN

NDC Package Code : 71796-064

Start Marketing Date : 2022-12-29

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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EMPAGLIFLOZIN

NDC Package Code : 71796-048

Start Marketing Date : 2022-03-30

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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EMPAGLIFLOZIN

NDC Package Code : 42765-016

Start Marketing Date : 2020-10-27

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (10kg/10kg)

Marketing Category : BULK INGREDIENT

Metrochem

07

KY/TN Water Professionals
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EMPAGLIFLOZIN

NDC Package Code : 65727-085

Start Marketing Date : 2021-12-01

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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KY/TN Water Professionals
Not Confirmed
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KY/TN Water Professionals
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EMPAGLIFLOZIN

NDC Package Code : 12714-920

Start Marketing Date : 2014-08-01

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (25mg/25mg)

Marketing Category : DRUG FOR FURTHER PROCESSING

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Cipla Ltd.

India
KY/TN Water Professionals
Not Confirmed
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Cipla Ltd.

India
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KY/TN Water Professionals
Not Confirmed

EMPAGLIFLOZIN

NDC Package Code : 53104-7723

Start Marketing Date : 2024-04-30

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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KY/TN Water Professionals
Not Confirmed
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EMPAGLIFLOZIN

NDC Package Code : 69766-052

Start Marketing Date : 2018-06-02

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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Listed Suppliers

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Polpharma

Poland
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Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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Empagliflozin

About the Company : Polpharma API, part of a leading Polish pharmaceutical group, has over 70 years of experience in process development and cGMP manufacturing. We offer end-to-end solutions, from API...

Polpharma API, part of a leading Polish pharmaceutical group, has over 70 years of experience in process development and cGMP manufacturing. We offer end-to-end solutions, from API development to scale-up, at our FDA-approved plant in Central Europe. Our expert team provides high-quality, tailor-made services for small molecule API clinical candidates, with strong regulatory support and world-class facilities. Trusted by global partners, we specialize in complex chemical processes and deliver exceptional customer experiences. Polpharma API – Your reliable European CDMO partner.
Polpharma CB

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Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

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Empagliflozin

About the Company : Established in 1984, Neuland Laboratories Limited is a publicly listed company headquartered in Hyderabad, India. The company provides solutions across the entire spectrum of the p...

Established in 1984, Neuland Laboratories Limited is a publicly listed company headquartered in Hyderabad, India. The company provides solutions across the entire spectrum of the pharmaceutical industry’s chemistry requirements, from the synthesis of library compounds to supplying NCEs and advanced intermediates at various stages in the clinical life cycle, as well as commercial launch. Neuland’s expertise is in the manufacturing of APIs and advanced intermediates from its USFDA-approved facilities. Its core competency lies in the application of powerful process chemistry to manufacturing in a regulatory-compliant environment.
Neuland

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Virtual BoothHonour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.

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Empagliflozin

About the Company : Honour is a leading global CDMO and a trusted manufacturer of specialty chemicals and ingredients. With seven world-class facilities built to meet global safety and quality standar...

Honour is a leading global CDMO and a trusted manufacturer of specialty chemicals and ingredients. With seven world-class facilities built to meet global safety and quality standards, we are committed to delivering excellence with innovative, holistic solutions to clients across the globe by leveraging our expertise in chemistry. Operating through our two core verticals - Honour Synthesis and Honour Specialty, we embrace the science of partnership and possibilities. Our team of over 2,500 professionals collaborates closely with pharmaceutical, biotechnology, and specialty industries worldwide to develop practical, scalable solutions.
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Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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Empagliflozin

About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...

Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale
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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Empagliflozin

About the Company : Granules is a fast-growing, vertically integrated pharma company based in Hyderabad, committed to operational excellence, quality, and customer service. It manufactures across the ...

Granules is a fast-growing, vertically integrated pharma company based in Hyderabad, committed to operational excellence, quality, and customer service. It manufactures across the entire value chain- APIs, Formulation Intermediates, & Formulations. With 11 facilities (8 in India, 2 in the US and 1 in Europe) approved by US FDA, EDQM, EU GMP, WHO GMP, & more, its products reach 300+ customers in 80+ countries. Granules has offices in India, the US, & Europe ensuring a strong global presence. Products listed herein may not be available for commercial use in countries where any relevant third-party intellectual property is in force.
Granules India

06

Minakem

France
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Virtual BoothMinakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

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Empagliflozin

About the Company : MINAKEM is a cGMP custom manufacturer of small molecule API, HPAPI and steroids. All development and manufacturing activities are supported by highly skilled R&D teams, supported b...

MINAKEM is a cGMP custom manufacturer of small molecule API, HPAPI and steroids. All development and manufacturing activities are supported by highly skilled R&D teams, supported by strong analytical and regulatory affairs services. The R&D team has an expertise in process development, organic synthesis, and works under a secrecy agreement to protect your IP. With 3 production sites in Europe and 1 in Canada, Minakem is ready to support your strategic sourcing projects or your reshoring activities. Recently launched commercial generic API: Apixaban, Mirabegron, Fulvestrant, remifentanil, esmolol,
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Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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Empagliflozin

About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...

Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
Metrochem

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Virtual BoothRochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

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Empagliflozin

About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...

Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quality ingredients manufactured in China. Headquartered in the Hauppauge, New York, Rochem has 16 offices spread across the globe to cater to the needs of its customers. Rochem’s operations are fully cGMP compliant and has been audited by the USFDA as well as several multinational organizations. It also trains and audits its partners to ensure all of their technologies and systems are FDA-compliant.
Rochem

09

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Virtual BoothEgis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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Empagliflozin

About the Company : Egis is a member of the Servier Group. Egis’ products are manufactured at 3 production sites in Hungary, which are certified by EMA,FDA, ANVISA, PMDA ,KFDA. Egis sells its produc...

Egis is a member of the Servier Group. Egis’ products are manufactured at 3 production sites in Hungary, which are certified by EMA,FDA, ANVISA, PMDA ,KFDA. Egis sells its products under Egis’ brand names in 18 countries. In total, the company’s APIs & finished products reach 100 countries. Egis’ focus lies on treating diseases of cardiovascular & central nervous systems; however, it also provides modern treatment solutions in the fields of diabetology, dermatology & wound care. Our research and development activities focus on high-quality, value-added branded generic products. From 2023, Egis offers its CDMO & CMO services as well.
Egis Pharmaceuticals

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Virtual BoothMoehs Group, a reference company in the production of pharmaceutical active ingredients.

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Empagliflozin

About the Company : Since its founding in 1962, MOEHS has produced Active Pharmaceutical Ingredients (APIs) for the international pharmaceutical industry. Thanks to a business history of more than 50 ...

Since its founding in 1962, MOEHS has produced Active Pharmaceutical Ingredients (APIs) for the international pharmaceutical industry. Thanks to a business history of more than 50 years, MOEHS has considerable technical experience in the production of these substances. At Moehs Group we have a large tradition and experience in the area of manufacturing of active pharmaceutical and veterinary ingredients, agrochemicals, nutraceutical, cosmetic, as well as fine chemistry in general, with high levels of quality and safety standards-GMP´s, ICH, approved by the FDA and TGA.
Moehs Iberica
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API Reference Price

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PU DONG","customer":"ALKEM LABORATORIES LTD","customerCountry":"INDIA","quantity":"16.40","actualQuantity":"16.4","unit":"KGS","unitRateFc":"850","totalValueFC":"14102.6","currency":"USD","unitRateINR":"73610","date":"12-Apr-2025","totalValueINR":"1207204","totalValueInUsd":"14102.6","indian_port":"Delhi Air","hs_no":"29419090","bill_no":"9452515","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"XUNQIAO LINHAI ZHEJIANG 317024 , , CHINA SDNF CHINA","customerAddress":"ALKEM HOUSE, DEVASHISH ADJACENT T"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1744741800,"product":"EMPAGLIFLOZIN I.H.S (CAS NO. 864070-44-0) (REIMPORT INDIAN ORIGIN REJECTED GOODS SB NO.4881666 DT.17.10.2024)EMPAGLINFLOZIN","address":"406,WORLD TRADE CENTRE,SAYAJIGUNJ,","city":"VADODARA GUJ.","supplier":"JORDAN RIVER PHARMACEUTICAL INDUSTR","supplierCountry":"INDIA","foreign_port":"AMMAN","customer":"CENTURY PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"35.00","actualQuantity":"35","unit":"KGS","unitRateFc":"850","totalValueFC":"30096.9","currency":"USD","unitRateINR":"73610","date":"16-Apr-2025","totalValueINR":"2576350","totalValueInUsd":"30096.9","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"9531789","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"AMMAN","supplierAddress":"IES (L.L.C) MUBES-BAQAA P.O. BOX 16 01, POSTAL CODE 11941, AMMAN, JORDA N JORDAN","customerAddress":"406,WORLD TRADE CENTRE,SAYAJIGUNJ,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1748889000,"product":"EMPAGLIFLOZIN( SB NO.2886500 DATE,01.08.2024) ORGANIC CHEMICALS","address":"SYNO.257 258\/1, DNO.11-6\/56,","city":"VILLAGE BALANGAR POST HYDERABAD","supplier":"FUTURE PHARMACEUTICAL INDUSTRIES","supplierCountry":"INDIA","foreign_port":"CAIRO","customer":"LEE PHARMA LTD","customerCountry":"INDIA","quantity":"45.00","actualQuantity":"45","unit":"KGS","unitRateFc":"403.4","totalValueFC":"18255","currency":"USD","unitRateINR":"34857","date":"03-Jun-2025","totalValueINR":"1568565","totalValueInUsd":"18255","indian_port":"Madras Air","hs_no":"29329990","bill_no":"2441481","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"CAIRO","supplierAddress":"2ND INDUSTRIAL ZONE-4G-BADR CITY CAIRO SDNF EG","customerAddress":"SYNO.257 258\/1, DNO.11-6\/56,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1750962600,"product":"EMPAGLIFLOZIN EMPAGLIFLOZIN","address":"PLOT NO 2A & 2B, BIOTECH PARK,,PHA","city":"HYDERABAD,TELANGANA","supplier":"ZHEJIANG TIANYU PHARMACEUTICAL COLTD","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"CHEMO INDIA FORMULATION PRIVATE LTD","customerCountry":"INDIA","quantity":"15.00","actualQuantity":"15","unit":"KGS","unitRateFc":"1200","totalValueFC":"18361.3","currency":"USD","unitRateINR":"105180","date":"27-Jun-2025","totalValueINR":"1577700","totalValueInUsd":"18361.3","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"2904707","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"Jiangkou Development Zone,Huangyan,Taizhou,Zhejiang, CHINA CN","customerAddress":"PLOT NO 2A & 2B, BIOTECH PARK,,PHA"}]
05-Jan-2022
27-Jun-2025
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Average Price (USD/KGS)

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Quantity (KGS) & Unit rate (USD/KGS) over time

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INTERMEDIATE SUPPLIERS

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01

Suanfarma

Spain
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSuanfarma, at the Core of a Better Life.

CAS Number : 915095-86-2

End Use API : Empagliflozin

About The Company : Suanfarma founded in 1993, is a B2B life science partner committed to health advancement by developing, manufacturing, & distributing high-quality APIs for the ...

Suanfarma

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMalladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.

CAS Number : 86087-23-2

End Use API : Empagliflozin

About The Company : Malladi Drugs & Pharmaceuticals Ltd was founded in 1980 by microbiologist Mr. M L N Sastry. Within a few years, Malladi established itself as a leader in manufa...

Malladi

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWith Virupaksha, you get a quality product with on-time delivery.

CAS Number : 915095-89-5

End Use API : Empagliflozin

About The Company : Virupaksha Organics, founded in 2003 by G. Chandra Mouliswar Reddy, is committed to delivering products of the utmost quality to its customers. In a span of les...

Virupaksha

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

CAS Number : 86087-24-3

End Use API : Empagliflozin

About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...

Aarti Industries Company Banner

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

CAS Number : 915095-94-2

End Use API : Empagliflozin

About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...

Aarti Industries Company Banner

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

CAS Number : 219823-47-9

End Use API : Empagliflozin

About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...

Aarti Industries Company Banner

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

CAS Number : 32384-65-9

End Use API : Empagliflozin

About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...

Aarti Industries Company Banner

08

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

CAS Number : 915095-89-5

End Use API : Empagliflozin

About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...

Aarti Industries Company Banner

09

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothJinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.

CAS Number : 1335210-23-5

End Use API : Empagliflozin

About The Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our cor...

Jinan Tantu Chemicals

10

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

CAS Number : 86087-23-2

End Use API : Empagliflozin

About The Company : ​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...

Shanghai Minbiotech CB
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FDF Dossiers

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01

  • fda
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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Empagliflozin

Brand Name : Empagliflozin

Dosage Form : Immediate Release Tablet

Dosage Strength : 25MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Granules India

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Empagliflozin; Linagliptin

Brand Name : Empagliflozin ; Linagliptin

Dosage Form : Immediate Release Tablet

Dosage Strength : 10MG; 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Granules India

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Empagliflozin; Metformin

Brand Name : Empagliflozin ; Metformin

Dosage Form : Immediate Release Tablet

Dosage Strength : 5MG; 500MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Granules India

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Empagliflozin; Metformin

Brand Name : Empagliflozin ; Metformin

Dosage Form : Immediate Release Tablet

Dosage Strength : 12.5MG; 500MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Granules India

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Empagliflozin; Metformin

Brand Name : Empagliflozin ; Metformin

Dosage Form : Immediate Release Tablet

Dosage Strength : 5MG; 1000MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Granules India

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Empagliflozin; Metformin

Brand Name : Empagliflozin ; Metformin

Dosage Form : Immediate Release Tablet

Dosage Strength : 5MG; 850MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Granules India

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Empagliflozin; Metformin

Brand Name : Empagliflozin ; Metformin

Dosage Form : Immediate Release Tablet

Dosage Strength : 12.5MG; 850MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Granules India

08

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Empagliflozin; Metformin

Brand Name : Empagliflozin ; Metformin

Dosage Form : Immediate Release Tablet

Dosage Strength : 12.5MG; 1000MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Granules India

09

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Empagliflozin; Metformin

Brand Name : Empagliflozin ; Metformin

Dosage Form : Extended Release Tablet

Dosage Strength : 5MG; 1MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Granules India

10

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Empagliflozin; Metformin

Brand Name : Empagliflozin ; Metformin

Dosage Form : Extended Release Tablet

Dosage Strength : 10MG; 1MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Granules India
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FDA Orange Book

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01

AIZANT

India
Chemicals America
Not Confirmed
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AIZANT

India
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Chemicals America
Not Confirmed

EMPAGLIFLOZIN

Brand Name : EMPAGLIFLOZIN

Dosage Form : TABLET;ORAL

Dosage Strength : 2.5MG

Approval Date :

Application Number : 212322

RX/OTC/DISCN :

RLD :

TE Code :

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02

AIZANT

India
Chemicals America
Not Confirmed
arrow

AIZANT

India
arrow
Chemicals America
Not Confirmed

EMPAGLIFLOZIN

Brand Name : EMPAGLIFLOZIN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date :

Application Number : 212322

RX/OTC/DISCN :

RLD :

TE Code :

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03

AIZANT

India
Chemicals America
Not Confirmed
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AIZANT

India
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Chemicals America
Not Confirmed

EMPAGLIFLOZIN

Brand Name : EMPAGLIFLOZIN

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG

Approval Date :

Application Number : 212322

RX/OTC/DISCN :

RLD :

TE Code :

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04

CIPLA LTD

India
Chemicals America
Not Confirmed
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CIPLA LTD

India
arrow
Chemicals America
Not Confirmed

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Brand Name : EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 5MG;1000MG

Approval Date :

Application Number : 212243

RX/OTC/DISCN :

RLD :

TE Code :

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05

KINAPSE LIMITED

United Kingdom
Chemicals America
Not Confirmed
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KINAPSE LIMITED

United Kingdom
arrow
Chemicals America
Not Confirmed

EMPAGLIFLOZIN; LINAGLIPTIN

Brand Name : EMPAGLIFLOZIN; LINAGLIPTIN

Dosage Form : TABLET; ORAL

Dosage Strength : 10MG/5MG

Approval Date :

Application Number : 212354

RX/OTC/DISCN :

RLD :

TE Code :

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06

KINAPSE LIMITED

United Kingdom
Chemicals America
Not Confirmed
arrow

KINAPSE LIMITED

United Kingdom
arrow
Chemicals America
Not Confirmed

EMPAGLIFLOZIN; LINAGLIPTIN

Brand Name : EMPAGLIFLOZIN; LINAGLIPTIN

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG/5MG

Approval Date :

Application Number : 212354

RX/OTC/DISCN :

RLD :

TE Code :

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07

Chemicals America
Not Confirmed
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Chemicals America
Not Confirmed

EMPAGLIFLOZIN; LINAGLIPTIN

Brand Name : EMPAGLIFLOZIN AND LINAGLIPTIN

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG;5MG

Approval Date :

Application Number : 212264

RX/OTC/DISCN :

RLD :

TE Code :

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08

Chemicals America
Not Confirmed
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Chemicals America
Not Confirmed

EMPAGLIFLOZIN

Brand Name : EMPAGLIFLOZIN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date :

Application Number : 212343

RX/OTC/DISCN :

RLD :

TE Code :

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09

Chemicals America
Not Confirmed
arrow
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Chemicals America
Not Confirmed

EMPAGLIFLOZIN

Brand Name : EMPAGLIFLOZIN

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG

Approval Date :

Application Number : 212343

RX/OTC/DISCN :

RLD :

TE Code :

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10

ZYDUS PHARMS

U.S.A
Chemicals America
Not Confirmed
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ZYDUS PHARMS

U.S.A
arrow
Chemicals America
Not Confirmed

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Brand Name : EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 12.5MG;500MG

Approval Date : 2022-07-07

Application Number : 212198

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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Europe

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01

Chemicals America
Not Confirmed
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Chemicals America
Not Confirmed

empagliflozin

Brand Name : Jardiance

Dosage Form : FILM COATED PILL

Dosage Strength : 10 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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02

Chemicals America
Not Confirmed
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Chemicals America
Not Confirmed

Empagliflozin; Metformin

Brand Name : Synjardy

Dosage Form : Empagliflozin+Metformin+85012.5 Mg 56 Combined Oral Use

Dosage Strength : 56x1 cpr riv 12.5 mg + 850 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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03

Chemicals America
Not Confirmed
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Chemicals America
Not Confirmed

Empagliflozin

Brand Name : Jardiance

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 10 mg

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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04

Chemicals America
Not Confirmed
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Chemicals America
Not Confirmed

Empagliflozin

Brand Name : Jardiance

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 10 mg

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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05

Chemicals America
Not Confirmed
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Chemicals America
Not Confirmed

Metformin; Empagliflozin

Brand Name : Synjardy

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 5MG; 1000MG

Packaging : Blister, endose

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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06

Chemicals America
Not Confirmed
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Chemicals America
Not Confirmed

Metformin; Empagliflozin

Brand Name : Synjardy

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 5MG; 850MG

Packaging : Blister, endose

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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07

Chemicals America
Not Confirmed
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Chemicals America
Not Confirmed

Empagliflozinum

Brand Name : Jardiance

Dosage Form : Filmtabl

Dosage Strength : 10mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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08

Chemicals America
Not Confirmed
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Chemicals America
Not Confirmed

Empagliflozinum; Linagliptinum

Brand Name : Glyxambi

Dosage Form : Filmtabl

Dosage Strength : 10mg/5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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09

Chemicals America
Not Confirmed
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Chemicals America
Not Confirmed

Empagliflozinum; Metformini hydrochloridum

Brand Name : Jardiance Met

Dosage Form : Filmtabl

Dosage Strength : 5/1000mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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10

Chemicals America
Not Confirmed
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Chemicals America
Not Confirmed

Empagliflozinum; Metformini hydrochloridum

Brand Name : Jardiance Met

Dosage Form : Filmtabl

Dosage Strength : 5/500mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 10MG

USFDA APPLICATION NUMBER - 204629

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DOSAGE - TABLET;ORAL - 25MG

USFDA APPLICATION NUMBER - 204629

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DOSAGE - TABLET;ORAL - 10MG;5MG

USFDA APPLICATION NUMBER - 206073

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DOSAGE - TABLET;ORAL - 25MG;5MG

USFDA APPLICATION NUMBER - 206073

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Patents & EXCLUSIVITIES

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US Patents

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EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE

US Patent Number : 11090323*PED

Drug Substance Claim :

Drug Product Claim :

Application Number : 212614

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2034-10-03

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02

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EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

US Patent Number : 9949997*PED

Drug Substance Claim :

Drug Product Claim :

Application Number : 208658

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2034-11-17

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03

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EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

US Patent Number : 10610489*PED

Drug Substance Claim :

Drug Product Claim :

Application Number : 206111

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2031-03-30

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04

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EMPAGLIFLOZIN; LINAGLIPTIN

US Patent Number : 7579449

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 206073

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2028-08-01

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05

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EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

US Patent Number : 10610489

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 206111

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2030-09-30

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06

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EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE

US Patent Number : 10596120

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 212614

Patent Use Code : U-2776

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2032-03-07

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07

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EMPAGLIFLOZIN

US Patent Number : 11813275

Drug Substance Claim :

Drug Product Claim :

Application Number : 204629

Patent Use Code : U-3759

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2034-04-03

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08

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EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

US Patent Number : 9949997

Drug Substance Claim :

Drug Product Claim :

Application Number : 208658

Patent Use Code : U-3532

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2034-05-17

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09

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EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE

US Patent Number : 11090323

Drug Substance Claim :

Drug Product Claim :

Application Number : 212614

Patent Use Code : U-3192

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2034-04-03

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10

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EMPAGLIFLOZIN

US Patent Number : 10258637

Drug Substance Claim :

Drug Product Claim :

Application Number : 204629

Patent Use Code : U-2290

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2034-04-03

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US Exclusivities

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EMPAGLIFLOZIN

Exclusivity Code : I-922

Exclusivity Expiration Date : 2026-09-21

Application Number : 204629

Product Number : 1

Exclusivity Details :

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EMPAGLIFLOZIN

Exclusivity Code : M-82

Exclusivity Expiration Date : 2025-02-24

Application Number : 204629

Product Number : 1

Exclusivity Details :

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EMPAGLIFLOZIN

Exclusivity Code : NPP

Exclusivity Expiration Date : 2026-06-20

Application Number : 204629

Product Number : 1

Exclusivity Details :

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EMPAGLIFLOZIN

Exclusivity Code : NPP

Exclusivity Expiration Date : 2026-06-20

Application Number : 204629

Product Number : 2

Exclusivity Details :

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Health Canada Patents

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Empagliflozin

Brand Name : JARDIANCE

Patent Number : 2557801

Filing Date : 2005-03-11

Strength per Unit : 10 mg

Dosage Form : TABLET

Human Or VET : Human

Route of Administration : ORAL

Patent Expiration Date : 2025-03-11

Date Granted : 2013-06-25

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Empagliflozin

Brand Name : JARDIANCE

Patent Number : 2606650

Filing Date : 2006-05-02

Strength per Unit : 10 mg

Dosage Form : TABLET

Human Or VET : Human

Route of Administration : ORAL

Patent Expiration Date : 2026-05-02

Date Granted : 2014-02-11

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Empagliflozin

Brand Name : JARDIANCE

Patent Number : 2606650

Filing Date : 2006-05-02

Strength per Unit : 25 mg

Dosage Form : TABLET

Human Or VET : Human

Route of Administration : ORAL

Patent Expiration Date : 2026-05-02

Date Granted : 2014-02-11

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Empagliflozin

Brand Name : JARDIANCE

Patent Number : 2557801

Filing Date : 2005-03-11

Strength per Unit : 25 mg

Dosage Form : TABLET

Human Or VET : Human

Route of Administration : ORAL

Patent Expiration Date : 2025-03-11

Date Granted : 2013-06-25

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REF. STANDARDS & IMPURITIES

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USP

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothUSP reference standards; highly characterized specimens of drug substances, impurities, excipients, degradation products & more.

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Digital Content Digital Content

1-Methoxy Empagliflozin

CAS Number : 1279691-36-9

Quantity Per Vial :

Price ($) : 1500

Catalog Number : 1A04540

Current Lot : 25 mg

Previous Lot :

NDC Code :

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02

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  • EDQM
  • WHO-GMP

Virtual BoothUSP reference standards; highly characterized specimens of drug substances, impurities, excipients, degradation products & more.

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Desfuranyl Empagliflozin

CAS Number : 864070-37-1

Quantity Per Vial :

Price ($) : 1350

Catalog Number : 1A04530

Current Lot : 25 mg

Previous Lot :

NDC Code :

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ABOUT THIS PAGE

Looking for 864070-44-0 / Empagliflozin API manufacturers, exporters & distributors?

Empagliflozin manufacturers, exporters & distributors 1

61

PharmaCompass offers a list of Empagliflozin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Empagliflozin manufacturer or Empagliflozin supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Empagliflozin manufacturer or Empagliflozin supplier.

PharmaCompass also assists you with knowing the Empagliflozin API Price utilized in the formulation of products. Empagliflozin API Price is not always fixed or binding as the Empagliflozin Price is obtained through a variety of data sources. The Empagliflozin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Empagliflozin

Synonyms

864070-44-0, Jardiance, Bi 10773, Bi-10773, Bi10773, Empagliflozin (bi 10773)

Cas Number

864070-44-0

Unique Ingredient Identifier (UNII)

HDC1R2M35U

About Empagliflozin

Empagliflozin is an orally available competitive inhibitor of sodium-glucose co-transporter 2 (SGLT2; SLC5A2) with antihyperglycemic activity. Upon oral administration, empagliflozin selectively and potently inhibits SGLT2 in the kidneys, thereby suppressing the reabsorption of glucose in the proximal tubule. Inhibition of SGLT2 increases urinary glucose excretion by the kidneys, resulting in a reduction of plasma glucose levels in an insulin-independent manner. Inhibition of SGLT2 in the kidneys also suppresses the renal reabsorption of 1,5-anhydroglucitol (1,5AG). This lowers serum 1,5AG and neutrophil 1,5-anhydroglucitol-6-phosphate (1,5AG6P) levels, which may improve neutropenia and neutrophil dysfunction in patients with glycogen storage disease type Ib (GSD Ib). SGLT2, a transport protein exclusively expressed in the proximal renal tubules, mediates approximately 90% of renal glucose reabsorption from tubular fluid.

(2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL Manufacturers

A (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL, including repackagers and relabelers. The FDA regulates (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

(2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL Suppliers

A (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL supplier is an individual or a company that provides (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL active pharmaceutical ingredient (API) or (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL finished formulations upon request. The (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL suppliers may include (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL API manufacturers, exporters, distributors and traders.

click here to find a list of (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

(2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL USDMF

A (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL DMF (Drug Master File) is a document detailing the whole manufacturing process of (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL active pharmaceutical ingredient (API) in detail. Different forms of (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL DMFs exist exist since differing nations have different regulations, such as (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL DMF submitted to regulatory agencies in the US is known as a USDMF. (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL USDMF includes data on (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL suppliers with USDMF on PharmaCompass.

(2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL Drug Master File in Korea ((2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL. The MFDS reviews the (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL KDMF as part of the drug registration process and uses the information provided in the (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL KDMF to evaluate the safety and efficacy of the drug.

After submitting a (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL API can apply through the Korea Drug Master File (KDMF).

click here to find a list of (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL suppliers with KDMF on PharmaCompass.

(2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL WC

A (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL written confirmation ((2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL WC) is an official document issued by a regulatory agency to a (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL manufacturer, verifying that the manufacturing facility of a (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL APIs or (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL finished pharmaceutical products to another nation, regulatory agencies frequently require a (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL WC (written confirmation) as part of the regulatory process.

click here to find a list of (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL suppliers with Written Confirmation (WC) on PharmaCompass.

(2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL suppliers with NDC on PharmaCompass.

(2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL GMP

(2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL GMP manufacturer or (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL GMP API supplier for your needs.

(2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL CoA

A (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL CoA (Certificate of Analysis) is a formal document that attests to (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL's compliance with (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL specifications and serves as a tool for batch-level quality control.

(2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL CoA mostly includes findings from lab analyses of a specific batch. For each (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

(2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL may be tested according to a variety of international standards, such as European Pharmacopoeia ((2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL EP), (2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL JP (Japanese Pharmacopeia) and the US Pharmacopoeia ((2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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