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1. (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6- (hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol
2. 2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2h-pyran-3,4,5-triol
3. Bms 512148
4. Bms-512148
5. Bms512148
6. Farxiga
7. Forxiga
1. 461432-26-8
2. Bms-512148
3. Forxiga
4. Bms 512148
5. (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol
6. Dagagflozin
7. (1s)-1,5-anhydro-1-c-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-d-glucitol
8. 1ull0qj8uc
9. Chembl429910
10. Chebi:85078
11. Lyn-045
12. Dapagliflozin [usan:inn]
13. (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6- (hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol
14. (2s,3r,4r,5s,6r)-2-{4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl}-6-(hydroxymethyl)oxane-3,4,5-triol
15. Bms512148
16. Forxiga (tn)
17. Chembl3125458
18. D-glucitol, 1,5-anhydro-1-c-(4-chloro-3-((4-ethoxyphenyl)methyl)phenyl)-, (1s)-
19. (2s,3r,4r,5s,6r)-2-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-6-(hydroxymethyl)oxane-3,4,5-triol
20. Dapagliflozin [usan]
21. Unii-1ull0qj8uc
22. Bms5121458
23. S1548_selleck
24. C-aryl Glucoside, 6
25. Dapagliflozin [mi]
26. Dapagliflozin [inn]
27. Dapagliflozin (usan/inn)
28. 2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2h-pyran-3,4,5-triol
29. Dapagliflozin [vandf]
30. Schembl157820
31. Dapagliflozin [who-dd]
32. Gtpl4594
33. Bdbm20880
34. Dtxsid20905104
35. Ex-a005
36. Bcpp000265
37. Dapagliflozin [orange Book]
38. Amy18541
39. Zinc3819138
40. Bdbm50448923
41. Mfcd13182359
42. S1548
43. Qternmet Component Dapaglifozin
44. Akos005145763
45. Dapagliflozin Component Qternmet
46. Bcp9000583
47. Bl-0052
48. Ccg-229917
49. Cs-0781
50. Db06292
51. Ex-7214
52. Ncgc00250402-09
53. Ac-24699
54. Bd164346
55. Hy-10450
56. Qternmet Xr Component Dapagliflozin
57. Dapagliflozin Component Of Qternmet Xr
58. A25150
59. C22193
60. D08897
61. 432d268
62. Q409898
63. J-500392
64. Brd-k58160573-001-01-3
65. Brd-k58160573-001-05-4
66. 1-[3-(beta-d-glucopyranosyl)-6-chlorobenzyl]-4-ethoxybenzene
67. (1s)-1,5-anhydro-1-[4-chloro-3-(4-ethoxybenzyl)phenyl]-d-glucitol
68. (2s, 3r, 4r, 5s, 6r)-2-[4-chloro-3-(4-ethoxy-benzyl)-phenyl]-6-hydroxymethyl-tetrahydro-pyran-3,4,5-triol
69. (2s,3r,4r,5s,6r)-2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-(hydroxymethyl)-tetrahydro-2h-pyran-3,4,5-triol
70. (2s,3r,4r,5s,6r)-2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-(hydroxymethyl)-tetrahydro-2h-pyran-3,4,5-triol;bms-512148
71. (2s,3r,4r,5s,6r)-2-[4-chloro-3-(4-ethoxy-benzyl)-phenyl]-6-hydroxymethyl-tetrahydro-pyran-3,4,5-triol
Molecular Weight | 408.9 g/mol |
---|---|
Molecular Formula | C21H25ClO6 |
XLogP3 | 2.3 |
Hydrogen Bond Donor Count | 4 |
Hydrogen Bond Acceptor Count | 6 |
Rotatable Bond Count | 6 |
Exact Mass | 408.1339662 g/mol |
Monoisotopic Mass | 408.1339662 g/mol |
Topological Polar Surface Area | 99.4 Ų |
Heavy Atom Count | 28 |
Formal Charge | 0 |
Complexity | 472 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 5 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
1 of 2 | |
---|---|
Drug Name | Farxiga |
PubMed Health | Dapagliflozin (By mouth) |
Drug Classes | Antidiabetic |
Drug Label | Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1S)-, compounded with (2S)-1,2-propanediol, hydrate (1:1:1). The empirical formula is C21H25ClO6C3H8O2H2O and the molecular weig... |
Active Ingredient | Dapagliflozin |
Dosage Form | Tablet |
Route | Oral |
Strength | 5mg; 10mg |
Market Status | Prescription |
Company | Astrazeneca Ab |
2 of 2 | |
---|---|
Drug Name | Farxiga |
PubMed Health | Dapagliflozin (By mouth) |
Drug Classes | Antidiabetic |
Drug Label | Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1S)-, compounded with (2S)-1,2-propanediol, hydrate (1:1:1). The empirical formula is C21H25ClO6C3H8O2H2O and the molecular weig... |
Active Ingredient | Dapagliflozin |
Dosage Form | Tablet |
Route | Oral |
Strength | 5mg; 10mg |
Market Status | Prescription |
Company | Astrazeneca Ab |
Dapagliflozin is indicated to improve glycemic control in adult patients with type 2 diabetes mellitus along with diet and exercise.
FDA Label
Forxiga is indicated in adults and children aged 10 years and above for the treatment of 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 type 2 diabetes.
For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied.
Heart failure
- Forxiga is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.
Chronic kidney disease
- Forxiga is indicated in adults for the treatment of chronic kidney disease.
Type 2 diabetes mellitus
Edistride is indicated in adults and children aged 10 years and above for the treatment of 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 type 2 diabetes.
For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 and 5. 1.
Heart failure
Edistride is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.
Chronic kidney disease
Edistride is indicated in adults for the treatment of chronic kidney disease.
Treatment of chronic kidney disease
Prevention of cardiovascular events in patients with chronic heart failure
Treatment of type I diabetes mellitus
Treatment of type II diabetes mellitus
Treatment of ischaemic heart disease
Treatment of Coronavirus disease 2019 (COVID-19)
Dapagliflozin inhibits the sodium-glucose contransporter 2(SGLT2) which is primarily located in the proximal tubule of the nephron. SGLT2 facilitates 90% of glucose resorption in the kidneys and so its inhibition allows for glucose to be excreted in the urine. This excretion allows for better glycemic control and potentially weight loss in patients with type 2 diabetes mellitus.
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.)
A10BK01
A10BK01
A10BK01
S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355
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
A10BK01 - Dapagliflozin
Absorption
Oral dapagliflozin reaches a maximum concentration within 1 hour of administration when patients have been fasting. When patients have consumed a high fat meal, the time to maximum concentration increases to 2 hours and the maximum concentration decreases by half though a dose adjustment is not necessary. Oral dapagliflozin is 78% bioavailable.
Route of Elimination
75.2% of dapagliflozin is recovered in the urine with 1.6% of the dose unchanged by metabolism. 21% of the dose is excreted in the feces with 15% of the dose unchanged by metabolism.
Volume of Distribution
118L.
Clearance
Oral plasma clearance was 4.9 mL/min/kg, and renal clearance was 5.6 mL/min.
Dapagliflozin is primarily glucuronidated to become the inactive 3-O-glucuronide metabolite(60.7%). Dapagliflozin also produces another minor glucuronidated metabolite(5.4%), a de-ethylated metabolite(<5%), and a hydroxylated metabolite(<5%). Metabolism of dapagliflozin is mediated by cytochrome p-450(CYP)1A1, CYP1A2, CYP2A6, CYP2C9, CYP2D6, CYP3A4, uridine diphosphate glucuronyltransferase(UGT)1A9, UGT2B4, and UGT2B7. Glucuronidation to the major metabolite is mediated by UGT1A9.
13.8h.
Dapagliflozin inhibits the sodium-glucose contransporter 2(SGLT2) which is primarily located in the proximal tubule of the nephron. SGLT2 facilitates 90% of glucose resorption in the kidneys and so its inhibition allows for glucose to be excreted in the urine. This excretion allows for better glycemic control and potentially weight loss in patients with type 2 diabetes mellitus.
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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Rev. Date :
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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
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Rev. Date : 2017-08-01
Pay. Date : 2017-06-14
DMF Number : 31762
Submission : 2017-07-03
Status : Active
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Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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Details:
Mankind Pharma has launched Justoza, a Dapagliflozin brand marketed by Mankind to treat diabetes, heart failure and chronic kidney disease. Launching API DMF grade dapagliflozin is an innovative futuristic approach to provide the best in class quality to the patients.
Lead Product(s): Dapagliflozin
Therapeutic Area: Endocrinology Brand Name: Justoza
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 22, 2021
Lead Product(s) : Dapagliflozin
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Mankind Pharma Launches Justoza to Treat Diabetes, Heart Failure & CKD
Details : Mankind Pharma has launched Justoza, a Dapagliflozin brand marketed by Mankind to treat diabetes, heart failure and chronic kidney disease. Launching API DMF grade dapagliflozin is an innovative futuristic approach to provide the best in class quality to...
Product Name : Justoza
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 22, 2021
Details:
Zemidapa is a fixed-dose combination therapy that brings together two active ingredients: Zemiglo, Korea’s first domestically developed DPP-4 inhibitor, and dapagliflozin, an SGLT-2 inhibitor.
Lead Product(s): Dapagliflozin,Gemigliptin
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Zemidapa
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 13, 2025
Lead Product(s) : Dapagliflozin,Gemigliptin
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
LG Chem Sets Sights on Global Market with Launch of Diabetes Combination Therapy Zemidapa
Details : Zemidapa is a fixed-dose combination therapy that brings together two active ingredients: Zemiglo, Korea’s first domestically developed DPP-4 inhibitor, and dapagliflozin, an SGLT-2 inhibitor.
Product Name : Zemidapa
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 13, 2025
Details:
Dapnec (dapagliflozin) is a SGLT2 inhibitor small molecule drug candidate, which is indicated for the treatment of Type 2 diabetes.
Lead Product(s): Dapagliflozin
Therapeutic Area: Endocrinology Brand Name: Dapnec
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 18, 2025
Lead Product(s) : Dapagliflozin
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Nectar Life Care Launches Affordable Anti-Diabetic Range of Medicines
Details : Dapnec (dapagliflozin) is a SGLT2 inhibitor small molecule drug candidate, which is indicated for the treatment of Type 2 diabetes.
Product Name : Dapnec
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 18, 2025
Details:
Akums launched apagliflozin and pioglitazone combination tablets, which acts as a dual-action therapy. It is indicated for diabetes management.
Lead Product(s): Dapagliflozin,Pioglitazone
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 04, 2025
Lead Product(s) : Dapagliflozin,Pioglitazone
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Akums Combines Two Potent Diabetes Medicines for Enhanced Treatment Efficacy
Details : Akums launched apagliflozin and pioglitazone combination tablets, which acts as a dual-action therapy. It is indicated for diabetes management.
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 04, 2025
Details:
Farxiga (dapagliflozin), is first-in-class, oral, USFDA approved, once-daily SGLT2 inhibitor, for paediatric patients with type-2 diabetes aged 10 years and older.
Lead Product(s): Dapagliflozin
Therapeutic Area: Endocrinology Brand Name: Farxiga
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 06, 2024
Lead Product(s) : Dapagliflozin
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Farxiga approved in the US for the treatment of paediatric type-2 diabetes
Details : Farxiga (dapagliflozin), is first-in-class, oral, USFDA approved, once-daily SGLT2 inhibitor, for paediatric patients with type-2 diabetes aged 10 years and older.
Product Name : Farxiga
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 06, 2024
Details:
Dapagliflozin, metformin and glimepiride fixed dose combination is approved for the treatment of patients with type 2 diabetes.
Lead Product(s): Glimepiride,Dapagliflozin,Metformin
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 11, 2023
Lead Product(s) : Glimepiride,Dapagliflozin,Metformin
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Mascot Sets New Diabetes Care Standard with DCGI-Approved Dapagliflozin FDC
Details : Dapagliflozin, metformin and glimepiride fixed dose combination is approved for the treatment of patients with type 2 diabetes.
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 11, 2023
Details:
DSR 2.0 (icodextrin, dextrose, dapagliflozin) is an implant small molecule drug combination, currently being investigated for heart failure management.
Lead Product(s): Icodextrin,Dapagliflozin,Dextrose
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: DSR 2.0
Study Phase: Phase I/ Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 29, 2023
Lead Product(s) : Icodextrin,Dapagliflozin,Dextrose
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : DSR 2.0 (icodextrin, dextrose, dapagliflozin) is an implant small molecule drug combination, currently being investigated for heart failure management.
Product Name : DSR 2.0
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 29, 2023
Details:
Jalra-Trio (vildagliptin + dapagliflozin + metformin) is a fixed dose combination medicine that helps control blood sugar levels. It is now approved for the treatment of type-2-diabetes mellitus.
Lead Product(s): Vildagliptin,Dapagliflozin,Metformin
Therapeutic Area: Endocrinology Brand Name: Jalra Trio
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 08, 2023
Lead Product(s) : Vildagliptin,Dapagliflozin,Metformin
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
USV Launches Jalra Trio for Management of Type 2 Diabetes in India
Details : Jalra-Trio (vildagliptin + dapagliflozin + metformin) is a fixed dose combination medicine that helps control blood sugar levels. It is now approved for the treatment of type-2-diabetes mellitus.
Product Name : Jalra Trio
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 08, 2023
Details:
Zita DM contains the DPP4 inhibitor, Teneligliptin, the SGLT2 inhibitor, Dapagliflozin, and Metformin SR in a fixed dose. It must be taken once daily, under prescription, to improve glycemic control in patients with Type 2 diabetes.
Lead Product(s): Teneligliptin Hydrobromide,Dapagliflozin,Metformin
Therapeutic Area: Endocrinology Brand Name: Zita D
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 18, 2023
Lead Product(s) : Teneligliptin Hydrobromide,Dapagliflozin,Metformin
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Zita DM contains the DPP4 inhibitor, Teneligliptin, the SGLT2 inhibitor, Dapagliflozin, and Metformin SR in a fixed dose. It must be taken once daily, under prescription, to improve glycemic control in patients with Type 2 diabetes.
Product Name : Zita D
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 18, 2023
Details:
Farxiga (dapagliflozin), is first-in-class, oral, USFDA approved, once-daily SGLT2 inhibitor, which reduces reabsorption of filtered glucose and thereby promotes urinary glucose excretion. Thus, reducing the risk of cardiovascular death and hospitalisation for heart failure.
Lead Product(s): Dapagliflozin
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Farxiga
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 05, 2023
Lead Product(s) : Dapagliflozin
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Farxiga (dapagliflozin), is first-in-class, oral, USFDA approved, once-daily SGLT2 inhibitor, which reduces reabsorption of filtered glucose and thereby promotes urinary glucose excretion. Thus, reducing the risk of cardiovascular death and hospitalisati...
Product Name : Farxiga
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 05, 2023
Regulatory Info :
Registration Country : Italy
Brand Name : Forxiga
Dosage Form : Dapagliflozin 10Mg 28 Units 10Mg Oral Use
Dosage Strength : 28 cpr riv 10 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Forxiga
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 5 mg
Packaging : Calendar Gasket
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Forxiga
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 5 mg
Packaging : Blister, endose
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Forxiga
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 5 mg
Packaging : Calendar Gasket
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Qtern
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 05MG; 10MG
Packaging : Calendar Gasket
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Xigduo
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 5MG; 1000MG
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Xigduo
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 5MG; 1000MG
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Switzerland
Metformini hydrochloridum; Dapagliflozinum
Brand Name : Xigduo XR
Dosage Form : Filmtabl
Dosage Strength : 10mg/500mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Metformini hydrochloridum; Dapagliflozinum
Brand Name : Xigduo XR
Dosage Form : Filmtabl
Dosage Strength : 5mg/1000mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Spain
Brand Name : Eucreas 50/100060 Mg Film-Coated Tablets
Dosage Form : Film Coated Tablet
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
DRUG PRODUCT COMPOSITIONS
Related Excipient Companies
Dosage Form : Tablet
Grade : Oral
Dosage Form : Tablet
Grade : Oral
Application : Emulsifying Agents
Excipient Details : HDK N20 Pharma is used as a pharmaceutical emulsifying agent in tablets, capsules, syrups, and solutions.
Dosage Form : Tablet
Grade : Oral
Brand Name : Titanium dioxide PRETIOX ...
Application : Coloring Agents
Excipient Details : Titanium dioxide Pretiox AV01FG is used as a coloring and coating agent in oral solid dosage forms such as capsules, tablets, granules, and pellets.
Pharmacopoeia Ref : Fami-QS, Kosher, Halal, OHSAS ...
Technical Specs : Ti 59.95% and O 40.05%
Ingredient(s) : Titanium Dioxide
Dosage Form : Tablet
Grade : Oral
Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : Microlose (Lactose Monohydrate & Microcrystalline Cellulose) is used as a diluent in oral dosage forms such as tablets.
Pharmacopoeia Ref : DMF, EXCiPAT, KOSHER, HALAL, W...
Technical Specs : Lactose Monohydrate – 40%, Microcrystalline cellulose – 60%
Ingredient(s) : Lactose Monohydrate
Dosage Form : Capsule
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : ProBlend (SMCC) is a co-processed excipient consists of microcrystalline cellulose & colloidal silicon dioxide, used as a diluent & binder in OSDs.
Pharmacopoeia Ref : USP-NF, DMF, EXCiPAT, KOSHER, ...
Technical Specs : NA
Ingredient(s) : Silicified Microcrystalline Cellulose
Dosage Form : Capsule
Grade : Oral
Application : Disintegrants & Superdisintegrants
Excipient Details : Sallyso (Croscarmellose Sodium) is a cross-linked polymer of carboxymethylcellulose sodium, used as a superdisintegrant in tablets and capsules.
Pharmacopoeia Ref : USP-NF, BP, IP, EP, DMF, EXCiP...
Technical Specs : Sallyso 0.5 to 3.0%
Ingredient(s) : Croscarmellose Sodium
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Topical, Oral
Dosage Form : Tablet
Grade : Oral & Topical
Application : Controlled & Modified Release
Excipient Details : Talc is a widely used as a dissolution retardant in the development of controlled release products. Talc is also used as a lubricant in tablet formulations.
Dosage Form : Tablet
Grade : Oral
Brand Name : Carboxymethylcellulose So...
Application : Fillers, Diluents & Binders
Excipient Details : Tablet binders and disintegrants
Dosage Form : Tablet
Grade : Oral
Brand Name : Croscarmellose Sodium
Application : Disintegrants & Superdisintegrants
Excipient Details : Tablet and capsule disintegrant.
Pharmacopoeia Ref : USP/BP/EP/CP
Technical Specs : Not Available
Ingredient(s) : Croscarmellose Sodium
Dosage Form : Tablet
Grade : Not Available
Brand Name : Magnesium Stearate
Application : Lubricants & Glidants
Excipient Details : Lubricants, Anti-adhesive, Glidant
Dosage Form : Tablet
Grade : Oral
Brand Name : Microcrystalline Cellulos...
Application : Fillers, Diluents & Binders
Excipient Details : Tablet and capsule diluent, Tablet disintegrant.
Pharmacopoeia Ref : USP/BP/EP/CP
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
Dosage Form : Tablet
Grade : Not Available
Application : Emulsifying Agents
Excipient Details : Glidant; Emulsion Stabilizer; Anti-caking Agent.
Dosage Form : Tablet
Grade : Not Available
Brand Name : Kollicoat Protect
Application : Coating Systems & Additives
Excipient Details : Flexible water soluble instant release coating polymer, especially used for moisture protection
Pharmacopoeia Ref : Excipient based on Kollicoat®...
Technical Specs : Not Available
Ingredient(s) : Polyvinyl Alcohol Graft Polyethylene Glycol Copolymer
Dosage Form : Emulsion
Grade : Topical
Application : Rheology Modifiers
Excipient Details : Polyglykol 400 is a liquid PEG excipient grade product which is used as solvent, humectant, coating agent and viscosity enhancer.
Pharmacopoeia Ref : USP-NF: Polyethylene glycol 40...
Technical Specs : average molar mass 400 g/mol
Ingredient(s) : Polyethylene Glycol 400
Dosage Form : Granule / Pellet
Grade : Not Available
Application : Coating Systems & Additives
Excipient Details : Colorcoat FC4S is used as a film coating agednt in various OSDs.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Methyl Cellulose
Dosage Form : Granule / Pellet
Grade : Not Available
Application : Coating Systems & Additives
Excipient Details : Colorcoat FC4W is used as a film coating agednt in various OSDs.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Methylcellulose
Dosage Form : Granule / Pellet
Grade : Not Available
Application : Coating Systems & Additives
Excipient Details : Colorcoat FC4WS is used as a film coating agednt in various OSDs.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Methylcellulose
Dosage Form : Granule / Pellet
Grade : Not Available
Application : Coating Systems & Additives
Excipient Details : Colorcoat MB4S is used as a film coating agednt in various OSDs.
Dosage Form : Granule / Pellet
Grade : Not Available
Application : Coating Systems & Additives
Excipient Details : Moisture Barrier Coating
Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders
Pharmacopoeia Ref : Conforms to USP-NF, Ph.Eur., J...
Technical Specs : Density- Tapped density- 440 g/l, Bulk density- 280 g/l; Particle size- D10- 25 ?m, D50- 60 ?m, D90-...
Ingredient(s) : Microcrystalline Cellulose
Dosage Form : Tablet
Grade : Oral
Application : Direct Compression
Pharmacopoeia Ref : Conforms to USP-NF, Ph.Eur., J...
Technical Specs : Density- Tapped density- 440 g/l, Bulk density- 310 g/l; Particle size- D10- 40 ?m, D50- 90 ?m, D90...
Ingredient(s) : Microcrystalline Cellulose
Dosage Form : Orodispersible Tablet
Grade : Oral
Application : Disintegrants & Superdisintegrants
Pharmacopoeia Ref : Conforms to USP-NF, Ph.Eur., J...
Technical Specs : Not Available
Ingredient(s) : Croscarmellose Sodium
Dosage Form : Tablet
Grade : Oral
Application : Direct Compression
Pharmacopoeia Ref : Conforms to Ph. Eur., Lactose ...
Technical Specs : Density- Tapped density- 906 g/l, Bulk density- 722 g/l; Particle size- D10-15 ?m, D50- 170 ?m, D90-...
Ingredient(s) : Anhydrous Lactose
Dosage Form : Tablet
Grade : Oral
Application : Controlled & Modified Release
Excipient Details : Espheres EM can be used as an inert base for modified release formulations promoting uniformity of release profile.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
Dosage Form : Tablet
Grade : Oral
Application : Coating Systems & Additives
Excipient Details : Instacoat EMB is an excellent moisture barrier which reduces degradation of moisture sensitive APIs.
Dosage Form : Tablet
Grade : Oral
Excipients by Applications
Grade : Oral
Category : Co-Processed Excipients, Fillers, Diluents & Binders
Application : Co-Processed Excipients, Fillers, Diluents & Binders
Excipient Details : ProBlend (SMCC) is a co-processed excipient consists of microcrystalline cellulose & colloidal silicon dioxide, used as a diluent & binder in OSDs.
Pharmacopoeia Ref : USP-NF, DMF, EXCiPAT, KOSHER, ...
Technical Specs : NA
Ingredient(s) : Silicified Microcrystalline Cellulose
Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Softgel Capsule, Softgels
Grade : Parenteral, Topical, Oral
Category : Fillers, Diluents & Binders, Film Formers & Plasticizers, Parenteral, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical
Brand Name : Polyethylene Glycol 400
Application : Fillers, Diluents & Binders, Film Formers & Plasticizers, Parenteral, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical
Excipient Details : PEG 400 is used as a suspending agent, stabilizer, plasticizer and filler in OSDs, liquids & semi-solids and as a solvent for parenteral formulations.
Application : Co-Processed Excipients, Fillers, Diluents & Binders
Excipient Details : Microlose (Lactose Monohydrate & Microcrystalline Cellulose) is used as a diluent in oral dosage forms such as tablets.
Pharmacopoeia Ref : DMF, EXCiPAT, KOSHER, HALAL, W...
Technical Specs : Lactose Monohydrate – 40%, Microcrystalline cellulose – 60%
Ingredient(s) : Lactose Monohydrate
Application : Fillers, Diluents & Binders
Excipient Details : TABCELL serves as an excellent excipient for solid dosage forms, providing numerous advantages for tablet formulations.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
Dosage Form : Tablet
Grade : Oral
Category : Direct Compression, Fillers, Diluents & Binders, Granulation
Application : Direct Compression, Fillers, Diluents & Binders, Granulation
Excipient Details : AceCel is suitable for majority of the directly compressible actives, combines good flow and high compressibility.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
Brand Name : Microcrystalline Cellulose
Application : Fillers, Diluents & Binders
Excipient Details : Microcrystalline Cellulose is most commonly used filler and binder in drug formulations, together with Lactose.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
Grade : Oral
Category : Fillers, Diluents & Binders, Lubricants & Glidants
Application : Fillers, Diluents & Binders, Lubricants & Glidants
Excipient Details : Most popular excipient for the production of tablets and capsules. Offering an efficient and low dosage in capsules.
Pharmacopoeia Ref : Monograph- Ph.Eur, USP/NF
Technical Specs : Specific Surface Area-6-10 m2/g; Particle Size-7-11 µm
Ingredient(s) : Magnesium Stearate
Dosage Form : Tablet
Grade : Oral
Category : Direct Compression, Fillers, Diluents & Binders, Granulation
Application : Direct Compression, Fillers, Diluents & Binders, Granulation
Excipient Details : HiCel acts as a strong dry binder. It facilitates low tablet friability & promotes rapid tablet disintegration.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
Grade : Oral
Category : Fillers, Diluents & Binders, Lubricants & Glidants
Application : Fillers, Diluents & Binders, Lubricants & Glidants
Excipient Details : Higher specific surface area and a smaller median particle size. This product is preferred for more critical and very fine herbal formulations.
Pharmacopoeia Ref : Monograph- Ph.Eur, USP/NF
Technical Specs : Specific Surface Area-8-12 m2/g; Particle Size-5-9 µm
Ingredient(s) : Magnesium Stearate
Application : Fillers, Diluents & Binders
Excipient Details : It is used as a filler in formulation.
Pharmacopoeia Ref : Not Available
Technical Specs : Also Available as Comprecel M102, M102CG, M103, M105, M124, M113,...
Ingredient(s) : Microcrystalline Cellulose
Dosage Form : Tablet
Grade : Oral
Category : Coating Systems & Additives, Controlled & Modified Release
Dosage Form : Capsule, Granule / Pellet, Tablet
Grade : Oral
Category : Coating Systems & Additives, Coloring Agents
Brand Name : Titanium dioxide PRETIOX AV01FG
Application : Coating Systems & Additives, Coloring Agents
Excipient Details : Titanium dioxide Pretiox AV01FG is used as a coloring and coating agent in oral solid dosage forms such as capsules, tablets, granules, and pellets.
Pharmacopoeia Ref : Fami-QS, Kosher, Halal, OHSAS ...
Technical Specs : Ti 59.95% and O 40.05%
Ingredient(s) : Titanium Dioxide
Dosage Form : Capsule, Granule / Pellet, Tablet
Grade : Oral
Category : Coating Systems & Additives, Coloring Agents
Dosage Form : Cream / Lotion / Ointment, Emulsion
Grade : Topical
Category : Coating Systems & Additives, Rheology Modifiers, Topical
Application : Coating Systems & Additives, Rheology Modifiers, Topical
Excipient Details : Polyglykol 400 is a liquid PEG excipient grade product which is used as solvent, humectant, coating agent and viscosity enhancer.
Pharmacopoeia Ref : USP-NF: Polyethylene glycol 40...
Technical Specs : average molar mass 400 g/mol
Ingredient(s) : Polyethylene Glycol 400
Application : Coating Systems & Additives
Excipient Details : Novomix is used as a ready mix film coating system in the production of pharmaceutical tablets.
Dosage Form : Tablet
Grade : Not Available
Category : Coating Systems & Additives, Controlled & Modified Release
Application : Coating Systems & Additives, Controlled & Modified Release
Excipient Details : Immediate Release
Grade : Not Available
Category : Coating Systems & Additives, Film Formers & Plasticizers
Brand Name : ReadiLYCOAT® D WHITE 010.01 MS
Application : Coating Systems & Additives, Film Formers & Plasticizers
Excipient Details : A natural inert polymer and ready-to-use coating system for fast aqueous film coating saves up to 50% or more time.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Pea Starch, Sorbitol, Titanium Dioxide, Stearic Acid
Dosage Form : Tablet
Grade : Not Available
Category : Coating Systems & Additives, Controlled & Modified Release
Application : Coating Systems & Additives, Controlled & Modified Release
Excipient Details : Immediate Release
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Methylcellulose
Dosage Form : Tablet
Grade : Not Available
Category : Coating Systems & Additives, Controlled & Modified Release
Application : Coating Systems & Additives, Controlled & Modified Release
Excipient Details : Immediate Release
Dosage Form : Tablet
Grade : Oral
Category : Direct Compression, Fillers, Diluents & Binders, Granulation
Application : Direct Compression, Fillers, Diluents & Binders, Granulation
Excipient Details : AceCel is suitable for majority of the directly compressible actives, combines good flow and high compressibility.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
Dosage Form : Tablet
Grade : Oral
Category : Direct Compression, Disintegrants & Superdisintegrants, Granulation
Dosage Form : Tablet
Grade : Oral
Category : Direct Compression, Fillers, Diluents & Binders, Granulation
Application : Direct Compression, Fillers, Diluents & Binders, Granulation
Excipient Details : HiCel acts as a strong dry binder. It facilitates low tablet friability & promotes rapid tablet disintegration.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
Application : Fillers, Diluents & Binders, Granulation
Application : Direct Compression, Granulation
Excipient Details : HiCellac is used in direct compression & dry granulation suitable for low dose formulations where API content uniformity is critical.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Lactose Monohydrate
Application : Disintegrants & Superdisintegrants, Granulation
Excipient Details : Hilose is used in oral pharmaceutical formulations as a super disintegrant for capsules and tablets formulations.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Croscarmellose Sodium
Brand Name : Microlex® MCC 101
Application : Direct Compression, Granulation
Excipient Details : Tablets made from these granules are typically easily disintegrated using conventional super disintegrates even when hard tablets are compressed.
Pharmacopoeia Ref : Monograph- USP/NF, JP/JPE
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
Brand Name : Microlex® LCA 60.m
Application : Direct Compression, Granulation
Pharmacopoeia Ref : Monograph- USP/NF, JP/JPE
Technical Specs : Milled; Also Available as Microlex® LCA 120.m, Microlex® LCA 20...
Ingredient(s) : Anhydrous Lactose
Brand Name : Sheffield™ Anhydrous 60M
Application : Direct Compression, Granulation
Excipient Details : Direct Compression & Granulation
Brand Name : Sheffield™ Anhydrous Impalpable
Application : Direct Compression, Granulation
Excipient Details : Direct Compression & Granulation
Global Sales Information
Main Therapeutic Indication : Diabetes
Currency : USD
2020 Revenue in Millions : 1,959
2019 Revenue in Millions : 1,543
Growth (%) : 27
Main Therapeutic Indication : Diabetes
Currency : USD
2020 Revenue in Millions : 198
2019 Revenue in Millions : 163
Growth (%) : 22
Main Therapeutic Indication : Diabetes
Currency : USD
2021 Revenue in Millions : 3,000
2020 Revenue in Millions : 1,959
Growth (%) : 53
Main Therapeutic Indication : Diabetes
Currency : USD
2021 Revenue in Millions : 274
2020 Revenue in Millions : 190
Growth (%) : 55
Main Therapeutic Indication : Diabetes
Currency : USD
2022 Revenue in Millions : 400
2021 Revenue in Millions : 274
Growth (%) : 46
Main Therapeutic Indication : Diabetes
Currency : USD
2022 Revenue in Millions : 4,381
2021 Revenue in Millions : 3,000
Growth (%) : 46
Main Therapeutic Indication : Diabetes
Currency : USD
2023 Revenue in Millions : 5,963
2022 Revenue in Millions : 4,381
Growth (%) : 36
Main Therapeutic Indication : Diabetes
Currency : USD
2023 Revenue in Millions : 488
2022 Revenue in Millions : 400
Growth (%) : 39
Main Therapeutic Indication : Diabetes
Currency : USD
2024 Revenue in Millions : 7,656
2023 Revenue in Millions : 5,963
Growth (%) : 28
Main Therapeutic Indication : Diabetes
Currency : USD
2024 Revenue in Millions : 563
2023 Revenue in Millions : 488
Growth (%) : 15
Market Place
Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
ANALYTICAL
Analyte : Dapagliflozin
Method : HPLC/MS/MS
LLOQ : 2
Units : ng/ml
Details : common method with linagliptin
ABOUT THIS PAGE
64
PharmaCompass offers a list of Dapagliflozin 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 Dapagliflozin manufacturer or Dapagliflozin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dapagliflozin manufacturer or Dapagliflozin supplier.
PharmaCompass also assists you with knowing the Dapagliflozin API Price utilized in the formulation of products. Dapagliflozin API Price is not always fixed or binding as the Dapagliflozin Price is obtained through a variety of data sources. The Dapagliflozin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Dapagliflozin Amorphous manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dapagliflozin Amorphous, including repackagers and relabelers. The FDA regulates Dapagliflozin Amorphous manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dapagliflozin Amorphous 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 Dapagliflozin Amorphous manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dapagliflozin Amorphous supplier is an individual or a company that provides Dapagliflozin Amorphous active pharmaceutical ingredient (API) or Dapagliflozin Amorphous finished formulations upon request. The Dapagliflozin Amorphous suppliers may include Dapagliflozin Amorphous API manufacturers, exporters, distributors and traders.
click here to find a list of Dapagliflozin Amorphous suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dapagliflozin Amorphous DMF (Drug Master File) is a document detailing the whole manufacturing process of Dapagliflozin Amorphous active pharmaceutical ingredient (API) in detail. Different forms of Dapagliflozin Amorphous DMFs exist exist since differing nations have different regulations, such as Dapagliflozin Amorphous USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dapagliflozin Amorphous DMF submitted to regulatory agencies in the US is known as a USDMF. Dapagliflozin Amorphous USDMF includes data on Dapagliflozin Amorphous's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dapagliflozin Amorphous USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dapagliflozin Amorphous suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Dapagliflozin Amorphous Drug Master File in Japan (Dapagliflozin Amorphous JDMF) empowers Dapagliflozin Amorphous API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Dapagliflozin Amorphous JDMF during the approval evaluation for pharmaceutical products. At the time of Dapagliflozin Amorphous JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Dapagliflozin Amorphous suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Dapagliflozin Amorphous Drug Master File in Korea (Dapagliflozin Amorphous KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dapagliflozin Amorphous. The MFDS reviews the Dapagliflozin Amorphous KDMF as part of the drug registration process and uses the information provided in the Dapagliflozin Amorphous KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dapagliflozin Amorphous 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 Dapagliflozin Amorphous API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Dapagliflozin Amorphous suppliers with KDMF on PharmaCompass.
A Dapagliflozin Amorphous written confirmation (Dapagliflozin Amorphous WC) is an official document issued by a regulatory agency to a Dapagliflozin Amorphous manufacturer, verifying that the manufacturing facility of a Dapagliflozin Amorphous active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dapagliflozin Amorphous APIs or Dapagliflozin Amorphous finished pharmaceutical products to another nation, regulatory agencies frequently require a Dapagliflozin Amorphous WC (written confirmation) as part of the regulatory process.
click here to find a list of Dapagliflozin Amorphous suppliers with Written Confirmation (WC) on PharmaCompass.
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 Dapagliflozin Amorphous as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dapagliflozin Amorphous API and other APIs are published in this directory by the FDA.
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 Dapagliflozin Amorphous 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.
The NDC directory also contains data on finished compounded human drug products that contain Dapagliflozin Amorphous and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dapagliflozin Amorphous NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dapagliflozin Amorphous suppliers with NDC on PharmaCompass.
Dapagliflozin Amorphous 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 Dapagliflozin Amorphous 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 Dapagliflozin Amorphous GMP manufacturer or Dapagliflozin Amorphous GMP API supplier for your needs.
A Dapagliflozin Amorphous CoA (Certificate of Analysis) is a formal document that attests to Dapagliflozin Amorphous's compliance with Dapagliflozin Amorphous specifications and serves as a tool for batch-level quality control.
Dapagliflozin Amorphous CoA mostly includes findings from lab analyses of a specific batch. For each Dapagliflozin Amorphous 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.
Dapagliflozin Amorphous may be tested according to a variety of international standards, such as European Pharmacopoeia (Dapagliflozin Amorphous EP), Dapagliflozin Amorphous JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dapagliflozin Amorphous USP).