Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
1. Calcium, Rosuvastatin
2. Crestor
3. Rosuvastatin
4. Zd 4522
5. Zd4522
1. 147098-20-2
2. Crestor
3. Rosuvastatin Hemicalcium
4. Fortius
5. Rostar
6. Rosuvastatin Calcium Salt
7. Rosuvastatin Calcium [usan]
8. Rozavel
9. Suvikan
10. Zd4522
11. S-4522
12. Zd 4522
13. Rosuvastatin (as Calcium)
14. Zd4522 (calcium Salt)
15. Zd4522 Calcium
16. Zd-4522 Calcium
17. 83mvu38m7q
18. Chebi:77249
19. Nsc-747274
20. Nsc-758930
21. Rosuvastatincalcium
22. Crestor (tn)
23. Calcium (3r,5s,e)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(n-methylmethylsulfonamido)pyrimidin-5-yl)-3,5-dihydroxyhept-6-enoate
24. Rovista
25. Zd 4522, Calcium Salt
26. Calcium;(e,3r,5s)-7-[4-(4-fluorophenyl)-2-[methyl(methylsulfonyl)amino]-6-propan-2-ylpyrimidin-5-yl]-3,5-dihydroxyhept-6-enoate
27. S 4522
28. Unii-83mvu38m7q
29. Provisacor
30. Shufutan
31. Ezallor
32. Zd 4522 Calcium
33. Rosuvastatin Calcium- Bio-x
34. Zd-4522 (calcium Salt)
35. Schembl150740
36. Schembl429217
37. Chembl1744447
38. Dtxsid9045928
39. Rosuvastatin Calcium (jan/usan)
40. Rosuvastatin Calcium [jan]
41. Azd-4522
42. Bcp04131
43. Rosuvastatin Calcium [mart.]
44. S2169
45. Rosuvastatin Calcium [usp-rs]
46. Rosuvastatin Calcium [who-dd]
47. Akos005145896
48. Akos017343682
49. Rosuvastatin Calcium Salt [mi]
50. Ccg-270606
51. Ks-1109
52. Nsc 747274
53. Nsc 758930
54. (s-((r*,s*-(e)))- 7-(4-(4-fluorophenyl)-6-(1-methylethyl)-2-(methyl(methylsulfonyl) Amino)-5-pyrimidinyl)-3,5-dihydroxy-6-heptenoic Acid, Calcium Salt (2:1)
55. (s-(r*,s*-(e)))-7-(4-(4-fluorophenyl)-6-(1-methylethyl)-2-(methyl(methylsulfonyl)amino)-5-pyrimidinyl)-3,5-dihydroxy-6-heptenoic Acid, Calcium Salt (2:1)
56. 6-heptenoic Acid, 7-(4-(4-fluorophenyl)-6-(1-methylethyl)-2-(methyl(methylsulfonyl)amino)-5-pyrimidinyl)-3,5-dihydroxy-, Calcium Salt (2:1), (3r,5s,6e)
57. As-12488
58. Br164378
59. Rosuvastatin Calcium [orange Book]
60. Rosuvastatin Calcium [ep Monograph]
61. Rosuvastatin Calcium [usp Monograph]
62. Roszet Component Rosuvastatin Calcium
63. R0180
64. D01915
65. Rosuvastatin Calcium Component Of Roszet
66. Q-201685
67. Q27146836
68. (s-((r*,s*-(e)))- 7-(4-(4-fluorophenyl)-6-(1-methylethyl)-2-(methyl(methylsulfonyl) Amino)-5-pyrimidinyl)-3,5-dihydroxy-6-heptenoic Acid, Calcium Salt (2:1)
69. (s-(r*,s*-(e)))-7-(4-(4-fluorophenyl)-6-(1-methylethyl)-2-(methyl(methylsulfonyl)amino)-5-pyrimidinyl)-3,5-dihydroxy-6-heptenoic Acid, Calcium Salt
70. 6-heptenoic Acid, 7-(4-(4-fluorophenyl)-6-(1-methylethyl)-2-(methylsulfonyl)amino)-5-pyrimidinyl)-3,5-dihydroxy-, Calcium Salt (2:1), (3r,5s,6e)-
71. Bis((e)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(methyl(methylsulfonyl)amino)-pyrimide-5-yl)-(3r,5s)3,5-dihydroxylhept-6-enoic Acid) Calcium
72. Calcium Bis[(3r,5s,6e)-7-{4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl}-3,5-dihydroxyhept-6-enoate]
73. Calcium(3r,5s,e)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(n-methylmethylsulfonamido)pyrimidin-5-yl)-3,5-dihydroxyhept-6-enoate
74. Monocalcium Bis((3r,5s,6e)-7-{4-(4-fluorophenyl)-6-isopropyl-2-[methanesulfonyl (methyl) Amino] Pyrimidin-5-yl}-3,5-dihydroxyhept-6-enoate)
1. Rosuvastatin
2. Crestor
3. X-plended
| Molecular Weight | 1001.1 g/mol |
|---|---|
| Molecular Formula | C44H54CaF2N6O12S2 |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 20 |
| Rotatable Bond Count | 18 |
| Exact Mass | 1000.2835107 g/mol |
| Monoisotopic Mass | 1000.2835107 g/mol |
| Topological Polar Surface Area | 304 Ų |
| Heavy Atom Count | 67 |
| Formal Charge | 0 |
| Complexity | 761 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 4 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 2 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 3 |
| 1 of 4 | |
|---|---|
| Drug Name | Crestor |
| Drug Label | CRESTOR (rosuvastatin calcium) is a synthetic lipid-lowering agent for oral administration. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhe... |
| Active Ingredient | Rosuvastatin calcium |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 5mg; 10mg; 40mg; 20mg |
| Market Status | Prescription |
| Company | Ipr |
| 2 of 4 | |
|---|---|
| Drug Name | Rosuvastatin calcium |
| PubMed Health | Rosuvastatin (By mouth) |
| Drug Classes | Antihyperlipidemic |
| Drug Label | CRESTOR (rosuvastatin calcium) is a synthetic lipid-lowering agent for oral administration. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhe... |
| Active Ingredient | Rosuvastatin calcium |
| Dosage Form | Tablet |
| Route | oral; Oral |
| Strength | 5mg; 10mg; 40mg; 20mg |
| Market Status | Tentative Approval |
| Company | Mylan Pharma; Apotex; Aurobindo Pharma; Sandoz; Sun Pharma Global; Par Pharm; Watson Labs; Glenmark Generics; Teva Pharms |
| 3 of 4 | |
|---|---|
| Drug Name | Crestor |
| Drug Label | CRESTOR (rosuvastatin calcium) is a synthetic lipid-lowering agent for oral administration. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhe... |
| Active Ingredient | Rosuvastatin calcium |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 5mg; 10mg; 40mg; 20mg |
| Market Status | Prescription |
| Company | Ipr |
| 4 of 4 | |
|---|---|
| Drug Name | Rosuvastatin calcium |
| PubMed Health | Rosuvastatin (By mouth) |
| Drug Classes | Antihyperlipidemic |
| Drug Label | CRESTOR (rosuvastatin calcium) is a synthetic lipid-lowering agent for oral administration. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhe... |
| Active Ingredient | Rosuvastatin calcium |
| Dosage Form | Tablet |
| Route | oral; Oral |
| Strength | 5mg; 10mg; 40mg; 20mg |
| Market Status | Tentative Approval |
| Company | Mylan Pharma; Apotex; Aurobindo Pharma; Sandoz; Sun Pharma Global; Par Pharm; Watson Labs; Glenmark Generics; Teva Pharms |
Homozygous Familial Hypercholesterolaemia, Prevention of cardiovascular events, Primary combined (mixed) dyslipidaemia, Primary hypercholesterolaemia
Anticholesteremic Agents
Substances used to lower plasma cholesterol levels. (See all compounds classified as Anticholesteremic Agents.)
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Compounds that inhibit HYDROXYMETHYLGLUTARYL COA REDUCTASES. They have been shown to directly lower CHOLESTEROL synthesis. (See all compounds classified as Hydroxymethylglutaryl-CoA Reductase Inhibitors.)
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
GDUFA
DMF Review : Complete
Rev. Date : 2017-11-17
Pay. Date : 2017-05-23
DMF Number : 31410
Submission : 2017-03-28
Status : Active
Type : II
Minakem is manufacturing small molecules APIs including corticosteroids
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-08
Pay. Date : 2015-09-25
DMF Number : 29190
Submission : 2015-12-03
Status : Active
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2016-12-23
Pay. Date : 2016-08-29
DMF Number : 30830
Submission : 2016-12-01
Status : Active
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27879
Submission : 2014-02-07
Status : Inactive
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-31
Pay. Date : 2013-01-02
DMF Number : 20671
Submission : 2007-07-12
Status : Active
Type : II
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
GDUFA
DMF Review : Complete
Rev. Date : 2022-07-11
Pay. Date : 2022-06-07
DMF Number : 36493
Submission : 2021-12-22
Status : Active
Type : II
Lee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.
GDUFA
DMF Review : Complete
Rev. Date : 2020-12-08
Pay. Date : 2020-09-23
DMF Number : 35115
Submission : 2020-09-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20592
Submission : 2007-06-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20629
Submission : 2007-06-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-05
Pay. Date : 2013-09-27
DMF Number : 20705
Submission : 2007-07-18
Status : Active
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
Upgrade, download data, analyse, strategize, subscribe with us 
Drugs in Development
Details:
Rozat Gold is a fixed dose combination medicine consisting aspirin, rosuvastatin & clopidogrel. It is indicated for the treatment of coronary artery diseases.
Lead Product(s): Aspirin,Clopidogrel,Rosuvastatin Calcium
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Rozat Gold
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 18, 2021
Lead Product(s) : Aspirin,Clopidogrel,Rosuvastatin Calcium
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Dr Reddy’s Launches Rozat Gold FDC in India (Aspirin, Rosuvastatin, Clopidogrel)
Details : Rozat Gold is a fixed dose combination medicine consisting aspirin, rosuvastatin & clopidogrel. It is indicated for the treatment of coronary artery diseases.
Product Name : Rozat Gold
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 18, 2021
Details:
Roseday CV (rosuvastatin + clopidogrel) is a fixed dose combination which is approved for the treatment of cardiac diseases like heart attack, angina & stroke.
Lead Product(s): Rosuvastatin Calcium,Clopidogrel
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Roseday CV
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 24, 2023
Lead Product(s) : Rosuvastatin Calcium,Clopidogrel
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
USV Launches Roseday CV at a Patient-Centric Price for Indian Cardiac Patients
Details : Roseday CV (rosuvastatin + clopidogrel) is a fixed dose combination which is approved for the treatment of cardiac diseases like heart attack, angina & stroke.
Product Name : Roseday CV
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 24, 2023
Details:
Rosuzet is a combination of rosuvastatin is an inhibitor of HMG CoA-reductase, the rate-limiting enzyme that converts the precursor of cholesterol and ezetimibe, a sterol transporter, NPC1L1, which is involved in the intestinal uptake of cholesterol.
Lead Product(s): Rosuvastatin Calcium,Ezetimibe
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Rosuzet
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 17, 2023
Lead Product(s) : Rosuvastatin Calcium,Ezetimibe
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Rosuzet is a combination of rosuvastatin is an inhibitor of HMG CoA-reductase, the rate-limiting enzyme that converts the precursor of cholesterol and ezetimibe, a sterol transporter, NPC1L1, which is involved in the intestinal uptake of cholesterol.
Product Name : Rosuzet
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 17, 2023
Details:
Razel (rosuvastatin) is an HMG-CoA reductase inhibitor used to lower lipid levels and reduce the risk of cardiovascular disease including myocardial infarction and stroke.
Lead Product(s): Rosuvastatin Calcium
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Razel
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: JB Pharma
Deal Size: $37.9 million Upfront Cash: $37.9 million
Deal Type: Divestment December 14, 2022
Lead Product(s) : Rosuvastatin Calcium
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : JB Pharma
Deal Size : $37.9 million
Deal Type : Divestment
JB Pharma To Acquire The Entire Razel (rousvastatin) Franchise From Glenmark Pharmaceuticals Ltd
Details : Razel (rosuvastatin) is an HMG-CoA reductase inhibitor used to lower lipid levels and reduce the risk of cardiovascular disease including myocardial infarction and stroke.
Product Name : Razel
Product Type : Other Small Molecule
Upfront Cash : $37.9 million
December 14, 2022
Details:
EDP-235 achieved excellent penetration into monocytes and macrophages, including lung AM. EDP-235 has the potential to eliminate viral replication of SARS-CoV-2 in these critical immune cells, thus mitigating macrophage-mediated cytokine storm in high-risk COVID-19 patients.
Lead Product(s): EDP-235,Midazolam,Rosuvastatin Calcium
Therapeutic Area: Infections and Infectious Diseases Brand Name: EDP-235
Study Phase: Phase IProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 19, 2022
Lead Product(s) : EDP-235,Midazolam,Rosuvastatin Calcium
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : EDP-235 achieved excellent penetration into monocytes and macrophages, including lung AM. EDP-235 has the potential to eliminate viral replication of SARS-CoV-2 in these critical immune cells, thus mitigating macrophage-mediated cytokine storm in high-ri...
Product Name : EDP-235
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 19, 2022
Details:
Apabetalone (RVX000222), is a first-in-class, small molecule, therapeutic candidate with an epigenetic mechanism of action. It is a BD2 (bromodomain) selective BET (bromodomain and extra-terminal) inhibitor that works in preventing and treating disease progression.
Lead Product(s): Apabetalone,Atorvastatin,Rosuvastatin Calcium
Therapeutic Area: Endocrinology Brand Name: RVX-208
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 22, 2022
Lead Product(s) : Apabetalone,Atorvastatin,Rosuvastatin Calcium
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Resverlogix Publishes New Data Highlighting Apabetalone’s Benefit in Non-alcoholic Fatty Liver D...
Details : Apabetalone (RVX000222), is a first-in-class, small molecule, therapeutic candidate with an epigenetic mechanism of action. It is a BD2 (bromodomain) selective BET (bromodomain and extra-terminal) inhibitor that works in preventing and treating disease p...
Product Name : RVX-208
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 22, 2022
Details:
Under the terms of this agreement, Grünenthal has acquired the exclusive rights to market CRESTOR™ and its second brands in more than 30 European markets.
Lead Product(s): Rosuvastatin Calcium
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Crestor
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Grunenthal
Deal Size: $350.0 million Upfront Cash: Undisclosed
Deal Type: Agreement October 02, 2021
Lead Product(s) : Rosuvastatin Calcium
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Grunenthal
Deal Size : $350.0 million
Deal Type : Agreement
Grünenthal Closes Deal with AstraZeneca for European Rights to CRESTOR™ (Rosuvastatin)
Details : Under the terms of this agreement, Grünenthal has acquired the exclusive rights to market CRESTOR™ and its second brands in more than 30 European markets.
Product Name : Crestor
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
October 02, 2021
Details:
COLSTAT clinical trial (Colchicine/Statin for the Prevention of COVID-19 Complications) will combine two broadly available medications, colchicine and rosuvastatin, to help reduce complications in Covid-19 infected patients.
Lead Product(s): Colchicine,Rosuvastatin Calcium
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Plant Extract/Herbal
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 22, 2021
Lead Product(s) : Colchicine,Rosuvastatin Calcium
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Yale-led Clinical Trial Offers Hope for COVID Patients and a Path Forward for Research
Details : COLSTAT clinical trial (Colchicine/Statin for the Prevention of COVID-19 Complications) will combine two broadly available medications, colchicine and rosuvastatin, to help reduce complications in Covid-19 infected patients.
Product Name : Undisclosed
Product Type : Plant Extract/Herbal
Upfront Cash : Inapplicable
February 22, 2021
Details:
Crestor is a statin approved for the treatment of dyslipidaemia and hypercholesterolaemia. The deal will give Gruenenthal rights to sell Crestor and associated medicines in more than 30 countries in Europe, except the UK and Spain.
Lead Product(s): Rosuvastatin Calcium
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Crestor
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Grunenthal
Deal Size: $350.0 million Upfront Cash: $320.0 million
Deal Type: Divestment January 12, 2020
Lead Product(s) : Rosuvastatin Calcium
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Grunenthal
Deal Size : $350.0 million
Deal Type : Divestment
AstraZeneca's Crestor to be Divested to Grünenthal in Europe
Details : Crestor is a statin approved for the treatment of dyslipidaemia and hypercholesterolaemia. The deal will give Gruenenthal rights to sell Crestor and associated medicines in more than 30 countries in Europe, except the UK and Spain.
Product Name : Crestor
Product Type : Other Small Molecule
Upfront Cash : $320.0 million
January 12, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - CAPSULE;ORAL - EQ 10MG BASE
USFDA APPLICATION NUMBER - 208647
DOSAGE - CAPSULE;ORAL - EQ 20MG BASE
USFDA APPLICATION NUMBER - 208647
DOSAGE - CAPSULE;ORAL - EQ 40MG BASE
USFDA APPLICATION NUMBER - 208647
DOSAGE - CAPSULE;ORAL - EQ 5MG BASE
USFDA APPLICATION NUMBER - 208647
DOSAGE - TABLET;ORAL - EQ 10MG BASE
USFDA APPLICATION NUMBER - 21366
DOSAGE - TABLET;ORAL - EQ 20MG BASE
USFDA APPLICATION NUMBER - 21366
DOSAGE - TABLET;ORAL - EQ 40MG BASE
USFDA APPLICATION NUMBER - 21366
DOSAGE - TABLET;ORAL - EQ 5MG BASE
USFDA APPLICATION NUMBER - 21366
Related Excipient Companies
Minakem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Minbiotech
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Aeon Procare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Alcedo Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ashland
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Avesta Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CD Formulation
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Clariant
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Corel Pharma Chem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Esteem Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Keval Exports
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kima Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nitika Pharmaceutical Specialities
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nomisma Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qianhao Chemical (Hebei) Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Welltone Material Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Silverline Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ulanqab Kema New Material
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients by Applications
Fillers, Diluents & Binders
Coating Systems & Additives
Direct Compression
Granulation
Disintegrants & Superdisintegrants
Lubricants & Glidants
Thickeners and Stabilizers
Controlled & Modified Release
Chewable & Orodispersible Aids
Taste Masking
Co-Processed Excipients
Topical
Solubilizers
Film Formers & Plasticizers
Parenteral
API Stability Enhancers
Emulsifying Agents
Empty Capsules
Rheology Modifiers
Vegetarian Capsules
Coloring Agents
Surfactant & Foaming Agents
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
ABOUT THIS PAGE
60
PharmaCompass offers a list of Rosuvastatin Calcium 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 Rosuvastatin Calcium manufacturer or Rosuvastatin Calcium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Rosuvastatin Calcium manufacturer or Rosuvastatin Calcium supplier.
PharmaCompass also assists you with knowing the Rosuvastatin Calcium API Price utilized in the formulation of products. Rosuvastatin Calcium API Price is not always fixed or binding as the Rosuvastatin Calcium Price is obtained through a variety of data sources. The Rosuvastatin Calcium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Rosuvastatin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rosuvastatin, including repackagers and relabelers. The FDA regulates Rosuvastatin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rosuvastatin 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 Rosuvastatin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rosuvastatin supplier is an individual or a company that provides Rosuvastatin active pharmaceutical ingredient (API) or Rosuvastatin finished formulations upon request. The Rosuvastatin suppliers may include Rosuvastatin API manufacturers, exporters, distributors and traders.
click here to find a list of Rosuvastatin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rosuvastatin DMF (Drug Master File) is a document detailing the whole manufacturing process of Rosuvastatin active pharmaceutical ingredient (API) in detail. Different forms of Rosuvastatin DMFs exist exist since differing nations have different regulations, such as Rosuvastatin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rosuvastatin DMF submitted to regulatory agencies in the US is known as a USDMF. Rosuvastatin USDMF includes data on Rosuvastatin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rosuvastatin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rosuvastatin 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 Rosuvastatin Drug Master File in Japan (Rosuvastatin JDMF) empowers Rosuvastatin 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 Rosuvastatin JDMF during the approval evaluation for pharmaceutical products. At the time of Rosuvastatin 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 Rosuvastatin 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 Rosuvastatin Drug Master File in Korea (Rosuvastatin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Rosuvastatin. The MFDS reviews the Rosuvastatin KDMF as part of the drug registration process and uses the information provided in the Rosuvastatin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Rosuvastatin 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 Rosuvastatin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Rosuvastatin suppliers with KDMF on PharmaCompass.
A Rosuvastatin CEP of the European Pharmacopoeia monograph is often referred to as a Rosuvastatin Certificate of Suitability (COS). The purpose of a Rosuvastatin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Rosuvastatin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Rosuvastatin to their clients by showing that a Rosuvastatin CEP has been issued for it. The manufacturer submits a Rosuvastatin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Rosuvastatin CEP holder for the record. Additionally, the data presented in the Rosuvastatin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Rosuvastatin DMF.
A Rosuvastatin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Rosuvastatin CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Rosuvastatin suppliers with CEP (COS) on PharmaCompass.
A Rosuvastatin written confirmation (Rosuvastatin WC) is an official document issued by a regulatory agency to a Rosuvastatin manufacturer, verifying that the manufacturing facility of a Rosuvastatin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Rosuvastatin APIs or Rosuvastatin finished pharmaceutical products to another nation, regulatory agencies frequently require a Rosuvastatin WC (written confirmation) as part of the regulatory process.
click here to find a list of Rosuvastatin 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 Rosuvastatin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Rosuvastatin 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 Rosuvastatin 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 Rosuvastatin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rosuvastatin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Rosuvastatin suppliers with NDC on PharmaCompass.
Rosuvastatin 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 Rosuvastatin 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 Rosuvastatin GMP manufacturer or Rosuvastatin GMP API supplier for your needs.
A Rosuvastatin CoA (Certificate of Analysis) is a formal document that attests to Rosuvastatin's compliance with Rosuvastatin specifications and serves as a tool for batch-level quality control.
Rosuvastatin CoA mostly includes findings from lab analyses of a specific batch. For each Rosuvastatin 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.
Rosuvastatin may be tested according to a variety of international standards, such as European Pharmacopoeia (Rosuvastatin EP), Rosuvastatin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rosuvastatin USP).
