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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)
| 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
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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 : 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
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
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
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 : 20765
Submission : 2007-08-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-11
Pay. Date : 2013-07-03
DMF Number : 20712
Submission : 2007-07-25
Status : Active
Type : II
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Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Certificate Number : R1-CEP 2015-090 - Rev 01
Status : Valid
Issue Date : 2022-04-20
Type : Chemical
Substance Number : 2631
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Rosuvastatin Calcium, Process G 2410
Certificate Number : R1-CEP 2017-018 - Rev 00
Status : Valid
Issue Date : 2022-05-20
Type : Chemical
Substance Number : 2631
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Certificate Number : R0-CEP 2015-079 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2016-08-12
Type : Chemical
Substance Number : 2631
Certificate Number : R0-CEP 2016-287 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2019-01-10
Type : Chemical
Substance Number : 2631
Certificate Number : R1-CEP 2015-240 - Rev 00
Status : Valid
Issue Date : 2021-07-13
Type : Chemical
Substance Number : 2631
Rosuvastatin Calcium, Process C
Certificate Number : R0-CEP 2016-321 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2019-04-15
Type : Chemical
Substance Number : 2631
Certificate Number : R0-CEP 2019-100 - Rev 00
Status : Valid
Issue Date : 2021-02-22
Type : Chemical
Substance Number : 2631
Certificate Number : R0-CEP 2018-227 - Rev 00
Status : Valid
Issue Date : 2020-09-11
Type : Chemical
Substance Number : 2631
Certificate Number : R0-CEP 2018-112 - Rev 00
Status : Valid
Issue Date : 2020-10-12
Type : Chemical
Substance Number : 2631
Certificate Number : R0-CEP 2015-117 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2016-07-22
Type : Chemical
Substance Number : 2631
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Average Price (USD/KGS) |
Number of Transactions |
|---|
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USFDA APPLICATION NUMBER - 208647
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USFDA APPLICATION NUMBER - 21366
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USFDA APPLICATION NUMBER - 21366
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USFDA APPLICATION NUMBER - 21366
DOSAGE - TABLET;ORAL - EQ 5MG BASE
USFDA APPLICATION NUMBER - 21366
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ABOUT THIS PAGE
A Rosuvastatin Calcium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rosuvastatin Calcium, including repackagers and relabelers. The FDA regulates Rosuvastatin Calcium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rosuvastatin Calcium 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 Calcium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rosuvastatin Calcium supplier is an individual or a company that provides Rosuvastatin Calcium active pharmaceutical ingredient (API) or Rosuvastatin Calcium finished formulations upon request. The Rosuvastatin Calcium suppliers may include Rosuvastatin Calcium API manufacturers, exporters, distributors and traders.
click here to find a list of Rosuvastatin Calcium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rosuvastatin Calcium DMF (Drug Master File) is a document detailing the whole manufacturing process of Rosuvastatin Calcium active pharmaceutical ingredient (API) in detail. Different forms of Rosuvastatin Calcium DMFs exist exist since differing nations have different regulations, such as Rosuvastatin Calcium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rosuvastatin Calcium DMF submitted to regulatory agencies in the US is known as a USDMF. Rosuvastatin Calcium USDMF includes data on Rosuvastatin Calcium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rosuvastatin Calcium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rosuvastatin Calcium 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 Calcium Drug Master File in Japan (Rosuvastatin Calcium JDMF) empowers Rosuvastatin Calcium 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 Calcium JDMF during the approval evaluation for pharmaceutical products. At the time of Rosuvastatin Calcium 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 Calcium 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 Calcium Drug Master File in Korea (Rosuvastatin Calcium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Rosuvastatin Calcium. The MFDS reviews the Rosuvastatin Calcium KDMF as part of the drug registration process and uses the information provided in the Rosuvastatin Calcium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Rosuvastatin Calcium 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 Calcium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Rosuvastatin Calcium suppliers with KDMF on PharmaCompass.
A Rosuvastatin Calcium CEP of the European Pharmacopoeia monograph is often referred to as a Rosuvastatin Calcium Certificate of Suitability (COS). The purpose of a Rosuvastatin Calcium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Rosuvastatin Calcium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Rosuvastatin Calcium to their clients by showing that a Rosuvastatin Calcium CEP has been issued for it. The manufacturer submits a Rosuvastatin Calcium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Rosuvastatin Calcium CEP holder for the record. Additionally, the data presented in the Rosuvastatin Calcium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Rosuvastatin Calcium DMF.
A Rosuvastatin Calcium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Rosuvastatin Calcium 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 Calcium suppliers with CEP (COS) on PharmaCompass.
A Rosuvastatin Calcium written confirmation (Rosuvastatin Calcium WC) is an official document issued by a regulatory agency to a Rosuvastatin Calcium manufacturer, verifying that the manufacturing facility of a Rosuvastatin Calcium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Rosuvastatin Calcium APIs or Rosuvastatin Calcium finished pharmaceutical products to another nation, regulatory agencies frequently require a Rosuvastatin Calcium WC (written confirmation) as part of the regulatory process.
click here to find a list of Rosuvastatin Calcium 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 Calcium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Rosuvastatin Calcium 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 Calcium 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 Calcium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rosuvastatin Calcium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Rosuvastatin Calcium suppliers with NDC on PharmaCompass.
Rosuvastatin Calcium 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 Calcium 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 Calcium GMP manufacturer or Rosuvastatin Calcium GMP API supplier for your needs.
A Rosuvastatin Calcium CoA (Certificate of Analysis) is a formal document that attests to Rosuvastatin Calcium's compliance with Rosuvastatin Calcium specifications and serves as a tool for batch-level quality control.
Rosuvastatin Calcium CoA mostly includes findings from lab analyses of a specific batch. For each Rosuvastatin Calcium 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 Calcium may be tested according to a variety of international standards, such as European Pharmacopoeia (Rosuvastatin Calcium EP), Rosuvastatin Calcium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rosuvastatin Calcium USP).
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