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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)
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.)
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Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
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DMF Number : 31410
Submission : 2017-03-28
Status : Active
Type : II
Minakem is manufacturing small molecules APIs including corticosteroids
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Submission : 2015-12-03
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TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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Rev. Date : 2016-12-23
Pay. Date : 2016-08-29
DMF Number : 30830
Submission : 2016-12-01
Status : Active
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TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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Submission : 2014-02-07
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TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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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
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DMF Number : 20592
Submission : 2007-06-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
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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 : 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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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 Crestor (TN) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Crestor (TN), including repackagers and relabelers. The FDA regulates Crestor (TN) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Crestor (TN) 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 Crestor (TN) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Crestor (TN) supplier is an individual or a company that provides Crestor (TN) active pharmaceutical ingredient (API) or Crestor (TN) finished formulations upon request. The Crestor (TN) suppliers may include Crestor (TN) API manufacturers, exporters, distributors and traders.
click here to find a list of Crestor (TN) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Crestor (TN) DMF (Drug Master File) is a document detailing the whole manufacturing process of Crestor (TN) active pharmaceutical ingredient (API) in detail. Different forms of Crestor (TN) DMFs exist exist since differing nations have different regulations, such as Crestor (TN) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Crestor (TN) DMF submitted to regulatory agencies in the US is known as a USDMF. Crestor (TN) USDMF includes data on Crestor (TN)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Crestor (TN) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Crestor (TN) 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 Crestor (TN) Drug Master File in Japan (Crestor (TN) JDMF) empowers Crestor (TN) 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 Crestor (TN) JDMF during the approval evaluation for pharmaceutical products. At the time of Crestor (TN) 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 Crestor (TN) 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 Crestor (TN) Drug Master File in Korea (Crestor (TN) KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Crestor (TN). The MFDS reviews the Crestor (TN) KDMF as part of the drug registration process and uses the information provided in the Crestor (TN) KDMF to evaluate the safety and efficacy of the drug.
After submitting a Crestor (TN) 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 Crestor (TN) API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Crestor (TN) suppliers with KDMF on PharmaCompass.
A Crestor (TN) CEP of the European Pharmacopoeia monograph is often referred to as a Crestor (TN) Certificate of Suitability (COS). The purpose of a Crestor (TN) CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Crestor (TN) EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Crestor (TN) to their clients by showing that a Crestor (TN) CEP has been issued for it. The manufacturer submits a Crestor (TN) CEP (COS) as part of the market authorization procedure, and it takes on the role of a Crestor (TN) CEP holder for the record. Additionally, the data presented in the Crestor (TN) CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Crestor (TN) DMF.
A Crestor (TN) CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Crestor (TN) 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 Crestor (TN) suppliers with CEP (COS) on PharmaCompass.
A Crestor (TN) written confirmation (Crestor (TN) WC) is an official document issued by a regulatory agency to a Crestor (TN) manufacturer, verifying that the manufacturing facility of a Crestor (TN) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Crestor (TN) APIs or Crestor (TN) finished pharmaceutical products to another nation, regulatory agencies frequently require a Crestor (TN) WC (written confirmation) as part of the regulatory process.
click here to find a list of Crestor (TN) 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 Crestor (TN) as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Crestor (TN) 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 Crestor (TN) 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 Crestor (TN) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Crestor (TN) NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Crestor (TN) suppliers with NDC on PharmaCompass.
Crestor (TN) 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 Crestor (TN) 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 Crestor (TN) GMP manufacturer or Crestor (TN) GMP API supplier for your needs.
A Crestor (TN) CoA (Certificate of Analysis) is a formal document that attests to Crestor (TN)'s compliance with Crestor (TN) specifications and serves as a tool for batch-level quality control.
Crestor (TN) CoA mostly includes findings from lab analyses of a specific batch. For each Crestor (TN) 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.
Crestor (TN) may be tested according to a variety of international standards, such as European Pharmacopoeia (Crestor (TN) EP), Crestor (TN) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Crestor (TN) USP).
