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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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GDUFA
DMF Review : Reviewed
Rev. Date : 2017-11-17
Pay. Date : 2017-05-23
DMF Number : 31410
Submission : 2017-03-28
Status : Active
Type : II
Certificate Number : R1-CEP 2015-090 - Rev 01
Issue Date : 2022-04-20
Type : Chemical
Substance Number : 2631
Status : Valid
Date of Issue : 2025-04-21
Valid Till : 2028-04-14
Written Confirmation Number : WC-0363
Address of the Firm :
Registrant Name : Daeshin Pharmaceutical Co., Ltd.
Registration Date : 2020-12-17
Registration Number : 20200707-209-J-677(1)
Manufacturer Name : Centrient Pharmaceuticals India Private Limited
Manufacturer Address : Bhai Mohan Singh Nagar, Toansa District SBS Nagar (Nawanshahr) Punjab 144 533, India
Emay Pharmaceuticals is a GMP-certified API manufacturing company.
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Minakem is manufacturing small molecules APIs including corticosteroids
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-04-08
Pay. Date : 2015-09-25
DMF Number : 29190
Submission : 2015-12-03
Status : Active
Type : II
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Rosuvastatin Calcium IP/BP/USP/Ph. Eur
Date of Issue : 2025-04-21
Valid Till : 2028-04-14
Written Confirmation Number : WC-0363
Address of the Firm : Bhai Mohan Singh Nagar, Toansa, Dist. SBS Nagar (Nawanshahr), Punjab -144533, In...
Apex Healthcare Limited: ISO 9001:2008, WHO-GMP, US FDA-audited manufacturer & exporter of APIs, bulk drugs, and formulations.
Rosuvastatin Calcium BP/EP/USP
Date of Issue : 2024-03-01
Valid Till : 2026-12-31
Written Confirmation Number : WC-0409
Address of the Firm : 4710, 4711, 4707-A/8, 4707-A/9, GIDC, Industrial Estate, Ankleshwar, Dist.Bharuc...
Rosuvastatin Calcium IH/Ph.Eur
Date of Issue : 2022-07-06
Valid Till : 2025-06-25
Written Confirmation Number : WC-0057n
Address of the Firm : Plot No. 3109, GIDC, Industrial Estate Ankleshwar, Distt- Bharuch - 393002, Guja...
Rosuvastatin Calcium IP/EP/USP
Date of Issue : 2022-06-09
Valid Till : 2025-12-08
Written Confirmation Number : WC-0077
Address of the Firm : Block No. 422, ECP Canal Road Village - Luna, Tal - Padra, Dist - Vadodara GUjar...
Date of Issue : 2022-06-07
Valid Till : 2025-06-25
Written Confirmation Number : WC-0023
Address of the Firm : Survey no. 52,53,58,59,61 to 78,127&128, Pydibhimanvaram Village &Sy.No. 1,2,4t0...
Rosuvastatin Calcium EP/USP/IH
Date of Issue : 2022-06-07
Valid Till : 2025-04-08
Written Confirmation Number : WC-0038n
Address of the Firm : Plot no. 213-215 & 216/B, IDA Phase II, Pashamylaram, Sangareddy (District), Tel...
Rosuvastatin Calcium (Amorphous) Ph.Eur
Date of Issue : 2022-09-30
Valid Till : 2025-08-08
Written Confirmation Number : WC-0066
Address of the Firm : Plot No 1, Hetero Infrastructure SEZ Ltd., N. Narasapuram, Anakapalli -531081, A...
Date of Issue : 2022-06-17
Valid Till : 2025-07-14
Written Confirmation Number : WC-0021n
Address of the Firm : Sy. Nos: 317, 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Man...
Rosuvastatin Calcium USP/Ph.Eur
Date of Issue : 2022-06-17
Valid Till : 2025-07-14
Written Confirmation Number : WC-0021n
Address of the Firm : Sy. Nos: 317, 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Man...
Date of Issue : 2022-05-02
Valid Till : 2025-07-25
Written Confirmation Number : WC-0027A4a
Address of the Firm : Sy. No. 14, Gaddapotharam Village, IDA, Kazipally, Jinnaram Mandal, Sangareddy D...
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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 X-Plended manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of X-Plended, including repackagers and relabelers. The FDA regulates X-Plended manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. X-Plended 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 X-Plended manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A X-Plended supplier is an individual or a company that provides X-Plended active pharmaceutical ingredient (API) or X-Plended finished formulations upon request. The X-Plended suppliers may include X-Plended API manufacturers, exporters, distributors and traders.
click here to find a list of X-Plended suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A X-Plended DMF (Drug Master File) is a document detailing the whole manufacturing process of X-Plended active pharmaceutical ingredient (API) in detail. Different forms of X-Plended DMFs exist exist since differing nations have different regulations, such as X-Plended USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A X-Plended DMF submitted to regulatory agencies in the US is known as a USDMF. X-Plended USDMF includes data on X-Plended's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The X-Plended USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of X-Plended 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 X-Plended Drug Master File in Japan (X-Plended JDMF) empowers X-Plended 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 X-Plended JDMF during the approval evaluation for pharmaceutical products. At the time of X-Plended 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 X-Plended 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 X-Plended Drug Master File in Korea (X-Plended KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of X-Plended. The MFDS reviews the X-Plended KDMF as part of the drug registration process and uses the information provided in the X-Plended KDMF to evaluate the safety and efficacy of the drug.
After submitting a X-Plended 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 X-Plended API can apply through the Korea Drug Master File (KDMF).
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A X-Plended CEP of the European Pharmacopoeia monograph is often referred to as a X-Plended Certificate of Suitability (COS). The purpose of a X-Plended CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of X-Plended EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of X-Plended to their clients by showing that a X-Plended CEP has been issued for it. The manufacturer submits a X-Plended CEP (COS) as part of the market authorization procedure, and it takes on the role of a X-Plended CEP holder for the record. Additionally, the data presented in the X-Plended CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the X-Plended DMF.
A X-Plended CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. X-Plended 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 X-Plended suppliers with CEP (COS) on PharmaCompass.
A X-Plended written confirmation (X-Plended WC) is an official document issued by a regulatory agency to a X-Plended manufacturer, verifying that the manufacturing facility of a X-Plended active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting X-Plended APIs or X-Plended finished pharmaceutical products to another nation, regulatory agencies frequently require a X-Plended WC (written confirmation) as part of the regulatory process.
click here to find a list of X-Plended 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 X-Plended as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for X-Plended 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 X-Plended 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 X-Plended and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a X-Plended NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of X-Plended suppliers with NDC on PharmaCompass.
X-Plended 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 X-Plended 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 X-Plended GMP manufacturer or X-Plended GMP API supplier for your needs.
A X-Plended CoA (Certificate of Analysis) is a formal document that attests to X-Plended's compliance with X-Plended specifications and serves as a tool for batch-level quality control.
X-Plended CoA mostly includes findings from lab analyses of a specific batch. For each X-Plended 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.
X-Plended may be tested according to a variety of international standards, such as European Pharmacopoeia (X-Plended EP), X-Plended JP (Japanese Pharmacopeia) and the US Pharmacopoeia (X-Plended USP).
