Synopsis
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
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
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]South Africa
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Storwin 10mg
Dosage Form : FCT
Dosage Strength : 10mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Storwin 20mg
Dosage Form : FCT
Dosage Strength : 20mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Storwin 40mg
Dosage Form : FCT
Dosage Strength : 40mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Reguchole 10/5mg
Dosage Form : TAB
Dosage Strength : 5mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Reguchole 10/10mg
Dosage Form : TAB
Dosage Strength : 10mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Reguchole 10/20mg
Dosage Form : TAB
Dosage Strength : 20mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Rosuzet 10 mg/10 mg
Dosage Form : FCT
Dosage Strength : 10mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Rosuvastatin 5 Cipla
Dosage Form : FCT
Dosage Strength : 5mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Vasrov 20 mg Tablets
Dosage Form : FCT
Dosage Strength : 20mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Rosvator 5
Dosage Form : FCT
Dosage Strength : 5mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
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]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]Kirsch Pharma
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
Controlled & Modified Release
Thickeners and Stabilizers
Chewable & Orodispersible Aids
Taste Masking
Topical
Co-Processed Excipients
Solubilizers
Parenteral
Film Formers & Plasticizers
API Stability Enhancers
Emulsifying Agents
Empty Capsules
Coloring Agents
Rheology Modifiers
Vegetarian Capsules
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
APIs
Reply
03 Oct 2025
Reply
19 Jun 2025
Reply
27 Jan 2025
Reply
24 Oct 2024
Reply
12 Aug 2024
Reply
22 Jul 2024
Reply
11 Jul 2024
Reply
05 Apr 2024
Reply
18 Sep 2023
Reply
12 Sep 2023
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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 Crestor manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Crestor, including repackagers and relabelers. The FDA regulates Crestor manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Crestor 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Crestor supplier is an individual or a company that provides Crestor active pharmaceutical ingredient (API) or Crestor finished formulations upon request. The Crestor suppliers may include Crestor API manufacturers, exporters, distributors and traders.
click here to find a list of Crestor suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Crestor DMF (Drug Master File) is a document detailing the whole manufacturing process of Crestor active pharmaceutical ingredient (API) in detail. Different forms of Crestor DMFs exist exist since differing nations have different regulations, such as Crestor USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Crestor DMF submitted to regulatory agencies in the US is known as a USDMF. Crestor USDMF includes data on Crestor's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Crestor USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Crestor 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 Drug Master File in Japan (Crestor JDMF) empowers Crestor 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Crestor 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 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 Drug Master File in Korea (Crestor KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Crestor. The MFDS reviews the Crestor KDMF as part of the drug registration process and uses the information provided in the Crestor KDMF to evaluate the safety and efficacy of the drug.
After submitting a Crestor 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Crestor suppliers with KDMF on PharmaCompass.
A Crestor CEP of the European Pharmacopoeia monograph is often referred to as a Crestor Certificate of Suitability (COS). The purpose of a Crestor CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Crestor EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Crestor to their clients by showing that a Crestor CEP has been issued for it. The manufacturer submits a Crestor CEP (COS) as part of the market authorization procedure, and it takes on the role of a Crestor CEP holder for the record. Additionally, the data presented in the Crestor CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Crestor DMF.
A Crestor CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Crestor 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 suppliers with CEP (COS) on PharmaCompass.
A Crestor written confirmation (Crestor WC) is an official document issued by a regulatory agency to a Crestor manufacturer, verifying that the manufacturing facility of a Crestor active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Crestor APIs or Crestor finished pharmaceutical products to another nation, regulatory agencies frequently require a Crestor WC (written confirmation) as part of the regulatory process.
click here to find a list of Crestor 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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Crestor 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Crestor NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Crestor suppliers with NDC on PharmaCompass.
Crestor 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 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 GMP manufacturer or Crestor GMP API supplier for your needs.
A Crestor CoA (Certificate of Analysis) is a formal document that attests to Crestor's compliance with Crestor specifications and serves as a tool for batch-level quality control.
Crestor CoA mostly includes findings from lab analyses of a specific batch. For each Crestor 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Crestor EP), Crestor JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Crestor USP).
Comment (3)
