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    Also known as: 147098-20-2, Crestor, Rosuvastatin hemicalcium, Fortius, Rostar, Rosuvastatin calcium salt
    Molecular Formula
    C44H54CaF2N6O12S2
    Molecular Weight
    1001.1  g/mol
    InChI Key
    LALFOYNTGMUKGG-BGRFNVSISA-L
    FDA UNII
    83MVU38M7Q
    Rosuvastatin Calcium
    A HYDROXYMETHYLGLUTARYL-COA-REDUCTASE INHIBITOR, or statin, that reduces the plasma concentrations of LDL-CHOLESTEROL; APOLIPOPROTEIN B, and TRIGLYCERIDES while increasing HDL-CHOLESTEROL levels in patients with HYPERCHOLESTEROLEMIA and those at risk for CARDIOVASCULAR DISEASES.
    1 2D Structure

    Rosuvastatin Calcium

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    calcium;(E,3R,5S)-7-[4-(4-fluorophenyl)-2-[methyl(methylsulfonyl)amino]-6-propan-2-ylpyrimidin-5-yl]-3,5-dihydroxyhept-6-enoate
    2.1.2 InChI
    InChI=1S/2C22H28FN3O6S.Ca/c2*1-13(2)20-18(10-9-16(27)11-17(28)12-19(29)30)21(14-5-7-15(23)8-6-14)25-22(24-20)26(3)33(4,31)32;/h2*5-10,13,16-17,27-28H,11-12H2,1-4H3,(H,29,30);/q;;+2/p-2/b2*10-9+;/t2*16-,17-;/m11./s1
    2.1.3 InChI Key
    LALFOYNTGMUKGG-BGRFNVSISA-L
    2.1.4 Canonical SMILES
    CC(C)C1=NC(=NC(=C1C=CC(CC(CC(=O)[O-])O)O)C2=CC=C(C=C2)F)N(C)S(=O)(=O)C.CC(C)C1=NC(=NC(=C1C=CC(CC(CC(=O)[O-])O)O)C2=CC=C(C=C2)F)N(C)S(=O)(=O)C.[Ca+2]
    2.1.5 Isomeric SMILES
    CC(C1=NC(=NC(=C1/C=C/[C@@H](O)C[C@@H](O)CC(=O)[O-])C2=CC=C(C=C2)F)N(S(=O)(=O)C)C)C.CC(C1=NC(=NC(=C1/C=C/[C@@H](O)C[C@@H](O)CC(=O)[O-])C2=CC=C(C=C2)F)N(S(=O)(=O)C)C)C.[Ca+2]
    2.2 Other Identifiers
    2.2.1 UNII
    83MVU38M7Q
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Calcium, Rosuvastatin

    2. Crestor

    3. Rosuvastatin

    4. Zd 4522

    5. Zd4522

    2.3.2 Depositor-Supplied Synonyms

    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)

    2.4 Create Date
    2005-10-11
    3 Chemical and Physical Properties
    Molecular Weight 1001.1 g/mol
    Molecular Formula C44H54CaF2N6O12S2
    Hydrogen Bond Donor Count4
    Hydrogen Bond Acceptor Count20
    Rotatable Bond Count18
    Exact Mass1000.2835107 g/mol
    Monoisotopic Mass1000.2835107 g/mol
    Topological Polar Surface Area304 Ų
    Heavy Atom Count67
    Formal Charge0
    Complexity761
    Isotope Atom Count0
    Defined Atom Stereocenter Count4
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count2
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count3
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameCrestor
    Drug LabelCRESTOR (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 IngredientRosuvastatin calcium
    Dosage FormTablet
    RouteOral
    Strength5mg; 10mg; 40mg; 20mg
    Market StatusPrescription
    CompanyIpr

    2 of 4  
    Drug NameRosuvastatin calcium
    PubMed HealthRosuvastatin (By mouth)
    Drug ClassesAntihyperlipidemic
    Drug LabelCRESTOR (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 IngredientRosuvastatin calcium
    Dosage FormTablet
    Routeoral; Oral
    Strength5mg; 10mg; 40mg; 20mg
    Market StatusTentative Approval
    CompanyMylan Pharma; Apotex; Aurobindo Pharma; Sandoz; Sun Pharma Global; Par Pharm; Watson Labs; Glenmark Generics; Teva Pharms

    3 of 4  
    Drug NameCrestor
    Drug LabelCRESTOR (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 IngredientRosuvastatin calcium
    Dosage FormTablet
    RouteOral
    Strength5mg; 10mg; 40mg; 20mg
    Market StatusPrescription
    CompanyIpr

    4 of 4  
    Drug NameRosuvastatin calcium
    PubMed HealthRosuvastatin (By mouth)
    Drug ClassesAntihyperlipidemic
    Drug LabelCRESTOR (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 IngredientRosuvastatin calcium
    Dosage FormTablet
    Routeoral; Oral
    Strength5mg; 10mg; 40mg; 20mg
    Market StatusTentative Approval
    CompanyMylan Pharma; Apotex; Aurobindo Pharma; Sandoz; Sun Pharma Global; Par Pharm; Watson Labs; Glenmark Generics; Teva Pharms

    4.2 Drug Indication

    Homozygous Familial Hypercholesterolaemia, Prevention of cardiovascular events, Primary combined (mixed) dyslipidaemia, Primary hypercholesterolaemia

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    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.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]; HMG-CoA Reductase Inhibitor [EPC]

    API Reference Price

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SDNF China","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1727721000,"product":"ROSUVASTATIN CALCIUM USP","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"CHANGZHOU PHARMACEUTICAL FACTORY","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"1200.00","actualQuantity":"1200","unit":"KGS","unitRateFc":"540","totalValueFC":"652422.3","currency":"USD","unitRateINR":"45684","date":"01-Oct-2024","totalValueINR":"54820800","totalValueInUsd":"652422.3","indian_port":"Hyderabad Air","hs_no":"29189990","bill_no":"5905561","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"NO.518 LAODONG EAST ROAD, CHANGZHOU , JIANGSU PROVINCE CHINA China SDNF China","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737052200,"product":"ROSUVASTATIN CALCIUM USP ROSUVASTATIN CALCIUM USP","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"CHANGZHOU PHARMACEUTICAL FACTORY","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"1250.00","actualQuantity":"1250","unit":"KGS","unitRateFc":"495","totalValueFC":"624998.6","currency":"USD","unitRateINR":"43114.5","date":"17-Jan-2025","totalValueINR":"53893125","totalValueInUsd":"624998.6","indian_port":"Hyderabad Air","hs_no":"29189990","bill_no":"7842674","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO.518 LAODONG EAST ROAD, CHANGZHOU , JIANGSU PROVINCE CHINA China SDNF China","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737138600,"product":"ROSUVASTATINE(HARMLESS BULK DRUG-ROSUVASTATIN CALCIUM EP)(RE-IMPORT S\/B NO.6469896 DT.02.01.2024)ROSUVASTATINE(HARMLESS BULK DRUG-ROSUVASTATIN CALCIUM EP)(RE","address":"PLOT NO. 221, G.I.D.C.,","city":"GUJARAT","supplier":"PHARLAB INDUSTRIA FARMACEUTICA S\/A.","supplierCountry":"INDIA","foreign_port":"BELO HORIZONTE, MG","customer":"AMOLI ORGANICS","customerCountry":"INDIA","quantity":"112.84","actualQuantity":"112.84","unit":"KGS","unitRateFc":"610.7","totalValueFC":"69608.3","currency":"N\/A","unitRateINR":"53192.7","date":"18-Jan-2025","totalValueINR":"6002267.81","totalValueInUsd":"69608.3","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"7863514","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BELO HORIZONTE, MG","supplierAddress":"OLIMPIO REZENDE DE OLIVEIRA 28, STR EET AMERICO SILVA LAGOA DA PRATA M INAS GERAIS-BRAZIL ZIP CODE-35590-1 Brazil","customerAddress":"PLOT NO. 221, G.I.D.C.,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737138600,"product":"ROSUVASTATINE(HARMLESS BULK DRUG-ROSUVASTATIN CALCIUM EP)(SBNO.8407261 DT.18.03.2024)ROSUVASTATINE(HARMLESS BULK DRUG-ROSUVASTATIN CALCIUM EP)(SB","address":"PLOT NO. 221, G.I.D.C.,","city":"GUJARAT","supplier":"PHARLAB INDUSTRIA FARMACEUTICA S\/A.","supplierCountry":"INDIA","foreign_port":"BELO HORIZONTE, MG","customer":"AMOLI ORGANICS","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"610.7","totalValueFC":"6168.8","currency":"N\/A","unitRateINR":"53192.7","date":"18-Jan-2025","totalValueINR":"531927.31","totalValueInUsd":"6168.8","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"7863514","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BELO HORIZONTE, MG","supplierAddress":"OLIMPIO REZENDE DE OLIVEIRA 28, STR EET AMERICO SILVA LAGOA DA PRATA M INAS GERAIS-BRAZIL ZIP CODE-35590-1 Brazil","customerAddress":"PLOT NO. 221, G.I.D.C.,"}]
    04-Jan-2021
    31-Jan-2025
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    ABOUT THIS PAGE

    Looking for 147098-20-2 / Rosuvastatin Calcium API manufacturers, exporters & distributors?

    Rosuvastatin Calcium manufacturers, exporters & distributors 1

    11

    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.

    API | Excipient name

    Rosuvastatin Calcium

    Synonyms

    147098-20-2, Crestor, Rosuvastatin hemicalcium, Fortius, Rostar, Rosuvastatin calcium salt

    Cas Number

    147098-20-2

    Unique Ingredient Identifier (UNII)

    83MVU38M7Q

    About Rosuvastatin Calcium

    A HYDROXYMETHYLGLUTARYL-COA-REDUCTASE INHIBITOR, or statin, that reduces the plasma concentrations of LDL-CHOLESTEROL; APOLIPOPROTEIN B, and TRIGLYCERIDES while increasing HDL-CHOLESTEROL levels in patients with HYPERCHOLESTEROLEMIA and those at risk for CARDIOVASCULAR DISEASES.

    Rosuvastatin Calcium Manufacturers

    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.

    Rosuvastatin Calcium Suppliers

    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.

    Rosuvastatin Calcium USDMF

    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.

    Rosuvastatin Calcium JDMF

    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.

    Rosuvastatin Calcium KDMF

    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.

    Rosuvastatin Calcium CEP

    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.

    Rosuvastatin Calcium WC

    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.

    Rosuvastatin Calcium NDC

    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).

    Finished drug products

    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.

    Unfinished drugs

    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.

    Compounded drug products

    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 GMP

    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.

    Rosuvastatin Calcium CoA

    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).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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