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1. (e,3r,5s)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic Acid
2. Itavastatin
3. Itavastatin Calcium
4. Nisvastatin
5. Nk 104
6. Nk-104
7. P 872441
8. P-872441
9. Pitavastatin
10. Pitavastatin Calcium
11. Pitavastatin Lactone
1. Pitavastatin Calcium
2. 147526-32-7
3. Livalo
4. Nisvastatin
5. Nk-104
6. Itavastatin Calcium
7. Pitavastatin Calcium Salt
8. Calcium (3r,5s,e)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoate
9. Nk 104
10. Iyd54xeg3w
11. Chebi:71258
12. Calcium;(e,3r,5s)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxyhept-6-enoate
13. P-872441
14. Pitavastatin Calcium (jan)
15. Pitavastatin Calcium [jan]
16. Alipza
17. Flovas
18. Livazo
19. Unii-iyd54xeg3w
20. Nk 104 (acid)
21. Redevant
22. Ccris 8652
23. Livalo (tn)
24. Schembl22720
25. Bis((3r,5s,6e)-7-(2-cyclopropyl-4-(4-fluorophenyl)-3-quinolyl)-3,5-dihydroxy-6-heptenoate), Monocalcium Salt
26. Chembl1237061
27. Dtxsid4046448
28. Chebi:94569
29. Pitavastatin Hemicalcium;nk-104
30. Nks-104
31. Act02718
32. Mfcd01937979
33. Pitavastatin Calcium [mart.]
34. Pitavastatin Calcium [who-dd]
35. Akos015900407
36. Pitavastatin Calcium Salt [mi]
37. Am84441
38. Ks-1220
39. (+)-monocalciumbis{(3r,5s,6e)-7-[2-cyclopropyl-4-(4-fluorophenyl)-3-quinolyl]-3,5-dihydroxy-6-hepten
40. 111ge002
41. 6-heptenoic Acid, 7-(2-cyclopropyl-4-(4-fluorophenyl)-3-quinolinyl)-3,5-dihydroxy-, Calcium Salt (2:1), (s-(r*,s*-(e)))-
42. Pitavastatin Calcium [orange Book]
43. D01862
44. Q-201590
45. Q27139472
46. (+)-monocalciumbis[(3r,5s,6e)-7-[2-cyclopropyl-4(4-fluorophenyl)-3-quinolyl]3,5-dihydroxy-6-hepteno Ate]
47. (3r,5s,6e)-7-[2-cyclopropyl-4-(4-fluorophenyl)-3-quinolinyl]-3,5-dihydroxy-6-heptenoic Acid Hemicalcium Salt
48. Bis((3r,5s,6e)-7-(2-cyclopropyl-4-(4-fluorophenyl)-3-quinolyl)-3,5-dihydroxy-6-heptenoate) Monocalcium Salt
49. Calcium (3r,5s,e)-7-(2-cyclopropyl-4-(4-fluorophenyl)-quinolin-3-yl)-3,5-dihydroxyhept-6-enoate
50. Calcium Bis{(3r,5s,6e)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxyhept-6-enoate}
| Molecular Weight | 881.0 g/mol |
|---|---|
| Molecular Formula | C50H46CaF2N2O8 |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 12 |
| Rotatable Bond Count | 14 |
| Exact Mass | 880.2848136 g/mol |
| Monoisotopic Mass | 880.2848136 g/mol |
| Topological Polar Surface Area | 187 Ų |
| Heavy Atom Count | 63 |
| Formal Charge | 0 |
| Complexity | 626 |
| 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 2 | |
|---|---|
| Drug Name | Livalo |
| PubMed Health | Pitavastatin (By mouth) |
| Drug Classes | Antihyperlipidemic |
| Active Ingredient | Pitavastatin calcium |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | eq 4mg base; eq 2mg base; eq 1mg base |
| Market Status | Prescription |
| Company | Kowa |
| 2 of 2 | |
|---|---|
| Drug Name | Livalo |
| PubMed Health | Pitavastatin (By mouth) |
| Drug Classes | Antihyperlipidemic |
| Active Ingredient | Pitavastatin calcium |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | eq 4mg base; eq 2mg base; eq 1mg base |
| Market Status | Prescription |
| Company | Kowa |
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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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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Registrant Name : JW Pharmaceutical Co., Ltd.
Registration Date : 2004-09-14
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Registrant Name : Kolon Life Science Co., Ltd.
Registration Date : 2020-01-13
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Manufacturer Address : 54, Gippdosi 1-ro, Daesowon-myeon, Chungju-si, Chungcheongbuk-do
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Status : Inactive
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DMF Number : 28384
Submission : 2014-06-13
Status : Inactive
Type : II
Registrant Name : Pharma Solution Co., Ltd.
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Registration Number : Su2816-6-ND(A)
Manufacturer Name : Solara Active Pharma Sciences Limited
Manufacturer Address : A-1/B, Sipcot Industrial Complex Kudikadu Village, Cuddalore - 607 005 Tamilnadu, India
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Manufacturer Name : Solara Active Pharma Sciences Limited
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Registration Date : 2020-01-13
Registration Number : 1607-1-ND
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Manufacturer Address : 54, Gippdosi 1-ro, Daesowon-myeon, Chungju-si, Chungcheongbuk-do
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Drugs in Development
Details:
RO7795081 is a drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Overweight.
Lead Product(s): RO7795081,Rosuvastatin Calcium,Pitavastatin
Therapeutic Area: Nutrition and Weight Loss Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Undisclosed
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 21, 2025
Lead Product(s) : RO7795081,Rosuvastatin Calcium,Pitavastatin
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
RO7795081 Safety & DDI with Pitavastatin/Rosuvastatin In Healthy Overweight/Obese Adults
Details : RO7795081 is a drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Overweight.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
May 21, 2025
Details:
Digoxin is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Anemia, Sickle Cell.
Lead Product(s): Digoxin,Pitavastatin,Metformin
Therapeutic Area: Genetic Disease Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 07, 2025
Lead Product(s) : Digoxin,Pitavastatin,Metformin
Therapeutic Area : Genetic Disease
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
A Research Study of the Effect of Etavopivat on Other Drugs in Healthy Participants
Details : Digoxin is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Anemia, Sickle Cell.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 07, 2025
Details:
Pitavastatin is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Lead Product(s): Pitavastatin,Ceftobiprole
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Biomedical Advanced Research and Development Authority
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 05, 2025
Lead Product(s) : Pitavastatin,Ceftobiprole
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Biomedical Advanced Research and Development Authority
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Pitavastatin is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 05, 2025
Details:
Pitavastatin is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Atherosclerosis.
Lead Product(s): Pitavastatin,Ezetimibe
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Daewon Pharm. Co., Ltd | Samjin Pharmaceutical
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 10, 2025
Lead Product(s) : Pitavastatin,Ezetimibe
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Daewon Pharm. Co., Ltd | Samjin Pharmaceutical
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Pitavastatin is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Atherosclerosis.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 10, 2025
Details:
Pitavastatin is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Osteoporosis.
Lead Product(s): Pitavastatin,Inapplicable
Therapeutic Area: Musculoskeletal Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: JW Pharmaceutical
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 11, 2024
Lead Product(s) : Pitavastatin,Inapplicable
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : JW Pharmaceutical
Deal Size : Inapplicable
Deal Type : Inapplicable
Effect of Pitavastatin on Bone
Details : Pitavastatin is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Osteoporosis.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 11, 2024
Details:
Pitavastatin tablet is a HMG-CoA reductase inhibitor indicated as an adjunctive therapy to diet in Adult patients with primary hyperlipidemia or mixed dyslipidemia.
Lead Product(s): Pitavastatin,Inapplicable
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Livalo-Generic
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 06, 2023
Lead Product(s) : Pitavastatin,Inapplicable
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Upsher-Smith Launches Pitavastatin Tablets
Details : Pitavastatin tablet is a HMG-CoA reductase inhibitor indicated as an adjunctive therapy to diet in Adult patients with primary hyperlipidemia or mixed dyslipidemia.
Product Name : Livalo-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 06, 2023
Details:
Tafolecimab is a Antibody drug candidate, which is currently being evaluated in clinical studies for the treatment of Acute Coronary Syndrome.
Lead Product(s): Tafolecimab,Atorvastatin,Rosuvastatin Calcium,Pitavastatin
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Antibody, Unconjugated
Sponsor: Innovent Biologics
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 24, 2023
Lead Product(s) : Tafolecimab,Atorvastatin,Rosuvastatin Calcium,Pitavastatin
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Innovent Biologics
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Tafolecimab is a Antibody drug candidate, which is currently being evaluated in clinical studies for the treatment of Acute Coronary Syndrome.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
October 24, 2023
Details:
Pitavastatin is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Lead Product(s): Pitavastatin,JW0101,C2101
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 28, 2022
Lead Product(s) : Pitavastatin,JW0101,C2101
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
To Evaluate the Pharmacokinetic Interactions and Safety in Healthy Volunteers
Details : Pitavastatin is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 28, 2022
Details:
Pitavastatin is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Hypercholesterolemia.
Lead Product(s): Pitavastatin,Ezetimibe
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 14, 2020
Lead Product(s) : Pitavastatin,Ezetimibe
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
To Evaluate the Efficacy and Safety in Patients With Primary Hypercholesterolemia
Details : Pitavastatin is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Hypercholesterolemia.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 14, 2020
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Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
CAS Number : 411235-57-9
End Use API : Pitavastatin
About The Company : MINAKEM is a cGMP custom manufacturer of small molecule API, HPAPI and steroids. All development and manufacturing activities are supported by highly skilled R&...
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Pitavastatin Zentiva
Dosage Form : Film Coated Tablet
Dosage Strength : 1mg
Packaging :
Approval Date : 18/07/2022
Application Number : 68219
Regulatory Info : Allowed
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Pitavastatin Zentiva
Dosage Form : Film Coated Tablet
Dosage Strength : 2mg
Packaging :
Approval Date : 18/07/2022
Application Number : 68219
Regulatory Info : Allowed
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Pitavastatin Zentiva
Dosage Form : Film Coated Tablet
Dosage Strength : 4mg
Packaging :
Approval Date : 18/07/2022
Application Number : 68219
Regulatory Info : Allowed
Registration Country : Switzerland
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info : Suspensed
Registration Country : Spain
Brand Name : Pitavastatin Thinks
Dosage Form : Film Coated Tablet
Dosage Strength : 1MG
Packaging :
Approval Date : 2020-03-10
Application Number : 84950
Regulatory Info : Suspensed
Registration Country : Spain
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Pitavastatin Thinks
Dosage Form : Film Coated Tablet
Dosage Strength : 2MG
Packaging :
Approval Date : 2020-03-10
Application Number : 84951
Regulatory Info : Authorized
Registration Country : Spain
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Pitavastatin Thinks
Dosage Form : Film Coated Tablet
Dosage Strength : 4MG
Packaging :
Approval Date : 2020-03-10
Application Number : 84952
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : RX
Registration Country : USA
Brand Name : LIVALO
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1MG BASE
Packaging :
Approval Date : 2009-08-03
Application Number : 22363
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : LIVALO
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 2MG BASE
Packaging :
Approval Date : 2009-08-03
Application Number : 22363
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : LIVALO
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 4MG BASE
Packaging :
Approval Date : 2009-08-03
Application Number : 22363
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : PITAVASTATIN CALCIUM
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1MG BASE
Packaging :
Approval Date : 2017-02-03
Application Number : 205932
Regulatory Info : RX
Registration Country : USA
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RLD : No
TE Code : AB
Brand Name : PITAVASTATIN CALCIUM
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 2MG BASE
Approval Date : 2024-08-20
Application Number : 205961
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : PITAVASTATIN CALCIUM
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 4MG BASE
Approval Date : 2024-08-20
Application Number : 205961
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : PITAVASTATIN CALCIUM
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1MG BASE
Approval Date : 2024-04-30
Application Number : 205977
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : Yes
TE Code : AB
Brand Name : LIVALO
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 4MG BASE
Approval Date : 2009-08-03
Application Number : 22363
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : No
TE Code : AB
Brand Name : PITAVASTATIN CALCIUM
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 2MG BASE
Approval Date : 2023-11-20
Application Number : 206029
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : PITAVASTATIN CALCIUM
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 4MG BASE
Approval Date : 2023-11-20
Application Number : 206029
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : Yes
TE Code :
Brand Name : NIKITA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 2MG BASE
Approval Date : 2017-08-04
Application Number : 209875
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : NIKITA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 4MG BASE
Approval Date : 2017-08-04
Application Number : 209875
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : No
TE Code : AB
Brand Name : PITAVASTATIN CALCIUM
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1MG BASE
Approval Date : 2017-02-03
Application Number : 205932
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : PITAVASTATIN CALCIUM
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 2MG BASE
Approval Date : 2017-02-03
Application Number : 205932
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Pitavastatin Zentiva
Dosage Form : Film Coated Tablet
Dosage Strength : 1mg
Packaging :
Approval Date : 18/07/2022
Application Number : 68219
Regulatory Info : Allowed
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Pitavastatin Zentiva
Dosage Form : Film Coated Tablet
Dosage Strength : 2mg
Packaging :
Approval Date : 18/07/2022
Application Number : 68219
Regulatory Info : Allowed
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Pitavastatin Zentiva
Dosage Form : Film Coated Tablet
Dosage Strength : 4mg
Packaging :
Approval Date : 18/07/2022
Application Number : 68219
Regulatory Info : Allowed
Registration Country : Switzerland
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info : Suspensed
Registration Country : Spain
Brand Name : Pitavastatin Thinks
Dosage Form : Film Coated Tablet
Dosage Strength : 1MG
Packaging :
Approval Date : 2020-03-10
Application Number : 84950
Regulatory Info : Suspensed
Registration Country : Spain
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Pitavastatin Thinks
Dosage Form : Film Coated Tablet
Dosage Strength : 2MG
Packaging :
Approval Date : 2020-03-10
Application Number : 84951
Regulatory Info : Authorized
Registration Country : Spain
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Pitavastatin Thinks
Dosage Form : Film Coated Tablet
Dosage Strength : 4MG
Packaging :
Approval Date : 2020-03-10
Application Number : 84952
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Alipza
Dosage Form : Film Coated Tablet
Dosage Strength : 1MG
Packaging :
Approval Date : 2015-07-31
Application Number : 5324603
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Pitavastatina Krka
Dosage Form : Film Coated Tablet
Dosage Strength : 4MG
Packaging :
Approval Date : 2020-02-18
Application Number : 84889
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Pitavastatin Normon
Dosage Form : Film Coated Tablet
Dosage Strength : 2MG
Packaging :
Approval Date : 2020-06-30
Application Number : 85212
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Pitavastatina Geprem
Dosage Form : Film Coated Tablet
Dosage Strength : 2MG
Packaging :
Approval Date : 2022-08-23
Application Number : 88045
Regulatory Info : Authorized
Registration Country : Spain
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Dossiers
Regulatory Info :
Registration Country : Lebanon
Brand Name : Livazo
Dosage Form : Tablet
Dosage Strength : 2MG; 4MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Lebanon
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 1MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 1MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : Brazil
Brand Name :
Dosage Form : Tablet
Dosage Strength : 2MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Brazil
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 2MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Brazil
Regulatory Info : Generic
Registration Country : South Korea
Brand Name : PITADUCE
Dosage Form : TABLET
Dosage Strength : 4MG
Packaging : 30T,100T
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Korea
Packaging : 30T,100T
Regulatory Info : Generic
Dosage : TABLET
Dosage Strength : 4MG
Brand Name : PITADUCE
Approval Date :
Application Number :
Registration Country : South Korea
Regulatory Info :
Registration Country : South Korea
Brand Name : Elvaro Tablet
Dosage Form : Tablet
Dosage Strength : 2MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : South Korea
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 2MG
Brand Name : Elvaro Tablet
Approval Date :
Application Number :
Registration Country : South Korea
Regulatory Info :
Registration Country : U.A.E
Brand Name : Itavas
Dosage Form : Tablet
Dosage Strength : 2MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : U.A.E
Regulatory Info :
Registration Country : U.A.E
Brand Name : Itavas
Dosage Form : Tablet
Dosage Strength : 4MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : U.A.E
Regulatory Info :
Registration Country : Portugal
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 2MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Portugal
Regulatory Info :
Registration Country : Portugal
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 4MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Portugal
Regulatory Info :
Registration Country : China
Brand Name :
Dosage Form : Tablet
Dosage Strength : 1MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : China
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 1MG
Brand Name :
Approval Date :
Application Number :
Registration Country : China
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
REF. STANDARDS & IMPURITIES
JP
Pitavastatin Methylbenzylamine
Monograph in Japanese Pharmacopoeia : Pitavastat...
Package Size : 100 mg
Price (¥) : 74,950
Storage Temperature °C : 8°C
Assay Test : A/ LC
Pitavastatin Methylbenzylamine
Monograph in Japanese Pharmacopoeia : Pitavastat...
Package Size : 100 mg
Price (¥) : 74,950
Storage Temperature °C : 8°C
Assay Test : U/ LC D/ LC
Pitavastatin Methylbenzylamine
Monograph in Japanese Pharmacopoeia :
Package Size : 100 mg
Price (¥) : 74,950
Storage Temperature °C : 8°C
Assay Test : A/ LC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
55
PharmaCompass offers a list of Pitavastatin 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 Pitavastatin manufacturer or Pitavastatin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Pitavastatin manufacturer or Pitavastatin supplier.
PharmaCompass also assists you with knowing the Pitavastatin API Price utilized in the formulation of products. Pitavastatin API Price is not always fixed or binding as the Pitavastatin Price is obtained through a variety of data sources. The Pitavastatin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Pitavastatin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pitavastatin, including repackagers and relabelers. The FDA regulates Pitavastatin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pitavastatin 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 Pitavastatin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pitavastatin supplier is an individual or a company that provides Pitavastatin active pharmaceutical ingredient (API) or Pitavastatin finished formulations upon request. The Pitavastatin suppliers may include Pitavastatin API manufacturers, exporters, distributors and traders.
click here to find a list of Pitavastatin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pitavastatin DMF (Drug Master File) is a document detailing the whole manufacturing process of Pitavastatin active pharmaceutical ingredient (API) in detail. Different forms of Pitavastatin DMFs exist exist since differing nations have different regulations, such as Pitavastatin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pitavastatin DMF submitted to regulatory agencies in the US is known as a USDMF. Pitavastatin USDMF includes data on Pitavastatin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pitavastatin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pitavastatin 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 Pitavastatin Drug Master File in Japan (Pitavastatin JDMF) empowers Pitavastatin 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 Pitavastatin JDMF during the approval evaluation for pharmaceutical products. At the time of Pitavastatin 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 Pitavastatin 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 Pitavastatin Drug Master File in Korea (Pitavastatin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Pitavastatin. The MFDS reviews the Pitavastatin KDMF as part of the drug registration process and uses the information provided in the Pitavastatin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Pitavastatin 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 Pitavastatin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Pitavastatin suppliers with KDMF on PharmaCompass.
A Pitavastatin written confirmation (Pitavastatin WC) is an official document issued by a regulatory agency to a Pitavastatin manufacturer, verifying that the manufacturing facility of a Pitavastatin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Pitavastatin APIs or Pitavastatin finished pharmaceutical products to another nation, regulatory agencies frequently require a Pitavastatin WC (written confirmation) as part of the regulatory process.
click here to find a list of Pitavastatin 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 Pitavastatin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Pitavastatin 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 Pitavastatin 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 Pitavastatin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pitavastatin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Pitavastatin suppliers with NDC on PharmaCompass.
Pitavastatin 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 Pitavastatin 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 Pitavastatin GMP manufacturer or Pitavastatin GMP API supplier for your needs.
A Pitavastatin CoA (Certificate of Analysis) is a formal document that attests to Pitavastatin's compliance with Pitavastatin specifications and serves as a tool for batch-level quality control.
Pitavastatin CoA mostly includes findings from lab analyses of a specific batch. For each Pitavastatin 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.
Pitavastatin may be tested according to a variety of international standards, such as European Pharmacopoeia (Pitavastatin EP), Pitavastatin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pitavastatin USP).
