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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.)
API SUPPLIERS
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USDMF
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-14
Pay. Date : 2013-05-07
DMF Number : 27106
Submission : 2013-05-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-22
Pay. Date : 2013-07-10
DMF Number : 27255
Submission : 2013-07-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15303
Submission : 2001-02-16
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-28
Pay. Date : 2013-07-08
DMF Number : 27242
Submission : 2013-07-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-12-17
Pay. Date : 2013-03-28
DMF Number : 23488
Submission : 2010-01-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14660
Submission : 2000-01-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-22
Pay. Date : 2013-07-30
DMF Number : 25956
Submission : 2012-04-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-19
Pay. Date : 2013-06-18
DMF Number : 27144
Submission : 2013-06-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26406
Submission : 2012-12-16
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-22
Pay. Date : 2013-07-29
DMF Number : 27333
Submission : 2013-07-31
Status : Active
Type : II
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Japanese Pharmacopoeia Pitavastatin Calcium Hydrate
Registration Number : 303MF10052
Registrant's Address : 5850-1 Higashineko, Higashine City, Yamagata Prefecture
Initial Date of Registration : 2021-03-26
Latest Date of Registration : 2021-03-26
Registration Number : 229MF10194
Registrant's Address : 2-36-1 Kanda Jinbocho, Chiyoda-ku, Tokyo
Initial Date of Registration : 2017-11-07
Latest Date of Registration : 2017-11-07
Registration Number : 303MF10039
Registrant's Address : 1978-96 Ogushi, Ube City, Yamaguchi Prefecture
Initial Date of Registration : 2021-02-24
Latest Date of Registration : 2021-02-24
Registration Number : 229MF10090
Registrant's Address : 1978-96 Ogushi, Ube City, Yamaguchi Prefecture
Initial Date of Registration : 2017-05-01
Latest Date of Registration : 2020-04-02
Registration Number : 302MF10150
Registrant's Address : 110, MAGOKDONG-RO, GANGSEO-GU, SEOUL, KOREA
Initial Date of Registration : 2020-12-15
Latest Date of Registration : 2020-12-15
Pitavastatin calcium hydrate "KBP"
Registration Number : 304MF10079
Registrant's Address : 174, Sirok-ro, Asan-si, Chungcheongnam-do, KOREA
Initial Date of Registration : 2022-05-25
Latest Date of Registration : 2022-05-25
Registration Number : 307MF10091
Registrant's Address : 2-5-1 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2025-07-30
Latest Date of Registration : 2025-07-30
Registration Number : 223MF10122
Registrant's Address : 2-5-1 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2011-07-28
Latest Date of Registration : 2015-05-25
Pitavastatin calcium hydrate M
Registration Number : 304MF10026
Registrant's Address : 2-36-1 Kanda Jinbocho, Chiyoda-ku, Tokyo
Initial Date of Registration : 2022-02-02
Latest Date of Registration : 2022-02-02
Registration Number : 224MF10148
Registrant's Address : 2nd Floor, Admin Block 27, Vandalooor kelambakkam Road, Keelakottaiyur Village, Melak...
Initial Date of Registration : 2012-07-31
Latest Date of Registration : 2025-10-08
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| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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Drugs in Development
Details:
Alirocumab is a Antibody drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Hypercholesterolemia.
Lead Product(s): Alirocumab,Pravastatin,Simvastatin,Fluvastatin,Atorvastatin,Pitavastatin,Rosuvastatin Calcium
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Antibody, Unconjugated
Sponsor: Regeneron Pharmaceuticals
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 08, 2014
Lead Product(s) : Alirocumab,Pravastatin,Simvastatin,Fluvastatin,Atorvastatin,Pitavastatin,Rosuvastatin Calcium
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Regeneron Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Alirocumab is a Antibody drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Hypercholesterolemia.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
April 08, 2014
Details:
Pitavastatin, a miscellaneous product targeting HMG-CoA reductase, shows promise in treating disseminated superficial actinic porokeratosis (DSAP).
Lead Product(s): Pitavastatin,Inapplicable
Therapeutic Area: Dermatology Brand Name: QTORIN pitavastatin
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 05, 2025
Lead Product(s) : Pitavastatin,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Palvella Therapeutics Unveils QTORIN™ Pitavastatin for DSAP, a Rare Genetic Skin Disease
Details : Pitavastatin, a miscellaneous product targeting HMG-CoA reductase, shows promise in treating disseminated superficial actinic porokeratosis (DSAP).
Product Name : QTORIN pitavastatin
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 05, 2025
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
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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 Livalo manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Livalo, including repackagers and relabelers. The FDA regulates Livalo manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Livalo 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 Livalo manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Livalo supplier is an individual or a company that provides Livalo active pharmaceutical ingredient (API) or Livalo finished formulations upon request. The Livalo suppliers may include Livalo API manufacturers, exporters, distributors and traders.
click here to find a list of Livalo suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Livalo DMF (Drug Master File) is a document detailing the whole manufacturing process of Livalo active pharmaceutical ingredient (API) in detail. Different forms of Livalo DMFs exist exist since differing nations have different regulations, such as Livalo USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Livalo DMF submitted to regulatory agencies in the US is known as a USDMF. Livalo USDMF includes data on Livalo's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Livalo USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Livalo 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 Livalo Drug Master File in Japan (Livalo JDMF) empowers Livalo 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 Livalo JDMF during the approval evaluation for pharmaceutical products. At the time of Livalo 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 Livalo 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 Livalo Drug Master File in Korea (Livalo KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Livalo. The MFDS reviews the Livalo KDMF as part of the drug registration process and uses the information provided in the Livalo KDMF to evaluate the safety and efficacy of the drug.
After submitting a Livalo 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 Livalo API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Livalo suppliers with KDMF on PharmaCompass.
A Livalo written confirmation (Livalo WC) is an official document issued by a regulatory agency to a Livalo manufacturer, verifying that the manufacturing facility of a Livalo active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Livalo APIs or Livalo finished pharmaceutical products to another nation, regulatory agencies frequently require a Livalo WC (written confirmation) as part of the regulatory process.
click here to find a list of Livalo 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 Livalo as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Livalo 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 Livalo 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 Livalo and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Livalo NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Livalo suppliers with NDC on PharmaCompass.
Livalo 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 Livalo 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 Livalo GMP manufacturer or Livalo GMP API supplier for your needs.
A Livalo CoA (Certificate of Analysis) is a formal document that attests to Livalo's compliance with Livalo specifications and serves as a tool for batch-level quality control.
Livalo CoA mostly includes findings from lab analyses of a specific batch. For each Livalo 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.
Livalo may be tested according to a variety of international standards, such as European Pharmacopoeia (Livalo EP), Livalo JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Livalo USP).
