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Chemistry

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Also known as: Pitavastatin calcium, 147526-32-7, Livalo, Nisvastatin, Nk-104, Itavastatin calcium
Molecular Formula
C50H46CaF2N2O8
Molecular Weight
881.0  g/mol
InChI Key
RHGYHLPFVJEAOC-FFNUKLMVSA-L
FDA UNII
IYD54XEG3W

Pitavastatin
Pitavastatin Calcium is a calcium salt formulation of pitavastatin, a novel statin that induces plaque regression and elevates HDL-cholesterol levels.
1 2D Structure

Pitavastatin

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
calcium;(E,3R,5S)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxyhept-6-enoate
2.1.2 InChI
InChI=1S/2C25H24FNO4.Ca/c2*26-17-9-7-15(8-10-17)24-20-3-1-2-4-22(20)27-25(16-5-6-16)21(24)12-11-18(28)13-19(29)14-23(30)31;/h2*1-4,7-12,16,18-19,28-29H,5-6,13-14H2,(H,30,31);/q;;+2/p-2/b2*12-11+;/t2*18-,19-;/m11./s1
2.1.3 InChI Key
RHGYHLPFVJEAOC-FFNUKLMVSA-L
2.1.4 Canonical SMILES
C1CC1C2=NC3=CC=CC=C3C(=C2C=CC(CC(CC(=O)[O-])O)O)C4=CC=C(C=C4)F.C1CC1C2=NC3=CC=CC=C3C(=C2C=CC(CC(CC(=O)[O-])O)O)C4=CC=C(C=C4)F.[Ca+2]
2.1.5 Isomeric SMILES
C1C(C1)C2=NC3=CC=CC=C3C(=C2/C=C/[C@@H](O)C[C@@H](O)CC(=O)[O-])C4=CC=C(C=C4)F.C1C(C1)C2=NC3=CC=CC=C3C(=C2/C=C/[C@@H](O)C[C@@H](O)CC(=O)[O-])C4=CC=C(C=C4)F.[Ca+2]
2.2 Other Identifiers
2.2.1 UNII
IYD54XEG3W
2.3 Synonyms
2.3.1 MeSH Synonyms

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

2.3.2 Depositor-Supplied Synonyms

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}

2.4 Create Date
2005-10-11
3 Chemical and Physical Properties
Molecular Weight 881.0 g/mol
Molecular Formula C50H46CaF2N2O8
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count12
Rotatable Bond Count14
Exact Mass880.2848136 g/mol
Monoisotopic Mass880.2848136 g/mol
Topological Polar Surface Area187 Ų
Heavy Atom Count63
Formal Charge0
Complexity626
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 2  
Drug NameLivalo
PubMed HealthPitavastatin (By mouth)
Drug ClassesAntihyperlipidemic
Active IngredientPitavastatin calcium
Dosage FormTablet
RouteOral
Strengtheq 4mg base; eq 2mg base; eq 1mg base
Market StatusPrescription
CompanyKowa

2 of 2  
Drug NameLivalo
PubMed HealthPitavastatin (By mouth)
Drug ClassesAntihyperlipidemic
Active IngredientPitavastatin calcium
Dosage FormTablet
RouteOral
Strengtheq 4mg base; eq 2mg base; eq 1mg base
Market StatusPrescription
CompanyKowa

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

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]

KDMF

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01

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pitavastatin calcium hydrate

Registrant Name : Boryeong Co., Ltd.

Registration Date : 2019-04-10

Registration Number : 1689-5-ND

Manufacturer Name : Boryeong Co., Ltd.

Manufacturer Address : 107, 109 Neungan-ro, Danwon-gu, Ansan-si, Gyeonggi-do

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02

Pittcon 2025
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pitavastatin calcium hydrate

Registrant Name : Kolon Life Science Co., Ltd.

Registration Date : 2020-01-13

Registration Number : 1607-1-ND

Manufacturer Name : Kolon Life Science Co., Ltd.

Manufacturer Address : 54, Gipyodosi 1-ro, Daesowon-myeon, Chungju-si, Chungcheongbuk-do

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03

Korea Biochem Pharm

South Korea
Pittcon 2025
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Korea Biochem Pharm

South Korea
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Pittcon 2025
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pitavastatin calcium hydrate

Registrant Name : Korea Biochem Pharmaceutical Co., Ltd.

Registration Date : 2021-06-22

Registration Number : 2152-12-ND

Manufacturer Name : Korea Biochem Pharmaceutical...

Manufacturer Address : 204 Sandan-gil, Jeonui-myeon, Sejong Special Self-Governing City

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04

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pitavastatin calcium hydrate

Registrant Name : Kyungbo Pharmaceutical Co., Ltd.

Registration Date : 2021-12-01

Registration Number : 1673-49-ND

Manufacturer Name : Kyungbo Pharmaceutical Co., ...

Manufacturer Address : 174 Silok-ro, Asan-si, Chungcheongnam-do  

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05

KyungDong Pharm

South Korea
Pittcon 2025
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KyungDong Pharm

South Korea
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pitavastatin calcium hydrate

Registrant Name : Kyungdong Pharmaceutical Co., Ltd.

Registration Date : 2020-01-30

Registration Number : 1574-8-ND

Manufacturer Name : Kyungdong Pharmaceutical Co....

Manufacturer Address : 15, Balan Industrial Complex Road 2-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do

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06

MFC

South Korea
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MFC

South Korea
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pitavastatin calcium hydrate

Registrant Name : MFC Corporation

Registration Date : 2017-01-09

Registration Number : 346-1-ND

Manufacturer Name : MFC Corporation

Manufacturer Address : 35 Cheongwon Industrial Complex 7-gil, Mado-myeon, Hwaseong-si, Gyeonggi-do

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07

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pitavastatin calcium

Registrant Name : Hanyoung Farm Co., Ltd.

Registration Date : 2022-07-18

Registration Number : No. 2816-6-ND(3)

Manufacturer Name : Solara Active Pharma Science...

Manufacturer Address : A-1/B, Sipcot Industrial Complex Kudikadu Village, Cuddalore - 607 005 Tamilnadu, Ind...

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08

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pitavastatin calcium

Registrant Name : Chodang Pharmaceutical Industry Co., Ltd.

Registration Date : 2020-01-13

Registration Number : No. 2816-6-ND(1)

Manufacturer Name : Solara Active Pharma Science...

Manufacturer Address : A-1/B, Sipcot Industrial Complex Kudikadu Village, Cuddalore - 607 005 Tamilnadu, Ind...

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09

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pitavastatin calcium

Registrant Name : Masung LS Co., Ltd.

Registration Date : 2016-07-13

Registration Number : No. 2816-6-ND

Manufacturer Name : Solara Active Pharma Science...

Manufacturer Address : A-1/B, Sipcot Industrial Complex Kudikadu Village, Cuddalore - 607 005 Tamilnadu, Ind...

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10

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pitavastatin calcium hydrate

Registrant Name : Pharmasolution Co., Ltd.

Registration Date : 2021-03-18

Registration Number : No. 2816-6-ND(A)

Manufacturer Name : Solara Active Pharma Science...

Manufacturer Address : A-1/B, Sipcot Industrial Complex Kudikadu Village, Cuddalore - 607 005 Tamilnadu, Ind...

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API Reference Price

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04-Jan-2021
18-Jan-2025
KGS
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01

Sanofi

France
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Pittcon 2025
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Switzerland

Pitavastatinum

Brand Name : Pitavastatin Zentiva

Dosage Form : Filmtabl

Dosage Strength : 1mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

02

Sanofi

France
arrow
Pittcon 2025
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Switzerland

Pitavastatinum

Brand Name : Pitavastatin Zentiva

Dosage Form : Filmtabl

Dosage Strength : 1mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

03

Sanofi

France
arrow
Pittcon 2025
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Switzerland

Pitavastatinum

Brand Name : Pitavastatin Zentiva

Dosage Form : Filmtabl

Dosage Strength : 2mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

04

Sanofi

France
arrow
Pittcon 2025
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Switzerland

Pitavastatinum

Brand Name : Pitavastatin Zentiva

Dosage Form : Filmtabl

Dosage Strength : 2mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

05

Sanofi

France
arrow
Pittcon 2025
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Switzerland

Pitavastatinum

Brand Name : Pitavastatin Zentiva

Dosage Form : Filmtabl

Dosage Strength : 4mg

Packaging :

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Pitavastatinum

Brand Name : Pitavastatin Zentiva

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Dosage Strength : 4mg

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pitavastatin calcium

Brand Name : Livazo

Dosage Form : FILM COATED PILL

Dosage Strength : 4 MG

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Lupin Ltd

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PITAVASTATIN SODIUM

Brand Name : NIKITA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 4MG BASE

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Approval Date : 2017-08-04

Application Number : 209875

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Registration Country : USA

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Recordati

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Pitavastatinum

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Spirig Healthcare

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Pitavastatinum

Brand Name : Pitavastatin Spirig HC

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ABOUT THIS PAGE

Looking for 147526-32-7 / Pitavastatin API manufacturers, exporters & distributors?

Pitavastatin manufacturers, exporters & distributors 1

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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.

API | Excipient name

Pitavastatin

Synonyms

Pitavastatin calcium, 147526-32-7, Livalo, Nisvastatin, Nk-104, Itavastatin calcium

Cas Number

147526-32-7

Unique Ingredient Identifier (UNII)

IYD54XEG3W

About Pitavastatin

Pitavastatin Calcium is a calcium salt formulation of pitavastatin, a novel statin that induces plaque regression and elevates HDL-cholesterol levels.

(E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid Manufacturers

A (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid, including repackagers and relabelers. The FDA regulates (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid 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 (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

(E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid Suppliers

A (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid supplier is an individual or a company that provides (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid active pharmaceutical ingredient (API) or (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid finished formulations upon request. The (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid suppliers may include (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid API manufacturers, exporters, distributors and traders.

click here to find a list of (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

(E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid USDMF

A (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid DMF (Drug Master File) is a document detailing the whole manufacturing process of (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid active pharmaceutical ingredient (API) in detail. Different forms of (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid DMFs exist exist since differing nations have different regulations, such as (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid DMF submitted to regulatory agencies in the US is known as a USDMF. (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid USDMF includes data on (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid suppliers with USDMF on PharmaCompass.

(E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid 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 (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid Drug Master File in Japan ((E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid JDMF) empowers (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid 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 (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid JDMF during the approval evaluation for pharmaceutical products. At the time of (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid 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 (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid suppliers with JDMF on PharmaCompass.

(E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid Drug Master File in Korea ((E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid. The MFDS reviews the (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid KDMF as part of the drug registration process and uses the information provided in the (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid KDMF to evaluate the safety and efficacy of the drug.

After submitting a (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid 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 (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid API can apply through the Korea Drug Master File (KDMF).

click here to find a list of (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid suppliers with KDMF on PharmaCompass.

(E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid WC

A (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid written confirmation ((E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid WC) is an official document issued by a regulatory agency to a (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid manufacturer, verifying that the manufacturing facility of a (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid APIs or (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid finished pharmaceutical products to another nation, regulatory agencies frequently require a (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid WC (written confirmation) as part of the regulatory process.

click here to find a list of (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid suppliers with Written Confirmation (WC) on PharmaCompass.

(E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid 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 (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid 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 (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid 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 (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid suppliers with NDC on PharmaCompass.

(E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid GMP

(E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid 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 (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid 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 (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid GMP manufacturer or (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid GMP API supplier for your needs.

(E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid CoA

A (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid CoA (Certificate of Analysis) is a formal document that attests to (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid's compliance with (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid specifications and serves as a tool for batch-level quality control.

(E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid CoA mostly includes findings from lab analyses of a specific batch. For each (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid 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.

(E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid may be tested according to a variety of international standards, such as European Pharmacopoeia ((E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid EP), (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid JP (Japanese Pharmacopeia) and the US Pharmacopoeia ((E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid 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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