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List of Drug Master Files (DMF) of Pitavastatin Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

Client Email

Product

Pitavastatin
Pitavastatin Magnesium
USDMF

EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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Bora Pharmaceuticals- Making success more certain.

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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

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Axplora- The partner of choice for complex APIs.

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Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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Pitavastatin

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

43 API Suppliers, 16 USDMF, 21 JDMF, 7 EU WC, 19 KDMF, 7 NDC API, 15 Listed Suppliers, $ API Reference Price

43 API Suppliers
16 USDMF
21 JDMF
7 EU WC
19 KDMF
7 NDC API
15 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Imports

API Reference Price
API Exports
API Imports
FDF Imports

INTERMEDIATES

1 API Suppliers

1 API Suppliers

FINISHED DOSAGE FORMULATIONS

95 FDF Dossiers, 30 FDA Orange Book, 50 Europe, 15 Listed Dossiers

95 FDF Dossiers
30 FDA Orange Book
50 Europe
15 Listed Dossiers

RELATED EXCIPIENT COMPANIES

3 DKSH, 4 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 1 Actylis, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 10 Corel Pharma Chem, 2 DFE Pharma, 5 Gangwal Chemicals, 4 Ideal Cures Pvt Ltd, 26 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 8 Microlex e.U, 1 Novo Excipients, 2 Pluviaendo, 1 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 2 Roquette, 6 Seppic, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 3 Sigachi Industries, 2 The Dow Chemical Company, 1 Vasa Pharmachem, 1 Vertellus

3 DKSH
4 Gangwal Healthcare
2 Nanjing Well Pharmaceutical
1 ACG Worldwide
1 Actylis
4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
10 Corel Pharma Chem
2 DFE Pharma
5 Gangwal Chemicals
4 Ideal Cures Pvt Ltd
26 Kerry
3 Kima Chemical
6 Lonza Capsugel
8 Microlex e.U
1 Novo Excipients
2 Pluviaendo
1 Prachin Chemical
1 Qianhao Chemical (Hebei) Co., Ltd
1 Qualicaps
2 Roquette
6 Seppic
2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
3 Sigachi Industries
2 The Dow Chemical Company
1 Vasa Pharmachem
1 Vertellus

EXCIPIENTS BY APPLICATIONS

43 Coating Systems & Additives, 31 Fillers, Diluents & Binders, 18 Controlled & Modified Release, 10 Direct Compression, 10 Lubricants & Glidants, 9 Film Formers & Plasticizers, 6 Granulation, 5 Co-Processed Excipients, 5 Empty Capsules, 5 Emulsifying Agents, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Coloring Agents, 3 Taste Masking, 3 Solubilizers, 3 Thickeners and Stabilizers, 2 Disintegrants & Superdisintegrants, 2 Surfactant & Foaming Agents, 1 Topical, 1 Rheology Modifiers, 1 Chewable & Orodispersible Aids, 1 Parenteral

43 Coating Systems & Additives
31 Fillers, Diluents & Binders
18 Controlled & Modified Release
10 Direct Compression
10 Lubricants & Glidants
9 Film Formers & Plasticizers
6 Granulation
5 Co-Processed Excipients
5 Empty Capsules
5 Emulsifying Agents
4 Vegetarian Capsules
4 API Stability Enhancers
4 Coloring Agents
3 Taste Masking
3 Solubilizers
3 Thickeners and Stabilizers
2 Disintegrants & Superdisintegrants
2 Surfactant & Foaming Agents
1 Topical
1 Rheology Modifiers
1 Chewable & Orodispersible Aids
1 Parenteral

DIGITAL CONTENT

19 NEWS #PharmaBuzz

19 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 47 Finished Drug Prices

1 US Medicaid Prescriptions
47 Finished Drug Prices

MARKET PLACE

17 APIs, 1 FDF Dossiers

17 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

12 US Patents, 3 US Exclusivities

12 US Patents
3 US Exclusivities

REF. STANDARDS & IMPURITIES

3 JP, 10 Others

3 JP
10 Others

$ API Ref.Price (USD/KG) : 10,542 Xls

Filters

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16 All

01 1Aurobindo Pharma Limited

02 1Fuxin Long Rui Pharmaceutical

03 1Hetero Drugs

04 1JILIN ASYMCHEM LABORATORIES CO LTD

05 1KOLON Life Science, Inc

06 1Kowa India

07 2Lupin Ltd

08 1MSN Laboratories

09 2Nissan Chemical

10 1Solara Active Pharma Sciences

11 1Viatris

12 1Wanbang Biopharmaceuticals

13 1Zhejiang Hisun Pharmaceutical

14 1Zydus Lifesciences

filter Subject Reset all filters

16 All

01 1NK-104 TABLETS

02 11PITAVASTATIN CALCIUM

03 1PITAVASTATIN CALCIUM (ASYMMETRIC SYNTHESIS METHOD)

04 1PITAVASTATIN CALCIUM (NON-STERILE DRUG SUBSTANCE)

05 1PITAVASTATIN CALCIUM (PENTAHYDRATE)

06 1PITAVASTATIN SODIUM

filter Country Reset all filters

16 All

01 3China

02 8India

03 2Japan

04 1South Korea

05 2U.S.A

filter Status Reset all filters

16 All

01 13Active

02 3Inactive

filter GDUFA DMF Review Reset all filters

16 All

01 9Complete

02 7Blank

API Suppliers
USDMF
JDMF
EU WC
KDMF
NDC API
Listed Suppliers

List of Suppliers

Product Main Page

01

Apitoria Pharma Private Ltd

USDMF

Discovery on Target

Not Confirmed

01

Apitoria Pharma Private Ltd

Discovery on Target

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Pitavastatin Calcium (non-sterile Drug Substan...

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

Portfolio PDF

Product Web Link

Digital Content

02

Hetero Drugs Ltd

USDMF

Discovery on Target

Not Confirmed

02

Hetero Drugs Ltd

Discovery on Target

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Pitavastatin Calcium

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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Lupin Ltd

USDMF

Discovery on Target

Not Confirmed

03

Lupin Ltd

Discovery on Target

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Pitavastatin Calcium

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

Product Web Link

Digital Content

Corporate PDF

04

Lupin Ltd

USDMF

Discovery on Target

Not Confirmed

04

Lupin Ltd

Discovery on Target

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Pitavastatin Sodium

GDUFA

DMF Review : Complete

Rev. Date : 2016-05-31

Pay. Date : 2015-11-12

DMF Number : 29650

Submission : 2015-11-06

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

05

Msn Laboratories Private Ltd

USDMF

Discovery on Target

Not Confirmed

05

Msn Laboratories Private Ltd

Discovery on Target

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Pitavastatin Calcium (pentahydrate)

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

Product Web Link

Digital Content

Corporate PDF

06

Nissan Chemical Corp

USDMF

Discovery on Target

Not Confirmed

06

Nissan Chemical Corp

Discovery on Target

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Pitavastatin Calcium (asymmetric Synthesis Met...

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 27761

Submission : 2013-12-10

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Nissan Chemical Corp

USDMF

Discovery on Target

Not Confirmed

07

Nissan Chemical Corp

Discovery on Target

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Post an Enquiry

Digital Content

Pitavastatin Calcium

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 14660

Submission : 2000-01-11

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Solara Active Pharma Sciences Ltd

USDMF

Discovery on Target

Not Confirmed

08

Solara Active Pharma Sciences Ltd

Discovery on Target

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Pitavastatin Calcium

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

Product Web Link

Digital Content

09

Tianish Laboratories Private Ltd

USDMF

Discovery on Target

Not Confirmed

09

Tianish Laboratories Private Ltd

Discovery on Target

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Pitavastatin Calcium

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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Zydus Lifesciences Ltd

USDMF

Discovery on Target

Not Confirmed

10

Zydus Lifesciences Ltd

Discovery on Target

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Pitavastatin Calcium

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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

1
2

Pitavastatin Manufacturers | Traders | Suppliers

Pitavastatin Manufacturers, Traders, Suppliers 1

32

We have 14 companies offering Pitavastatin

Get in contact with the supplier of your choice:

Aurobindo Pharma Limited
Fuxin Long Rui Pharmaceutical
Hetero Drugs
JILIN ASYMCHEM LABORATORIES CO LTD
KOLON Life Science, Inc
Kowa India
Lupin Ltd
MSN Laboratories
Nissan Chemical
Solara Active Pharma Sciences
Viatris
Wanbang Biopharmaceuticals
Zhejiang Hisun Pharmaceutical
Zydus Lifesciences

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