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

Client Email

Product

Simvastatin
Mls006010119
Lovastatin
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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Simvastatin

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

71 API Suppliers, 39 USDMF, 41 CEP/COS, 6 JDMF, 10 EU WC, 50 KDMF, 12 NDC API, 17 Listed Suppliers, $ API Reference Price

71 API Suppliers
39 USDMF
41 CEP/COS
6 JDMF
10 EU WC
50 KDMF
12 NDC API
17 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

PRICE INFORMATION

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

API Reference Price
API Exports
API Imports
FDF Exports
FDF Imports

FINISHED DOSAGE FORMULATIONS

971 FDF Dossiers, 128 FDA Orange Book, 572 Europe, 65 Canada, 50 Australia, 86 South Africa, 70 Listed Dossiers

971 FDF Dossiers
128 FDA Orange Book
572 Europe
65 Canada
50 Australia
86 South Africa
70 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG, TABLET;ORAL - 20MG, TABLET;ORAL - 40MG, TABLET;ORAL - 5MG, TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SUSPENSION;ORAL - 20MG/5ML, SUSPENSION;ORAL - 40MG/5ML, TABLET;ORAL - 10MG;10MG, TABLET;ORAL - 10MG;20MG, TABLET;ORAL - 10MG;40MG, TABLET;ORAL - 10MG;80MG

TABLET;ORAL - 10MG
TABLET;ORAL - 20MG
TABLET;ORAL - 40MG
TABLET;ORAL - 5MG
TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SUSPENSION;ORAL - 20MG/5ML
SUSPENSION;ORAL - 40MG/5ML
TABLET;ORAL - 10MG;10MG
TABLET;ORAL - 10MG;20MG
TABLET;ORAL - 10MG;40MG
TABLET;ORAL - 10MG;80MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 Rochem International Inc, 5 SPI Pharma, 2 Seqens, 5 DKSH, 1 Jai Radhe Sales, 1 Pharm-RX Chemical, 1 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 3 Actylis, 2 Aeon Procare, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 26 BASF, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 8 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 36 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 2 Nomisma Healthcare, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 6 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 7 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

74 Fillers, Diluents & Binders, 51 Coating Systems & Additives, 36 Direct Compression, 30 Controlled & Modified Release, 27 Thickeners and Stabilizers, 24 Granulation, 22 Disintegrants & Superdisintegrants, 21 Lubricants & Glidants, 20 Solubilizers, 18 Film Formers & Plasticizers, 16 Co-Processed Excipients, 15 Topical, 12 Taste Masking, 9 Parenteral, 7 API Stability Enhancers, 6 Chewable & Orodispersible Aids, 6 Emulsifying Agents, 6 Rheology Modifiers, 5 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents

74 Fillers, Diluents & Binders
51 Coating Systems & Additives
36 Direct Compression
30 Controlled & Modified Release
27 Thickeners and Stabilizers
24 Granulation
22 Disintegrants & Superdisintegrants
21 Lubricants & Glidants
20 Solubilizers
18 Film Formers & Plasticizers
16 Co-Processed Excipients
15 Topical
12 Taste Masking
9 Parenteral
7 API Stability Enhancers
6 Chewable & Orodispersible Aids
6 Emulsifying Agents
6 Rheology Modifiers
5 Empty Capsules
5 Coloring Agents
4 Vegetarian Capsules
3 Surfactant & Foaming Agents

DIGITAL CONTENT

7 DATA COMPILATION #PharmaFlow, 48 NEWS #PharmaBuzz

7 DATA COMPILATION #PharmaFlow
48 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 525 Finished Drug Prices, 10 Annual Reports

2 US Medicaid Prescriptions
525 Finished Drug Prices
10 Annual Reports

MARKET PLACE

18 APIs, 6 FDF Dossiers

18 APIs
6 FDF Dossiers

PATENTS & EXCLUSIVITIES

16 US Patents, 5 Health Canada Patents

16 US Patents
5 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 5 USP, 4 JP, 11 Others

2 EDQM
5 USP
4 JP
11 Others

ANALYTICAL

7 BioAnalytical Methods

7 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 227 Xls

Filters

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Filters

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39 All

01 1Artemis Biotech

02 1Aurobindo Pharma Limited

03 2Biocon

04 1Glenmark Pharmaceuticals

05 2HEC Pharm

06 4HENAN TOPFOND PHARMACEUTICAL Co,. Ltd

07 2Hetero Drugs

08 1Jubilant Generics

09 2Krebs Biochemicals & Industries Ltd

10 1Lek Pharmaceuticals

11 1Lupin Ltd

12 1RANBAXY LABORATORIES LIMITED

13 1SYNTHON Chemicals GmbH & Co. KG

14 1Sandoz B2B

15 2Southwest Synthetic Pharmaceutical

16 2Sterling Biotech

17 2Teva API

18 1Viatris

19 1Zhejiang Apeloa Kangyu Pharmaceutical Co. Ltd

20 2Zhejiang Hisun Pharmaceutical

21 4Zhejiang Jiangbei Pharmaceutical

22 1Zhejiang Ruibang Laboratories

23 3Zydus Lifesciences

filter Subject Reset all filters

39 All

01 9SIMVASTATIN

02 1SIMVASTATIN (DRUG SUBSTANCE)

03 1SIMVASTATIN ( LOVASTATIN ROUTE)

04 1SIMVASTATIN (AMMONIUM SALT ROUTE)

05 1SIMVASTATIN (BHA ADDED) USP

06 1SIMVASTATIN (ETHANOL PROCESS)

07 1SIMVASTATIN (WITH 0.01% BHA)

08 2SIMVASTATIN AMMONIUM SALT

09 1SIMVASTATIN AMMONIUM SALT (ALTERNATIVE PROCESS)

10 1SIMVASTATIN AMMONIUM SALT (DRUG SUBSTANCE INTERMEDIATE)

11 2SIMVASTATIN AMMONIUM SALT (INTERMEDIATE)

12 1SIMVASTATIN AMMONIUM SALT(DRUG SUBSTANCE INTERMEDIATE)

13 1SIMVASTATIN NON-STERILE BULK DRUG SUBSTANCE

14 1SIMVASTATIN NON-STERILE DRUG SUBSTANCE, BULK FORM

15 12SIMVASTATIN USP

16 1SIMVASTATIN USP BULK

17 1SIMVASTATIN, NON-STERILE BULK FORM

18 1SIMVASTATIN, USP (PROCESS II)

filter Country Reset all filters

39 All

01 16China

02 1Germany

03 17India

04 2Israel

05 1Slovenia

06 1Switzerland

07 1U.S.A

filter Status Reset all filters

39 All

01 15Active

02 24Inactive

filter GDUFA DMF Review Reset all filters

39 All

01 9Complete

02 30Blank

API Suppliers
USDMF
CEP/COS
JDMF
EU WC
KDMF
NDC API
Listed Suppliers

List of Suppliers

Product Main Page

01

Apitoria Pharma Private Ltd

USDMF

Luxepack

Not Confirmed

01

Apitoria Pharma Private Ltd

Luxepack

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

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Digital Content

Simvastatin Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 17829

Submission : 2004-11-08

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

02

Biocon Ltd

USDMF

Discovery on Target

Not Confirmed

02

Biocon 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

Simvastatin

GDUFA

DMF Review : Complete

Rev. Date : 2013-03-15

Pay. Date : 2013-03-01

DMF Number : 18449

Submission : 2005-06-23

Status : Active

Type : II

Product Web Link

Digital Content

03

Henan Topfond Pharmaceutical Co Ltd

USDMF

Discovery on Target

Not Confirmed

03

Henan Topfond Pharmaceutical Co 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

Simvastatin, Non-sterile Bulk Form

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 19545

Submission : 2006-04-20

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Jubilant Pharmova Ltd

USDMF

Discovery on Target

Not Confirmed

04

Jubilant Pharmova 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

Simvastatin Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 18755

Submission : 2005-09-13

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Lupin Ltd

USDMF

Discovery on Target

Not Confirmed

05

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

Simvastatin Usp

GDUFA

DMF Review : Complete

Rev. Date : 2017-03-17

Pay. Date : 2017-02-28

DMF Number : 17934

Submission : 2004-12-27

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

06

Southwest Synthetic Pharmaceutical C...

USDMF

Discovery on Target

Not Confirmed

06

Southwest Synthetic Pharmaceutical C...

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

Simvastatin Usp

GDUFA

DMF Review : Complete

Rev. Date : 2014-08-18

Pay. Date : 2013-09-23

DMF Number : 23425

Submission : 2009-12-29

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Teva Pharmaceutical Industries Ltd

USDMF

Discovery on Target

Not Confirmed

07

Teva Pharmaceutical Industries 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

Simvastatin (ethanol Process)

GDUFA

DMF Review : Complete

Rev. Date : 2014-01-13

Pay. Date : 2012-11-13

DMF Number : 25024

Submission : 2011-06-08

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

08

Teva Pharmaceutical Industries Ltd

USDMF

Discovery on Target

Not Confirmed

08

Teva Pharmaceutical Industries 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

Simvastatin

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 14599

Submission : 1999-11-29

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

09

Zhejiang Hisun Pharmaceutical Co Ltd

USDMF

Discovery on Target

Not Confirmed

09

Zhejiang Hisun Pharmaceutical Co 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

Simvastatin Usp

GDUFA

DMF Review : Complete

Rev. Date : 2013-08-29

Pay. Date : 2012-11-15

DMF Number : 16305

Submission : 2002-12-11

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Zhejiang Jiangbei Pharmaceutical Co ...

USDMF

Discovery on Target

Not Confirmed

10

Zhejiang Jiangbei Pharmaceutical Co ...

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

Simvastatin

GDUFA

DMF Review : Complete

Rev. Date : 2017-03-20

Pay. Date : 2016-09-26

DMF Number : 26971

Submission : 2013-03-04

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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Last

Simvastatin Manufacturers | Traders | Suppliers

Simvastatin Manufacturers, Traders, Suppliers 1

50

We have 23 companies offering Simvastatin

Get in contact with the supplier of your choice:

Artemis Biotech
Aurobindo Pharma Limited
Biocon
Glenmark Pharmaceuticals
HEC Pharm
HENAN TOPFOND PHARMACEUTICAL Co,. Ltd
Hetero Drugs
Jubilant Generics
Krebs Biochemicals & Industries Ltd
Lek Pharmaceuticals
Lupin Ltd
RANBAXY LABORATORIES LIMITED
Sandoz B2B
Southwest Synthetic Pharmaceutical
Sterling Biotech
SYNTHON Chemicals GmbH & Co. KG
Teva API
Viatris
Zhejiang Apeloa Kangyu Pharmaceutical Co. Ltd
Zhejiang Hisun Pharmaceutical
Zhejiang Jiangbei Pharmaceutical
Zhejiang Ruibang Laboratories
Zydus Lifesciences

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