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List of Drug Master Files (DMF) of NCGC00024859-04 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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Product

NCGC00024859-04
USDMF

Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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xyz-pharma-m-2024-09-09

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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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xyz-pharma-m-2024-09-09

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NCGC00024859-04

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

35 API Suppliers, 22 USDMF, 5 CEP/COS, 8 JDMF, 40 KDMF, 10 NDC API, 5 Listed Suppliers, $ API Reference Price

35 API Suppliers
22 USDMF
5 CEP/COS
8 JDMF
40 KDMF
10 NDC API
5 Listed Suppliers
$ API Reference Price

PRICE INFORMATION

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

API Reference Price
API Exports
API Imports
FDF Exports

INTERMEDIATES

1 API Suppliers

1 API Suppliers

FINISHED DOSAGE FORMULATIONS

130 FDF Dossiers, 71 FDA Orange Book, 2 Europe, 7 Canada, 27 South Africa, 23 Listed Dossiers

130 FDF Dossiers
71 FDA Orange Book
2 Europe
7 Canada
27 South Africa
23 Listed Dossiers

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 2 Seqens, 2 DKSH, 2 Jai Radhe Sales, 1 Boai NKY Pharmaceuticals Ltd, 12 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 24 BASF, 10 Corel Pharma Chem, 4 DFE Pharma, 1 Finar, 9 Gangwal Chemicals, 6 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 16 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 9 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 5 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 13 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 4 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

49 Coating Systems & Additives, 46 Fillers, Diluents & Binders, 32 Controlled & Modified Release, 30 Disintegrants & Superdisintegrants, 29 Direct Compression, 23 Solubilizers, 20 Thickeners and Stabilizers, 20 Granulation, 15 Lubricants & Glidants, 13 Film Formers & Plasticizers, 13 Co-Processed Excipients, 11 Topical, 10 Parenteral, 10 Taste Masking, 6 Chewable & Orodispersible Aids, 6 Emulsifying Agents, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 4 API Stability Enhancers, 4 Coloring Agents, 4 Rheology Modifiers

49 Coating Systems & Additives
46 Fillers, Diluents & Binders
32 Controlled & Modified Release
30 Disintegrants & Superdisintegrants
29 Direct Compression
23 Solubilizers
20 Thickeners and Stabilizers
20 Granulation
15 Lubricants & Glidants
13 Film Formers & Plasticizers
13 Co-Processed Excipients
11 Topical
10 Parenteral
10 Taste Masking
6 Chewable & Orodispersible Aids
6 Emulsifying Agents
5 Empty Capsules
4 Vegetarian Capsules
4 Surfactant & Foaming Agents
4 API Stability Enhancers
4 Coloring Agents
4 Rheology Modifiers

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 7 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
7 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 9 Finished Drug Prices

2 US Medicaid Prescriptions
9 Finished Drug Prices

MARKET PLACE

25 APIs, 2 FDF Dossiers

25 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

2 Health Canada Patents

2 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 8 Others

3 EDQM
1 USP
8 Others

$ API Ref.Price (USD/KG) : 56 Xls

Filters

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22 All

01 1Apotex Pharmachem

02 1Corden Pharma Bergamo S.p.A

03 2EURAND

04 1Eastman Chemical Company

05 3GSK

06 1Gedeon Richter

07 1Lek Pharmaceuticals

08 1Quimica Sintetica

09 1UNILEVER CANADA INC.

10 1UQUIFA

11 1Wuxi Kaili Pharmaceutical

12 8Blank

filter Subject Reset all filters

22 All

01 1CET ISOTHIOUREA

02 12CIMETIDINE

03 2CIMETIDINE AND CIMETIDINE HCL

04 1CIMETIDINE BASE MICROCAPSULES

05 1CIMETIDINE HCL

06 1CIMETIDINE USP

07 1CIMETIDINE USP XXII

08 1COATED CIMETIDINE POWDER

09 1ENCAPSULATED CIMETIDINE DURKOTE 130M-50 AND DURKOTE 145-50

10 1MICROCAPS CIMETIDINE, USP

filter Country Reset all filters

22 All

01 2Canada

02 1China

03 1Hungary

04 1Italy

05 1Slovenia

06 2Spain

07 3U.S.A

08 3United Kingdom

09 8Blank

filter Status Reset all filters

22 All

01 2Active

02 20Inactive

filter GDUFA DMF Review Reset all filters

22 All

01 1Complete

02 21Blank

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

List of Suppliers

Product Main Page

01

Corden Pharma Bergamo Spa

USDMF

Formnext Forum

Not Confirmed

01

Corden Pharma Bergamo Spa

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Not Confirmed

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Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 5497

Submission : 1984-07-30

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Eastman Chemical Co

USDMF

Formnext Forum

Not Confirmed

02

Eastman Chemical Co

Formnext Forum

Not Confirmed

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Digital Content

Cet Isothiourea

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 3950

Submission : 1980-10-08

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Eurand America Inc

USDMF

Formnext Forum

Not Confirmed

03

Eurand America Inc

Formnext Forum

Not Confirmed

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Digital Content

Cimetidine Base Microcapsules

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 7234

Submission : 1987-11-17

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Smithkline And Beckman Inc

USDMF

Formnext Forum

Not Confirmed

04

Smithkline And Beckman Inc

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Not Confirmed

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Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 5123

Submission : 1983-09-30

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Smithkline Beecham Corp Dba Glaxosmi...

USDMF

Formnext Forum

Not Confirmed

05

Smithkline Beecham Corp Dba Glaxosmi...

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Not Confirmed

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Digital Content

Cimetidine And Cimetidine Hcl

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 2716

Submission : 1976-08-10

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Unilever United States Inc

USDMF

Formnext Forum

Not Confirmed

06

Unilever United States Inc

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Digital Content

Encapsulated Cimetidine Durkote 130m-50 And Du...

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 7201

Submission : 1987-10-23

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Union Quimico Farmaceutica Sa (uquif...

USDMF

Formnext Forum

Not Confirmed

07

Union Quimico Farmaceutica Sa (uquif...

Formnext Forum

Not Confirmed

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Digital Content

Cimetidine Usp

GDUFA

DMF Review : Complete

Rev. Date : 2021-07-15

Pay. Date : 2021-07-12

DMF Number : 10982

Submission : 1994-07-11

Status : Active

Type : II

Product Web Link

Digital Content

08

Shanghai No 6 Pharmaceutical Factory

Country

USDMF

Formnext Forum

Not Confirmed

08

Shanghai No 6 Pharmaceutical Factory

Country

Formnext Forum

Not Confirmed

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Country

Virtual Booth

Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 7541

Submission : 1988-06-21

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

09

Sk&f Lab Co Sub Sk Beckman Corp

Country

USDMF

Formnext Forum

Not Confirmed

09

Sk&f Lab Co Sub Sk Beckman Corp

Country

Formnext Forum

Not Confirmed

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Country

Virtual Booth

Digital Content

Cimetidine And Cimetidine Hcl

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 3239

Submission : 1978-07-18

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

10

Syntex Usa Inc

Country

USDMF

Formnext Forum

Not Confirmed

10

Syntex Usa Inc

Country

Formnext Forum

Not Confirmed

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Country

Virtual Booth

Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 2991

Submission : 1977-08-17

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

1
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3

NCGC00024859-04 Manufacturers | Traders | Suppliers

NCGC00024859-04 Manufacturers, Traders, Suppliers 1

36

We have 11 companies offering NCGC00024859-04

Get in contact with the supplier of your choice:

Apotex Pharmachem
Corden Pharma Bergamo S.p.A
Eastman Chemical Company
EURAND
Gedeon Richter
GSK
Lek Pharmaceuticals
Quimica Sintetica
UNILEVER CANADA INC.
UQUIFA
Wuxi Kaili Pharmaceutical

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