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List of Drug Master Files (KDMF) for Famotidine Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

Client Email

Product

Famotidine
CAS 106649-96-1
Calcium Carbonate
KDMF

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Famotidine

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

61 API Suppliers, 24 USDMF, 16 CEP/COS, 13 JDMF, 16 EU WC, 33 KDMF, 25 NDC API, 35 Listed Suppliers, $ API Reference Price

61 API Suppliers
24 USDMF
16 CEP/COS
13 JDMF
16 EU WC
33 KDMF
25 NDC API
35 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

10 Drugs in Development

10 Drugs in Development

PRICE INFORMATION

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

API Reference Price
API Exports
API Imports
FDF Imports

INTERMEDIATES

16 API Suppliers

16 API Suppliers

FINISHED DOSAGE FORMULATIONS

215 FDF Dossiers, 143 FDA Orange Book, 24 Europe, 13 Canada, 2 Australia, 33 Listed Dossiers

215 FDF Dossiers
143 FDA Orange Book
24 Europe
13 Canada
2 Australia
33 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
FOR SUSPENSION;ORAL - 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Evonik, 7 Rochem International Inc, 17 SPI Pharma, 2 Seqens, 6 DKSH, 2 Jai Radhe Sales, 2 Pharm-RX Chemical, 1 Boai NKY Pharmaceuticals Ltd, 14 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 ACG Worldwide, 10 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 30 BASF, 1 Bioplus Life Sciences, 2 Clariant, 13 Corel Pharma Chem, 7 DFE Pharma, 2 Finar, 12 Gangwal Chemicals, 11 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 18 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 10 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 28 Roquette, 13 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

97 Fillers, Diluents & Binders, 69 Coating Systems & Additives, 44 Direct Compression, 40 Controlled & Modified Release, 36 Thickeners and Stabilizers, 35 Solubilizers, 33 Disintegrants & Superdisintegrants, 28 Granulation, 28 Taste Masking, 25 Parenteral, 22 Topical, 19 Co-Processed Excipients, 18 Lubricants & Glidants, 17 Chewable & Orodispersible Aids, 15 Film Formers & Plasticizers, 10 Emulsifying Agents, 10 Rheology Modifiers, 9 API Stability Enhancers, 5 Empty Capsules, 5 Surfactant & Foaming Agents, 4 Vegetarian Capsules, 4 Coloring Agents

97 Fillers, Diluents & Binders
69 Coating Systems & Additives
44 Direct Compression
40 Controlled & Modified Release
36 Thickeners and Stabilizers
35 Solubilizers
33 Disintegrants & Superdisintegrants
28 Granulation
28 Taste Masking
25 Parenteral
22 Topical
19 Co-Processed Excipients
18 Lubricants & Glidants
17 Chewable & Orodispersible Aids
15 Film Formers & Plasticizers
10 Emulsifying Agents
10 Rheology Modifiers
9 API Stability Enhancers
5 Empty Capsules
5 Surfactant & Foaming Agents
4 Vegetarian Capsules
4 Coloring Agents

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 61 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
61 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions, 31 Finished Drug Prices, 3 Annual Reports

4 US Medicaid Prescriptions
31 Finished Drug Prices
3 Annual Reports

MARKET PLACE

40 APIs, 42 FDF Dossiers

40 APIs
42 FDF Dossiers

PATENTS & EXCLUSIVITIES

5 US Patents, 4 Health Canada Patents

5 US Patents
4 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 6 USP, 16 Others

3 EDQM
6 USP
16 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 101 Xls

Filters

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Filters

FILTER :

filter Manufacturer Reset all filters

34 All

01 1Alembic Pharmaceuticals Limited (API Unit-I)

02 1Gedeon Richter Plc.

03 5IPCA Laboratories Limited.

04 1Kekule Pharma Limited

05 7Nakoda Chemicals Limited

06 1Orchev Pharma Pvt. Ltd.

07 1Phalanx Labs Private Limited

08 2Rakshit Pharmaceuticals Limited

09 3SMS Lifesciences India Limited (Unit-Ⅰ)

10 1SMS Lifesciences India Limited.

11 5SMS Pharmaceuticals Limited

12 5Union Quimico Farmaceutica SA

13 1Union quimico farmaceutica, SA

filter Registrant Name Reset all filters

34 All

01 1Ace Biopharm Co., Ltd.

02 3Daeshin Pharmaceutical Co., Ltd.

03 1Dong-A ST Co., Ltd.

04 2Hanyoung Farm Co., Ltd.

05 1Hiple Co., Ltd.

06 1Hwaduk Pharmaceutical Co., Ltd.

07 2Hwail Pharmaceutical Co., Ltd.

08 3IMCD Korea Co., Ltd.

09 1Ilhwa Co., Ltd.

10 1Jeil Pharmaceutical Co., Ltd.

11 1Masung LS Co., Ltd.

12 1Myungin Pharmaceutical Co., Ltd.

13 1Narsha Farm Co., Ltd.

14 1Pampia Co., Ltd.

15 2Pharmapia Co., Ltd.

16 1SSFarm Co., Ltd.

17 1Samoh Pharmaceutical Co., Ltd.

18 1Sangjin Corporation

19 4Sanil Pharma Co., Ltd.

20 2Sanil Pharmaceutical Co., Ltd.

21 2Sungjin Exim Co., Ltd.

22 1Toru Corporation

filter Product Name Reset all filters

34 All

01 34Famotidine

filter Country Reset all filters

34 All

01 1Hungary

02 27India

03 6Spain

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

List of Suppliers

Product Main Page

01

Alembic Pharmaceuticals Limited

BioJapan 2024

Not Confirmed

Alembic Pharmaceuticals Limited

BioJapan 2024

Not Confirmed

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Digital Content

Registrant Name : Pharmapia Co., Ltd.

Registration Date : 2024-03-18

Registration Number : 20240318-67-B-476-15

Manufacturer Name : Alembic Pharmaceuticals Limi...

Manufacturer Address : AT-Panelav, PO Tajpura, Nr. Baska, Tal-Halol, City: Panelav, Dist: Panchmahal, Gujara...

Product Web Link

Digital Content

02

Ipca Laboratories

BioJapan 2024

Not Confirmed