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List of Drug Master Files (KDMF) for NCGC00024983-08 Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

Client Email

Product

NCGC00024983-08
KDMF

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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NCGC00024983-08

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

58 API Suppliers, 38 USDMF, 9 CEP/COS, 7 JDMF, 4 EU WC, 7 KDMF, 19 NDC API, 18 Listed Suppliers, $ API Reference Price

58 API Suppliers
38 USDMF
9 CEP/COS
7 JDMF
4 EU WC
7 KDMF
19 NDC API
18 Listed Suppliers
$ API Reference Price

PRICE INFORMATION

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

API Reference Price
API Exports
API Imports
FDF Exports
FDF Imports

INTERMEDIATES

3 API Suppliers

3 API Suppliers

FINISHED DOSAGE FORMULATIONS

273 FDF Dossiers, 75 FDA Orange Book, 100 Europe, 18 Canada, 8 Australia, 32 South Africa, 40 Listed Dossiers

273 FDF Dossiers
75 FDA Orange Book
100 Europe
18 Canada
8 Australia
32 South Africa
40 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 10MG, CAPSULE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 30MG, TABLET, EXTENDED RELEASE;ORAL - 60MG, TABLET, EXTENDED RELEASE;ORAL - 90MG, TABLET, EXTENDED RELEASE;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - 10MG
CAPSULE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 30MG
TABLET, EXTENDED RELEASE;ORAL - 60MG
TABLET, EXTENDED RELEASE;ORAL - 90MG
TABLET, EXTENDED RELEASE;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Evonik, 2 Rochem International Inc, 6 SPI Pharma, 2 Seqens, 12 DKSH, 4 Boai NKY Pharmaceuticals Ltd, 12 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 8 Actylis, 1 Aeon Procare, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 26 BASF, 1 Clariant, 12 Corel Pharma Chem, 5 DFE Pharma, 3 Doshion Polyscience, 3 Finar, 8 Gangwal Chemicals, 11 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 39 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 2 Nomisma Healthcare, 3 Novo Excipients, 2 Pharmatrans-Sanaq, 7 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 24 Roquette, 10 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

81 Fillers, Diluents & Binders, 63 Coating Systems & Additives, 40 Controlled & Modified Release, 33 Direct Compression, 28 Thickeners and Stabilizers, 23 Film Formers & Plasticizers, 23 Granulation, 21 Parenteral, 21 Solubilizers, 20 Topical, 20 Taste Masking, 19 Co-Processed Excipients, 17 Lubricants & Glidants, 13 Disintegrants & Superdisintegrants, 9 Empty Capsules, 8 Chewable & Orodispersible Aids, 7 Emulsifying Agents, 6 Rheology Modifiers, 6 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Soft Gelatin

81 Fillers, Diluents & Binders
63 Coating Systems & Additives
40 Controlled & Modified Release
33 Direct Compression
28 Thickeners and Stabilizers
23 Film Formers & Plasticizers
23 Granulation
21 Parenteral
21 Solubilizers
20 Topical
20 Taste Masking
19 Co-Processed Excipients
17 Lubricants & Glidants
13 Disintegrants & Superdisintegrants
9 Empty Capsules
8 Chewable & Orodispersible Aids
7 Emulsifying Agents
6 Rheology Modifiers
6 API Stability Enhancers
5 Coloring Agents
4 Vegetarian Capsules
4 Surfactant & Foaming Agents
1 Soft Gelatin

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 18 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
18 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 106 Finished Drug Prices, 10 Annual Reports

2 US Medicaid Prescriptions
106 Finished Drug Prices
10 Annual Reports

MARKET PLACE

20 APIs, 16 FDF Dossiers

20 APIs
16 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 Health Canada Patents

4 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 3 USP, 15 Others

3 EDQM
3 USP
15 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 81 Xls

Filters

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Filters

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filter Manufacturer Reset all filters

7 All

01 1Bayer AG

02 1Bayer AG@Bayer AG

03 1Bayer Hispania SL, La Felguera

04 1FIS Fabbrica Italiana Sintetici SpA@[micronization process manufacturing plant] Micro-Macinazione SA

05 1Siegfried AG._x000D_

06 1Unique Chemicals (A Division of JB Chemicals & Pharmaceuticals Limited)_x000D_

07 1Unique chemicals (A Division of JB Chemicals & Pharmaceuticals Limited)

filter Registrant Name Reset all filters

7 All

01 3Bayer Korea Co., Ltd.

02 2Ellison Pharmaceutical Co., Ltd.

03 1Kwangdong Pharmaceutical Co., Ltd.

04 1Masung LS Co., Ltd.

filter Product Name Reset all filters

7 All

01 7nifedipine

filter Country Reset all filters

7 All

01 3Germany

02 1Italy

03 1Switzerland

04 2Blank

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

List of Suppliers

Product Main Page

01

Bayer AG

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Bayer AG

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Registrant Name : Bayer Korea Co., Ltd.

Registration Date : 2011-04-29

Registration Number : 20110429-134-H-54-03

Manufacturer Name : Bayer AG@Bayer AG

Manufacturer Address : 51368 Leverkusen@Friedrich-Ebert-Str. 217-333, 42117 Wuppertal, Germany

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02

Bayer AG

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Bayer AG

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Digital Content

Registrant Name : Bayer Korea Co., Ltd.

Registration Date : 2011-04-29

Registration Number : 20110429-134-H-46-02

Manufacturer Name : Bayer AG

Manufacturer Address : Friedrich-Ebert-Str.217-333, 42117 Wuppertal

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Corporate PDF

03

Bayer AG

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Bayer AG

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Digital Content

Registrant Name : Bayer Korea Co., Ltd.

Registration Date : 2022-10-24

Registration Number : 20221024-134-H-404-06

Manufacturer Name : Bayer Hispania SL, La Felgue...

Manufacturer Address : Bayer Hispania SL Sabino Alonso Fueyo, 77, 33934 La Felguera, Asturias, Spain

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04

F.I.S. Fabbrica Italiana Sintetici

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F.I.S. Fabbrica Italiana Sintetici

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Registrant Name : Kwangdong Pharmaceutical Co., Ltd.

Registration Date : 2011-09-02

Registration Number : 20110902-134-H-31-04

Manufacturer Name : FIS Fabbrica Italiana Sintet...

Manufacturer Address : Via Dovaro 36045 Lonigo@[Pulverization Process Manufactory] Via Cantonale 4, 6998 Mon...

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05

Siegfried AG

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Siegfried AG

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Registrant Name : Ellison Pharmaceutical Co., Ltd.

Registration Date : 2011-03-31

Registration Number : 20110331-134-H-99-01

Manufacturer Name : Siegfried AG._x000D_

Manufacturer Address : Untere Bruhlstrasse 4, 4800 Zofingen, switzerland

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06

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Registrant Name : Masung LS Co., Ltd.

Registration Date : 2023-08-08

Registration Number : 20141208-134-H-266-05(1)

Manufacturer Name : Unique chemicals (A Division...

Manufacturer Address : Plot No. 5, Phase IV, GIDC Industrial area, City: Panoli-394 116, Dist. Bharuch, Guja...

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07

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Country

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Registrant Name : Ellison Pharmaceutical Co., Ltd.

Registration Date : 2014-12-08

Registration Number : 20141208-134-H-266-05

Manufacturer Name : Unique Chemicals (A Division...

Manufacturer Address : Plot No. 5, Phase IV, GIDC Industrial area, City: Panoli-394 116, Dist. Bharuch, Guja...

Portfolio PDF

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Website

Corporate PDF

NCGC00024983-08 Manufacturers | Traders | Suppliers

NCGC00024983-08 Manufacturers, Traders, Suppliers 1

91

We have 3 companies offering NCGC00024983-08

Get in contact with the supplier of your choice:

Bayer AG
F.I.S. Fabbrica Italiana Sintetici
Siegfried AG

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