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List of Drug Master Files (KDMF) for Prestwick3_000052 Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

Client Email

Product

Prestwick3_000052
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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Prestwick3_000052

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

61 API Suppliers, 22 USDMF, 17 CEP/COS, 7 JDMF, 8 EU WC, 10 KDMF, 20 NDC API, 30 Listed Suppliers, $ API Reference Price

61 API Suppliers
22 USDMF
17 CEP/COS
7 JDMF
8 EU WC
10 KDMF
20 NDC API
30 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 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

INTERMEDIATES

1 API Suppliers

1 API Suppliers

FINISHED DOSAGE FORMULATIONS

289 FDF Dossiers, 91 FDA Orange Book, 91 Europe, 16 Canada, 17 Australia, 16 South Africa, 58 Listed Dossiers

289 FDF Dossiers
91 FDA Orange Book
91 Europe
16 Canada
17 Australia
16 South Africa
58 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 200MG, TABLET, EXTENDED RELEASE;ORAL - 100MG, TABLET, EXTENDED RELEASE;ORAL - 200MG, TABLET, EXTENDED RELEASE;ORAL - 400MG, SOLUTION;INTRAVENOUS - 200MG/20ML (10MG/ML), CAPSULE, EXTENDED RELEASE;ORAL - 100MG, CAPSULE, EXTENDED RELEASE;ORAL - 200MG, CAPSULE, EXTENDED RELEASE;ORAL - 300MG

TABLET;ORAL - 200MG
TABLET, EXTENDED RELEASE;ORAL - 100MG
TABLET, EXTENDED RELEASE;ORAL - 200MG
TABLET, EXTENDED RELEASE;ORAL - 400MG
SOLUTION;INTRAVENOUS - 200MG/20ML (10MG/ML)
CAPSULE, EXTENDED RELEASE;ORAL - 100MG
CAPSULE, EXTENDED RELEASE;ORAL - 200MG
CAPSULE, EXTENDED RELEASE;ORAL - 300MG

RELATED EXCIPIENT COMPANIES

2 Evonik, 4 Rochem International Inc, 17 SPI Pharma, 2 Seqens, 10 DKSH, 1 Jai Radhe Sales, 1 Pharm-RX Chemical, 1 Boai NKY Pharmaceuticals Ltd, 14 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 7 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 31 BASF, 16 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 10 Gangwal Chemicals, 9 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 31 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 16 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 8 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 29 Roquette, 10 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 2 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

91 Fillers, Diluents & Binders, 64 Coating Systems & Additives, 43 Controlled & Modified Release, 42 Direct Compression, 34 Thickeners and Stabilizers, 30 Disintegrants & Superdisintegrants, 30 Granulation, 27 Taste Masking, 24 Solubilizers, 24 Film Formers & Plasticizers, 21 Parenteral, 20 Topical, 19 Lubricants & Glidants, 17 Co-Processed Excipients, 16 Chewable & Orodispersible Aids, 12 Emulsifying Agents, 9 Empty Capsules, 7 API Stability Enhancers, 5 Coloring Agents, 5 Rheology Modifiers, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Dry Powder Inhalation, 1 Soft Gelatin

91 Fillers, Diluents & Binders
64 Coating Systems & Additives
43 Controlled & Modified Release
42 Direct Compression
34 Thickeners and Stabilizers
30 Disintegrants & Superdisintegrants
30 Granulation
27 Taste Masking
24 Solubilizers
24 Film Formers & Plasticizers
21 Parenteral
20 Topical
19 Lubricants & Glidants
17 Co-Processed Excipients
16 Chewable & Orodispersible Aids
12 Emulsifying Agents
9 Empty Capsules
7 API Stability Enhancers
5 Coloring Agents
5 Rheology Modifiers
4 Vegetarian Capsules
4 Surfactant & Foaming Agents
1 Dry Powder Inhalation
1 Soft Gelatin

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 33 NEWS #PharmaBuzz

2 DATA COMPILATION #PharmaFlow
33 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

5 US Medicaid Prescriptions, 67 Finished Drug Prices, 1 Annual Reports

5 US Medicaid Prescriptions
67 Finished Drug Prices
1 Annual Reports

MARKET PLACE

28 APIs, 15 FDF Dossiers

28 APIs
15 FDF Dossiers

PATENTS & EXCLUSIVITIES

12 US Patents

12 US Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 3 USP, 15 Others

2 EDQM
3 USP
15 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 137 Xls

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10 All

01 3Pharmaceutical Works Polpharma S.A.

02 1Divi's Laboratories Limited (Unit-2)

03 1FIS FABBRICA ITALIANA SINTETICI SPA

04 1Jubilant Pharmova Limited

05 1Myungin Pharmaceutical Co., Ltd.

06 1Zhejiang Raybow Pharmaceutical Co., Ltd.

07 2Zhejiang Raybow Pharmaceutical Co.,Ltd.

filter Registrant Name Reset all filters

10 All

01 1Aging Life Science Co., Ltd.

02 1Bukwang Pharmaceutical Co., Ltd.

03 1Farm & Biz Co., Ltd.

04 1Huseed Co., Ltd.

05 1Hwail Pharmaceutical Co., Ltd.

06 1Myungin Pharmaceutical Co., Ltd.

07 2Novartis Korea Co., Ltd.

08 1Samo Pharmaceutical Co., Ltd.

09 1Wooshin Rabotachi Co., Ltd.

filter Product Name Reset all filters

10 All

01 10Carbamazepine

filter Country Reset all filters

10 All

01 2India

02 1Italy

03 3Poland

04 1South Korea

05 3U.S.A

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

List of Suppliers

Product Main Page

01

Polpharma

CPhI Worldwide, Milan

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

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Digital Content

Carbamazepine

Registrant Name : Huseed Co., Ltd.

Registration Date : 2023-02-16

Registration Number : 20210524-209-J-660(2)

Manufacturer Name : Pharmaceutical Works Polphar...

Manufacturer Address : 19, Pelplinska Street., 83-200 Starogard Gdanski, Poland

Product Web Link

Digital Content

02

Polpharma

CPhI Worldwide, Milan

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

Contact Supplier

Contact Supplier

Digital Content

Carbamazepine

Registrant Name : Hwail Pharmaceutical Co., Ltd.

Registration Date : 2021-05-24

Registration Number : 20210524-209-J-660

Manufacturer Name : Pharmaceutical Works Polphar...

Manufacturer Address : 19. Pelplinska Str, 83-200 Starogard Gdanski, Poland

Product Web Link

Digital Content

03

Polpharma

CPhI Worldwide, Milan

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

Contact Supplier

Contact Supplier

Digital Content

Carbamazepine

Registrant Name : Wooshin Rabotachi Co., Ltd.

Registration Date : 2021-10-29

Registration Number : 20210524-209-J-660(1)

Manufacturer Name : Pharmaceutical Works Polphar...

Manufacturer Address : 19. Pelplinska Str, 83-200 Starogard Gdanski, Poland

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04

Divis Laboratories

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Divis Laboratories

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Carbamazepine

Registrant Name : Novartis Korea Co., Ltd.

Registration Date : 2021-03-10

Registration Number : 20210310-209-J-864

Manufacturer Name : Divi's Laboratories Limited ...

Manufacturer Address : Chippada Village Annavaram Post Bheemunipatnam Mandal, Visakhapatnam District – 531...

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05

F.I.S. Fabbrica Italiana Sintetici

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F.I.S. Fabbrica Italiana Sintetici

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Carbamazepine

Registrant Name : Samo Pharmaceutical Co., Ltd.

Registration Date : 2018-08-24

Registration Number : 20180824-209-J-109

Manufacturer Name : FIS FABBRICA ITALIANA SINTET...

Manufacturer Address : Via Massimo D'Antona, 13 - 86039 TERMOLI (CB), Italy

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06

Jubilant Generics

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Jubilant Generics

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Carbamazepine

Registrant Name : Aging Life Science Co., Ltd.

Registration Date : 2021-05-13

Registration Number : 20210513-209-J-987

Manufacturer Name : Jubilant Pharmova Limited

Manufacturer Address : Plot No. 18, 56, 57 & 58 KIADB Industrial Area Nanjangud - 571 302, Mysore District K...

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07

Myung In Pharm

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Myung In Pharm

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Carbamazepine

Registrant Name : Myungin Pharmaceutical Co., Ltd.

Registration Date : 2022-05-17

Registration Number : 20220517-209-J-1299

Manufacturer Name : Myungin Pharmaceutical Co., ...

Manufacturer Address : 17 Balangongdan-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do

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08

Zhejiang Raybow Pharma

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Zhejiang Raybow Pharma

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Carbamazepine

Registrant Name : Bukwang Pharmaceutical Co., Ltd.

Registration Date : 2022-01-10

Registration Number : 20210807-209-J-1086(1)

Manufacturer Name : Zhejiang Raybow Pharmaceutic...

Manufacturer Address : No. 18 Nanyangsan Road, Linhai, Taizhou City, Zhejiang Province, China

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09

Zhejiang Raybow Pharma

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Zhejiang Raybow Pharma

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Carbamazepine

Registrant Name : Farm & Biz Co., Ltd.

Registration Date : 2021-08-07

Registration Number : 20210807-209-J-1086

Manufacturer Name : Zhejiang Raybow Pharmaceutic...

Manufacturer Address : No. 18, Nanyangsan Road, Linhai, Taizhou City, Zhejiang Province People's Republic of...

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10

Zhejiang Raybow Pharma

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Zhejiang Raybow Pharma

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Digital Content

Carbamazepine

Registrant Name : Novartis Korea Co., Ltd.

Registration Date : 2021-02-26

Registration Number : 20210226-209-J-602

Manufacturer Name : Zhejiang Raybow Pharmaceutic...

Manufacturer Address : No. 18 Nanyangsan Road, Linhai, Taizhou City, Zhejiang Province, China

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Prestwick3_000052 Manufacturers | Traders | Suppliers

Prestwick3_000052 Manufacturers, Traders, Suppliers 1

63

We have 6 companies offering Prestwick3_000052

Get in contact with the supplier of your choice:

Polpharma
Divis Laboratories
F.I.S. Fabbrica Italiana Sintetici
Jubilant Generics
Myung In Pharm
Zhejiang Raybow Pharma

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