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List of Drug Master Files (KDMF) for Tox21_300270 Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

Client Email

Product

Tox21_300270
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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Tox21_300270

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

26 API Suppliers, 17 USDMF, 12 CEP/COS, 9 JDMF, 3 EU WC, 8 KDMF, 4 NDC API, 10 Listed Suppliers, $ API Reference Price

26 API Suppliers
17 USDMF
12 CEP/COS
9 JDMF
3 EU WC
8 KDMF
4 NDC API
10 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

FINISHED DOSAGE FORMULATIONS

442 FDF Dossiers, 78 FDA Orange Book, 234 Europe, 51 Canada, 36 Australia, 27 South Africa, 16 Listed Dossiers

442 FDF Dossiers
78 FDA Orange Book
234 Europe
51 Canada
36 Australia
27 South Africa
16 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 10MG **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**
TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Rochem International Inc, 23 SPI Pharma, 3 DKSH, 2 Jai Radhe Sales, 8 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 13 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 2 Aeon Procare, 2 Alcedo Pharmachem, 11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 21 BASF, 11 Corel Pharma Chem, 6 DFE Pharma, 10 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 37 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 7 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 2 The Dow Chemical Company, 3 Ulanqab Kema New Material, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

91 Fillers, Diluents & Binders, 50 Direct Compression, 47 Coating Systems & Additives, 36 Disintegrants & Superdisintegrants, 30 Granulation, 28 Lubricants & Glidants, 25 Controlled & Modified Release, 22 Co-Processed Excipients, 20 Thickeners and Stabilizers, 20 Chewable & Orodispersible Aids, 17 Taste Masking, 15 Solubilizers, 10 API Stability Enhancers, 9 Parenteral, 9 Film Formers & Plasticizers, 6 Emulsifying Agents, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Coloring Agents, 3 Topical, 3 Rheology Modifiers, 2 Surfactant & Foaming Agents

91 Fillers, Diluents & Binders
50 Direct Compression
47 Coating Systems & Additives
36 Disintegrants & Superdisintegrants
30 Granulation
28 Lubricants & Glidants
25 Controlled & Modified Release
22 Co-Processed Excipients
20 Thickeners and Stabilizers
20 Chewable & Orodispersible Aids
17 Taste Masking
15 Solubilizers
10 API Stability Enhancers
9 Parenteral
9 Film Formers & Plasticizers
6 Emulsifying Agents
5 Empty Capsules
4 Vegetarian Capsules
4 Coloring Agents
3 Topical
3 Rheology Modifiers
2 Surfactant & Foaming Agents

DIGITAL CONTENT

20 NEWS #PharmaBuzz

20 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 228 Finished Drug Prices, 1 Annual Reports

1 US Medicaid Prescriptions
228 Finished Drug Prices
1 Annual Reports

MARKET PLACE

8 APIs, 2 FDF Dossiers

8 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 Health Canada Patents

4 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 4 USP, 6 JP, 5 Others

3 EDQM
4 USP
6 JP
5 Others

$ API Ref.Price (USD/KG) : 620 Xls

Filters

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8 All

01 2Biocon Limited

02 1Daiichi Sankyo Chemical Pharma Co., Ltd.

03 1Guangdong Blue Treasure Pharmaceuticals Co., Ltd.

04 1Teva Pharmaceutical Works Limited

05 1Teva Pharmaceutical Works Private Limited

06 1Youngjin Pharmaceutical Co., Ltd.

07 1Zhejiang Hisun Pharmaceutical Co., Ltd.

filter Registrant Name Reset all filters

8 All

01 1Aging Life Science Co., Ltd.

02 1HK Innoen Co., Ltd.

03 1Kookjeon Pharmaceutical Co., Ltd.

04 1Samo Pharmaceutical Co., Ltd.

05 1Sungwoo Chemical Co., Ltd.

06 1Yooyoung Pharmaceutical Co., Ltd.

07 2Youngjin Pharmaceutical Co., Ltd.

filter Product Name Reset all filters

8 All

01 8Pravastatin Sodium

filter Country Reset all filters

8 All

01 2China

02 2India

03 2Israel

04 1Japan

05 1South Korea

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

List of Suppliers

Product Main Page

01

Biocon

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Biocon

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Digital Content

Pravastatin Sodium

Registrant Name : Sungwoo Chemical Co., Ltd.

Registration Date : 2015-10-15

Registration Number : 20151015-70-B-379-08

Manufacturer Name : Biocon Limited

Manufacturer Address : Plot No. 2, 3, 4 & 5 Phase-IV, Bommasandra-Jigani Link Road, Bommasandra Post, Bengal...

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02

Biocon

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Biocon

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Pravastatin Sodium

Registrant Name : Aging Life Science Co., Ltd.

Registration Date : 2020-02-06

Registration Number : 20151015-70-B-379-08(1)

Manufacturer Name : Biocon Limited

Manufacturer Address : Plot No. 2,3,4 & 5, Phase-IV, Bommasandra Jigani Link Road, Bommasandra Post Bengalur...

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03

Daiichi Sankyo

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Daiichi Sankyo

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Pravastatin Sodium

Registrant Name : HK Innoen Co., Ltd.

Registration Date : 2005-08-31

Registration Number : 20050831-70-B-192-07

Manufacturer Name : Daiichi Sankyo Chemical Phar...

Manufacturer Address : 389-4 Izumimachi Shimokawa, Aza-ohtsurugi, Iwaki, Fukushima 971-8183, Japan

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04

Guangdong Blue Treasure Pharmaceuti...

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Pravastatin Sodium

Registrant Name : Youngjin Pharmaceutical Co., Ltd.

Registration Date : 2014-07-04

Registration Number : 20140704-70-B-364-07

Manufacturer Name : Guangdong Blue Treasure Phar...

Manufacturer Address : Renmin One Road, Qingyuan, Guangdong Province, China

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05

Teva Pharmaceutical Industries

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Teva Pharmaceutical Industries

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Pravastatin Sodium

Registrant Name : Samo Pharmaceutical Co., Ltd.

Registration Date : 2005-08-31

Registration Number : 20050831-70-B-191-06

Manufacturer Name : Teva Pharmaceutical Works Li...

Manufacturer Address : 13 Pallagi Street Debrecen, H-4042, Hungary (Teva Group API Division 5. Basel Street,...

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06

Teva Pharmaceutical Industries

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Teva Pharmaceutical Industries

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Pravastatin Sodium

Registrant Name : Yooyoung Pharmaceutical Co., Ltd.

Registration Date : 2015-05-12

Registration Number : 20050831-70-B-191-06(1)

Manufacturer Name : Teva Pharmaceutical Works Pr...

Manufacturer Address : 4042 Debrecen Pallagi UT 13, Hungary

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07

Youngjin Pharm

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Youngjin Pharm

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Pravastatin Sodium

Registrant Name : Youngjin Pharmaceutical Co., Ltd.

Registration Date : 2005-08-31

Registration Number : 20050831-70-B-187-03

Manufacturer Name : Youngjin Pharmaceutical Co.,...

Manufacturer Address : 31-17, Seokam-ro 7-gil, Iksan-si, Jeollabuk-do

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08

Zhejiang Hisun Pharmaceutical

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Zhejiang Hisun Pharmaceutical

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Pravastatin Sodium

Registrant Name : Kookjeon Pharmaceutical Co., Ltd.

Registration Date : 2022-06-07

Registration Number : 20220607-70-B-464-09

Manufacturer Name : Zhejiang Hisun Pharmaceutica...

Manufacturer Address : No.56, Binhai Road, Jiaojiang District, Taizhou City, Zhejiang Province, China

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Tox21_300270 Manufacturers | Traders | Suppliers

Tox21_300270 Manufacturers, Traders, Suppliers 1

35

We have 6 companies offering Tox21_300270

Get in contact with the supplier of your choice:

Biocon
Daiichi Sankyo
Guangdong Blue Treasure Pharmaceutical Co. Ltd.
Teva Pharmaceutical Industries
Youngjin Pharm
Zhejiang Hisun Pharmaceutical

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