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

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01 COPRIMA SL (1)

02 Teva API India Private Limited (Malanpur site) (1)

03 @Chongqing Beisheng Pharmaceutical Co., Ltd. (2)

04 Cadila Healthcare Limited (1)

05 DAIICHI SANKYO CHEMICAL PHARMA CO., LTD., Onahama Plant (1)

06 FIS Fabbrica Italiana Sintetici SpA (1)

07 Hanseochem Co., Ltd. (1)

08 Honor Lab Limited (Unit III) (2)

09 Honor Lab Limited (Unit-III) (1)

10 Korea Biochem Pharmaceutical Co., Ltd. (1)

11 MSN Life Sciences Private Limited (2)

12 Pharmacotech Co., Ltd. (1)

13 Zydus Lifescience Limited (6)

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01 Aging Life Science Co., Ltd. (1)

02 Bahnsen Co., Ltd. (1)

03 Daiichi Sankyo Korea Co., Ltd. (2)

04 Foosung Bio Co., Ltd. (2)

05 Grace Farm (1)

06 Hanseochem Co., Ltd. (1)

07 Hiple Co., Ltd. (1)

08 Hwail Pharmaceutical Co., Ltd. (1)

09 Kookjeon Pharmaceutical Co., Ltd. (1)

10 Korea Biochem Pharmaceutical Co., Ltd. (1)

11 Kyungbo Pharmaceutical Co., Ltd. (2)

12 Leesung International Co., Ltd. (1)

13 Lihu Healthcare Co., Ltd. (1)

14 Masung LS Co., Ltd. (1)

15 Mpeak Korea Co., Ltd. (1)

16 Pharmacotech Co., Ltd. (1)

17 Samo Pharmaceutical Co., Ltd. (1)

18 Shinil Pharmaceutical Co., Ltd. (1)

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01 Edoxaban (1)

02 Edoxaban besylate hydrate (1)

03 Edoxabantosylate hydrate (19)

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01 India (12)

02 Israel (1)

03 Italy (1)

04 Japan (1)

05 South Korea (5)

06 Spain (1)

Samo Pharmaceutical Co., Ltd.
2023-06-07
Wed207-60-ND
COPRIMA SL
Spain
Pablo Picasso, 15 08213 P...
URL Supplier Web Content
Bahnsen Co., Ltd.
2023-04-21
Number 720-8-ND
Teva API India Private Li...
India
Plot Nos. Q1 to Q4 Indust...
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Daiichi Sankyo Korea Co., Ltd.
2023-12-01
Number 256-5-ND
FIS Fabbrica Italiana Sin...
Italy
Viale Milano, 26 Montecch...
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Foosung Bio Co., Ltd.
2023-07-24
Wed21-15-ND(2)
Honor Lab Limited (Unit-I...
India
Plot No.4, Hetero Infrast...
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Korea Biochem Pharmaceutical Co., Ltd.
2022-05-31
2152-17-ND
Korea Biochem Pharmaceuti...
South Korea
204 Sandan-gil, Jeonui-my...
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Foosung Bio Co., Ltd.
2023-07-24
Number 674-2-ND(5)
Zydus Lifescience Limited
India
Plot No. 26 to 29 & 31 Vi...
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Masung LS Co., Ltd.
2023-06-21
Number 674-2-ND(4)
Cadila Healthcare Limited
India
Plot No. 26 to 29 & 31 Vi...
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Hwail Pharmaceutical Co., Ltd.
2023-06-14
Number 674-2-ND(3)
Zydus Lifescience Limited
India
Plot No. 26 to 29 & 31, D...
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Hiple Co., Ltd.
2022-07-08
Number 674-2-ND(2)
Zydus Lifescience Limited
India
Plot No. 26 to 29 & 31, D...
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Mpeak Korea Co., Ltd.
2023-10-23
Number 674-2-ND(6)
Zydus Lifescience Limited
India
Plot No. 26 to 29 & 31 Vi...
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Looking for 480449-70-5 / Edoxaban API manufacturers, exporters & distributors?

Edoxaban manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Edoxaban API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Edoxaban manufacturer or Edoxaban supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Edoxaban manufacturer or Edoxaban supplier.

PharmaCompass also assists you with knowing the Edoxaban API Price utilized in the formulation of products. Edoxaban API Price is not always fixed or binding as the Edoxaban Price is obtained through a variety of data sources. The Edoxaban Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Edoxaban

Synonyms

480449-70-5, 912273-65-5, Du-176, Du-176b, Ndu3j18apo, N1-(5-chloropyridin-2-yl)-n2-((1s,2r,4s)-4-(dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl)oxalamide

Cas Number

480449-70-5

Unique Ingredient Identifier (UNII)

NDU3J18APO

About Edoxaban

Edoxaban is an orally active inhibitor of coagulation factor Xa (activated factor X) with anticoagulant activity. Edoxaban is administered as edoxaban tosylate. This agent has an elimination half-life of 9-11 hours and undergoes renal excretion.

Edoxaban Manufacturers

A Edoxaban manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Edoxaban, including repackagers and relabelers. The FDA regulates Edoxaban manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Edoxaban API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Edoxaban manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Edoxaban Suppliers

A Edoxaban supplier is an individual or a company that provides Edoxaban active pharmaceutical ingredient (API) or Edoxaban finished formulations upon request. The Edoxaban suppliers may include Edoxaban API manufacturers, exporters, distributors and traders.

click here to find a list of Edoxaban suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Edoxaban KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Edoxaban Drug Master File in Korea (Edoxaban KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Edoxaban. The MFDS reviews the Edoxaban KDMF as part of the drug registration process and uses the information provided in the Edoxaban KDMF to evaluate the safety and efficacy of the drug.

After submitting a Edoxaban KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Edoxaban API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Edoxaban suppliers with KDMF on PharmaCompass.

Edoxaban Manufacturers | Traders | Suppliers

Edoxaban Manufacturers, Traders, Suppliers 1
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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