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

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01 Dr. Reddy's Laboratories Limited (1)

02 Piramal Pharma Limited (Piramal Enterprise Limited) (1)

03 Teva API India Pvt. LTD. (1)

04 Teva API India Pvt. Ltd. (1)

05 Alembic Pharmaceuticals Limited (API Unit-lll) (1)

06 Apotex Pharmachem India Pvt. Ltd. (1)

07 Bidachem SpA (1)

08 Biocon Limited (1)

09 Boehringer Ingelheim Pharma GmbH & Co. K.G. (1)

10 Dasan Pharmaceutical Co., Ltd.@NGChem Life Science Co., Ltd. (1)

11 Glenmark Life Sciences Limited (1)

12 Hanmi Fine Chemical Co., Ltd. @[Starting material manufacturer] Jiangxi Synergy Pharmaceutical Co., Ltd (1)

13 Hetero Drugs Limited (Unit-IX) (1)

14 Inist ST Co., Ltd. (1)

15 MSN Laboratories Private Limited (4)

16 Sichuan Qingmu Pharmaceutical Co., Ltd. (1)

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

02 Bahnsen Co., Ltd. (1)

03 Boehringer Ingelheim Korea Co., Ltd. (2)

04 Dasan Pharmaceutical Co., Ltd. (1)

05 Hanmi Fine Chemical Co., Ltd. (1)

06 Hwail Pharmaceutical Co., Ltd. (1)

07 Inist ST Co., Ltd. (1)

08 Kookjeon Pharmaceutical Co., Ltd. (2)

09 Korea United Pharmaceutical Co., Ltd. (1)

10 Mpeak Korea Co., Ltd. (1)

11 Otran Farm Korea Co., Ltd. (1)

12 Pharmapia Co., Ltd. (2)

13 Saehan Pharmaceutical Co., Ltd. (1)

14 Samo Pharmaceutical Co., Ltd. (1)

15 Sangjin Trading Co., Ltd. (1)

16 Sungwoo Chemical Co., Ltd. (1)

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01 Dabigatran etexilate (1)

02 Dabigatran etexilate hemisuccinate (1)

03 Dabigatran etexilate mesylate (16)

04 Dabigatran etexilate tosylate (1)

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01 Canada (1)

02 China (1)

03 Germany (1)

04 India (9)

05 Israel (2)

06 Italy (1)

07 South Korea (3)

08 U.S.A (1)

Sangjin Trading Co., Ltd.
2021-07-05
Number 583-29-ND
Dr. Reddy's Laboratories ...
India
CTD-VI, APIIC Industrial ...
URL Supplier Web Content
Hwail Pharmaceutical Co., Ltd.
2018-01-22
Number 331-14-ND
Piramal Pharma Limited (P...
India
Sy. Nos. 7-70, 70/1 and 7...
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Samo Pharmaceutical Co., Ltd.
2016-11-24
Wed207-29-ND
Teva API India Pvt. Ltd.
India
Plot no. Q1 to Q4, Indust...
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Korea United Pharmaceutical Co., Ltd.
2017-06-28
Wed207-29-ND(1)
Teva API India Pvt. LTD.
India
Plot no. Q1 to Q4, Indust...
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Bahnsen Co., Ltd.
2020-07-14
Number 720-4-ND
Biocon Limited
India
Plot No. 213 – 215 and ...
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Inist ST Co., Ltd.
2018-05-15
2220-10-ND
Inist ST Co., Ltd.
South Korea
500 Sinnae-ro, Geumwang-e...
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Kookjeon Pharmaceutical Co., Ltd.
2018-05-29
Number 258-6-ND(1)
MSN Laboratories Private ...
India
Sy. No. 317, 320, 321, 32...
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Pharmapia Co., Ltd.
2019-03-20
Wed258-10-ND
MSN Laboratories Private ...
India
Sy. No. 317, 320, 321, 32...
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Kookjeon Pharmaceutical Co., Ltd.
2020-08-20
Number 258-10-ND(1)
MSN Laboratories Private ...
India
Sy. No. 317, 320, 321, 32...
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Otran Farm Korea Co., Ltd.
2022-12-20
Number 695-14-ND
Sichuan Qingmu Pharmaceut...
China
No. 55, South Shunjiang A...
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Looking for 872728-81-9 / Dabigatran Etexilate Mesylate API manufacturers, exporters & distributors?

Dabigatran Etexilate Mesylate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Dabigatran Etexilate Mesylate 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 Dabigatran Etexilate Mesylate manufacturer or Dabigatran Etexilate Mesylate supplier for your needs.

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

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

API | Excipient name

Dabigatran Etexilate Mesylate

Synonyms

872728-81-9, Pradaxa, Ethyl 3-[[2-[[4-[(z)-n'-hexoxycarbonylcarbamimidoyl]anilino]methyl]-1-methylbenzimidazole-5-carbonyl]-pyridin-2-ylamino]propanoate;methanesulfonic acid, Dtxsid20236248, Ex-a1966, Mfcd25424070

Cas Number

872728-81-9

About Dabigatran Etexilate Mesylate

A THROMBIN inhibitor which acts by binding and blocking thrombogenic activity and the prevention of thrombus formation. It is used to reduce the risk of stroke and systemic EMBOLISM in patients with nonvalvular atrial fibrillation.

Dabigatran Manufacturers

A Dabigatran manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dabigatran, including repackagers and relabelers. The FDA regulates Dabigatran manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dabigatran 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 Dabigatran manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Dabigatran Suppliers

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

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

Dabigatran KDMF

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

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

After submitting a Dabigatran 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 Dabigatran API can apply through the Korea Drug Master File (KDMF).

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

Dabigatran Manufacturers | Traders | Suppliers

Dabigatran 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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