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

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$ API Ref.Price (USD/KG) : 797Xls
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01 1Dr. Reddy's Laboratories Limited

02 1Alembic Pharmaceuticals Limited (API Unit-lll)

03 1Apotex Pharmachem India Pvt. Ltd.

04 1Bidachem SpA

05 1Biocon Limited

06 1Boehringer Ingelheim Pharma GmbH & Co. K.G.

07 1Dasan Pharmaceutical Co., Ltd.@NGChem Life Science Co., Ltd.

08 1Glenmark Life Sciences Limited

09 1Hanmi Fine Chemical Co., Ltd. @[Starting material manufacturer] Jiangxi Synergy Pharmaceutical Co., Ltd

10 1Hetero Drugs Limited (Unit-IX)

11 4MSN Laboratories Private Limited

12 1Piramal Pharma Limited (Piramal Enterprise Limited)

13 1Sichuan Qingmu Pharmaceutical Co., Ltd.

14 1Teva API India Pvt. LTD.

15 1Teva API India Pvt. Ltd.

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Dabigatran etexilate mesylate

Registrant Name : Sangjin Trading Co., Ltd.

Registration Date : 2021-07-05

Registration Number : Number 583-29-ND

Manufacturer Name : Dr. Reddy's Laboratories Lim...

Manufacturer Address : CTD-VI, APIIC Industrial Estate, Pydhibeemavaram, Ranasthalam Mandal, Srikakulam Dist...

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02

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

Dabigatran etexilate mesylate

Registrant Name : Bahnsen Co., Ltd.

Registration Date : 2020-07-14

Registration Number : Number 720-4-ND

Manufacturer Name : Biocon Limited

Manufacturer Address : Plot No. 213 – 215 and 216/B Phase – II, IDA, Pashamylaram, Sangareddy District-5...

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03

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

Dabigatran etexilate mesylate

Registrant Name : Aging Life Science Co., Ltd.

Registration Date : 2018-02-02

Registration Number : Number 434-2-ND

Manufacturer Name : Glenmark Life Sciences Limit...

Manufacturer Address : Plot No. Z-103/I, DAHEJ SEZ, Phase II, City : DAHEJ, Dist : BHARUCH, GUJARATE, INDIA

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04

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

Dabigatran etexilate hemisuccinate

Registrant Name : Hanmi Fine Chemical Co., Ltd.

Registration Date : 2018-01-16

Registration Number : 1444-8-ND

Manufacturer Name : Hanmi Fine Chemical Co., Ltd...

Manufacturer Address : 57 Gyeongje-ro, Siheung-si, Gyeonggi-do (1248-10)@[Starting material manufacturer] Fe...

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05

BioProcess International
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BioProcess International
Not Confirmed

Dabigatran etexilate mesylate

Registrant Name : Pharmapia Co., Ltd.

Registration Date : 2018-02-12

Registration Number : Number 258-6-ND

Manufacturer Name : MSN Laboratories Private Lim...

Manufacturer Address : Sy. No. 317, 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Mandal), ...

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06

BioProcess International
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BioProcess International
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Dabigatran etexilate mesylate

Registrant Name : Kookjeon Pharmaceutical Co., Ltd.

Registration Date : 2018-05-29

Registration Number : Number 258-6-ND(1)

Manufacturer Name : MSN Laboratories Private Lim...

Manufacturer Address : Sy. No. 317, 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Mandal), ...

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07

BioProcess International
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BioProcess International
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Dabigatran etexilate mesylate

Registrant Name : Pharmapia Co., Ltd.

Registration Date : 2019-03-20

Registration Number : Wed258-10-ND

Manufacturer Name : MSN Laboratories Private Lim...

Manufacturer Address : Sy. No. 317, 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Mandal), ...

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08

BioProcess International
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BioProcess International
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Dabigatran etexilate mesylate

Registrant Name : Kookjeon Pharmaceutical Co., Ltd.

Registration Date : 2020-08-20

Registration Number : Number 258-10-ND(1)

Manufacturer Name : MSN Laboratories Private Lim...

Manufacturer Address : Sy. No. 317, 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Mandal), ...

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09

BioProcess International
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BioProcess International
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Dabigatran etexilate mesylate

Registrant Name : Hwail Pharmaceutical Co., Ltd.

Registration Date : 2018-01-22

Registration Number : Number 331-14-ND

Manufacturer Name : Piramal Pharma Limited (Pira...

Manufacturer Address : Sy. Nos. 7-70, 70/1 and 70/2, Digwal Village, Kohir Mandal, Sangareddy District, Tela...

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10

BioProcess International
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BioProcess International
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Dabigatran etexilate mesylate

Registrant Name : Otran Farm Korea Co., Ltd.

Registration Date : 2022-12-20

Registration Number : Number 695-14-ND

Manufacturer Name : Sichuan Qingmu Pharmaceutica...

Manufacturer Address : No. 55, South Shunjiang Avenue, East Economic Development Zone, Dongpo District, Meis...

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Dabigatran Etexilate Manufacturers | Traders | Suppliers

Dabigatran Etexilate Manufacturers, Traders, Suppliers 1