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01 1Dr. Reddy's Laboratories Limited

02 1Teva API India Pvt. LTD.

03 1Teva API India Pvt. Ltd.

04 1Alembic Pharmaceuticals Limited (API Unit-lll)

05 1Apotex Pharmachem India Pvt. Ltd.

06 1Bidachem SpA

07 1Biocon Limited

08 1Boehringer Ingelheim Pharma GmbH & Co. K.G.

09 1Dasan Pharmaceutical Co., Ltd. @ Enzychem Life Science Co., Ltd.

10 1Glenmark Life Sciences Limited

11 1Hanmi Precision Chemical Co., Ltd @ [Starting Material Manufacturer] Jiangxi Synergy Pharmaceutical Co., Ltd

12 1Hetero Drugs Limited(Unit-IX)

13 4MSN Laboratories Private Limited

14 1Piramal Pharma Limited (Piramal Enterprise Limited)

15 1Sichuan Qingmu Pharmaceutical Co., Ltd.

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PharmaCompass

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 Corporation

Registration Date : 2021-07-05

Registration Number : No. 583-29-ND

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

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

Dr Reddy Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

Dabigatran etexilate mesylate

Registrant Name : Korea United Pharmaceutical Co., Ltd.

Registration Date : 2017-06-28

Registration Number : 207-29-ND(1)

Manufacturer Name : Teva API India Pvt. LTD.

Manufacturer Address : Plot no. Q1 to Q4, Industrial Area, Ghirongi, Malanpur, Distt. Bhind M.P., India

TAPI Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

Dabigatran etexilate mesylate

Registrant Name : Samoh Pharmaceutical Co., Ltd.

Registration Date : 2016-11-24

Registration Number : 207-29-ND

Manufacturer Name : Teva API India Pvt. Ltd.

Manufacturer Address : Plot no. Q1 to Q4, Industrial Area, Ghirongi, Malanpur, Distt. Bhind M.P., India

TAPI Company Banner

04

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Dabigatran etexilate mesylate

Registrant Name : Bansen Co., Ltd.

Registration Date : 2020-07-14

Registration Number : Su720-4-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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05

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Dabigatran etexilate mesylate

Registrant Name : Aging Life Science Co., Ltd.

Registration Date : 2018-02-02

Registration Number : Su434-2-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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06

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Dabigatran etexilate mesylate

Registrant Name : Pharmapia Co., Ltd.

Registration Date : 2019-03-20

Registration Number : Su258-10-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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07

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Dabigatran etexilate mesylate

Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

Registration Date : 2020-08-20

Registration Number : Su258-10-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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08

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Dabigatran etexilate mesylate

Registrant Name : Pharmapia Co., Ltd.

Registration Date : 2018-02-12

Registration Number : Su258-6-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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09

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Dabigatran etexilate mesylate

Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

Registration Date : 2018-05-29

Registration Number : No. 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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10

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Dabigatran etexilate mesylate

Registrant Name : Otran Pharm Korea Co., Ltd.

Registration Date : 2022-12-20

Registration Number : No. 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 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.