DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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.
01 1Aging Life Science Co., Ltd.
02 1Bansen Co., Ltd.
03 2Boehringer Ingelheim Korea Ltd.
04 1Dasan Pharmaceutical Co., Ltd.
05 1Hanmi Precision Chemical Co., Ltd.
06 1Hwail Pharmaceutical Co., Ltd.
07 1Korea United Pharmaceutical Co., Ltd.
08 2Kukjeon Pharmaceutical Co., Ltd.
09 1M-Peak Korea Co., Ltd.
10 1Otran Pharm Korea Co., Ltd.
11 2Pharmapia Co., Ltd.
12 1Saehan Pharmaceutical Co., Ltd.
13 1Samoh Pharmaceutical Co., Ltd.
14 1Sangjin Corporation
15 1Sungwoo Chemical Co., Ltd.
01 1Dabigatran etexilate
02 1Dabigatran etexilate hemisuccinate
03 16Dabigatran etexilate mesylate
01 1Canada
02 1China
03 1Germany
04 9India
05 2Israel
06 1Italy
07 2South Korea
08 1U.S.A
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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
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...
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
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), ...
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), ...
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), ...
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), ...
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...
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.
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.
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.
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