01 1Amino Chemicals Ltd
02 1Amino Chemicals Ltd.
03 1Korea Biochem Pharmaceutical Co., Ltd.
04 1Mylan Laboratories Limited (Unit-7)
05 1SPC Co., Ltd.
06 1Takeda Pharmaceutical Company Ltd., Hikari plant
07 2Tianish Laboratories Limited (Unit-7)
01 2Ace Biopharm Co., Ltd.
02 1Korea Biochem Pharmaceutical Co., Ltd.
03 1Korea Takeda Pharmaceutical Co., Ltd.
04 1SPC Co., Ltd.
05 2Samoh Pharmaceutical Co., Ltd.
06 1Yuhan Corporation
01 6Dexlansoprazole
02 2Dexlansoprazole hydrate
01 1Japan
02 2Malta
03 2South Korea
04 3U.S.A
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2020-12-17
Registration Number : 20201217-209-J-786
Manufacturer Name : Amino Chemicals Ltd.
Manufacturer Address : MRA 050X Industrial Estate, Marsa, MRS 3000, Malta
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2019-10-21
Registration Number : 20191021-209-J-391
Manufacturer Name : Amino Chemicals Ltd
Manufacturer Address : MRA 050X industrial Estate, Marsa, MRS 3000, Malta
Registrant Name : Korea Biochem Pharmaceutical Co., Ltd.
Registration Date : 2019-01-11
Registration Number : 20190111-209-J-301
Manufacturer Name : Korea Biochem Pharmaceutical...
Manufacturer Address : 204 Sandan-gil, Jeonui-myeon, Sejong Special Self-Governing City
Registrant Name : SPC Co., Ltd.
Registration Date : 2022-07-11
Registration Number : 20220711-209-J-1330
Manufacturer Name : SPC Co., Ltd.
Manufacturer Address : 386 Pyeongtaek Port Road, Poseung-eup, Pyeongtaek-si, Gyeonggi-do
Registrant Name : Korea Takeda Pharmaceutical Co., Ltd.
Registration Date : 2022-02-08
Registration Number : 20220208-209-J-1231
Manufacturer Name : Takeda Pharmaceutical Compan...
Manufacturer Address : 4720, Takeda Mitsui, Hikari, Yamaguchi, 743-8502, Japan
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2020-09-22
Registration Number : 20200922-209-J-497
Manufacturer Name : Tianish Laboratories Limited...
Manufacturer Address : Plot No. 14, 99 & 100, IDA, Pashamylaram Phase-II, Patancheru, Sangareddy District 50...
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2017-10-24
Registration Number : 20171024-209-J-174
Manufacturer Name : Tianish Laboratories Limited...
Manufacturer Address : Plot No. 14, 99 & 100, IDA, Pashamylaram Phase-II, Patancheru, Sangareddy District 50...
Registrant Name : Yuhan Corporation
Registration Date : 2018-08-14
Registration Number : 20171024-209-J-174(1)
Manufacturer Name : Mylan Laboratories Limited (...
Manufacturer Address : Plot No. 14, 99 & 100, IDA, Pashamylaram Phase-II, Patancheru, Sangareddy District 50...
A Dexlansoprazole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dexlansoprazole, including repackagers and relabelers. The FDA regulates Dexlansoprazole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dexlansoprazole 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 Dexlansoprazole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dexlansoprazole supplier is an individual or a company that provides Dexlansoprazole active pharmaceutical ingredient (API) or Dexlansoprazole finished formulations upon request. The Dexlansoprazole suppliers may include Dexlansoprazole API manufacturers, exporters, distributors and traders.
click here to find a list of Dexlansoprazole 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 Dexlansoprazole Drug Master File in Korea (Dexlansoprazole KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dexlansoprazole. The MFDS reviews the Dexlansoprazole KDMF as part of the drug registration process and uses the information provided in the Dexlansoprazole KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dexlansoprazole 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 Dexlansoprazole API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Dexlansoprazole suppliers with KDMF on PharmaCompass.
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