01 1Hanseochem Co., Ltd.
02 2Kashima Plant, Eisai Co., Ltd.
01 1Bukwang Pharmaceutical Co., Ltd.
02 1Hanseochem Co., Ltd.
03 1Korea Ezai Co., Ltd.
01 3Teprenone
01 2Japan
02 1South Korea
Registrant Name : Korea Ezai Co., Ltd.
Registration Date : 2012-08-22
Registration Number : 20120822-169-I-77-01
Manufacturer Name : Kashima Plant, Eisai Co., Lt...
Manufacturer Address : 22 Sunayama, Kamisu-shi, Ibaraki-ken 314-0255
Registrant Name : Bukwang Pharmaceutical Co., Ltd.
Registration Date : 2016-06-09
Registration Number : 20120822-169-I-77-01(1)
Manufacturer Name : Kashima Plant, Eisai Co., Lt...
Manufacturer Address : 22 Sunayama, Kamisu-shi, Ibaraki-ken 314-0255
Registrant Name : Hanseochem Co., Ltd.
Registration Date : 2012-11-12
Registration Number : 20121112-169-I-261-02
Manufacturer Name : Hanseochem Co., Ltd.
Manufacturer Address : 41 Poseung Industrial Complex-ro, Poseung-eup, Pyeongtaek-si, Gyeonggi-do
A Teprenone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Teprenone, including repackagers and relabelers. The FDA regulates Teprenone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Teprenone 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 Teprenone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Teprenone supplier is an individual or a company that provides Teprenone active pharmaceutical ingredient (API) or Teprenone finished formulations upon request. The Teprenone suppliers may include Teprenone API manufacturers, exporters, distributors and traders.
click here to find a list of Teprenone 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 Teprenone Drug Master File in Korea (Teprenone KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Teprenone. The MFDS reviews the Teprenone KDMF as part of the drug registration process and uses the information provided in the Teprenone KDMF to evaluate the safety and efficacy of the drug.
After submitting a Teprenone 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 Teprenone API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Teprenone suppliers with KDMF on PharmaCompass.
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