01 1Engichem Life Sciences Co., Ltd.
02 2Estifarm Co., Ltd.
03 1SPC Co., Ltd.
01 1Engichem Life Sciences Co., Ltd.
02 2Estifarm Co., Ltd.
03 1SPC Co., Ltd.
01 4Cycloserine
01 3South Korea
02 1Blank
Registrant Name : SPC Co., Ltd.
Registration Date : 2020-07-14
Registration Number : 20200714-209-J-689
Manufacturer Name : SPC Co., Ltd.
Manufacturer Address : 386 Pyeongtaek Port Road, Poseung-eup, Pyeongtaek-si, Gyeonggi-do
Registrant Name : Estifarm Co., Ltd.
Registration Date : 2022-10-14
Registration Number : 20221014-209-J-1379
Manufacturer Name : Estifarm Co., Ltd.
Manufacturer Address : 231, Hyeop-ro, Siheung-si, Gyeonggi-do
Registrant Name : Estifarm Co., Ltd.
Registration Date : 2022-08-17
Registration Number : 20220817-209-J-1345
Manufacturer Name : Estifarm Co., Ltd.
Manufacturer Address : 171 Haean-ro, Danwon-gu, Ansan-si, Gyeonggi-do
Registrant Name : Engichem Life Sciences Co., Ltd.
Registration Date : 2021-06-08
Registration Number : 20210608-209-J-1013
Manufacturer Name : Engichem Life Sciences Co., ...
Manufacturer Address : 59 Biovalley-ro, Jecheon-si, Chungcheongbuk-do
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A Cycloserine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cycloserine, including repackagers and relabelers. The FDA regulates Cycloserine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cycloserine 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 Cycloserine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cycloserine supplier is an individual or a company that provides Cycloserine active pharmaceutical ingredient (API) or Cycloserine finished formulations upon request. The Cycloserine suppliers may include Cycloserine API manufacturers, exporters, distributors and traders.
click here to find a list of Cycloserine 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 Cycloserine Drug Master File in Korea (Cycloserine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cycloserine. The MFDS reviews the Cycloserine KDMF as part of the drug registration process and uses the information provided in the Cycloserine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Cycloserine 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 Cycloserine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Cycloserine suppliers with KDMF on PharmaCompass.
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