01 1Chong Kun Dang Bio Co., Ltd._x000D_
02 1Lupin Limited,
01 1Chong Kun Dang Bio Co., Ltd.
02 1Masung LS Co., Ltd.
01 2Rifampicin
01 1India
02 1South Korea
Registrant Name : Chong Kun Dang Bio Co., Ltd.
Registration Date : 2009-01-30
Registration Number : 20090130-103-F-36-01
Manufacturer Name : Chong Kun Dang Bio Co., Ltd....
Manufacturer Address : B-Block Complex 16 (425-100), 454, 486 Moknae-dong, Danwon-gu, Ansan-si, Gyeonggi-do ...
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2009-10-27
Registration Number : 20091027-103-F-48-03
Manufacturer Name : Lupin Limited,
Manufacturer Address : India, T-142, MIDC, Tarapur, Via Boisar, Maharashtra 401 506
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A Eremfat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eremfat, including repackagers and relabelers. The FDA regulates Eremfat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eremfat 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 Eremfat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Eremfat supplier is an individual or a company that provides Eremfat active pharmaceutical ingredient (API) or Eremfat finished formulations upon request. The Eremfat suppliers may include Eremfat API manufacturers, exporters, distributors and traders.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Eremfat Drug Master File in Korea (Eremfat KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Eremfat. The MFDS reviews the Eremfat KDMF as part of the drug registration process and uses the information provided in the Eremfat KDMF to evaluate the safety and efficacy of the drug.
After submitting a Eremfat 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 Eremfat API can apply through the Korea Drug Master File (KDMF).
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