01 1Pharmacostec Co., Ltd.
01 1Pharmacostec Co., Ltd.
01 1Clebudin
01 1South Korea
Registrant Name : Pharmacostec Co., Ltd.
Registration Date : 2016-09-12
Registration Number : 20160912-202-I-505-02
Manufacturer Name : Pharmacostec Co., Ltd.
Manufacturer Address : 47, Yakjedanji-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do
A Clevudine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Clevudine, including repackagers and relabelers. The FDA regulates Clevudine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Clevudine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Clevudine supplier is an individual or a company that provides Clevudine active pharmaceutical ingredient (API) or Clevudine finished formulations upon request. The Clevudine suppliers may include Clevudine API manufacturers, exporters, distributors and traders.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Clevudine Drug Master File in Korea (Clevudine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Clevudine. The MFDS reviews the Clevudine KDMF as part of the drug registration process and uses the information provided in the Clevudine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Clevudine 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 Clevudine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Clevudine suppliers with KDMF on PharmaCompass.
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