01 1FIS Fabbrica Italiana Sintetici SpA
01 1Sam-O Pharmaceutical Co., Ltd.
01 1Chlordiazepoxide
01 1Italy
Registrant Name : Sam-O Pharmaceutical Co., Ltd.
Registration Date : 2021-05-04
Registration Number : 20210504-209-J-978
Manufacturer Name : FIS Fabbrica Italiana Sintet...
Manufacturer Address : Viale Milano, 26-36075 MONTECCHIO MAGGIORE (VI), Italy
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A Zetran manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zetran, including repackagers and relabelers. The FDA regulates Zetran manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zetran 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 Zetran manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Zetran supplier is an individual or a company that provides Zetran active pharmaceutical ingredient (API) or Zetran finished formulations upon request. The Zetran suppliers may include Zetran API manufacturers, exporters, distributors and traders.
click here to find a list of Zetran suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 Zetran Drug Master File in Korea (Zetran KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Zetran. The MFDS reviews the Zetran KDMF as part of the drug registration process and uses the information provided in the Zetran KDMF to evaluate the safety and efficacy of the drug.
After submitting a Zetran 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 Zetran API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Zetran suppliers with KDMF on PharmaCompass.
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