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 Napton manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Napton, including repackagers and relabelers. The FDA regulates Napton manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Napton 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 Napton manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Napton supplier is an individual or a company that provides Napton active pharmaceutical ingredient (API) or Napton finished formulations upon request. The Napton suppliers may include Napton API manufacturers, exporters, distributors and traders.
click here to find a list of Napton 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 Napton Drug Master File in Korea (Napton KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Napton. The MFDS reviews the Napton KDMF as part of the drug registration process and uses the information provided in the Napton KDMF to evaluate the safety and efficacy of the drug.
After submitting a Napton 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 Napton API can apply through the Korea Drug Master File (KDMF).
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