01 1Gnosis Bioresearch SA
01 1Abbott Korea Ltd.
01 1Ademethionine 1,4-butanedisulfonate
01 1France
Ademethionine 1,4-butanedisulfonate
Registrant Name : Abbott Korea Ltd.
Registration Date : 2020-08-25
Registration Number : 20200825-209-J-722
Manufacturer Name : Gnosis Bioresearch SA
Manufacturer Address : Via Lischedi, 6592 Sant't Antonino Switzerland
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A Ademetionine 1,4-Butanedisulfonate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ademetionine 1,4-Butanedisulfonate, including repackagers and relabelers. The FDA regulates Ademetionine 1,4-Butanedisulfonate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ademetionine 1,4-Butanedisulfonate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Ademetionine 1,4-Butanedisulfonate supplier is an individual or a company that provides Ademetionine 1,4-Butanedisulfonate active pharmaceutical ingredient (API) or Ademetionine 1,4-Butanedisulfonate finished formulations upon request. The Ademetionine 1,4-Butanedisulfonate suppliers may include Ademetionine 1,4-Butanedisulfonate 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 Ademetionine 1,4-Butanedisulfonate Drug Master File in Korea (Ademetionine 1,4-Butanedisulfonate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ademetionine 1,4-Butanedisulfonate. The MFDS reviews the Ademetionine 1,4-Butanedisulfonate KDMF as part of the drug registration process and uses the information provided in the Ademetionine 1,4-Butanedisulfonate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ademetionine 1,4-Butanedisulfonate 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 Ademetionine 1,4-Butanedisulfonate API can apply through the Korea Drug Master File (KDMF).
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