01 1Shionogi Pharma Co., Ltd. Itami Plant@SANKYO KASEI Co., Ltd@일동약(주)
01 1Ildong Pharmaceutical Co., Ltd.
01 1Benexate hydrochloride betadex
01 1Japan
Benexate hydrochloride betadex
Registrant Name : Ildong Pharmaceutical Co., Ltd.
Registration Date : 2021-05-17
Registration Number : 20210517-209-J-838
Manufacturer Name : Shionogi Pharma Co., Ltd. It...
Manufacturer Address : 4-323, Senzo, Itami-shi, Hyogo 664-0898 Japan@1-58-1 Osadanocho, Fukuchiyama, Kyoto, ...
A Benexate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Benexate, including repackagers and relabelers. The FDA regulates Benexate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Benexate 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 Benexate supplier is an individual or a company that provides Benexate active pharmaceutical ingredient (API) or Benexate finished formulations upon request. The Benexate suppliers may include Benexate 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 Benexate Drug Master File in Korea (Benexate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Benexate. The MFDS reviews the Benexate KDMF as part of the drug registration process and uses the information provided in the Benexate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Benexate 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 Benexate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Benexate suppliers with KDMF on PharmaCompass.
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