01 1"Dojin lyaku-Kako Co., Ltd"
01 1Hanol Biopharma Co., Ltd.
01 1Pudosteine
01 1South Korea
Registrant Name : Hanol Biopharma Co., Ltd.
Registration Date : 2004-06-22
Registration Number : 35-1-ND
Manufacturer Name : "Dojin lyaku-Kako Co., Ltd"
Manufacturer Address : 263-1, Higashidai Ottozowa, Okum-machi, Futa-gun Fukishima-prefecture, Japan
A Fudosteine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fudosteine, including repackagers and relabelers. The FDA regulates Fudosteine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fudosteine 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 Fudosteine supplier is an individual or a company that provides Fudosteine active pharmaceutical ingredient (API) or Fudosteine finished formulations upon request. The Fudosteine suppliers may include Fudosteine API manufacturers, exporters, distributors and traders.
click here to find a list of Fudosteine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price 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 Fudosteine Drug Master File in Korea (Fudosteine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Fudosteine. The MFDS reviews the Fudosteine KDMF as part of the drug registration process and uses the information provided in the Fudosteine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Fudosteine 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 Fudosteine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Fudosteine suppliers with KDMF on PharmaCompass.
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