01 1Carbogen Amcis AG
01 1Handok Co., Ltd.
01 1migalastat hydrochloride
01 1Switzerland
Registrant Name : Handok Co., Ltd.
Registration Date : 2020-11-04
Registration Number : Su318-5-ND
Manufacturer Name : Carbogen Amcis AG
Manufacturer Address : Hauptstrasse 171, 4416 Bubendorf, Switzerland
A Migalastat Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Migalastat Hydrochloride, including repackagers and relabelers. The FDA regulates Migalastat Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Migalastat Hydrochloride 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 Migalastat Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Migalastat Hydrochloride supplier is an individual or a company that provides Migalastat Hydrochloride active pharmaceutical ingredient (API) or Migalastat Hydrochloride finished formulations upon request. The Migalastat Hydrochloride suppliers may include Migalastat Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Migalastat Hydrochloride 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 Migalastat Hydrochloride Drug Master File in Korea (Migalastat Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Migalastat Hydrochloride. The MFDS reviews the Migalastat Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Migalastat Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Migalastat Hydrochloride 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 Migalastat Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Migalastat Hydrochloride suppliers with KDMF on PharmaCompass.
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