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
83
PharmaCompass offers a list of Migalastat API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Migalastat manufacturer or Migalastat supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Migalastat manufacturer or Migalastat supplier.
PharmaCompass also assists you with knowing the Migalastat API Price utilized in the formulation of products. Migalastat API Price is not always fixed or binding as the Migalastat Price is obtained through a variety of data sources. The Migalastat Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Migalastat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Migalastat, including repackagers and relabelers. The FDA regulates Migalastat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Migalastat 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Migalastat supplier is an individual or a company that provides Migalastat active pharmaceutical ingredient (API) or Migalastat finished formulations upon request. The Migalastat suppliers may include Migalastat API manufacturers, exporters, distributors and traders.
click here to find a list of Migalastat 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 Drug Master File in Korea (Migalastat KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Migalastat. The MFDS reviews the Migalastat KDMF as part of the drug registration process and uses the information provided in the Migalastat KDMF to evaluate the safety and efficacy of the drug.
After submitting a Migalastat 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Migalastat suppliers with KDMF on PharmaCompass.
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