01 1North China Pharmaceutical Huasheng Co., Ltd.
02 2Xellia Pharmaceuticals ApS
01 1DKS Korea Co., Ltd.
02 1Gilead Sciences Korea Ltd.
03 1Hiple Co., Ltd.
01 2Amphoteric Mystery
02 1Amphotericin B
01 1China
02 2Denmark
Registrant Name : Hiple Co., Ltd.
Registration Date : 2023-06-08
Registration Number : 20230608-210-J-1507
Manufacturer Name : North China Pharmaceutical H...
Manufacturer Address : No.8 Yangzi Road, Shijiazhuang Economic & Technological Development Zone, Hebei 05216...
Registrant Name : DKS Korea Co., Ltd.
Registration Date : 2020-10-13
Registration Number : 20200727-210-J-391(1)
Manufacturer Name : Xellia Pharmaceuticals ApS
Manufacturer Address : Dalslandsgade 11, Kobenhavn S, 2300 Denmark
Registrant Name : Gilead Sciences Korea Ltd.
Registration Date : 2020-07-27
Registration Number : 20200727-210-J-391
Manufacturer Name : Xellia Pharmaceuticals ApS
Manufacturer Address : Dalslandsgade 11, Kobenhavn S, 2300 Denmark
A Amphotericin B manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amphotericin B, including repackagers and relabelers. The FDA regulates Amphotericin B manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amphotericin B 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 Amphotericin B manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Amphotericin B supplier is an individual or a company that provides Amphotericin B active pharmaceutical ingredient (API) or Amphotericin B finished formulations upon request. The Amphotericin B suppliers may include Amphotericin B API manufacturers, exporters, distributors and traders.
click here to find a list of Amphotericin B 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 Amphotericin B Drug Master File in Korea (Amphotericin B KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Amphotericin B. The MFDS reviews the Amphotericin B KDMF as part of the drug registration process and uses the information provided in the Amphotericin B KDMF to evaluate the safety and efficacy of the drug.
After submitting a Amphotericin B 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 Amphotericin B API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Amphotericin B suppliers with KDMF on PharmaCompass.
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