01 1Asahi Kasei Finechem Co., Ltd. Nobeoka Pharmaceuticals Plant
01 1Handok Co., Ltd.
01 1Cytarabine
01 1Japan
Registrant Name : Handok Co., Ltd.
Registration Date : 2022-07-13
Registration Number : 20220713-210-J-1332
Manufacturer Name : Asahi Kasei Finechem Co., Lt...
Manufacturer Address : 6-2633-7 Asahimachi, Nobeoka, Miyazaki 882-0847, Japan
A Alexan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alexan, including repackagers and relabelers. The FDA regulates Alexan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alexan 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 Alexan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alexan supplier is an individual or a company that provides Alexan active pharmaceutical ingredient (API) or Alexan finished formulations upon request. The Alexan suppliers may include Alexan API manufacturers, exporters, distributors and traders.
click here to find a list of Alexan 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 Alexan Drug Master File in Korea (Alexan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Alexan. The MFDS reviews the Alexan KDMF as part of the drug registration process and uses the information provided in the Alexan KDMF to evaluate the safety and efficacy of the drug.
After submitting a Alexan 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 Alexan API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Alexan suppliers with KDMF on PharmaCompass.
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