01 1Asahi Kasei Finechem Co., Ltd. Nobeoka Pharmaceuticals Plant
01 1Handok Co., Ltd.
01 1Sitarabin
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
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PharmaCompass offers a list of Cytarabine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Cytarabine manufacturer or Cytarabine supplier for your needs.
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A Ara-Cytidine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ara-Cytidine, including repackagers and relabelers. The FDA regulates Ara-Cytidine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ara-Cytidine 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 Ara-Cytidine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Ara-Cytidine supplier is an individual or a company that provides Ara-Cytidine active pharmaceutical ingredient (API) or Ara-Cytidine finished formulations upon request. The Ara-Cytidine suppliers may include Ara-Cytidine API manufacturers, exporters, distributors and traders.
click here to find a list of Ara-Cytidine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 Ara-Cytidine Drug Master File in Korea (Ara-Cytidine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ara-Cytidine. The MFDS reviews the Ara-Cytidine KDMF as part of the drug registration process and uses the information provided in the Ara-Cytidine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ara-Cytidine 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 Ara-Cytidine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ara-Cytidine suppliers with KDMF on PharmaCompass.
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