01 1Ash Stevens LLC
02 1Fresenius Kabi Oncology Ltd.
01 1Fresenius Kabi Korea Co., Ltd.
02 1Korea Otsuka Pharmaceutical Co., Ltd.
01 2Attached plate
01 1Sweden
02 1U.S.A
Registrant Name : Korea Otsuka Pharmaceutical Co., Ltd.
Registration Date : 2022-09-26
Registration Number : 20220926-210-J-1369
Manufacturer Name : Ash Stevens LLC
Manufacturer Address : 18655 Krause St., Riverview, MI 48193, USA
Registrant Name : Fresenius Kabi Korea Co., Ltd.
Registration Date : 2018-07-26
Registration Number : 20180726-210-J-248
Manufacturer Name : Fresenius Kabi Oncology Ltd.
Manufacturer Address : D-35, Industrial Area, Kalyani, Dist Nadia, West Bengal, INDIA
85
PharmaCompass offers a list of Busulfan 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 Busulfan manufacturer or Busulfan supplier for your needs.
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A Myleran, Busulfex, Busulfan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Myleran, Busulfex, Busulfan, including repackagers and relabelers. The FDA regulates Myleran, Busulfex, Busulfan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Myleran, Busulfex, Busulfan API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Myleran, Busulfex, Busulfan supplier is an individual or a company that provides Myleran, Busulfex, Busulfan active pharmaceutical ingredient (API) or Myleran, Busulfex, Busulfan finished formulations upon request. The Myleran, Busulfex, Busulfan suppliers may include Myleran, Busulfex, Busulfan API manufacturers, exporters, distributors and traders.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Myleran, Busulfex, Busulfan Drug Master File in Korea (Myleran, Busulfex, Busulfan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Myleran, Busulfex, Busulfan. The MFDS reviews the Myleran, Busulfex, Busulfan KDMF as part of the drug registration process and uses the information provided in the Myleran, Busulfex, Busulfan KDMF to evaluate the safety and efficacy of the drug.
After submitting a Myleran, Busulfex, Busulfan 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 Myleran, Busulfex, Busulfan API can apply through the Korea Drug Master File (KDMF).
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