01 1Olon SpA
02 1Sterling Biotech Limited
01 1Handok Co., Ltd.
02 1Korea United Pharmaceutical Co., Ltd.
01 2Daunorubicin hydrochloride
01 1India
02 1Italy
Registrant Name : Handok Co., Ltd.
Registration Date : 2022-07-13
Registration Number : 20220713-210-J-1333
Manufacturer Name : Olon SpA
Manufacturer Address : Via Schiapparelli 2, 10036 Settimo Torinese (TO), Italy
Registrant Name : Korea United Pharmaceutical Co., Ltd.
Registration Date : 2021-04-09
Registration Number : 20210409-210-J-429
Manufacturer Name : Sterling Biotech Limited
Manufacturer Address : Jambusar State Highway, Village Masar-391 421, Ta.Padra, Vadodara, Gujarat, India
62
PharmaCompass offers a list of Daunorubicin HCl 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 Daunorubicin HCl manufacturer or Daunorubicin HCl supplier for your needs.
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A Daunomycin HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Daunomycin HCl, including repackagers and relabelers. The FDA regulates Daunomycin HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Daunomycin HCl 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 Daunomycin HCl supplier is an individual or a company that provides Daunomycin HCl active pharmaceutical ingredient (API) or Daunomycin HCl finished formulations upon request. The Daunomycin HCl suppliers may include Daunomycin HCl 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 Daunomycin HCl Drug Master File in Korea (Daunomycin HCl KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Daunomycin HCl. The MFDS reviews the Daunomycin HCl KDMF as part of the drug registration process and uses the information provided in the Daunomycin HCl KDMF to evaluate the safety and efficacy of the drug.
After submitting a Daunomycin HCl 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 Daunomycin HCl API can apply through the Korea Drug Master File (KDMF).
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