01 1Ajinomoto OmniChem nv
02 1Ampac Fine Chemicals
01 2Korea Takeda Pharmaceutical Co., Ltd.
01 2Brigatinib
01 1Japan
02 1U.S.A
Registrant Name : Korea Takeda Pharmaceutical Co., Ltd.
Registration Date : 2020-04-21
Registration Number : 108-11-ND
Manufacturer Name : Ajinomoto OmniChem nv
Manufacturer Address : Cooppallaan 91 Wetteren, 9230, Belgium
Registrant Name : Korea Takeda Pharmaceutical Co., Ltd.
Registration Date : 2020-04-21
Registration Number : 108-10-ND
Manufacturer Name : Ampac Fine Chemicals
Manufacturer Address : Highway 50 & Hazel Avenue, Rancho Cordova, CA 95670, USA
A Brigatinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Brigatinib, including repackagers and relabelers. The FDA regulates Brigatinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Brigatinib 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 Brigatinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Brigatinib supplier is an individual or a company that provides Brigatinib active pharmaceutical ingredient (API) or Brigatinib finished formulations upon request. The Brigatinib suppliers may include Brigatinib API manufacturers, exporters, distributors and traders.
click here to find a list of Brigatinib 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 Brigatinib Drug Master File in Korea (Brigatinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Brigatinib. The MFDS reviews the Brigatinib KDMF as part of the drug registration process and uses the information provided in the Brigatinib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Brigatinib 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 Brigatinib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Brigatinib suppliers with KDMF on PharmaCompass.
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