01 1ESTEVE QUIMICA, SA@Esteve Quimica, SA
01 1Big Think Co., Ltd.
01 1Neratinib maleate
01 1Spain
Registrant Name : Big Think Co., Ltd.
Registration Date : 2021-10-19
Registration Number : No. 954-1-ND
Manufacturer Name : ESTEVE QUIMICA, SA@Esteve Qu...
Manufacturer Address : C/Ter, 94. Polígon Industrial, 17460 Celrà (Girona), Spain@Ctra. del Vendrell a St....
A Neratinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Neratinib, including repackagers and relabelers. The FDA regulates Neratinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Neratinib 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 Neratinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Neratinib supplier is an individual or a company that provides Neratinib active pharmaceutical ingredient (API) or Neratinib finished formulations upon request. The Neratinib suppliers may include Neratinib API manufacturers, exporters, distributors and traders.
click here to find a list of Neratinib 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 Neratinib Drug Master File in Korea (Neratinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Neratinib. The MFDS reviews the Neratinib KDMF as part of the drug registration process and uses the information provided in the Neratinib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Neratinib 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 Neratinib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Neratinib suppliers with KDMF on PharmaCompass.
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