01 1ESTEVE QUIMICA, SA
01 1Korea Pfizer Pharmaceutical Co., Ltd.
01 1Tucatinib hemiethanolate
01 1Spain
Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.
Registration Date : 2023-12-14
Registration Number : Su90-30-ND
Manufacturer Name : ESTEVE QUIMICA, SA
Manufacturer Address : C/Ter, 94. Polígon Industrial, 17460 Celrà (Girona), Spain
A Tucatinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tucatinib, including repackagers and relabelers. The FDA regulates Tucatinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tucatinib 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 Tucatinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tucatinib supplier is an individual or a company that provides Tucatinib active pharmaceutical ingredient (API) or Tucatinib finished formulations upon request. The Tucatinib suppliers may include Tucatinib API manufacturers, exporters, distributors and traders.
click here to find a list of Tucatinib 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 Tucatinib Drug Master File in Korea (Tucatinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tucatinib. The MFDS reviews the Tucatinib KDMF as part of the drug registration process and uses the information provided in the Tucatinib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tucatinib 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 Tucatinib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tucatinib suppliers with KDMF on PharmaCompass.
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