01 1ESTEVE QUIMICA, SA
01 1Pfizer Korea
01 1Tucatinib hemiethanolate
01 1Spain
Registrant Name : Pfizer Korea
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
64
PharmaCompass offers a list of Tucatinib 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 Tucatinib manufacturer or Tucatinib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tucatinib manufacturer or Tucatinib supplier.
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, and COA 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, and COA 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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