01 1Pfizer Ireland Pharmaceuticals
01 1Korea Pfizer Pharmaceutical Co., Ltd.
01 1Dacomitinib hydrate
01 1U.S.A
Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.
Registration Date : 2020-02-13
Registration Number : Number 87-27-ND
Manufacturer Name : Pfizer Ireland Pharmaceutica...
Manufacturer Address : Ringaskiddy Active Pharmaceutical Ingredient Plant, PO Box 140, Ringaskiddy, County C...
A Dacomitinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dacomitinib, including repackagers and relabelers. The FDA regulates Dacomitinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dacomitinib 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 Dacomitinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dacomitinib supplier is an individual or a company that provides Dacomitinib active pharmaceutical ingredient (API) or Dacomitinib finished formulations upon request. The Dacomitinib suppliers may include Dacomitinib API manufacturers, exporters, distributors and traders.
click here to find a list of Dacomitinib 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 Dacomitinib Drug Master File in Korea (Dacomitinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dacomitinib. The MFDS reviews the Dacomitinib KDMF as part of the drug registration process and uses the information provided in the Dacomitinib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dacomitinib 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 Dacomitinib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Dacomitinib suppliers with KDMF on PharmaCompass.
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