01 1Pfizer Ireland Pharmaceuticals Unlimited Company
01 1Pfizer Korea
01 1Abrocitinib
01 1U.S.A
Registrant Name : Pfizer Korea
Registration Date : 2021-11-23
Registration Number : Su87-29-ND
Manufacturer Name : Pfizer Ireland Pharmaceutica...
Manufacturer Address : Ringaskiddy API Plant, Ringaskiddy, Co. Cork, P43 X336, Ireland
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A compound 25 [PMID: 29298069] manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of compound 25 [PMID: 29298069], including repackagers and relabelers. The FDA regulates compound 25 [PMID: 29298069] manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. compound 25 [PMID: 29298069] API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A compound 25 [PMID: 29298069] supplier is an individual or a company that provides compound 25 [PMID: 29298069] active pharmaceutical ingredient (API) or compound 25 [PMID: 29298069] finished formulations upon request. The compound 25 [PMID: 29298069] suppliers may include compound 25 [PMID: 29298069] API manufacturers, exporters, distributors and traders.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a compound 25 [PMID: 29298069] Drug Master File in Korea (compound 25 [PMID: 29298069] KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of compound 25 [PMID: 29298069]. The MFDS reviews the compound 25 [PMID: 29298069] KDMF as part of the drug registration process and uses the information provided in the compound 25 [PMID: 29298069] KDMF to evaluate the safety and efficacy of the drug.
After submitting a compound 25 [PMID: 29298069] 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 compound 25 [PMID: 29298069] API can apply through the Korea Drug Master File (KDMF).
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We have 1 companies offering compound 25 [PMID: 29298069]
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