01 1Dottikon Exclusive Synthesis AG
01 1AstraZeneca Korea Ltd.
01 1Acalabrutinib
01 1Switzerland
Registrant Name : AstraZeneca Korea Ltd.
Registration Date : 2021-02-05
Registration Number : Su248-15-ND
Manufacturer Name : Dottikon Exclusive Synthesis...
Manufacturer Address : Hembrunnstrasse 17, 5605 Dottikon, Switzerland
A Acalabrutinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Acalabrutinib, including repackagers and relabelers. The FDA regulates Acalabrutinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Acalabrutinib 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 Acalabrutinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Acalabrutinib supplier is an individual or a company that provides Acalabrutinib active pharmaceutical ingredient (API) or Acalabrutinib finished formulations upon request. The Acalabrutinib suppliers may include Acalabrutinib API manufacturers, exporters, distributors and traders.
click here to find a list of Acalabrutinib 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 Acalabrutinib Drug Master File in Korea (Acalabrutinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Acalabrutinib. The MFDS reviews the Acalabrutinib KDMF as part of the drug registration process and uses the information provided in the Acalabrutinib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Acalabrutinib 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 Acalabrutinib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Acalabrutinib suppliers with KDMF on PharmaCompass.
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