01 2Dottikon Exclusive Synthesis AG
01 2AstraZeneca Korea
01 1Acalabrutinib maleate hydrate
02 1acalabrutinib
01 2Switzerland
Registrant Name : AstraZeneca Korea
Registration Date : 2023-02-25
Registration Number : Su248-19-ND
Manufacturer Name : Dottikon Exclusive Synthesis...
Manufacturer Address : Hembrunnstrasse 17, 5605 Dottikon, Switzerland
Registrant Name : AstraZeneca Korea
Registration Date : 2021-02-05
Registration Number : Su248-15-ND
Manufacturer Name : Dottikon Exclusive Synthesis...
Manufacturer Address : Hembrunnstrasse 17, 5605 Dottikon, Switzerland
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PharmaCompass offers a list of Acalabrutinib 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 Acalabrutinib manufacturer or Acalabrutinib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Acalabrutinib manufacturer or Acalabrutinib supplier.
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, and COA 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, 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 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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