01 1Novartis Pharmaceutical Manufacturing LLC_x000D_
01 1Novartis Korea
01 1Alpelisib
01 1Slovenia
Registrant Name : Novartis Korea
Registration Date : 2021-05-12
Registration Number : Su196-21-ND
Manufacturer Name : Novartis Pharmaceutical Manu...
Manufacturer Address : Kolodvorska Cesta 27, Menges, 1234, Slovenia
89
PharmaCompass offers a list of Alpelisib 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 Alpelisib manufacturer or Alpelisib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Alpelisib manufacturer or Alpelisib supplier.
A Alpelisib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alpelisib, including repackagers and relabelers. The FDA regulates Alpelisib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alpelisib 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 Alpelisib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Alpelisib supplier is an individual or a company that provides Alpelisib active pharmaceutical ingredient (API) or Alpelisib finished formulations upon request. The Alpelisib suppliers may include Alpelisib API manufacturers, exporters, distributors and traders.
click here to find a list of Alpelisib 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 Alpelisib Drug Master File in Korea (Alpelisib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Alpelisib. The MFDS reviews the Alpelisib KDMF as part of the drug registration process and uses the information provided in the Alpelisib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Alpelisib 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 Alpelisib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Alpelisib suppliers with KDMF on PharmaCompass.
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