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
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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 [ORANGE BOOK] manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ALPELISIB [ORANGE BOOK], including repackagers and relabelers. The FDA regulates ALPELISIB [ORANGE BOOK] manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ALPELISIB [ORANGE BOOK] 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 [ORANGE BOOK] manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A ALPELISIB [ORANGE BOOK] supplier is an individual or a company that provides ALPELISIB [ORANGE BOOK] active pharmaceutical ingredient (API) or ALPELISIB [ORANGE BOOK] finished formulations upon request. The ALPELISIB [ORANGE BOOK] suppliers may include ALPELISIB [ORANGE BOOK] API manufacturers, exporters, distributors and traders.
click here to find a list of ALPELISIB [ORANGE BOOK] 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 [ORANGE BOOK] Drug Master File in Korea (ALPELISIB [ORANGE BOOK] KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of ALPELISIB [ORANGE BOOK]. The MFDS reviews the ALPELISIB [ORANGE BOOK] KDMF as part of the drug registration process and uses the information provided in the ALPELISIB [ORANGE BOOK] KDMF to evaluate the safety and efficacy of the drug.
After submitting a ALPELISIB [ORANGE BOOK] 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 [ORANGE BOOK] API can apply through the Korea Drug Master File (KDMF).
click here to find a list of ALPELISIB [ORANGE BOOK] suppliers with KDMF on PharmaCompass.
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