01 1ScinoPharm Taiwan Ltd
01 1ALPELISIB
01 1Taiwan
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40708
Submission : 2024-10-29
Status : Active
Type : II
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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.
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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.
A Alpelisib DMF (Drug Master File) is a document detailing the whole manufacturing process of Alpelisib active pharmaceutical ingredient (API) in detail. Different forms of Alpelisib DMFs exist exist since differing nations have different regulations, such as Alpelisib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Alpelisib DMF submitted to regulatory agencies in the US is known as a USDMF. Alpelisib USDMF includes data on Alpelisib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alpelisib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Alpelisib suppliers with USDMF on PharmaCompass.
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