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01 1ALPELISIB
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01 1Active
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40708
Submission : 2024-10-29
Status : Active
Type : II
Portfolio PDF
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Virtual Booth
Digital Content
Website
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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, Price,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.
PharmaCompass also assists you with knowing the Alpelisib API Price utilized in the formulation of products. Alpelisib API Price is not always fixed or binding as the Alpelisib Price is obtained through a variety of data sources. The Alpelisib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
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, COA and API Price 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, COA and API Price 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.
