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01 1ScinoPharm Taiwan Ltd
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01 1ALPELISIB
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01 1Taiwan
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01 1Active
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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, Price,and more, enabling you to easily find the right Alpelisib manufacturer or Alpelisib supplier for your needs.
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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 08W5N2C97Q manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 08W5N2C97Q, including repackagers and relabelers. The FDA regulates 08W5N2C97Q manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 08W5N2C97Q API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A 08W5N2C97Q supplier is an individual or a company that provides 08W5N2C97Q active pharmaceutical ingredient (API) or 08W5N2C97Q finished formulations upon request. The 08W5N2C97Q suppliers may include 08W5N2C97Q API manufacturers, exporters, distributors and traders.
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A 08W5N2C97Q DMF (Drug Master File) is a document detailing the whole manufacturing process of 08W5N2C97Q active pharmaceutical ingredient (API) in detail. Different forms of 08W5N2C97Q DMFs exist exist since differing nations have different regulations, such as 08W5N2C97Q USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 08W5N2C97Q DMF submitted to regulatory agencies in the US is known as a USDMF. 08W5N2C97Q USDMF includes data on 08W5N2C97Q's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 08W5N2C97Q USDMF is kept confidential to protect the manufacturer’s intellectual property.
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