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
100
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 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.
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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, COA and API Price related information on PharmaCompass.
A ALPELISIB [ORANGE BOOK] DMF (Drug Master File) is a document detailing the whole manufacturing process of ALPELISIB [ORANGE BOOK] active pharmaceutical ingredient (API) in detail. Different forms of ALPELISIB [ORANGE BOOK] DMFs exist exist since differing nations have different regulations, such as ALPELISIB [ORANGE BOOK] USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ALPELISIB [ORANGE BOOK] DMF submitted to regulatory agencies in the US is known as a USDMF. ALPELISIB [ORANGE BOOK] USDMF includes data on ALPELISIB [ORANGE BOOK]'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ALPELISIB [ORANGE BOOK] USDMF is kept confidential to protect the manufacturer’s intellectual property.
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