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TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40708
Submission : 2024-10-29
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
NDC Package Code : 0078-1364
Start Marketing Date : 2022-04-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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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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, COA and API Price 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, COA and API Price related information on PharmaCompass.
We have 9 companies offering ALPELISIB [ORANGE BOOK]
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