01 1Beijing Sjar Technology Development
02 1Olon S.p.A
03 1Blank
01 1China
02 1Italy
03 1Blank
01 2Active
02 1Blank
01 3Blank
01 3Blank
01 3Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-06-26
Pay. Date : 2024-06-17
DMF Number : 39814
Submission : 2024-04-15
Status : Active
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-06-14
Pay. Date : 2024-05-20
DMF Number : 39659
Submission : 2024-05-24
Status : Active
Type : II
NDC Package Code : 73005-0010
Start Marketing Date : 2024-02-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
A Pralsetinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pralsetinib, including repackagers and relabelers. The FDA regulates Pralsetinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pralsetinib 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 Pralsetinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pralsetinib supplier is an individual or a company that provides Pralsetinib active pharmaceutical ingredient (API) or Pralsetinib finished formulations upon request. The Pralsetinib suppliers may include Pralsetinib API manufacturers, exporters, distributors and traders.
click here to find a list of Pralsetinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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