01 1Olon S.p.A
02 1Blank
01 2PRALSETINIB
01 1Italy
02 1Blank
01 2Active
01 2Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-06-14
Pay. Date : 2024-05-20
DMF Number : 39659
Submission : 2024-05-24
Status : Active
Type : II
USDMF
GDUFA
DMF Review : Complete
Rev. Date : 2024-06-26
Pay. Date : 2024-06-17
DMF Number : 39814
Submission : 2024-04-15
Status : Active
Type : II
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PharmaCompass offers a list of Pralsetinib API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Pralsetinib manufacturer or Pralsetinib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Pralsetinib manufacturer or Pralsetinib supplier.
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, and COA 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, and COA related information on PharmaCompass.
A Pralsetinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Pralsetinib active pharmaceutical ingredient (API) in detail. Different forms of Pralsetinib DMFs exist exist since differing nations have different regulations, such as Pralsetinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pralsetinib DMF submitted to regulatory agencies in the US is known as a USDMF. Pralsetinib USDMF includes data on Pralsetinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pralsetinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pralsetinib suppliers with USDMF on PharmaCompass.
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