01 1Chongqing Huapont Pharmaceutical
02 1MSN Laboratories
03 1Navinta
01 3CRIZOTINIB
01 1China
02 1India
03 1U.S.A
01 3Active
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40033
Submission : 2024-05-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38108
Submission : 2023-03-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39325
Submission : 2024-01-08
Status : Active
Type : II
A Crizotinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Crizotinib, including repackagers and relabelers. The FDA regulates Crizotinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Crizotinib 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 Crizotinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Crizotinib supplier is an individual or a company that provides Crizotinib active pharmaceutical ingredient (API) or Crizotinib finished formulations upon request. The Crizotinib suppliers may include Crizotinib API manufacturers, exporters, distributors and traders.
click here to find a list of Crizotinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Crizotinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Crizotinib active pharmaceutical ingredient (API) in detail. Different forms of Crizotinib DMFs exist exist since differing nations have different regulations, such as Crizotinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Crizotinib DMF submitted to regulatory agencies in the US is known as a USDMF. Crizotinib USDMF includes data on Crizotinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Crizotinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Crizotinib suppliers with USDMF on PharmaCompass.
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