01 1Chongqing Carelife Pharmaceutical
02 1MSN Laboratories
01 1DACOMITINIB
02 1DACOMITINIB MONOHYDRATE
01 1China
02 1India
01 2Active
01 1Complete
02 1Blank
GDUFA
DMF Review : Complete
Rev. Date : 2024-09-30
Pay. Date : 2024-08-26
DMF Number : 38816
Submission : 2023-11-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35213
Submission : 2020-09-29
Status : Active
Type : II
A Dacomitinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dacomitinib, including repackagers and relabelers. The FDA regulates Dacomitinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dacomitinib 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 Dacomitinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dacomitinib supplier is an individual or a company that provides Dacomitinib active pharmaceutical ingredient (API) or Dacomitinib finished formulations upon request. The Dacomitinib suppliers may include Dacomitinib API manufacturers, exporters, distributors and traders.
click here to find a list of Dacomitinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dacomitinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Dacomitinib active pharmaceutical ingredient (API) in detail. Different forms of Dacomitinib DMFs exist exist since differing nations have different regulations, such as Dacomitinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dacomitinib DMF submitted to regulatory agencies in the US is known as a USDMF. Dacomitinib USDMF includes data on Dacomitinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dacomitinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dacomitinib suppliers with USDMF on PharmaCompass.
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