01 1MSN Laboratories
02 1TOPHARMAN SHANDONG CO LTD
03 1Teva Pharmaceutical Industries
01 1NERATINIB MALEATE
02 1NERATINIB MALEATE (MONOHYDRATE)
03 1NERATINIB MALEATE MONOHYDRATE
01 1China
02 1India
03 1Israel
01 3Active
01 1Complete
02 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34652
Submission : 2020-02-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-04-27
Pay. Date : 2020-12-17
DMF Number : 35457
Submission : 2021-01-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37407
Submission : 2022-08-29
Status : Active
Type : II
A Neratinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Neratinib, including repackagers and relabelers. The FDA regulates Neratinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Neratinib 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 Neratinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Neratinib supplier is an individual or a company that provides Neratinib active pharmaceutical ingredient (API) or Neratinib finished formulations upon request. The Neratinib suppliers may include Neratinib API manufacturers, exporters, distributors and traders.
click here to find a list of Neratinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Neratinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Neratinib active pharmaceutical ingredient (API) in detail. Different forms of Neratinib DMFs exist exist since differing nations have different regulations, such as Neratinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Neratinib DMF submitted to regulatory agencies in the US is known as a USDMF. Neratinib USDMF includes data on Neratinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Neratinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Neratinib suppliers with USDMF on PharmaCompass.
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