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01 1MSN Laboratories
02 1TOPHARMAN SHANDONG CO LTD
03 1Teva Pharmaceutical Industries
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01 1NERATINIB MALEATE
02 1NERATINIB MALEATE (MONOHYDRATE)
03 1NERATINIB MALEATE MONOHYDRATE
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01 1China
02 1India
03 1Israel
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01 3Active
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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
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PharmaCompass offers a list of Neratinib API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Neratinib manufacturer or Neratinib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Neratinib manufacturer or Neratinib supplier.
PharmaCompass also assists you with knowing the Neratinib API Price utilized in the formulation of products. Neratinib API Price is not always fixed or binding as the Neratinib Price is obtained through a variety of data sources. The Neratinib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Neratinib Maleate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Neratinib Maleate, including repackagers and relabelers. The FDA regulates Neratinib Maleate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Neratinib Maleate 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 Maleate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Neratinib Maleate supplier is an individual or a company that provides Neratinib Maleate active pharmaceutical ingredient (API) or Neratinib Maleate finished formulations upon request. The Neratinib Maleate suppliers may include Neratinib Maleate API manufacturers, exporters, distributors and traders.
click here to find a list of Neratinib Maleate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Neratinib Maleate DMF (Drug Master File) is a document detailing the whole manufacturing process of Neratinib Maleate active pharmaceutical ingredient (API) in detail. Different forms of Neratinib Maleate DMFs exist exist since differing nations have different regulations, such as Neratinib Maleate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Neratinib Maleate DMF submitted to regulatory agencies in the US is known as a USDMF. Neratinib Maleate USDMF includes data on Neratinib Maleate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Neratinib Maleate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Neratinib Maleate suppliers with USDMF on PharmaCompass.
We have 3 companies offering Neratinib Maleate
Get in contact with the supplier of your choice: