01 1Blank
01 1AMONAFIDE L-MALATE
01 1Blank
01 1Inactive
01 1Blank
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16372
Submission : 2003-01-17
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
53
PharmaCompass offers a list of Amonafide 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 Amonafide manufacturer or Amonafide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Amonafide manufacturer or Amonafide supplier.
PharmaCompass also assists you with knowing the Amonafide API Price utilized in the formulation of products. Amonafide API Price is not always fixed or binding as the Amonafide Price is obtained through a variety of data sources. The Amonafide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Amonafide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amonafide, including repackagers and relabelers. The FDA regulates Amonafide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amonafide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Amonafide supplier is an individual or a company that provides Amonafide active pharmaceutical ingredient (API) or Amonafide finished formulations upon request. The Amonafide suppliers may include Amonafide API manufacturers, exporters, distributors and traders.
click here to find a list of Amonafide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Amonafide DMF (Drug Master File) is a document detailing the whole manufacturing process of Amonafide active pharmaceutical ingredient (API) in detail. Different forms of Amonafide DMFs exist exist since differing nations have different regulations, such as Amonafide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Amonafide DMF submitted to regulatory agencies in the US is known as a USDMF. Amonafide USDMF includes data on Amonafide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amonafide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Amonafide suppliers with USDMF on PharmaCompass.
