01 1Industriale Chimica
02 1Suzhou Lixin Pharmaceutical
01 1IDEBENONE
02 1IDEBENONE (NON-STERILE)
01 1China
02 1Italy
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18428
Submission : 2005-06-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32079
Submission : 2017-08-28
Status : Active
Type : II
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PharmaCompass offers a list of Idebenone 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 Idebenone manufacturer or Idebenone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Idebenone manufacturer or Idebenone supplier.
PharmaCompass also assists you with knowing the Idebenone API Price utilized in the formulation of products. Idebenone API Price is not always fixed or binding as the Idebenone Price is obtained through a variety of data sources. The Idebenone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Idebenone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Idebenone, including repackagers and relabelers. The FDA regulates Idebenone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Idebenone 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 Idebenone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Idebenone supplier is an individual or a company that provides Idebenone active pharmaceutical ingredient (API) or Idebenone finished formulations upon request. The Idebenone suppliers may include Idebenone API manufacturers, exporters, distributors and traders.
click here to find a list of Idebenone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Idebenone DMF (Drug Master File) is a document detailing the whole manufacturing process of Idebenone active pharmaceutical ingredient (API) in detail. Different forms of Idebenone DMFs exist exist since differing nations have different regulations, such as Idebenone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Idebenone DMF submitted to regulatory agencies in the US is known as a USDMF. Idebenone USDMF includes data on Idebenone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Idebenone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Idebenone suppliers with USDMF on PharmaCompass.
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