01 1Asahi Kasei Finechem
02 1KANEKA AMERICA CORP
03 1Kaneka Corporation
04 1Kyowa Hakko Bio
05 1Blank
01 3UBIDECARENONE
02 1UBIDECARENONE (COENZYME Q 10)
03 1UBIDECARENONE BULK
01 3Japan
02 1U.S.A
03 1Blank
01 1Active
02 4Inactive
01 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20532
Submission : 2007-05-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11180
Submission : 1994-10-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30051
Submission : 2015-11-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14207
Submission : 1999-05-20
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9545
Submission : 1992-02-10
Status : Inactive
Type : II
Portfolio PDF
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Corporate PDF
A Ubidecarenone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ubidecarenone, including repackagers and relabelers. The FDA regulates Ubidecarenone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ubidecarenone 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 Ubidecarenone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ubidecarenone supplier is an individual or a company that provides Ubidecarenone active pharmaceutical ingredient (API) or Ubidecarenone finished formulations upon request. The Ubidecarenone suppliers may include Ubidecarenone API manufacturers, exporters, distributors and traders.
click here to find a list of Ubidecarenone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ubidecarenone DMF (Drug Master File) is a document detailing the whole manufacturing process of Ubidecarenone active pharmaceutical ingredient (API) in detail. Different forms of Ubidecarenone DMFs exist exist since differing nations have different regulations, such as Ubidecarenone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ubidecarenone DMF submitted to regulatory agencies in the US is known as a USDMF. Ubidecarenone USDMF includes data on Ubidecarenone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ubidecarenone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ubidecarenone suppliers with USDMF on PharmaCompass.
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