01 1Nippon Kayaku
01 1UBENIMEX
01 1Japan
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29536
Submission : 2015-07-31
Status : Active
Type : II
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PharmaCompass offers a list of Ubenimex API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Ubenimex manufacturer or Ubenimex supplier for your needs.
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A Ubenimex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ubenimex, including repackagers and relabelers. The FDA regulates Ubenimex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ubenimex 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 Ubenimex manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Ubenimex supplier is an individual or a company that provides Ubenimex active pharmaceutical ingredient (API) or Ubenimex finished formulations upon request. The Ubenimex suppliers may include Ubenimex API manufacturers, exporters, distributors and traders.
click here to find a list of Ubenimex suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Ubenimex DMF (Drug Master File) is a document detailing the whole manufacturing process of Ubenimex active pharmaceutical ingredient (API) in detail. Different forms of Ubenimex DMFs exist exist since differing nations have different regulations, such as Ubenimex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ubenimex DMF submitted to regulatory agencies in the US is known as a USDMF. Ubenimex USDMF includes data on Ubenimex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ubenimex USDMF is kept confidential to protect the manufacturer’s intellectual property.
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