01 1Formosa Laboratories
01 1IXABEPILONE
01 1Taiwan
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25894
Submission : 2012-03-19
Status : Active
Type : II
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A Ixempra manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ixempra, including repackagers and relabelers. The FDA regulates Ixempra manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ixempra 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 Ixempra manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Ixempra supplier is an individual or a company that provides Ixempra active pharmaceutical ingredient (API) or Ixempra finished formulations upon request. The Ixempra suppliers may include Ixempra API manufacturers, exporters, distributors and traders.
click here to find a list of Ixempra suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Ixempra DMF (Drug Master File) is a document detailing the whole manufacturing process of Ixempra active pharmaceutical ingredient (API) in detail. Different forms of Ixempra DMFs exist exist since differing nations have different regulations, such as Ixempra USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ixempra DMF submitted to regulatory agencies in the US is known as a USDMF. Ixempra USDMF includes data on Ixempra's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ixempra USDMF is kept confidential to protect the manufacturer’s intellectual property.
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