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