01 1BASF
01 1POLOXALENE USP
01 1Germany
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18382
Submission : 2005-05-27
Status : Active
Type : II
47
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A Pluronic F77 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pluronic F77, including repackagers and relabelers. The FDA regulates Pluronic F77 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pluronic F77 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 Pluronic F77 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Pluronic F77 supplier is an individual or a company that provides Pluronic F77 active pharmaceutical ingredient (API) or Pluronic F77 finished formulations upon request. The Pluronic F77 suppliers may include Pluronic F77 API manufacturers, exporters, distributors and traders.
click here to find a list of Pluronic F77 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Pluronic F77 DMF (Drug Master File) is a document detailing the whole manufacturing process of Pluronic F77 active pharmaceutical ingredient (API) in detail. Different forms of Pluronic F77 DMFs exist exist since differing nations have different regulations, such as Pluronic F77 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pluronic F77 DMF submitted to regulatory agencies in the US is known as a USDMF. Pluronic F77 USDMF includes data on Pluronic F77's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pluronic F77 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pluronic F77 suppliers with USDMF on PharmaCompass.
