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 F68 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pluronic F68, including repackagers and relabelers. The FDA regulates Pluronic F68 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pluronic F68 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 F68 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Pluronic F68 supplier is an individual or a company that provides Pluronic F68 active pharmaceutical ingredient (API) or Pluronic F68 finished formulations upon request. The Pluronic F68 suppliers may include Pluronic F68 API manufacturers, exporters, distributors and traders.
click here to find a list of Pluronic F68 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Pluronic F68 DMF (Drug Master File) is a document detailing the whole manufacturing process of Pluronic F68 active pharmaceutical ingredient (API) in detail. Different forms of Pluronic F68 DMFs exist exist since differing nations have different regulations, such as Pluronic F68 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pluronic F68 DMF submitted to regulatory agencies in the US is known as a USDMF. Pluronic F68 USDMF includes data on Pluronic F68's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pluronic F68 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pluronic F68 suppliers with USDMF on PharmaCompass.
