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 F108 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pluronic F108, including repackagers and relabelers. The FDA regulates Pluronic F108 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pluronic F108 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 F108 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Pluronic F108 supplier is an individual or a company that provides Pluronic F108 active pharmaceutical ingredient (API) or Pluronic F108 finished formulations upon request. The Pluronic F108 suppliers may include Pluronic F108 API manufacturers, exporters, distributors and traders.
click here to find a list of Pluronic F108 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Pluronic F108 DMF (Drug Master File) is a document detailing the whole manufacturing process of Pluronic F108 active pharmaceutical ingredient (API) in detail. Different forms of Pluronic F108 DMFs exist exist since differing nations have different regulations, such as Pluronic F108 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pluronic F108 DMF submitted to regulatory agencies in the US is known as a USDMF. Pluronic F108 USDMF includes data on Pluronic F108's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pluronic F108 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pluronic F108 suppliers with USDMF on PharmaCompass.
