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 Poloxamer 108 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Poloxamer 108, including repackagers and relabelers. The FDA regulates Poloxamer 108 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Poloxamer 108 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 Poloxamer 108 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Poloxamer 108 supplier is an individual or a company that provides Poloxamer 108 active pharmaceutical ingredient (API) or Poloxamer 108 finished formulations upon request. The Poloxamer 108 suppliers may include Poloxamer 108 API manufacturers, exporters, distributors and traders.
click here to find a list of Poloxamer 108 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Poloxamer 108 DMF (Drug Master File) is a document detailing the whole manufacturing process of Poloxamer 108 active pharmaceutical ingredient (API) in detail. Different forms of Poloxamer 108 DMFs exist exist since differing nations have different regulations, such as Poloxamer 108 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Poloxamer 108 DMF submitted to regulatory agencies in the US is known as a USDMF. Poloxamer 108 USDMF includes data on Poloxamer 108's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Poloxamer 108 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Poloxamer 108 suppliers with USDMF on PharmaCompass.
