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 P104 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pluronic P104, including repackagers and relabelers. The FDA regulates Pluronic P104 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pluronic P104 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 P104 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Pluronic P104 supplier is an individual or a company that provides Pluronic P104 active pharmaceutical ingredient (API) or Pluronic P104 finished formulations upon request. The Pluronic P104 suppliers may include Pluronic P104 API manufacturers, exporters, distributors and traders.
click here to find a list of Pluronic P104 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Pluronic P104 DMF (Drug Master File) is a document detailing the whole manufacturing process of Pluronic P104 active pharmaceutical ingredient (API) in detail. Different forms of Pluronic P104 DMFs exist exist since differing nations have different regulations, such as Pluronic P104 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pluronic P104 DMF submitted to regulatory agencies in the US is known as a USDMF. Pluronic P104 USDMF includes data on Pluronic P104's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pluronic P104 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pluronic P104 suppliers with USDMF on PharmaCompass.
