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 Poloxalene L64 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Poloxalene L64, including repackagers and relabelers. The FDA regulates Poloxalene L64 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Poloxalene L64 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 Poloxalene L64 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Poloxalene L64 supplier is an individual or a company that provides Poloxalene L64 active pharmaceutical ingredient (API) or Poloxalene L64 finished formulations upon request. The Poloxalene L64 suppliers may include Poloxalene L64 API manufacturers, exporters, distributors and traders.
click here to find a list of Poloxalene L64 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Poloxalene L64 DMF (Drug Master File) is a document detailing the whole manufacturing process of Poloxalene L64 active pharmaceutical ingredient (API) in detail. Different forms of Poloxalene L64 DMFs exist exist since differing nations have different regulations, such as Poloxalene L64 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Poloxalene L64 DMF submitted to regulatory agencies in the US is known as a USDMF. Poloxalene L64 USDMF includes data on Poloxalene L64's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Poloxalene L64 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Poloxalene L64 suppliers with USDMF on PharmaCompass.
