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