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 Pronon 208 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pronon 208, including repackagers and relabelers. The FDA regulates Pronon 208 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pronon 208 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 Pronon 208 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Pronon 208 supplier is an individual or a company that provides Pronon 208 active pharmaceutical ingredient (API) or Pronon 208 finished formulations upon request. The Pronon 208 suppliers may include Pronon 208 API manufacturers, exporters, distributors and traders.
click here to find a list of Pronon 208 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Pronon 208 DMF (Drug Master File) is a document detailing the whole manufacturing process of Pronon 208 active pharmaceutical ingredient (API) in detail. Different forms of Pronon 208 DMFs exist exist since differing nations have different regulations, such as Pronon 208 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pronon 208 DMF submitted to regulatory agencies in the US is known as a USDMF. Pronon 208 USDMF includes data on Pronon 208's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pronon 208 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pronon 208 suppliers with USDMF on PharmaCompass.
