01 1AXYNTIS Group
01 1PROTOPORPHYRIN IX DIMETHYL ESTER (PPIX-DME)
01 1France
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20372
Submission : 2007-03-16
Status : Active
Type : II
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A Protoporphyrin IX Dimethyl Ester manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Protoporphyrin IX Dimethyl Ester, including repackagers and relabelers. The FDA regulates Protoporphyrin IX Dimethyl Ester manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Protoporphyrin IX Dimethyl Ester 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 Protoporphyrin IX Dimethyl Ester supplier is an individual or a company that provides Protoporphyrin IX Dimethyl Ester active pharmaceutical ingredient (API) or Protoporphyrin IX Dimethyl Ester finished formulations upon request. The Protoporphyrin IX Dimethyl Ester suppliers may include Protoporphyrin IX Dimethyl Ester API manufacturers, exporters, distributors and traders.
click here to find a list of Protoporphyrin IX Dimethyl Ester suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Protoporphyrin IX Dimethyl Ester DMF (Drug Master File) is a document detailing the whole manufacturing process of Protoporphyrin IX Dimethyl Ester active pharmaceutical ingredient (API) in detail. Different forms of Protoporphyrin IX Dimethyl Ester DMFs exist exist since differing nations have different regulations, such as Protoporphyrin IX Dimethyl Ester USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Protoporphyrin IX Dimethyl Ester DMF submitted to regulatory agencies in the US is known as a USDMF. Protoporphyrin IX Dimethyl Ester USDMF includes data on Protoporphyrin IX Dimethyl Ester's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Protoporphyrin IX Dimethyl Ester USDMF is kept confidential to protect the manufacturer’s intellectual property.
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