01 1Sato Yakuhin Kogyo Co., Ltd
01 1PROTOPORPHYRIN IX DIMETHYLESTER(PPME)
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14384
Submission : 1999-08-31
Status : Inactive
Type : II
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A Protoporphyrin Ix manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Protoporphyrin Ix, including repackagers and relabelers. The FDA regulates Protoporphyrin Ix manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Protoporphyrin Ix 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 supplier is an individual or a company that provides Protoporphyrin Ix active pharmaceutical ingredient (API) or Protoporphyrin Ix finished formulations upon request. The Protoporphyrin Ix suppliers may include Protoporphyrin Ix API manufacturers, exporters, distributors and traders.
click here to find a list of Protoporphyrin Ix suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Protoporphyrin Ix DMF (Drug Master File) is a document detailing the whole manufacturing process of Protoporphyrin Ix active pharmaceutical ingredient (API) in detail. Different forms of Protoporphyrin Ix DMFs exist exist since differing nations have different regulations, such as Protoporphyrin Ix USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Protoporphyrin Ix DMF submitted to regulatory agencies in the US is known as a USDMF. Protoporphyrin Ix USDMF includes data on Protoporphyrin Ix's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Protoporphyrin Ix USDMF is kept confidential to protect the manufacturer’s intellectual property.
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