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01 1DIHEMATOPORPHYRIN ETHERS (DHE) TRADE NAME, PHOTOFRIN II
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01 1Inactive
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5249
Submission : 1984-01-03
Status : Inactive
Type : II
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A Photofrin Porfimer Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Photofrin Porfimer Sodium, including repackagers and relabelers. The FDA regulates Photofrin Porfimer Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Photofrin Porfimer Sodium 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 Photofrin Porfimer Sodium supplier is an individual or a company that provides Photofrin Porfimer Sodium active pharmaceutical ingredient (API) or Photofrin Porfimer Sodium finished formulations upon request. The Photofrin Porfimer Sodium suppliers may include Photofrin Porfimer Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Photofrin Porfimer Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Photofrin Porfimer Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Photofrin Porfimer Sodium active pharmaceutical ingredient (API) in detail. Different forms of Photofrin Porfimer Sodium DMFs exist exist since differing nations have different regulations, such as Photofrin Porfimer Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Photofrin Porfimer Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Photofrin Porfimer Sodium USDMF includes data on Photofrin Porfimer Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Photofrin Porfimer Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Photofrin Porfimer Sodium suppliers with USDMF on PharmaCompass.
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