01 1ALP Pharm
01 1VERTEPORFIN
01 1China
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24377
Submission : 2010-11-04
Status : Inactive
Type : II
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A Visudyne manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Visudyne, including repackagers and relabelers. The FDA regulates Visudyne manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Visudyne 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 Visudyne supplier is an individual or a company that provides Visudyne active pharmaceutical ingredient (API) or Visudyne finished formulations upon request. The Visudyne suppliers may include Visudyne API manufacturers, exporters, distributors and traders.
click here to find a list of Visudyne suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Visudyne DMF (Drug Master File) is a document detailing the whole manufacturing process of Visudyne active pharmaceutical ingredient (API) in detail. Different forms of Visudyne DMFs exist exist since differing nations have different regulations, such as Visudyne USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Visudyne DMF submitted to regulatory agencies in the US is known as a USDMF. Visudyne USDMF includes data on Visudyne's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Visudyne USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Visudyne suppliers with USDMF on PharmaCompass.
