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